Delhi High Court
Astrazeneca Ab & Anr. vs Alkem Laboratories Limited on 2 November, 2020
$~J-1 & 2
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Judgement reserved on 22.10.2020
Judgement pronounced on 02.11.2020
I.A. No. 8826/2020
in
+ CS (COMM) No. 410/2020
ASTRAZENECA AB & ANR .....Plaintiffs
Through : Mr. Kapil Sibal, Mr. Harish Salve and
Mr. Sudhir Chandra, Senior Advocates
with Mr. Pravin Anand, Ms. Vaishali
Mittal, Mr. Rohin Koolwal, Mr. Siddhant
Chamola, Ms. Devyani Nath and Mr.
Souradeep Mukhopadhyay, Advocates.
versus
INTAS PHARMACEUTICALS LIMITED .....Defendant
Through : Mr. C.S. Vaidyanathan, Senior Advocate
with Ms. Bitika Sharma, Ms. Namrita
Kocchar, Ms. Nitya Sharma and Ms.
Vrinda Pathak, Advocates.
I.A. No. 8859/2020
in
+ CS (COMM) No. 411/2020
ASTRAZENECA AB & ANR .....Plaintiffs
Through : Mr. Kapil Sibal, Mr. Harish Salve and
Mr. Sudhir Chandra, Senior Advocates
with Mr. Pravin Anand, Ms. Vaishali
Mittal, Mr. Rohin Koolwal, Mr. Siddhant
Chamola, Ms. Devyani Nath and Mr.
Souradeep Mukhopadhyay, Advocates.
versus
ALKEM LABORATORIES LIMITED .....Defendant
Through : Mr. Adarsh Ramanujam, Advocate with
Ms. Bitika Sharma, Ms. Namrita
Kocchar, Ms. Nitya Sharma and Ms.
Vrinda Pathak, Advocates.
Signature Not
I.A.Verified
No. 8826/2020 in CS (COMM) No. 410/2020 & I.A. No. 8859/2020 in CS (COMM) No.
Digitally Signed
411/2020 Page 1 of 84
By:VIPIN KUMAR RAI
Signing Date:02.11.2020
15:05:16
CORAM:
HON'BLE MR. JUSTICE RAJIV SHAKDHER
RAJIV SHAKDHER, J.:
Table of Contents
Preface: - ............................................................................................................... 3
Background
: - ........................................................................................................ 3
Submissions of the parties: - ................................................................................. 6
On behalf of the plaintiffs: - .............................................................................. 6
On behalf of the defendants: - ......................................................................... 23
Rejoinder arguments on behalf of the plaintiffs: - .......................................... 41
Analysis and reasons: - ....................................................................................... 44
ARE THE SUIT PATENTS VULNERABLE? .............................................. 52
PUBLIC INTEREST: -.................................................................................... 80
Conclusion: - ....................................................................................................... 84
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No. 8826/2020 in CS (COMM) No. 410/2020 & I.A. No. 8859/2020 in CS (COMM) No.
Digitally Signed
By:VIPIN KUMAR RAI
Signing Date:02.11.2020
15:05:16
Preface: -
1. The captioned actions concern, principally, two patents. These being:
a) Indian Patent No. 205147 [hereinafter referred to as: IN 147]
b) Indian Patent No. 235625 [hereinafter referred to as: IN 625]
2. IN 147, as per the averments made in the plaint, is the genus patent while
IN 625 is claimed to be the species patent. The moot point, which arises for
consideration in the instant actions, is: whether the compound-in-issue i.e.
Dapagliflozin [in short "DAPA"] which, according to the plaintiffs, is covered
in IN 147 stands disclosed both, in law as well as on facts?
2.1 I must also state, at the very outset, that there are various shades and
limbs to this broad frame which is the essence of the dispute obtaining between
the parties.
2.2 Furthermore, for the sake of convenience, I would be referring to plaintiff
no. 1 i.e. AstraZeneca AB as "Astra Sweden" and plaintiff no. 2 i.e.
AstraZeneca Pharma India Limited as "Astra India". The defendant in CS
(COMM) 410/2020 i.e. Intas Pharmaceuticals Limited will be referred to as
"Intas"; while the defendant in CS (COMM) 411/2020 i.e. Alkem Laboratories
Limited will be referred to as "Alkem".
2.3 Besides this, wherever the context requires, Astra Sweden and Astra India
will collectively be referred to as the plaintiffs, and likewise, Intas and Alkem
will be collectively referred to as the defendants.
Background: -
3. Before I proceed further, the following broad contours of the case are
required to be noticed.
3.1 The first registered patent holder i.e. the grantee of these two patents is an
entity going by the name Bristol Myers Squibb Company [in short "Bristol"].
Bristol, it appears, via an assignment deed dated 01.02.2014, assigned the rights
in the aforementioned patents in favour of Astra Sweden. It is claimed that this
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15:05:16
assignment deed was placed on record of the patent's office by Astra Sweden
via its application dated 02.06.2014 and that as a result of this step having been
taken, it was registered as the patent holder qua the aforementioned patents.
3.2 Insofar as Astra India is concerned, it is averred in the plaint that it is the
only company in the country which has obtained the necessary statutory
approvals for importing and marketing DAPA in India.
3.3 The plaintiffs claim that DAPA is used worldwide to treat people
suffering from type-II diabetes mellitus. According to the plaintiffs, this is
achieved by DAPA acting as an inhibitor of sodium-dependant glucose
transporter i.e. SGLT2 in the kidneys.
3.4 It is, thus, claimed that DAPA aids in normalisation of plasma glucose
levels, and perhaps, body weight by enhancing glucose excretion. It is averred,
hyperglycaemia is a hallmark of type-II diabetes and the challenge, therefore, is
to control plasma glucose levels so as to prevent complications which arise
when the disease reaches an advance stage.
3.5 It is stated that plasma glucose is normally filtered in the kidneys in the
glomerulus which is then actively reabsorbed in the proximal tubule. SGLT2,
according to the plaintiffs, is a major transporter which is responsible for the
reuptake of glucose in the glomerulus. The SGLT2 inhibitors such as phlorizin
and other closely related analogues inhibit the re-uptake process. The selective
inhibition of SGLT2 normalises plasma glucose by enhancing excretion of
glucose in the urine, thereby, improving insulin sensitivity and, thus, delaying
the development of diabetic complications such as neuropathy, nephropathy,
and retinopathy, wound healing and other related diseases.
3.6 It is also averred by the plaintiffs that the main claim in IN 147 is a
Markush structure, in other words, a patent covering a group of compounds
which disclosed the possibility of individual permutations and combinations that
can run into several million [if not more] structurally diverse compounds. In this
context, it is also averred by the plaintiffs that, although, IN 147 [which is the
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genus patent and bears a Markush structure] covered DAPA, it did not disclose
the same. The case set up by the plaintiffs is that it was only when further
research and development was carried out to discover the most suitable, stable
and viable SGLT2 inhibitor, was DAPA invented.
4. Given this backdrop, it would be relevant, at this stage, to note the
bibliography of IN 147 [the genus patent] and IN 625 [the species patent].
IN 147 - THE GENUS PATENT
Title A C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND
METHOD
Application number IN/PCT/2002/00433/MUM
Applicant name BRISTOL-MYERS SQUIBB CO.
PCT International filing date 02.10.2000
International publication date 19.04.2001
Priority date 12.10.1999
Section 11A publication date 18.03.2005
Date of grant 15.03.2007
Date of expiry 02.02.2020
IN 625- THE SPECIES PATENT
Title A COMPOUND (2S, 3R, 4R, 5S, 6R)-2(4-CHLOTO-
3(4-ETHOXYBENZYL PHENYL)-6-
(HYDROXYMETHLY) TETRAHYDRO-2H-PYRAN-
3,4,5-TRIOL AND COMPOSITION COMPRISING
Application number 3573/DELNP/2004
Applicant name BRISTOL-MYERS SQUIBB CO.
PCT International filing date 15.05.2003
International publication date 04.12.2003
Priority date 20.05.2002
Section 11A publication date 01.04.2005
Date of grant 09.07.2009
Date of expiry 15.05.2023
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15:05:16
Submissions of the parties: -
5. It is in this background that the submissions were advanced on behalf of
the plaintiffs by Mr. Kapil Sibal, Mr. Harish Salve and Mr. Sudhir Chandra,
learned senior counsels and Mr. Pravin Anand instructed by Ms. Vaishali
Mittal.
5.1 Likewise, submissions on behalf of Intas were advanced by Mr. C.S.
Vaidyanathan, senior advocate instructed by Ms. Bitika Sharma while
submissions on behalf of Alkem were advanced by Mr. Adarsh Ramanujam also
instructed by Ms. Bitika Sharma. There was, in fact, another action listed before
me i.e. CS (COMM) 407/2020 in which arguments were made by Mr. J Sai
Deepak instructed by Mr. Guruswamy Nataraj. This action, at the interlocutory
stage, was de-tagged from the captioned actions as Mr. Natraj, on instructions,
made the following statement before me [which is recorded in the order dated
22.10.2020] albeit at the nth hour when the judgement in matter was about to be
reserved:
"I.A. No. 8791/2020
1. Mr. Guru Nataraj, who appears for the defendant, in the captioned matter, says
that he has received fresh instructions [even while arguments were being heard in the
captioned application] that the defendant will not be manufacturing and/or launching
its product as it has lost commercial interest in Dapagliflozin. 1.1 The statement of
Mr. Nataraj is taken on record. The defendant will be bound by the statement made
before me.
2. Mr. Pravin Anand, who appears on behalf of the plaintiffs, in the captioned matter,
says that in view of the statement made by Mr. Nataraj today, he would have no
objection if the captioned application is disposed of. 3. The captioned application is,
accordingly, closed in terms of the statement made on behalf of the defendant."
6. The broad framework of the submissions made by each of the counsel
are, set forth hereafter.
On behalf of the plaintiffs: -
i. DAPA is a new, novel and man-made molecule which was first
synthesized in 2001. It is a SGLT2 inhibitor which is useful in treatment
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15:05:16
of type-II diabetes. It normalizes plasma glucose by enhancing excretion
of glucose in urine and, thus, improves insulin sensitivity.
ii. This drug, which is sold under the name Forxiga/Farxiga, has been
approved in 2020 for treatment of hypertensive heart failure [HHF] as
well. The plaintiffs' two distributors i.e. Sun Pharma Laboratories
Limited and Abbott Healthcare Private Limited [hereafter referred to as
"Sun" and "Abbott" respectively] market and sell the very same drug
under various brand names such as OXRA, OXRAMET, OXRAMET IR,
OXRAMET XR, GLEDEPA, GLEDEPA MET, GLEDEPA MET IR,
AND GLEDEPA MET XR.
iii. IN 147, which is, the genus patent claims a Markush structure which has
22 variables and, hence, can lead to millions and perhaps billions of
possible permutations and combinations. While the Markush structure
claimed by the plaintiffs qua its genus patent i.e. IN 147 covers DAPA, it
does not disclose the same.
iv. While the genus patent i.e. IN 147 discloses 80 exemplified compounds
[as is evident from the complete specification of the said patent], DAPA
is not one of the disclosed compounds.
v. DAPA has been specifically disclosed in the species patent i.e. IN 625.
This patent has only two claims which specifically relate to DAPA. Claim
1 specifically lays the claim to compound DAPA as well as its
pharmaceutical acceptable salts stereoisomers or produgesters. Claim 2
lays, likewise, specific claims to pharmaceutical compositions prepared
using DAPA.
vi. IN 625 is a valid and a subsisting patent in India. It was granted on
07.07.2009, with 20.05.2002 as its priority date, and, accordingly, expires
on 15.05.2023. It was published, in India, on 01.04.2005. The plaintiffs
have been granted patents qua DAPA in approximately 70 countries. In
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India, DAPA has not been subjected to any pre-grant or post-grant
opposition or even revocation proceedings prior to 2020.
vii. It is only in 2020, some entities have embarked on infringing the
aforementioned patents which led to institution of suits including the
captioned suits for patent infringement. It is only in 2020 that some of
these entities have initiated post-grant opposition, revocation proceedings
or counter-claims against IN 625.
viii. Insofar as the genus patent i.e. IN 147 is concerned, in India, it was
granted on 15.03.2007, with a priority date of 12.10.1999 and, thus,
expired on 02.02.2020. The patent was first published, in India, on
18.03.2005.
ix. Since DAPA was first synthesized in 2001, that is, after the priority date
of genus patent [IN 147] i.e. 12.10.1999, there can be no question of
DAPA being disclosed in the genus patent.
x. The Patents Act, 1970 [in short "the Act] requires the patentee to
disclose, with specificity, two aspects.
a) First, what is the invention?
b) Second, what is the best method of performing the invention as
known to the inventor? Reliance, in this behalf, was placed on
provisions of Section 10(4)(b), 11(3), 11(3)(a) and 11(4) of the
Act.
xi. The defendants have placed considerable reliance on formula of Claim
1B within IN 147 i.e. the genus patent to emphasize their point that it
discloses DAPA. This contention is flawed for the reason that formula 1B
itself would have more than 1 billion permutations and combinations.
xii. The attempt of the defendants to reach DAPA, either through Claim 1 of
IN 147 or from the genus formula 1B, is nothing but an application of
hindsight wisdom which is a technique which Courts have not accepted
under the patent law.
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xiii. Disclosure is a question of fact which can be ascertained only by reading
the patent document i.e. document pertaining to IN 147. Disclosure of
information can only occur upon it being disclosed to the public at large.
General or fleeting disclosure is not countenanced under patent law.
Disclosure in the context of novelty can be established only if it is
referred to in the earlier patent by way of chemical name; chemical
formula; chemical structure etcetera. [See: Eli Lily, Apotex, 2010 FCA
214]
xiv. Markush formulae are well recognised under the Indian patent law. Thus,
while assessing novelty of the latter patent, which is, said to be covered
with a Markush structure of an earlier patent, is determined by looking
for clear, unambiguous and individual disclosures. In this behalf, reliance
was placed on Patent Office Guidelines, 2013; Patents Office Manual,
2011; Patents Office Manual, 2008; Terrel on the law of patents, 18 th
edition, Sweet & Maxwell; and Modern law of patents, 2nd Edition,
Consultant Editor - His Honor Judge Fysh, QC, SC.
xv. The crux of these references is briefly as follows. The mere possibility of
an embodiment falling within the scope or periphery of a particular claim
does not mean that the particular embodiment or compound has been
disclosed with specificity. In other words, if prior art discloses a family of
compounds with a general formula, which includes a particular
compound which is not disclosed with specificity, then, that particular
compound will still constitute an invention which is novel.
xvi. The contention of the defendants that reference to the aforementioned two
patents in the working statements i.e. Form 27 filed with the Controller's
office and submissions made in the United States of America [US] for
patent term extension [PTE] as also to US Food and Drug Administration
[FDA] Orange Book constitute admission is erroneous. In none of these
documents, it is stated that DAPA was disclosed in IN 147 i.e. genus
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patent. The PTE only states that Forxiga/Farxiga [which is the brand
name for DAPA, as indicated above] is claimed by the aforementioned
patents. There is no admission whatsoever that the genus patents i.e. IN
147 disclosed DAPA.
xvii. Assuming without admitting that these are admissions, admissions made
after the priority date of the patent cannot alter the scope of the claims
either by enlargement or reduction. [See: Glaverbel vs. British Coal,
1995 RPC 255; and F. Hoffmann La Roche Ltd. and Anr. vs. Cipla Ltd.,
MIPR 2016 (1) 0001]
xviii. Likewise, the working statements i.e. Form 27 and US FDA orange book
only advert to the fact that the drug Forxiga/Farxiga work with both
genus and species patent. This is so as the genus patent, which covers
DAPA, is necessarily worked through commercialisation of the drug
which was disclosed in the species patent and, therefore, would not
amount to an admission, as alleged or at all. [See: Judgement dated
15.01.2020, passed in CS (COMM) 561/2019, titled AstraZeneca AB &
Anr. vs. Emcure Pharmaceuticals Limited]
xix. A single product may cover thousands of patents. By way of illustration,
reference was made to a mobile phone which is covered by multiple
patents. In this behalf, reliance was placed on Section 141, Section 19 and
Section 91(1) of the Act. If this rationale is followed through, the
defendants are not free to make use of DAPA for manufacture and/or sale
of their product(s) until all patents containing the said compound expire.
xx. The contention that because the plaintiffs filed a "terminal disclaimer" in
the USA concerning the corresponding genus patent i.e. US 126 and
species patent i.e. US 117, the instant case was of double-patenting and
ever-greening and, therefore, the Indian species patent i.e. IN 625 stands
invalidated, is flawed. The plaintiffs had filed the species patent in the US
i.e. US 117, in 2002 as a continuation-in-part of the genus patent i.e. US
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126 to overcome the non-final double patenting objection flagged by the
US Patent Office [USPTO]. In the US, the mere filing of a terminal
disclaimer is not construed as an admission of double patenting. It is an
instance of expedient obviation rather than obviousness. It is an often use
methodology to overcome such objections raised by USPTO. [See: Quad
Environment vs. Union Sanitary, 946 F2d 870]
xxi. The defendants' contention that because the plaintiffs filed the US species
patent [US 117] as continuation-in-part of the corresponding genus patent
[US 126] and, hence, should be construed as an admission of the fact that
it disclosed no new subject matter is completely erroneous. Under the US
law MPEP 201.08, a continuation-in-part application is an application
filed during the lifetime of an earlier nonprovisional application,
repeating some substantial portion or all of the earlier nonprovisional
application and adding matter not disclosed in the said earlier
nonprovisional application [See: In re Klein, 1930 C.D 2., 393, O.G. 519
(Comm'r Pat., 1930)]. The continuation-in-part application may only be
filed under 37 CFR 1.53 (b).
xxii. Furthermore, the attempt on the part of the defendants to draw a parallel
between a continuation-in-part application and an application filed in
India qua a patent for any improvement in or modification of an invention
for grant of a patent of addition is flawed. The reason being that patents
of addition as envisaged under Section 54 of the Act envisage minor
improvements over an earlier patent. In India, patents of addition are
never granted where the application claims new subject matter which was
not disclosed in the prior application. It is this conceptual difference
between the application for continuation-in-part filed in the USA and an
application for grant of patents of addition which has been missed by the
defendants. It is for this reason that the Controller of Patents in India does
not scrutinize an application for grant of patents of addition from the
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point of view of lack of inventive step or obviousness when compared
with the main patent application. This aspect emerges upon a careful
perusal of Section 56 of the Act.
xxiii. The reliance by the defendants on the judgement of the Supreme Court
rendered in Novartis vs. Union of India, (2013) 6 SCC 1 [hereafter
referred to as Novartis case] is erroneous on account of the following
distinguishing features.
a) Novartis was a case where the claimed invention i.e. imatinib
mesylate had been disclosed in an earlier patent i.e. the
Zimmerman patent and a finding to that effect had been recorded
by the US board of appeals.
b) It was, thus, a case where the Supreme Court found that Novartis
had not only claimed but also disclosed imatinib mesylate. The
contention advanced by Novartis that the disclosure of imatinib in
the Zimmerman patent did not involve disclosure of its invention
i.e. beta crystalline form of imatinib mesylate was rejected by the
Supreme Court as there was a clear disclosure of methane-
sulphonic acid of imatinib in its patent application - a claim which
included imatinib in its pharmaceutically acceptable salts.
c) In the Novartis case, the inventor himself had written articles
wherein a reference had been made to the fact that imatinib
mesylate had been disclosed in the Zimmerman patent.
d) On the other hand, there is no disclosure of DAPA in IN 147.
Unlike the Novartis case, there is no finding of any Court or
tribunal to this effect.
e) The contention of Novartis that beta crystalline form of imatinib
mesylate was a two-step invention i.e. from imatinib to imatinib
mesylate and from imatinib mesylate to its beta crystalline form
was rejected as it was hit was Section 3 (d) of the Act. The beta
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crystalline form was considered only as a polymorph which did not
reveal any enhanced therapeutic efficacy. DAPA, on the other
hand, is a new compound. It is not a salt, ester, ether, polymorph,
metabolite etcetera of a known substance and, hence, does not fall
within the purview of Section 3 (d) of the Act. Importantly, in the
instant case, Dr. William N. Washburn's affidavit [who led the
group which invented the compound-in-issue] has demonstrated
DAPA's enhanced efficacy over example 12 of IN 147. In this
behalf, the following assertions have been made by Dr. Washburn.
A. Enhanced ability: for blood sugar 25%; for plasma sugar
58% and 1.7 times selective for SGLT2 over SGLT1.
B. Example 12 never morphed into a drug and had no known
efficacy as it was never tested on human beings.
C. DAPA was synthesized only in 2001.
f) The aspect concerning whether a compound is covered or disclosed
should be construed as an obiter as it came up because of
arguments advanced on behalf of Novartis that there was no
disclosure of imatinib mesylate in the Zimmerman patent,
although, it was covered by its broad claims.
g) The reliance placed by the defendants on paragraph 134 of the
Novartis case needs to be examined in the background of the
following factors.
A. It displays a desire for the law to develop in a certain way in
future.
B. There is no finding in the judgement that Markush claims are
bad in law. The Supreme Court was not concerned with this
issue. There is, in fact, a recognition by the Supreme Court
in the very same paragraph that there could be some gap
between what is covered as against that which is disclosed.
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Therefore, what the defendants submit requires not a judicial
decision but a legislative interdiction. In this behalf, it
requires to be borne in mind that the Court did not rule one
way or the other on the issue: if the gap between what was
disclosed and covered was too wide, would that invalidate
the patent? In other words, would the patent become
unenforceable qua compounds which are not disclosed? In
any event, in the instant case there is no gap between the
genus patent and species patent i.e. IN 147 and IN 625. In
the Novartis case, public interest was an issue as the drug
manufactured by Novartis cost INR 1, 20,000 whereas that
manufactured by the defendant in that case cost INR 8, 000.
The price difference was vast. In the present case, the price
difference is only INR 37 per capsule. In this context, one
cannot lose sight of the fact that DAPA, which is, used to
treat diabetes is not a life-threatening disease. [See: Merck
Sharp and Dohme Corporation and Ors. vs. Glenmark
Pharmaceuticals, MANU/DE/0852/2015]
xxiv. Section 13 (1) (b) of the Act, which concerns the defence of anticipation
by prior claiming has no application in the instant case as the earlier
claim i.e. IN 147 and the patent claim i.e. IN 625 are not identical. [See:
Daikin Kogyo Co. Ltd. (Shingu and Another's) Application, (1974)
R.P.C. 18; and Manual of Patent Office Practice and Procedure Version
01.11 as modified on March 22, 2011]
xxv. The invention of IN 147, as claimed, is different from the invention
claimed in IN 625. IN 147 claims a class of compounds of the Markush
structure.
xxvi. IN 147 teaches a pharmacophore comprising elements:
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A. A sugar that is a glucoside;
B. A C-aryl link;
C. A phenyl proximal moiety attached to a linker and a distal phenyl moiety;
D. There could be many substitutions on the 9 carbon atoms on the 2 phenyl
moieties;
E. The substitutions can be in hundreds or thousands - H, Halogen (Cl, Br,
F), OCF3, OCH3, OC2H5, OBe, SCH3, CH3, C2H5, C3H7, OH,
COCH3 etc. [spread over 22 variables].
xxvii. Extensive research is required to understand which linker required
research. Extensive research was also required to understand which
substitutions are required, as indicated above. Furthermore, which of the
9 carbon positions had to be substituted, also requires extensive research.
xxviii. On the other hand, IN 625 has only one specific molecule, i.e.,
Dapagliflozin. Therefore, it is clear that prior claiming has no application
to the present case.
xxix. The defence of anticipation by prior publication does not apply in this
case for the following reasons.
a) IN 147 is not prior art as it was published only on 18.03.2005, that
is, after the priority date of IN 625 which is 20.05.2002.
b) There can be no disclosure in law if a forest or a library of
compounds is encompassed by a Markush structure wherein few
species are disclosed only by way of examples. [See: Dr Reddy's
Laboratories (UK) Ltd vs. Eli Lilly and Co Ltd. (2009) EWCA
1362; In re: Petering, 301 F.2d 676; and Apotex Pty Ltd (formerly
GenRx Pty Ltd) vs Sanofi-Aventis [2008] FCA 1194]
xxx. The defendants are wrong in contending that where a genus patent is
granted, subsequent species patent cannot be granted. Unique features of
breakthrough inventions are critical and, hence, need to be protected by a
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grant of patents. [See: F. Hoffmann La Roche Ltd. and Anr. vs. Cipla
Ltd., MIPR 2016 (1) 0001; and Eisai Co. Ltd. and Ors. vs. Satish Reddy
and Ors., MANU/DE/1621/2019]
xxxi. For the defence of obviousness to apply, it must be demonstrated that a
person with average skill and average knowledge, who has no creative or
inventive faculties, can reach claimed inventions on reading the prior art.
Thus, simply put, obviousness is something which is claimed and easily
understood by persons skilled in art. To reach a conclusion of
obviousness, the teaching contained in the document must be read as a
whole. The document must not teach away from a certain concept.
Pertinently, hindsight reconstruction is not permissible. [See: Judgement
dated 30.01.2020, passed in CS (COMM) 27/2020, titled Bristol-Myers
Squibb Holdings Ireland Unlimited Company & Ors. vs. BDR
Pharmaceuticals International Pvt. Ltd. & Anr.; and The General Tire
& Rubber Company vs. The Firestone Tyre and Rubber Company
Limited and Others, (1972) RPC 17]
xxxii. DAPA, on the other hand, is not obvious contrary to what is contended by
the defendants. The reliance of the defendants, in this behalf, on example
12 of IN 147 is flawed. The reasons for the same are as follows:
A. First, why should one look at example 12 when genus formula 1B
has large number of compounds?
B. Second, why should one look at example 12 when 80 examples are
given of which examples 1 and 2 are synthesised on a large scale?
C. Third, if example 12 is relevant, why is the need to change
methoxy?
D. Fourth, in any case, properties of example 12 i.e. efficacy or other
data or SAR are not known.
E. Fifth, the teaching of IN 147 is to add hydrogen on central phenyl
ring [in 60 % of examples].
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F. Sixth, there is no ethoxy on the distal phenyl in any of the 80
examples.
G. Lastly, DAPA is far more effective than example 12.
xxxiii. For defence of obviousness to be sustained, it would have to be
established that the earlier patent was published as on the date when the
latter patent was granted. In the instant case, the admitted facts reveal that
the species patent i.e. IN 625 has a priority date of 20.05.2002 whereas
the genus patent was published under Section 11A of the Act only on
18.03.2005. This being the position, there can be no question of a person
of ordinary skill in the art, having read example 12 or any other teaching
in the genus patent i.e. IN 147, to arrive at DAPA. This submission is
further strengthened by the fact that the corresponding species patent US
117 bears a priority date of 20.05.2002 while the corresponding genus
patent i.e. US 126 was published in the US only in September 2002.
xxxiv. Since there was no publication of the genus patent in USA prior to the
filing of the species patent there is no question of the person of ordinary
skill in the art of reaching DAPA by absorbing the teaching given in
example 12 or any other teaching given in the genus patent i.e. IN 147.
xxxv. DAPA is not obvious because formula 1B of IN 147 has a million
possibilities. Any attempt to reach DAPA from the Markush structure of
Claim 1 of IN 147 or genus formula 1B is nothing but an attempt to take
recourse to hindsight which is discouraged under patent law.
xxxvi. Of the 25 examples in IN 147 that fall within the genus of compounds of
Structure IB, 13 (over 50%) have hydrogen as R1. Of the remaining 12
examples that have non-hydrogen R1 groups, over 65% (8/12) have lower
alkyls ‒ not a chloro group as in dapagliflozin.
xxxvii. Similarly, over 50% (13/25) of the examples in IN 147 that fall within the
genus of compounds of Structure IB have alkyl or thioalkyl at R4 and of
the remaining Examples that fall within the genus of compounds of
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Structure 1B that have an alkoxy at R4, none is ethoxy as in
dapagliflozin.
xxxviii. Thus, given the complete absence of structure-activity data in IN 147, the
large number of potential modifications of any exemplified compound
therein, the clear preference demonstrated for compounds having
hydrogens on the central phenyl ring, and the absence of any examples
with an ethoxy substituent on the distal ring, one of ordinary skill in the
art would not have had a reason or motivation to make dapagliflozin with
a reasonable expectation of success.
xxxix. It is, thus, the case of the plaintiffs that a person of ordinary skill in the art
would have to take recourse to various permutations and combinations
before it could reach DAPA. This is so as the prior art i.e. IN 147 gives
no indication as to which parameters are critical or even which direction
if taken out of the many choices available would lead to success.
xl. The Court is required to take secondary factors also in account while
appreciating the defence of obviousness. In DAPA's case, the following
secondary factors need to be noticed.
A. DAPA is a drug which has attained great commercial success.
B. It is the first SGLT2 inhibitor.
C. It has been approved for treatment of hypertensive heart failure.
D. Various entities are attempting to copy the drug either by
infringing or attempting to infringe the species patent
E. Had DAPA been so obvious then why is it that no other entity has
been able to develop the same. [See: Graham vs. John Deere Co.,
383 U.S. 1 (1966)]
xli. There is a presumption that the patent is valid having regard to its age.
[See: Bristol-Myers Squibb Company and Ors. vs. J.D. Joshi and Ors.,
MANU/DE/1889/2015] Likewise, it is also settled law that if there is no
presumption of validity, there is also no presumption of invalidity of
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patent. [See: Order dated 15.03.2018, passed in CS (COMM) 737/2018,
titled Pfizer Inc. and Ors. vs. Nagesh Palepu and Ors.; and Judgement
dated 09.07.2015, passed in CS(OS) 442/2013, titled Telefonaktiebolaget
LM Ericsson (PUBL) vs. Mercury Electronics & Anr.]
xlii. The assertion of the defendants that the plaintiffs have kept back
information from the Controller of Patents in India concerning
corresponding foreign applications filed with USPTO is incorrect. The
plaintiffs have disclosed all material information with the Indian Patent
Office. There has been substantial compliance with the provisions of
Section 8 of the Act. This is demonstrated by having regard to the
following.
A. Form 3 was filed by Bristol i.e. the erstwhile owner of the patent
which was assigned to the plaintiffs only in 2014. Since then Astra
Sweden has made filings under Form 3 as required under Section
8(1) of the Act on 16.11.2004, 10.01.2005, 01.09.2009 and
17.12.2009. In these forms there is a specific reference to the
corresponding species patent granted in USA i.e. US 117. Insofar
as the Indian Patent Office was concerned an objection under
Section 8(2) of the Act was raised via the first examination report
dated 12.10.2007. The patent office, thus, required the plaintiffs to
provide details regarding corresponding patents in major patent
offices. Resultantly, the plaintiffs provided documents pertaining to
European Patent [EP] and the consequent grant of patent.
Furthermore, the plaintiffs on their own vide letter dated
10.01.2005 and Form 3 filings furnished documents concerning the
corresponding US patent as well. In particular, with the letter of
10.01.2005, the plaintiffs enclosed the application for US species
patent i.e. US 117 along with its granted claims. This application
revealed that it is a continuation-in-part of the genus patent i.e. US
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126. As would be evident, all relevant information and material
particulars concerning the corresponding US species patent i.e. US
117 were provided to the Indian Patent Office nearly two years
before objection was raised on 12.10.2007. Thus, the assertion of
the defendants that there was a concealment is not borne out from
the facts on record.
B. In any case, at the highest, errors, if any, in filing can only be
considered as inadvertent which perhaps occurred as an oversight.
These errors cannot be construed as material suppression given the
conduct of the plaintiffs. There has been no failure on part of the
plaintiffs to comply with the mandatory requirement. The
allegation of the defendants that there has been a failure to comply
with the provisions of Section 8 of the Act is ultimately a matter of
trial. [See: Judgement dated 07.11.2014, passed in FAO (OS) No.
16/2014, titled Maj. (Retd.) Sukesh Behl & Anr. vs. Koninklijke
Phillips Electronics; and F. Hoffmann La Roche Ltd. and Anr.
vs. Cipla Ltd., MIPR 2016 (1) 0001]
xliii. According to the plaintiffs, the defendants should be denied the relief of
injunction for the following reasons.
A. The defendants are either manufacturing or intending to
manufacture DAPA and, therefore, infringement is admitted.
B. DAPA is a man-made drug which is used for treating not only
type-2 diabetes but is also approved for treating hypertensive heart
failure in 2020.
C. The species patent is an old and established patent and, therefore,
carried with it the presumption of validity. This patent is in its 18 th
year of life cycle.
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D. The species patent was subjected to examination by the Indian
Patent Office for seven years i.e. between 2002 [the year of
priority] and 2009 [the year of grant].
E. Both genus and species patent have not been subjected to any pre-
grant or post grant opposition or even subjected to revocation
proceedings up until 2020. Proceedings filed in 2020 are mala fide,
counter-blast or peremptory strikes against patent infringement suit
actions filed by the plaintiffs.
F. The defendants have not conducted any research and development
and, therefore, want to piggyback the inventions of the plaintiffs
concerning DAPA.
G. The plaintiffs have been selling the products under various brand
names since 2015, both, directly and/or through their distributors
i.e. Sun and Abbott at reasonable prices.
H. Insofar as the defendant in CS (COMM) 410/2020 is concerned,
the plaintiffs have acquired knowledge from their investigator that
it was planning to launch its product using the DAPA compound.
Although, the defendants before this Court, on 01.10.2020, stated
that they have not commenced manufacture of their drug, that may
not be quite correct. The defendants being aware of the fact that the
plaintiffs have been granted a patent for DAPA should have the
way cleared for proceeding further with their manufacturing and/or
selling activities by adopting any one of the following routes.
▪ Seek a voluntary license.
▪ Seek a compulsory license.
▪ Filing revocations.
▪ Filing a pre-grant or a post-grant opposition.
▪ File a declaratory action for non-infringement.
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I. Likewise, the defendants at the appropriate stage could have also
filed pre or post-grant opposition; a step that they did not take.
[See: Eisai Co. Ltd. and Ors. vs. Satish Reddy and Ors.,
MANU/DE/1621/2019; and Merck Sharp and Dohme
Corporation and Ors. vs. Glenmark Pharmaceuticals,
MANU/DE/0852/2015.]
J. For the aforesaid routes to be taken, the defendants had 15 years at
their disposal since both patents were published under Section 11A
of the Act in 2005. Likewise, if the date of grant is taken the
defendants had available to them 13 and 11 years since the
registration of the genus patent i.e. IN 147 and the species patent
i.e. IN 625 respectively.
K. The plaintiffs have filed several suit actions in which interim
injunctions have been granted by this court.
L. Thus, according to the plaintiffs, given what is stated above, the
defendants have failed to make out a prima facie case and the
balance of convenience is also titled against them.
M. Plaintiffs will suffer an irreparable loss if injunction, as prayed, is
not granted as it will destroy the market for them whereas, insofar
as the defendants are concerned, the launch of their product will
only be postponed. Furthermore, since 3 companies i.e. Eris Life
Sciences, USV and Zydus have already launched their infringing
products, despite suits filed against them, which are pending
adjudication, the market has already been flooded with the
infringing products.
N. Besides this, medical practitioners have expressed concerns as to
what would be the ultimate quality of the drug if the defendants are
permitted to launch their products. Damages caused by the
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infringing activity are difficult to compute in monetary terms and
that in any event they are not adequate.
O. The plaintiffs have an interest in enforcing the provisions of the
Act. Their victory has to be real and not pyrrhic. [See: Merck
Sharp and Dohme Corporation and Ors. vs. Glenmark
Pharmaceuticals, MANU/DE/0852/2015]
xliv. In a nutshell, the defendants should be restrained from infringing
plaintiffs' species patent i.e. IN 625 during the pendency of the suit
action.
On behalf of the defendants: -
7. There were joint-arguments addressed on behalf of the defendants [to
avoid overlap] not only qua the captioned applications, filed in the two suits
referred to hereinabove, but also in I.A. No. 8791/2020, filed in CS (COMM)
407/2020, as indicated right at the outset.
7.1 The burden of the arguments, though, for the sake of convenience, on
behalf of the defendants, was shared up until then by the following three
counsels who appeared on behalf of the defendants i.e. Mr. C.S. Vaidyanathan,
Senior Advocate, Mr. Adarsh Ramanujam and Mr. J Sai Deepak. The written
submissions were also circulated by these counsels having regard to the same.
Pertinently, Mr. J Sai Deepak had advanced arguments on behalf of Emcure
Pharmaceuticals Limited [in short "Emcure"] in CS (COMM) No. 407/2020.
Given the development, concerning CS (COMM) No. 407/2020, Mr.
Vaidyanathan and Mr. Ramanujam stated that they would adopt the legal
submissions made by Mr. Sai Deepak apart from what had been argued by them
to avoid repetition.
8. With this preface, let me indicate the broad contours of the submissions
advanced on behalf of the defendants.
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i. The plaintiffs cannot be permitted to take mutually destructive pleas. The
plaintiffs, having alleged that manufacture and/or sale etcetera of DAPA
infringes IN 147 i.e. the genus patent, it stands to reason that the said
compound stands fully and particularly described in IN 147 i.e. the genus
patent; this being a mandatory requirement of Section 10(4)(a) read with
Section 10(4)(c) of the Act.
ii. Strangely, when defendants cite IN 147 [i.e. the genus patent] as prior art
or prior published document to invalidate the species patent [i.e. IN 625],
the plaintiffs aver that DAPA, though covered/claimed, is not disclosed in
IN 147 i.e. the genus patent. If this assertion of the plaintiffs is accepted,
then, it is quite clear that they would fall foul of the provisions of Section
10(5) of the Act.
iii. Insofar as the defendants are concerned, since they have not
manufactured DAPA [a statement which was made on the first date of
hearing i.e. 01.10.2020]; there cannot be any infringement by them of IN
147 i.e. the genus patent.
iv. The plaintiffs have averred that there is a reasonable apprehension of the
defendants manufacturing DAPA without producing any tenable material
on record. What is, however, admitted by the plaintiffs is that the
defendants have not launched their product containing DAPA. Since IN
147 i.e. the genus patent, admittedly, expired on 02.10.2020, there is no
case of grant of injunction qua IN 147 i.e. the genus patent in the future.
v. There is no case for grant of injunction qua IN 625 as the defendants have
raised a credible challenge as to its validity. The Statute i.e. Section 13(4)
of the Act makes that amply clear. [See: Bishwanath Prasad Radhey
Shyam vs. Hindustan Metal Industries, (1979) 2 SCC 511]
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vi. This Court should, therefore, evaluate as to whether or not defendants
have established a credible challenge to the validity of IN 625. In this
behalf, the defendants are only required to demonstrate that IN 625 is
vulnerable to challenge and/or there is an issue which requires trial. [See:
Hoffman La Roche vs. Cipla, 2009 (110) DRJ 452 (DB)]
vii. IN 625 i.e. the species patent is vulnerable to challenge under the
provisions of Section 64(1)(a), (e) and (f) of the Act. The test, however,
to be applied vis-à-vis the provisions of Section 64(1)(a) and the other
two sections i.e. 64(1)(e) and (f) are different. While the provisions of
Section 64(1)(a) requires comparison of claims, insofar as Section
64(1)(e) and (f) are concerned, a broader assessment is to be made as to
what is "publicly known or used in India" and/or what was "published in
India or elsewhere".
viii. Clause (a) of subsection (1) of Section 64 of the Act was adopted from a
pari materia provision contained in Section 32 (1) (a) of the UK Patents
Act, 1949 which reads thus:
"32. Revocation of patent by court
(1) Subject to the provisions of this Act, a patent may, on the petition of any person
interested, be revoked by the court on any of the following grounds, that is to say, --
(a)that the invention, so far as claimed in any claim of the complete specification, was
claimed in a valid claim of earlier priority date contained in the complete
specification of another patent granted in the United Kingdom; ....."
ix. Interestingly, while India has retained subclause (a) of subsection (1) of
Section 64, in UK, in the 1977 enactment, Section 32(1) has not been
retained. However, interpretation accorded by the English courts to
Section 32(1)(a) is that the Court is required to assess whether the
subsequent patent seeks to re-monopolise something which already stands
protected. [See: Merck & Co (Macek's) Patent, [1966] F.S.R. 381].
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x. In this context, it is necessary to bear in mind the admissions made by the
plaintiffs that DAPA is already claimed in IN 147 [See: plaint paragraphs
36 and 86 of the plaint in CS (COMM) No. 410/2020]; and statements
made in the US litigation and the contents of Form 27 filed in IN 147].
Form 27 constitutes working statement which has to be read in the
context of Section 146 (2) and Section 10(4)(c) of the Act.
xi. The fact that DAPA is prior claimed in IN 147 is apparent by the conduct
of the plaintiffs while pursuing their patent applications before USPTO.
The record would show that the plaintiffs' US patent application i.e. US
117 which is equivalent to IN 625, when objected to on the ground of
prior claiming i.e. "obviousness-type double patenting", it was resolved
by the plaintiffs filing a terminal disclaimer. Such a step taken by the
plaintiffs would be a clue that the patentee did not consider IN 625 to be
distinct from IN 147. In any case, it raises a credible challenge to the
validity of IN 625 under Section 64(1)(a) of the Act.
xii. IN 625 is vulnerable to challenge also because it is anticipated by what is
published or publicly known from IN 147. In this behalf, the following
dates and events need to be borne in mind.
A. IN 147 was first published on 19.04.2001, whereas, the priority date of IN
625 is 20.05.2002.
B. Since the plaintiffs, while filing their specification qua IN 147, have
claimed as also fully and particularly described the same in IN 147,
DAPA would be publicly known in India. The expression "publicly
known" will necessary mean that patented invention is known to persons
who are engaged in the pursuit of knowledge concerning the patented
product. Such persons would inter alia be men of science. [See:
Monsanto Company v. Coromandel Indag Products, (1986) 1 SCC 642]
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xiii. The Supreme Court in Novartis case dealt with the expression "known"
in the context of Section 3(d) of the Act. In that case, the Supreme Court
rejected the argument that there was a dichotomy between coverage and
disclosure. In that case, the Supreme Court was called upon to rule
whether the salt imatinib mesylate was known in the earlier Zimmerman
patent which concerned free base (Imatinib). The Supreme Court
concluded that both, the free base and the salt were known from the
Zimmerman patent which was a genus patent much like IN 147. The
Supreme Court, therefore, upon reading the Zimmerman patent which
was prior published came to determine as to what was known. The Court
ruled that all molecules covered by the genus patent i.e. Zimmerman
patent are or were known. Therefore, since the plaintiffs have admitted
that DAPA is covered by prior patent i.e. IN 147 and assert that
defendants infringe this prior patent, it undoubtedly presents a
circumstance that DAPA is also known from IN 147.
xiv. Without prejudice to the contentions made hereinabove, IN 625 is also
vulnerable to challenge as it lacks inventive step based on what was
published or publicly known from IN 147. [In this behalf, See: Section
64(1)(f) and Section 2 (1) (ja) of the Act].
xv. Inventive step requires an assessment of two aspects as per the provisions
of Section 2(1)(ja) and both aspects/conditions are conjunctive in nature.
First, the invention should involve "technical advance" as compared to
existing knowledge or have economic significance. Second, the invention
should not be obvious to the person skilled in art. A new product, which
does not involve inventive step as per the condition stipulated in Section
2 (1) (ja) and is not capable of industrial application, falls foul of Section
64 (1) (f).
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xvi. The term technical advance was borrowed from German law which
requires IN 625 to demonstrate technical superiority over IN 147. IN 625
does not state that DAPA is superior to the compound adverted to in IN
147 with reference to any property. [See: Toshiko Takenaka (ed.), Patent
Law and Theory: A Handbook of Contemporary Research (Edward Elgar,
2008)] Importantly, for the person skilled in the art, IN 625 simply
denotes that DAPA will have the same function as compounds of IN 147
i.e. SGLT2 inhibition activity.
xvii. Furthermore, IN 625 does not set out the economic significance over
compounds of IN 147. Consequently, IN 625 fails the inventive step
requirement as there is failure to demonstrate technical advance or
economic significance which was not previously known from IN 147.
xviii. Besides this [and without prejudice to what is stated hereinabove, that is,
IN 625 fails the test of inventive step], DAPA is obvious to a person
skilled in art from IN 147 if the five-step analysis as laid down in F.
Hoffman-La Roche vs. Cipla Ltd., 2015 (225) DLT 391 is followed.
A. Step 1 requires the identification of the person skilled in the art.
Such a person would be [in the context of the present case] a
person who is a PhD in medical or organic chemistry with a few
years' experience in drug development. He would also be a person
of ordinary creativity, although, not an automaton but at the same
time would not be inventive. He would have the ability to make
workshop improvement modification furthering the stage of
knowledge. He will also be someone who would read all relevant
literature carefully and with sufficient interest to be in a position to
apply his mind to practical application. Plaintiffs have failed to
identify such a person.
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B. Step 2, in this case, doesn't require further enquiry as the only
inventive concept is the compound DAPA.
C. Step 3 requires an input of a person skilled in the art having
common general knowledge. The independent expert, in this case,
Dr. Stephen F. Martin has stated that methyl and ethyl being
homologues possessing similar properties can routinely involve
substitution of methyl group with ethyl group in organic chemistry;
being common general knowledge.
D. Step 4 involves identification of differences between inventive
concepts and prior knowledge. The defendants contend that there is
no difference between the two in the instant case as DAPA has
been disclosed as one of the most preferred structure in IN 147
patent. This is so, in view of structure I (B) and preferred
definitions of alkyl and halogen in IN 147. Alternatively, according
to the defendants, the best scenario for the plaintiffs is that IN 625
differs from IN 147 on account of methyl vs. ethyl substitution or
methoxy vs. ethoxy substitution when example 12 of IN 147 is
compared with DAPA. However, as per the expert i.e. Dr. Martin;
this is a matter of common general knowledge for the person
skilled in the art and, therefore, this distinction cannot be used to
justify that IN 625 involves an inventive step.
E. Step 5: To decide whether those differences viewed in the
knowledge of the alleged invention constituted steps which would
have been obvious to the person skilled in the art without taking
recourse to hindsight wisdom.
xix. Without prejudice to the aforesaid, the plaintiffs' contention that the
defendants must demonstrate as to why one must select DAPA from
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infinite compounds of IN 147 or isolate example 12 as the starting point
or what would motivate substitution of methyl group with ethyl group
especially when there are unexpected benefits as suggested by the
affidavit of Dr. Washburn, is flawed, due to the following reasons.
A. Such an argument that an inventive step arises due to a selection
from purported infinite compound was rejected both in the
European Union (EU) and the United Kingdom (UK) [See: AgrEvo
UK Limited, Case Number T 0938/92 -3.3.1 which was approved
by The United Kingdom Supreme Court in Actavis Group PTC
EHF and others vs. ICOS Corporation and another, [2019]
UKSC 15] The observation therein was that even if prior art
comprises of an infinite number of starting point every such prior
art is deemed to be suggestive to the person skilled in the art. It
went on to state that a mere arbitrary selection of one or more
compounds from a laundry list in the prior art cannot itself confer
inventive step. The only exception to this is where the patentee is
able to fulfil two conditions.
▪ The identification/selection is based on an "unknown
technical effect".
▪ This unknown technical effect must be justified by
difference in structure between the identified/selected
compound and the rest of the molecules from the prior art.
B. IN 625 fails on both counts. It neither discloses unknown technical
effect not does it justify such unknown technical effect by
reference to substitution with methyl group at one location. It
simply states that DAPA has the same activity/utility as the
compounds of IN 147 which is a known technical effect. The
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attempt of the plaintiffs to overcome this fatal error by relying on
Dr. Washburn's affidavit will not shore up their case for the
following reasons.
a) This affidavit was sworn in April 2020 and was placed
before the Court for the first time on 12.10.2020. Dr.
Washburn's affidavit did not form part of IN 625 from its
inception and most certainly did not exist on its priority date
i.e. 20.05.2002. This submission, though, is made dehors the
stand of the defendants concerning credibility and the
veracity of the data relied upon in Dr. Washburn's affidavit.
b) The plaintiffs could have relied upon such data post the
priority date only if the specification itself "plausibly
demonstrated" such unknown technical effect. This is so
because the validity of the patent is to be assessed on its
priority date. IN 625 does not state, let alone plausibly
demonstrate, such unknown technical effect, on its priority
date. [See: Generics (UK) Limited vs. Yeda Research and
Development Co. Limited, (2014) R.P.C. 4]
xx. Without prejudice to the above, it requires to be noticed that DAPA
would be obvious to the person skilled in the art on account of the manner
in which he would appreciate the contents of IN 147. Reliance by the
plaintiffs on the judgement rendered in In re Petering, 301 F.2d 676, in
fact, supports the submissions of the defendants. This judgement holds
that even a prior art disclosure of an infinite number of molecules would
be construed by a person skilled in the art in a logical manner to filter
down to a smaller class of compound if the document itself lays out series
of specific preferences which allows him to envisage a smaller class of
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compounds. The submissions advanced by the plaintiffs seem to suggest
that a person skilled in the art does not have ordinary intelligence but is a
dullard. The instant case presents, precisely, this situation which is
captured in In re Petering.
xxi. Without prejudice to the above, it is submitted that IN 625 is vulnerable
to challenge because of the plaintiffs having breached the provisions of
Section 8 of the Act and, hence, had opened IN 625 to revocation under
Section 64(1)(m). The requirements of Section 8 are mandatory. The
provisions of this section oblige the applicant to keep the Indian Patent
Office informed about the status of all corresponding foreign patent
applications, which are filed in respect of the same or substantially the
same invention qua which patent is sought.
xxii. Under the provisions of Section 8, the applicant is required to disclose
details with regard to grant, refusal or abandonment of any foreign
application. Subsection (1) of Section 8 requires an applicant to file, on
its own, all material particulars including office actions and examination
reports issued by foreign patent offices. This obligation becomes
inescapable under subsection (2) of Section 8 where the patent examiner
calls for information concerning examination report and office action
issued by foreign patent offices.
xxiii. In the instant case, the plaintiffs supressed the office actions/examination
reports dated 30.07.2002 issued by the USPTO concerning US 117 which
corresponds to IN 625. In the said examination report, the USPTO had
expressly found, in relation to US 117, that the subject matter claimed
therein was fully disclosed in US 126 which corresponds to IN 147. In
this context, it is important to note that the plaintiffs, via their response
dated 19.08.2002, voluntarily offered to limit the term of US 117
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[equivalent to IN 625] to that of US 126 [equivalent to IN 147] which
expired on 04.10.2020. The methodology adopted, which, in USA, is
known as a "terminal disclaimer", prevented the rejection of application
preferred for grant of US 117 on the ground of obviousness and double
patenting.
xxiv. US 117 was granted on 20.09.2002 by the USPTO only upon acceptance
of the terminal disclaimer offered by the plaintiffs. The plaintiffs ought to
have disclosed, on their own, the said information in consonance with
Section 8(1) of the Act. The plaintiffs did not do so. The plaintiffs failed
to furnish this information even when the Indian Patent Office, vide its
first examination report [FER] dated 12.10.2007, issued in relation to IN
625, sought the information. [See: Serial no. 13 of FER dated 12.10.2007]
The plaintiffs, instead, furnished copies of the European patent. [See:
Plaintiffs response dated 08.10.2008] The plaintiffs' response that since
the patent in the USA had already been granted, there was no statutory
obligation cast on them under Section 8 of the Act to submit office
actions issued by USPTO, is contrary to the intent of Section 8 [See:
Chemtura Corporation vs. Union of India (UOI) and Ors., 2009 (41)
PTC260(Del)]
xxv. The assertion of the plaintiffs that they had furnished the information
concerning the corresponding US patent along with their letter of
10.01.2005 is incorrect since the said letter did not enclose either the non-
final rejection letter issued by USPTO dated 30.07.2002 or the terminal
disclaimer dated 19.07.2002. This omission was deliberate. The omission
was material as it would have alerted the Indian Patent Office to raise a
prior claiming objection which would have constrained the patentee to
amend IN 625 to a patent of addition under Section 54 of the Act. In other
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words, IN 625 would, then, have a validity period which would terminate
with the tenure of IN 147 i.e. 02.10.2020.
xxvi. The submission advanced on behalf of the plaintiffs that termination
disclaimer is only an obviation and not an admission of
obviousness/double patenting based on the judgement rendered in Quad
Environment vs. Union Sanitary, 946 F2d 870 does not appear to be in
line with the current thinking in USA. [See: Festo Corp. vs. Shoketsu
Kinzoku, 535 U.S 722 (2002); and SimpleAir, Inc. vs. Google LLC,
Appeal Number: 16-2738, United States Court of Appeals for the Federal
Circuit].
xxvii. The admissions made in the plaint, in at least 18 paragraphs, i.e.
paragraph numbers 2, 3, 16, 22, 26, 28, 53, 54, 56, 70, 71, 73, 76, 77, 79,
83, 84, 87, 88 and the prayer clause [i.e. 101] that DAPA is covered by
both suit patents would propel the Court to dismiss the interlocutory
application in view of the express language of Section 53(4) and Section
13(1)(b) and Section 64(1) of the Act. In support of this plea, that is,
DAPA is covered by the claims made in the genus patent i.e. IN 147
reference is also made to Form 27 filed by the plaintiffs between 2015-
2019 with the Indian Patent Office in relation to IN 147. Form 27
supports the plea of the defendants that even according to the plaintiffs
DAPA is covered by IN 147.
xxviii. Besides this, a perusal of PTE applications dated 06.03.2014 filed for the
corresponding patents i.e. US 117 and US 126 would show that the
plaintiffs have identified the "approved product" for which the PTE was
being sought as Farxiga [the generic name being DAPA]. It is emphasised
that while PTE of US 117 was filed by the plaintiffs, the similar
application i.e. PTE dated 06.03.2014 qua US 126 was kept back.
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xxix. In this context, it was submitted that the PTE filed in respect of US 126
inter alia states at internal page 12 that claims 1-8 and 14-28 "read on"
the product DAPA. This clearly demonstrates that even according to the
plaintiffs DAPA is covered by US 126 and, therefore, is also covered by
Indian genus patent i.e. IN 147. It is in the backdrop of these PTE
applications that USPTO required the plaintiffs to elect, between one of
the two patents for grant of PTE vide its final notice of election dated
15.06.2020. The record would show that on 10.07.2020 plaintiffs elected
US 117 and, therefore, US 117 was granted PTE. It is also relevant to
note that before US FDA, qua US 126 along with other US patents, the
plaintiffs have stated that it covers DAPA which, by logical corollary,
would also stand covered by IN 147.
xxx. In this context, it is important to note the plaintiffs stand vis-à-vis an
entity going by the name Zydus Pharmaceuticals USA, in an action filed
by them against the said entity in the District Court of Delaware, wherein,
one of the patents asserted was US 126 [equivalent to IN 147]. In
paragraphs 28, 29, and 31 to 33 of the complaint which was the subject
matter of the aforementioned action, it is averred that Zydus
Pharmaceutical USA's application to the US FDA to market DAPA
tablets would infringe at least claims 1 and 26 of US 126 if approval is
granted before the expiry of the said patent. It is important to bear in
mind that Claim 1 of US 126 is identical to Claim 1 of IN 147 and claim
26 of IN 147 claims the same structure as Claim 27 of US 126.
xxxi. Given these admissions, not only should the interlocutory application be
dismissed but also the suit as no trial would be required. These
admissions trigger the bar contained in Section 53 (4) of the Act which
inter alia states that on expiry of the term of the patent, the subject matter
covered by the said patent shall not be entitled to any protection. The
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admissions in the plaint and other documents show that DAPA is covered
by IN 147 which expired on 02.10.2020 and, therefore, no further
protection can be given to DAPA through the route of the species patent
i.e. IN 625.
xxxii. Section 53(4) which was introduced in the Act pursuant to the 2002
amendment sought to protect abuse by the patentee of its monopoly rights
by resorting to double patenting. It is in this context that extension of
protection of subject matter which is covered by an expired patent is not
countenanced by the Statute.
xxxiii. Section 53(4) along with Section 107A of the Act was introduced to
balance the interest of public in lieu of extension of patent term to 20
years for patents across the board for all inventions. Section 107A, in this
spirit, facilitates timely entry of generic drugs by exempting certain
activities such as research and development and obtaining regulatory
approvals from the pale of infringement actions. The purpose being that
manufacturers of generic drugs should be in a position to commence their
activities immediately upon the expiry of the patent in the interest of the
public at large. These statutory safeguards were put in place to balance its
international commitment under the Agreement on Trade-Related
Aspects of Intellectual Property Rights [in short "TRIPS agreement"] as
against India's obligation to protect the health of its citizens. [See: Doha
declaration on the TRIPS agreement and Public Health dated
14.11.2001].
xxxiv. In this context, it was emphasized that when Section 13(1)(b) is read with
Section 64(1)(a) of the Act, it would show that it allows the examiner to
invoke anticipatory prior art even where the claim made in another
complete specification filed in India is dated before or has a priority date
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earlier than the patent application placed before him for examination to
ascertain whether the invention of the subject matter is the same.
A. In other words, unlike other grounds of anticipation which require
prior publication of documents sought to be used as anticipatory
prior art Section 13(1)(b) makes an exception. There is, in fact, no
statutory exception or defence provided to anticipation by prior
claiming. Therefore, once it is established [and, in this case,
admitted by the plaintiffs] that DAPA is covered by the claims of
genus patent IN 147, the plaintiffs cannot be heard to say that
anticipation by prior claiming is not established under Section
64(1)(a) of the Act since DAPA, while being covered by the claims
of IN 147 only because it is not disclosed by the said patent.
B. It is important to note that for a defendant to establish prior
claiming, it is not important to show that the prior art contained in
the prior patent is identical to the impugned claim in the impugned
patent. All that the defendant has to establish is that the subject
matter claimed that the impugned patent falls within the scope or is
covered by the prior claim of the prior patent. In the facts of the
instant case since the prior claim of IN 147 such as 1, 14 to 26
being broader, encompass within their scope, the entire principal
claim of the impugned patent i.e. IN 625, it renders the entire
principal claim of IN 625 vulnerable to revocation.
C. Significantly, Section 64(1)(a) read with Section 13(1)(b) of the
Act only requires coverage of the subject matter by a prior claim,
there being no requirement of disclosure whatsoever. This, though,
is without prejudice to the submission of the defendants that DAPA
is, in fact, disclosed in IN 147. If this position is held to be true,
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then, the stand taken by the plaintiff that DAPA is covered but not
disclosed will not help its cause. In this regard, it has to be borne in
mind that Section 11 of the Act requires that every claim of a
patent is based on a matter which is fairly disclosed.
xxxv. In the instant case, preferred embodiments leading to DAPA form
structure claimed in claims 1, 14, 15 and 26 are expressly set out in
internal pages 29 and 33 of the complete specification of IN 147 wherein
ethyl for the alkyl group and chlorine for halogen are specifically
captured as most preferred embodiments. Therefore, not only is DAPA
covered by claims of IN 147, as is admitted by the plaintiffs, the said
claims are, as indicated above, supported by the disclosure of the
specification.
xxxvi. IN 625 is also vulnerable on the ground of prior publication. This is
evident if one were to read section 64(1)(e) along with Section 13(2) of
the Act. In the instant case, IN 625 is liable to be revoked on the ground
of lack of novelty due to prior publication of WO2001/27128 [in short
"WO'128"] which is the PCT equivalent of the genus patent IN 147.
WO'128 was published on 19.04.2001 whereas the priority date of IN
625 admittedly is 20.05.2002.
xxxvii. A careful perusal of WO'128 with IN 625 would show that the written
description qua the background of respective purported inventions is
identical. A perusal of the detailed description of two documents would
also show that in large swathes they are identical and is, therefore, a
classic case of cut, copy, paste. Besides this, the description of preferred
embodiments substituents possible combinations with other
pharmaceutical ingredients and suggestive doses are all identical. What is
ironical and also similar is: that there is a complete absence of any
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example concerning actual pharmaceutical formulation containing
purportedly novel compounds in either document. There is, in both
documents, a complete absence of any data relating to efficacy let alone
significant enhancement of efficacy or indeed any activity whatsoever.
xxxviii. The balance of convenience is in favour of the defendants since they
would be manufacturing their drug in India which would generate
employment and align with the policies of Government of India i.e. Make
in India. The plaintiffs, on the other hand, would be importing their
product for marketing in India.
xxxix. The plaintiffs are guilty of misrepresentation and concealment. The
plaintiffs have concealed relevant facts from the Indian Patent Office at
the time of filing patent application for IN 625 including the following.
▪ The plaintiffs already hold a valid patent which discloses the sale
compound i.e. DAPA;
▪ As per the plaintiffs' own admission, IN 625 is part of a catalogue
of patents including IN 147, therefore, it was incumbent on the
plaintiffs to disclose the same to the examiner
▪ The Plaintiffs have failed to disclose material particulars of their
corresponding US patents which is violative of Section 8(2) of the
Act.
▪ The plaintiffs failed to disclose the non-final rejection letter issued
by USPTO dated 30.07.2002 and the terminal disclaimer dated
19.07.2002 field in response thereto to the said objection.
xl. The plaintiffs have failed to demonstrate irreparable injury. Irreparable
injury is understood to be an injury which is not monetarily compensable.
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There is no presumption qua irreparable injury where the validity of a
patent has not been tested in litigation. [See: Nutrition 21 vs. The United
States of America, US 930 F.2d 867] This principal is important for cases
in India as there is no presumption of validity in India as provided in
Section 13(4) of the Act.
xli. There are at least two entities i.e. Sun and Abbott which have obtained a
license qua IN 625. The packaging of the two products which are used by
Sun and Abbott establish this fact. Therefore, the plaintiffs, clearly, have
not sought market exclusivity but have shown willingness to monetise the
patent via licensing. The logical sequitur of this would be that the royalty
payable by the aforementioned licensees could provide a reasonable basis
to assess the damages if the plaintiffs were to finally succeed in the
instant actions. [See: Polymer Technologies, Inc. vs. Bridwell, 103 F.3d
970, 974 (Fed.Cir.1996); T.J. Smith and Nephew Ltd. vs. Consolidated
Medical Equip. Inc., 821 F.2d 646; and Dynamic Mfg. Inc. vs. Craze,
No. 97-1165, 1998 WL 241201]
xlii. The defendants being large enterprises who possess financial wherewithal
and are not fly by night operators would be able to pay damages if proved
under the law.
xliii. Furthermore, without prejudice to the contentions made hereinabove,
interim injunction ought to be denied to the plaintiffs given the
considerations of the public interest.
xliv. The plaintiffs and their aforementioned licensees [i.e. Sun and Abbott]
are marketing DAPA under various brand names such as FORXIGA,
XIGDUO, OXRA, GLADEPA and various fixed dose combinations at
Rs. 54.4 for a 5-milligram dose and Rs. 57.29 for a 10-milligram dose.
Thus, a strip of 14 tablets would cost, qua the aforesaid dosages, between
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Rs. 761.60 and Rs. 802.90 respectively. The cost per patient vis-à-vis
plaintiffs' drug in the market would range approximately between Rs.
1523.20 and Rs. 1605.80. As against this, the defendants propose to sell
their drugs for Rs. 13.90 for 5-milligram and Rs. 17.50 for a 10-milligram
dose. Thus, a strip comprising of 14 tablets would have a price range of
Rs. 194.60 and Rs. 245 respectively. Thus, the drugs manufactured by the
defendants would lay a financial burden on a patient that would range
between Rs. 490 and 554.50 per month. The difference in percentage
would be approximately 250%.
xlv. More importantly, in the present times when the Coronavirus pandemic is
prevalent, the probability of a diabetic person being afflicted with the
virus is exponentially high.
Rejoinder arguments on behalf of the plaintiffs: -
9. In the rejoinder, the plaintiffs were led by Mr. Harish Salve, learned
senior counsel, who addressed arguments, in some detail, with regard to two
aspects:
a. First, the true and correct ratio of the Novartis judgement.
b. Second, the applicability of Section 53(4) of the Act to the instant case.
10. In respect of the first aspect, Mr. Salve drew my attention to various
paragraphs of the Novartis judgement to demonstrate that the said judgement
concerned, essentially, the applicability and interpretation of Section 3(d) of the
Act [along with the explanation appended thereto] in the context of facts
obtaining in that case. It was sought to be pointed out by Mr. Salve that Novartis
before the Supreme Court had inter alia contended that beta crystalline imatinib
mesylate was a new invention qua which there were no teachings in the earlier
patent i.e. the Zimmerman patent.
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10.1 It was pointed out that Novartis had argued that while imatinib-in-free-
base was claimed in the Zimmerman patent, there were no teachings in the
Zimmerman patent on how to prepare imatinib mesylate from the former and
that there was no mention of polymorphism or crystalline structure in the said
patent.
10.2 Mr. Salve endeavoured to demonstrate that it was, in this context, that
one of the arguments, which was advanced on behalf of Novartis was that while
imatinib mesylate was covered by the Zimmerman patent, it was not disclosed
therein and that coverage or claim in a patent was distinct from the disclosure
made in a patent.
10.3 In other words, the boundary laid out by the claim for coverage is
permitted to be wider than disclosure or enablement or teaching in a patent. It
was sought to be pointed out that in Novartis case, on facts, the Supreme Court
found that the US Board of Patent Appeals had noticed that the Zimmerman
patent taught the person skilled in the art how to use imatinib - a compound of
formulae 1 or a pharmaceutically acceptable salt thereof in a pharmaceutical
composition for treating tumours or a method of treating warm-blooded animals
suffering from a tumoral disease.
10.4 Apart from this, as pointed out by Mr. Salve, the Supreme Court had also
noticed the fact that in an article published in a journal going by the name
Cancer Research and Nature Medicine [which was co-authored by several
persons including Jurg Zimmerman], there was a detailed discussion about anti-
tumoral properties of imatinib and its methanesulfonate salt i.e. imatinib
mesylate. My attention was drawn also to the fact that the Court noticed yet
another article published in the aforementioned journal in which there was a
discussion about imatinib designed to inhibit Abl Protein-Tyrosine Kinase in
Vitro and in Vivo by a 2-phenulaminopyrimidine derivative.
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10.5 Mr. Salve, thus, submitted that it was in this background that the Supreme
Court concluded that imatinib mesylate was not a new product and that it was a
known substance seen in the Zimmerman patent. Furthermore, Mr. Salve
pointed out that the Supreme Court said that for imatinib mesylate to be
construed as a new product i.e. an invention it should have features which
involved technical advance over existence knowledge and would make
invention not obvious to the person skilled in the art.
10.6 In short, Mr. Salve submitted that the observations made in paragraphs
118 and 119 of the Novartis case concerning coverage and disclosure have to be
understood in this context. According to Mr. Salve, what was emphasized was
that Novartis was not able to prove inter alia therapeutic efficacy of its claimed
invention. It was emphasized that what the Court disapproved was, perhaps,
clever drafting of descriptions and specifications which, then, are used as a ploy
to extend the validity period of the patent.
10.7 According to Mr. Salve, the Court did not do away with the Markush
structure which is what the plaintiffs are relying upon in the instant case and
that this aspect is evident if one were to carefully peruse the observations made
in paragraph 134 of the Novartis case.
10.8 As regards, Section 53(4) of the Act, Mr. Salve contended that it had no
application to the facts obtaining in the instant case.
11. Mr. Sudhir Chandra, learned senior counsel, in rejoinder, concentrated on
the aspects concerning balance of convenience apart from what was stated in the
opening by him which was recorded in my order dated 01.10.2020.
12. Mr. Anand also made submissions in rejoinder and submitted an
additional note of written submissions to counter the arguments raised by the
defendants and also distinguish the judgements cited by the defendants in
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support of their case.
Analysis and reasons: -
13. I have heard the matter, at some length, on 9 dates running into several
hours. Counsels on both sides have relied upon a plethora of documents,
pleadings, written submissions and judgements in support of their respective
stand. I have attempted to capture the significant parts of the submissions
advanced on both sides.
13.1 To my mind, what is important, at this juncture, is to bear in mind the
stage of the proceedings and, therefore, contextualise the submissions and
pleadings bearing this aspect in mind.
14. Given this backdrop, let me begin by noticing certain facts over which
there is no dispute.
i. First, the actions concern two patents i.e. the genus patent i.e. IN 147 and
the species patent i.e. IN 625.
ii. Second, the aforementioned patents have corresponding patents in the
USA i.e. US 126 [which is the genus patent] and US 117 [which is the
species patent]
iii. Third, the Indian genus patent i.e. IN 147 expired on 02.10.2020.
iv. The Indian species patent i.e. IN 625 expires on 15.05.2023.
v. The prayers made in the suit actions including the captioned interlocutory
applications seek injunction against purported infringement of not only
IN 147 but also of IN 625. The suit actions were filed on 30.09.2020 i.e.
two days prior to expiry of validity period of IN 147 which, as indicated
above, ended on 02.10.2020.
vi. Before the USPTO, the plaintiffs filed a terminal disclaimer which, in
sum, meant that the validity period of the corresponding US patent i.e.
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US 126 [US genus patent] and US 117 [US species patent] would end on
the same date. The terminal disclaimer was filed by the plaintiffs as an
objection had been raised by the USPTO qua non-obviousness/double
patenting. The plaintiffs, of course, claim that such applications are filed
in the normal course in the USA to obviate objections raised by the
USPTO and that this step cannot be construed as an admission of the
objection qua obviousness and double patenting raised by USPTO.
vii. Apart from the plaintiffs, DAPA is being marketed with the permission of
the plaintiffs by two entities namely Sun and Abbott. The brand names,
under which DAPA is being marketed, are FORXIGA, XIGDUO,
OXRA, GLADEPA. The defendants claim that Sun and Abbott are
plaintiffs' licensees whereas the plaintiffs assert that these entities are
only their distributors. This fact is noted only in the context of the
argument advanced that damages if any caused, are compensable. This
aspect of the matter will be discussed by me in the latter part of the
judgement.
15. Thus, given the aforesaid broad points of reference, it would be important
to deal, in the very first instance, with the issue as to whether or not, at this
stage, I am required to ascertain the validity of IN 625 by conducting a mini-
trial. In other words, would it suffice from the defendants' point of view, given
the fact that the actions are at the stage where the plaintiffs are seeking a
preliminary injunction, to demonstrate that they have raised a credible challenge
to IN 625?
15.1 In this context, on behalf of the defendants, it was argued that a patent is
valid only till such time it is challenged and, therefore, there is no presumption
as to its validity. It was emphasized that a challenge could be raised both, at the
pre and post-grant of a patent, and also by way of revocation or counter-claim.
15.2 The plaintiffs, on the other hand, have sought to bring to fore the fact that
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because there has been no challenge to the suit patents either by way of pre or
post-grant challenge or even by way of revocation or counter-claim, up-until
2020, is the very reason why this Court should not countenance arguments
which seek to raise doubts qua the validity of the suit patents.
15.3 The plaintiffs argue that although given the scheme of the Act, there are
various stages at which validity of a patent can be challenged, it does not follow
that there is a presumption as to the invalidity of the patent. Mr. Chandra, in this
context, had cited the following judgements.
a) Order dated 15.03.2018, passed in CS (COMM) 737/2018, titled Pfizer
Inc. and Ors. vs. Nagesh Palepu and Ors.; and
b) Judgement dated 09.07.2015, passed in CS(OS) 442/2013, titled
Telefonaktiebolaget LM Ericsson (PUBL) vs. Mercury Electronics &
Anr.
16. Given the arguments and counter-arguments, it would be helpful if one
were to look to the scheme of the Act.
16.1 Section 25(1) accords leeway to oppose grant of a patent once an
application for the said purpose has been published. The grounds on which
opposition can be filed are set out in subclause (a) to (k) of Subsection (1) of
Section 25 of the Act.
16.2 Subsection (2) of Section 25 of the Act allows a person who is interested
in opposing the patent granted by the Controller by giving notice to him in the
prescribed manner on one or more grounds referred to in clause (a) to (k) of the
said subsection. However, the notice of opposition has to be given at any time
after the grant of the patent but before the expiry of the period of one year from
the grant of the patent. Pertinently, both under subsection (1) and (2), the
grounds of opposition are restricted to those referred to in the respective sub-
clauses.
16.3 Section 48 sets out the rights of the patentee subject to other provisions
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contained in the Act and conditions specified in Section 47. The section,
broadly, gives a right of exclusivity to the patentee whereby he can exclude
third parties from acts of making ["act of using" in a process patent], using,
offering for sale, selling or importing for the purposes indicated herein before,
that product ["that process" in the case of process patent] in India as long as
they do not have the consent of the patentee.
16.4 Section 64 of the Act confers a right revocation of a patent. Thus, any
person interested [or the Central Government] can seek revocation of a patent
by either moving the appellate board constituted under the Act or by filing a
counter-claim in an infringement suit filed before the High Court. This apart,
Section 105 confers an independent right to file a declaratory suit for non-
infringement.
16.5 Pertinently, the grounds of revocation are set out in subclause (a) to (q) of
subsection (1) of Section 64 of the Act. Besides this, there are special provisions
for seeking revocation of patent or amendment of complete specification
conferred on the Central Government in matters relating to atomic energy.
16.6 Likewise, Central Government can also seek revocation of a patent in the
public interest if it believes that the patent or the mode in which it is exercised is
mischievous to the State or generally prejudicial to the public, albeit, after
giving the patentee an opportunity of being heard in the matter.
17. Therefore, what is clear [and something which is conceded by both sides
as noticed above], a challenge can be laid either at the stage when an application
is moved for grant of a patent, albeit, after its publication or after its grant,
although, within the timeframe provided in the relevant provision or even by
seeking revocation by moving the appellate board or by way of a counterclaim
in the infringement suit.
18. All this, points in the direction that the interested third parties can lay
challenge to an invention which is the subject matter of either the patent
application or the patent at various stages. The clearest indication of the
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legislative intent is embedded in subsection (4) of Section 13. Section 13 is a
provision which empowers the examiner before whom an application for grant
of patent is placed to make investigations to ascertain if a patent is anticipated
by previous publication and/or by a prior claim.
18.1 In this context, subsection (4) makes it clear that examination and
investigations required under Section 12 or Section 13 shall not be deemed, in
any way, to warrant inter alia the validity of the patent. In other words, even
when the patent crosses the threshold of examination by the patent office, it
does not, as per the Statute, warrant its validity. Therefore, quite clearly,
irrespective of when the challenge is laid, the challenger [i.e. the person
interested] can put the patent in jeopardy. [See: Bishwanath Prasad Radhey
Shyam vs. Hindustan Metal Industries1, (1979) 2 SCC 511]
18.2 Thus, till the time the patent is invalidated i.e. revoked, the patentee has
the right to exclude third parties. Therefore, the observations made in Pfizer
Inc. and Ors. case and Telefonaktiebolaget LM Ericsson (PUBL) case cannot,
in my view, be read in a manner whereby they roil against express provisions of
the statute.
18.3 Furthermore, the argument advanced on behalf of the plaintiffs that since
the suit patents are old and thus, should be presumed to be valid cannot be
accepted for two reasons.
i. First, there is a period of overlap between the genus patent i.e. IN 147
and the species patent i.e. IN 625. The defendants, in this case, chose
This extract is taken from Bishwanath Prasad Radhey Shyam vs. Hindustan Metal
Industries, (1979) 2 SCC 511 at page 521.
"32. It is noteworthy that the grant and sealing of the patent, or the decision rendered by the
Controller in the case of opposition, does not guarantee the validity of the patent, which can
be challenged before the High Court on various grounds in revocation or infringement
proceedings. It is pertinent to note that this position viz. the validity of a patent is not
guaranteed by the grant, is now expressly provided in Section 13(4) of the Patents Act. 1970.
In the light of this principle, Mr Mehta's argument that there is a presumption in favour of the
validity of the patent, cannot be accepted."
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to wait [in line with arguments advanced in their defence of the suit
actions] till such time the validity period of the genus patent i.e. IN
147 expired.
ii. Second, as indicated above, the scheme of the Act does not foreclose
the right of the defendants in defence to an infringement action to
question the validity of the patent. Section 107 of the Act, expressly
confers a right on the defendants to raise, in defence, in an
infringement suit, all those grounds on which the patent can be
revoked under Section 64 of the very same Act. Therefore, the
judgement in Bristol-Myers Squibb Company and Ors vs. J.D. Joshi
and Ors., MANU/DE/1889/2015, if read in context, would
demonstrate that it has not emasculated the right of the defendant, as
conferred under the Act, to challenge the validity of the patent. The
presumption of validity exists only till such time the patent is
challenged - a challenge which is credible and no further. In my
opinion, if the plaintiffs' argument was to be accepted, then, it would
have to be held that the older the patent, the stronger the firewall. Such
an interpretation, in my view, would be contrary to the plain words of
the Statute.
19. The next question which arises for consideration is: at the stage of
preliminary injunction, what is the threshold that the challenger has to meet? In
other words, is the challenger required to demonstrate that the patent is invalid
or is the challenger required to establish that the patent is vulnerable and that the
validity is not vexatious.
19.1 This issue came up for consideration before a Division Bench of this
Court in F. Hoffmann-LA Roche Ltd. & Anr. vs. Cipla Ltd., 2009 (110) DRJ
452 (DB), wherein, the Court clearly set out the judicial standard which ought to
operate at the preliminary injunction stage. The Court, in no uncertain terms,
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stated that validity of a patent is required to be looked at the stage of trial.
19.2 However, at the stage of preliminary injunction all that the defendant is
required to demonstrate is that she/he has made a credible challenge or that the
patent is vulnerable and that validity is not vexatious. The relevant observations
made by the Division Bench in this behalf are extracted hereafter.
"53. The plea of the plaintiff that since there is a multi-layered, multi-level
examination of the opposition to the grant of patent it should accorded the highest
weightage, is not entirely correct. The contention that there is a heavy burden on the
defendant to discharge since it has to establish that it has a stronger prima facie case of
the plaintiff is contra indicated of the decisions in the context of Section 13(4). Reference
may be made to the decisions in Biswanath Prasad Radhey Shyam v. Hindustan Metal
Industries, AIR 1982 SC 1444 : PTC (Suppl)(1) 731 (SC), Standipack Pvt. Ltd. v. Oswal
Trading Co. Ltd., AIR 2000 Del 23 : 1999 PTC (19) 479 (Del), Bilcare Ltd. v. Amartara
Pvt. Ltd., 2007 (34) PTC 419 (Del), Surendra Lal Mahendra v. Jain Glazers, (1979) 11
SCC 511. In Beecham Group Ltd. v. Bristol Laboratories Pty Ltd., (1967-1968) 118 CLR
618 and Australian Broadcasting Corporation v. O'Neill, (2006) 229 ALR 457 it was held
that the defendant alleging invalidity bears the onus of establishing that there is "a
serious question" to be tried on that issue. In Hexal Australai Pty Ltd. v. Roche
Therapeutics Inc., 66 IPR 325 it was held that where the validity of a patent is raised in
interlocutory proceedings, "the onus lies on the party asserting invalidity to show that
want of validity is a triable question." In Abbot Laboratories v. Andrx Pharmaceuticals
Inc. (decision dated 22nd June 2006 of the U.S. Court of Appeals for the Federal Circuit
05-1433) the Court of Appeals followed its earlier ruling in Helifix Ltd. v. Blok-Lok
Ltd. 208 F.3d 1339 where it was held (at 1359): "In resisting a preliminary injunction,
however, one need not make out a case of actual invalidity. Vulnerability is the issue at
the preliminary injunction stage, while validity is the issue at trial. The showing of a
substantial question as to invalidity thus requires less proof than the clear and
convincing showing necessary to establish invalidity itself." (emphasis supplied)
In Erico Int'll Corprn v. Vutec Corprn (U.S. Court of Appeals for the Federal Circuit,
2007-1168) it was held that the "defendant must put forth a substantial question of
invalidity to show that the claims at issue are vulnerable."
54. In the present case, the grant of a patent to the plaintiffs for Erlotinib
Hydrochloride as a mixture of Polymorphs A and B will not ipso facto entitle them to an
interim injunction if the defendant is able to satisfy the court that there is a serious
question to be tried as to the validity of the patent. The use by the learned Single Judge
of the expressions "strong credible challenge", "arguable case" or that the defendants
claim being not unfounded, cannot be termed as vague and inconsistent since they
convey the same meaning in the context of the strength of the defendant's challenge.
55. The question before this Court is when can it be said that the defendant has raised
a credible challenge to the validity of a patent held by the plaintiff in an infringement
action? During the course of the argument it was suggested by counsel that the challenge
had to be both strong and credible. Also, the defendant resisting the grant of injunction
by challenging the validity of the patent is at this stage required to show that the patent is
"vulnerable" and that the challenge raises a "serious substantial question" and a triable
issue. Without indulging in an exercise in semantics, the Court when faced with a prayer
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for grant of injunction and a corresponding plea of the defendant challenging the validity
of the patent itself, must enquire whether the defendant has raised a credible challenge.
In other words, that would in the context of pharmaceutical products, invite scrutiny of
the order granting patent in the light of Section 3(d) and the grounds set out in Section 64
of the Patents Act 1970. At this stage of course the Court is not expected to examine the
challenge in any great detail and arrive at a definite finding on the question of validity.
That will have to await the trial. At the present stage of considering the grant of an
interim injunction, the defendant has to show that the patent that has been granted is
vulnerable to challenge. Consequently, this Court rejects the contentions of the
plaintiffs on this issue and affirms the impugned judgment of the learned Single
Judge."
[Emphasis is mine]
19.3 This view has been reiterated in Natco Pharma vs. Bear Healthcare
LLC, 2019 80 PTC 131 [See: paragraphs 17 to 21]; and Natco Pharma vs.
Bristol Myers Squibb Holding, 263 (2019) DLT 622 [See: paragraphs 34 and
35].
19.4 The reliance by the plaintiffs on Telefonaktiebolaget LM Ericsson
(PUBL) case is, in my view, misplaced as that case concerned decision on the
issue as to which of the contesting parties should be burdened with proving a
particular issue. Interestingly, the Court, while distinguishing the judgement
rendered in TEN XC Wireless Inc. & Anr. vs. Mobi Antenna Technologies
(Shenzhen) Co. Ltd., 2011 SCC OnLine Del 4648 : (2012) 187 DLT 632 made
the following observations.
10. Reliance on Bishwanath (supra) and Ten XC Wireless (supra) by the learned
counsel for the defendants is also misplaced. In fact, Bishwanath was premised on
Section 13(4) of the Patents Act, according to which there is no presumption of validity of
a patent only to the extent that no liability shall be incurred by the Central Government
or any other officer thereof in connection with the grant of patent. In Ten XC Wireless,
no presumption was drawn in favour of the patent only for the purposes of an interim
injunction and not for onus of proof.
[Emphasis is mine]
19.5 Likewise, a perusal of the order in Pfizer Inc. and Ors. case shows that
the defendants in that case did not make any submission as to how the challenge
raised by them qua the patent-in-issue was credible. It is in this context, that the
Court granted the injunction. Pertinently, this order was passed when the suit
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was listed for issuance of summons and notice in the interlocutory application.
The defendants, obviously, at that stage had no chance of showing to the Court
that there was a credible challenge to the patent-in-issue. The Court left that
window open by observing as follows.
"... Of course, this would not debar the defendants to raise a substantial, tenable and
credible challenge in its pleading."
19.6 This judgement is distinguishable as in the instant suit actions the
defendants have raised a credible challenge as discussed hereafter.
19.7 Similarly, J.D. Joshi case is distinguishable as the Court came to a prima
facie conclusion that the plaintiffs had a valid patent and the defences raised did
not enable it, at that juncture, to doubt the validity of the patent. [See: paragraph
88 in J.D. Joshi] Such is not the position in the present case.
ARE THE SUIT PATENTS VULNERABLE?
20. The challenge to the species patent i.e. IN 625 is, broadly, laid on the
following five grounds.
i. First, since IN 147 expired on 02.10.2020 and according to the
admissions made by the plaintiffs in various paragraphs of the plaint that
DAPA is covered in the suit patents, in particular, in the genus patent i.e.
IN 147, it cannot be protected in terms of Section 53(4) of the Act.
ii. Second, IN 625 is vulnerable to revocation under Section 64(1)(a) read
with Section 13(1)(b) of the Act on the ground of lack of novelty in view
of prior claiming by the genus patent i.e. IN 147.
iii. Third, IN 625 is vulnerable to revocation under Section 64(1)(e) of the
Act on the ground of lack of novelty due to prior publication of WO'128
which is the PCT equivalent of the genus patent i.e. IN 147.
iv. Fourth, IN 625 is vulnerable to revocation under Section 64(1)(f) of the
Act as it lacks inventive step as provided in Section 2 (1) (ja) i.e. lacks
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technical advance or economic significance and is obvious to a person
skilled in the art.
v. Lastly, IN 625 is vulnerable to revocation under Section 64(1) of the Act
in view of the failure of the plaintiffs to make full and fair disclosure as
required under Section 8 of the Act.
21. Insofar as the first aspect is concerned, let me quote the relevant extracts
from some of the paragraphs in the plaint.
CS (COMM) 410/2020
"16. The Plaintiffs' suit patents IN 205147 [genus patent] and IN 23 5 625 [ species
patent] cover the Plaintiffs' drugs comprising inter alia its invention
DAPAGLIFLOZIN, which are made available by the Plaintiff under the brands
FORXIGA, XIGDUO, XIGDUO XR, XIGDUO IR, QTERN.
xxx xxx xxx
V. THE PLAINTIFFS' SUIT PATENTS
22. DAPAGLIFLOZIN falls within the scope of the Plaintiffs Indian Patent
Numbers IN 205147; IN 235625. ...
36. DAPAGLIFLOZIN is covered by the Markush claim in patent IN '147. However, it
is specifically disclosed only in patent IN 235625 (IN '625) and falls within the scope
of claim 1 thereof which specifically claims said compound as well as
pha11naceutically acceptable salts, stereoisomers, or prodrug esters thereof. Further,
claim 2 of the suit paten t IN '625 claims pharmaceutical 32 compositions prepared
using DAP AGLIFLOZIN. The Plaintiffs have filed a copy of the complete
specification and granted claims of IN '625 in the present proceedings and are not
extracting the above claims for the sake of brevity."
[Emphasis is mine]
21.1 There are several other paragraphs, for instance, paragraphs nos. 56 and
86 of the plaint filed in CS (COMM) 410/2020, wherein, a similar averment has
been made by the plaintiffs.
21.2 The fact that IN 147 has been worked commercially in India cannot be
disputed if one were to peruse Form 27 filed by the plaintiffs in consonance
with the provisions of Section 146(2) read with Rule 131 of The Patent Rules,
2003 [in short "Rules"].
21.3 The fact that PTE applications were moved for the extension of the term
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of US 117 is not in dispute. It is not in dispute that both applications concerned
the drug Farxiga which is the brand name for the compound DAPA. The
documents on record show that the USPTO informed the plaintiffs via
AstraZeneca Medimmune through "notice of final determination and
requirement for election" that they needed to elect one of the two PTE's. The
relevant extract from the aforementioned communication is set forth below.
"ASTRAZENECA MEDIMMUNE
One Med.Immune Way
Gaithersburg MD 20878
In Re: Patent Term Extension
Application for
U.S. Patent No. 6,515,117
June 15, 2020
A determination has been made that U.S. Patent No. 6,515,117, claims of which cover
the human drug product and methods of using the human drug product known by the
tradename FARXIGA~ (dapagliflozin), is eligible for patent term extension under 35
U.S.C. § 156. The period of extension has been determined to be 5 years.
xxx xxx xxx
Applicant also has applied for patent term extension of U.S. Patent No. 6,414,126
based on the regulatory review period for the human drug product, FARXIGA®
(dapagliflozin), of NDA 202293.
When patent term extension applications are filed for extension of the terms of
different patents based upon the same regulatory review period for a product, the
certificate of extension is issued to the patent having the earliest date of issuance
unless applicant elects a different patent. In the absence of an election by applicant
within one month of the date of this notice, and in accordance with 37 CFR L785(b),
the application for patent term extension in the above-identified patent will be denied.
Accordingly, the application for patent term extension of the patent having the earlier
date of issuance will be granted. A certificate of extension will be issued to U.S.
Patent No. 6,414,126, for 5 years. In the absence of such request for reconsideration
and if U.S. Patent No. 6,515.117 is elected, the Director will issue to the applicant a
certificate of extension, under seal, for a period of 5 years in U.S. Patent No. 6,515,
xxx xxx xxx
Upon issuance of the certificate of extension, the following information will be
published in the
Official Gazette:
U.S. Patent No.: 6,515,117
Granted: February 4, 2003
Original Expiration Date2: October 4, 2020
Applicant: Ellsworth et al.
Owner of Record: AstraZeneca AB
Title: C-Aryl Glucoside SGL T2 Inhibitors and Method
Product Trade Name: FARXIGA® (dapagliflozin)
Term Extended: 5 years
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Expiration Date of Extension: October 4, 2025"
[Emphasis is mine]
21.4 It is in response to the aforesaid notice that election was made seeking an
extension of US patent 117 from the date of its expiration which was
04.10.2020 for 5 years i.e. till 04.10.2025. The response gave up the request
made in the PTE application filed qua US patent 126. This is evident from the
following extract taken from the communication issued in that behalf.
"RESPONSE TO NOTICE OF FINAL DETERMINATION AND
REOUIREMENT FOR ELECTION
In response to the Notice of Final Determination and Requirement for Election dated
June 15, 2020, pursuant to 35 U.S.C. § 156(c)(4), Applicant hereby elects the
Certificate of Extension to be issued to U.S. Patent No. 6,515,117 for a period of 5
years from the date of expiration and not for U.S Patent No. 6,414,126 in
connection with the patent term extension filed for the approved pharmaceutical
product FARXIGA® (dapagliflozin)."
[Emphasis is mine]
21.5 Likewise, in an infringement action filed against Zydus Pharmaceuticals
(USA) Inc., in the US district court for the District of Delaware, inter alia
assertions have been made by Astra Sweden that grant of approval by the US
FDA for its 5mg and 10 mg DAPA tablets which are generic versions of the
drug sold under the brand name Farxiga would infringe at least claim no. 1 and
claim no. 26 of US patent 126. Claim no. 1 and 26 of US patent 126 is identical
to/or similar in structure to claim no. 1 and 27 of corresponding claims made in
IN 147.
21.6 Therefore, the fact that both in the pleadings and in the aforementioned
documents, there is a definitive assertion that DAPA is covered in both the
genus patents granted in USA and India i.e. US 126 and IN 147 cannot be
disputed. The plaintiffs, however, submit [and an averment to that effect has
been made in paragraph 28 of the plaint], that while DAPA is covered in IN
147, it is not disclosed. The plaintiffs rely upon the Markush structure in support
of their plea.
21.7 Markush structure or Markush claim/group is a methodology employed
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by a patent drafter to select a particular element of the invention wherein all
elements share a common characteristic. Thus, a patent drafter who does not use
a Markush claim/group would be required to write a series of alternate
dependent claims claiming use of each of the elements selected from the group.
In a nutshell, Markush claim allows a patent drafter to condense a multitude of
alternate dependent claims into one single claim2.
21.8 The argument advanced on behalf of the plaintiffs that coverage does not
necessarily include disclosure is founded on the Markush claim/group. It is also
contended by the plaintiffs that the judgement of the Supreme Court did not
close this gap between what is covered and that which is disclosed. The
emphasis, in this behalf, was laid on paragraph 134 of the Novartis case. This
argument though was apart from the other features of the Novartis case which
were sought to be highlighted to establish that case was distinguishable on facts
from those obtaining in the instant suit actions.
21.9 Mr. Vaidyanathan, on the other hand, relied upon portions of the Novartis
case to demonstrate that in the very least what is claimed is certainly disclosed;
although according to him, the observations in paragraph 118 and 119 of the
Novartis case obliterate the distinction between coverage and disclosure. In
support of this plea, Mr. Vaidyanathan pointed out the submissions advanced by
the counsel for Novartis before the Supreme Court to the effect that imatinib
mesylate which was covered in the Zimmerman patent was not disclosed - a
submission which was ultimately rejected by the Supreme Court.
22. In my view, the fact that the plaintiffs have taken out an infringement
action both for IN 147 and IN 625 is a sufficient clue, at least at this juncture,
that DAPA is claimed in both suit patents. It seems incongruous to me that a
patent holder can take out an infringement action for a patent and yet aver it is
See: Eric, Markush Claims, what are they, when should I use one, and how do I use one?
Jafari Intellectual Property Law (June 2014), Available at:
https://www.jafarilawgroup.com/markush-claims-use-one-use-one/, last accessed on
26.10.2020 at 16:00 hours.
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not disclosed.
22.1 This is especially so as under our Act the "complete specification"
provision encapsulated in various subclauses of subsection (4) of Section 10
require setting out by an applicant who seeks grant of patent to fully and
particularly describe the invention and its operation or use and the method by
which it is performed, disclose the method of performing the invention which is
known to her/him and for which she/he is entitled to claim protection and end
with a claim or claims defining the scope of the invention. [See: Section
10(4)(a) to (c)] The applicant is also required to provide an abstract of technical
information qua the subject invention. The claim or claims forming part of
complete specification inter alia are required to be "fairly based on the matter
disclosed in the specification" [See: Section 10(5) of the Act].
22.2 Therefore, in my view, the defendants' submission that IN 625 should be
revoked on account of prior claiming under the provisions of Section 64(1)(a) of
the Act has substance, at least at this stage.
22.3 What lends credence to this plea are the provisions of Section 13 (1) (b)
of the Act which require the examiner to ascertain as to whether the application
referred to him for investigation under Section 12 adverts to an invention which
is anticipated by a prior claim. Section 13 (1) (b), simply put, allows an
examiner to make use of an Indian patent application or an Indian patent which,
though published, after the impugned patent bears a priority date which is
earlier than the impugned patent. The fact that the said patent was published
after the impugned patent does not come in the way of the investigation carried
out by the examiner.
22.4 In the present case, the Indian genus patent i.e. IN 147 bears the priority
dates 12.10.1999 and 05.04.2000 whereas the Indian species patent i.e. IN 625
bears 20.05.2002 as its priority date. For the purposes of Section 64(1)(a) this
ingredient is sufficient. Therefore, as long as the defendant can establish that the
inventions so far claimed in any claim of the complete specification [in this case
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IN 625] was claimed in a valid claim of an earlier priority date contained in the
complete specification of another patent [i.e. IN 147] - a ground for revocation
is made out.
22.5 I must indicate that the plaintiffs, in support of their submission, have
cited the judgement rendered by the English Court of Appeal in Daikin Kogyo
Co. Ltd. (Shingu and Another's) Application, (1974) R.P.C. 18. This was a
case where grant of process patent was opposed on the grounds of prior claim
and insufficiency of description. The specification related to a process for
making tetrafluoroethylene [TFE] by pyrolysis of chlorodifluoromethane
[CDM] with water vapour. Furthermore, it was specifically asserted that the
invention insofar as claimed in Claim 2 of the application in suit is claimed in
Claim 21 of the opponent's patent.
22.6 The Court ultimately concluded that the process claimed differed in terms
of steps and features. One specific feature that the Court noticed was that
surface to volume ratio had to be less than 130 reciprocal metres, a feature
which was not contained in example 2 of the cited patent. The Court noted that
the reaction zone was such that the surface to volume ratio was over 130.
Importantly, the Court based its decision on an earlier judgement rendered in
Kromshroder's Patent [1960] R.P.C. 75. The Court of Appeal also noted the
judgement rendered in Merck & Co. (Macek's) Patent, [1967] R.P.C. 157
which was a case of revocation based on prior claiming. Pertinently, the Court
of Appeal did not, in any manner, dilute the ratio of the Merck & Co. (Macek's)
case. The facts in Merck & Co. (Macek's) case reveal that 4 claims of the letters
patent in the suit read as follows.
"The four claims of the letters patent in suit read as follows :
1. A composition having enhanced bactericidal activity comprising novobiocin
in combination with at least one other antibiotic selected from the following,
namely, penicillin, tetracycline, oxytetracydine, chlortetracycline, streptomycin,
chloramphenicol, bacitracin, neomycin, spiramycin, streptothricin and grisein.
2. A composition as claimed in claim 1 in which the antibiotics are incorporated
in a solid carrier.
3. A composition as claimed in claim 1 in which the antibiotics are incorpora- ted in a
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parenteral liquid.
4. A composition as claimed in claim 1 in which the antibiotics are incorpora- ted in
an ointment vehicle."
22.7 Noticing the aforementioned claims, the Court observed that Claim 1 is
comprehensive which permits alternative additions to novobiocin which
alternative additions consist of one or more of the named antibiotics. According
to the Court, it was a convenient submission of what, in effect, were number of
separate claims to different compositions of which some would relate to
compositions having two ingredients and some to three or more ingredients.
22.8 The Court went on to re-write the claim to make plain this differentiation.
The patentees contended [an aspect which was noticed by the Court] that such
notional dismemberment of their claim necessarily involved destruction of the
generality of the inventive step and, thus, deprived them of the real
differentiation between what they sought to protect and that which was cited as
prior document. The Court, in this background, made the following pertinent
observations.
"They point to the phraseology of section 14 of the Patents Act, 1949. wherein the
ground of objection is set out, and urge that the phrase "the invention so far as
claimed in any claim" should be construed to mean the inventive step taken by the
patentee to the full extent to which the claim covers it and not to the area of the
monopoly which the claim confers. They seek to support their contention by pointing
to the emphasis laid upon the phrase by the judgment of the Court of Appeal in the
Kromschroder ease; and referer.ee to the report shows that, without actually
defining its precise significance, the court took it to require that the invention
claimed in the later patent should be the subject of a distinct claim to protection in the
earlier patent, and to justify rejection of the plea of prior claiming where "the
invention in question is only covered or comprehended by the claim as being a part or
integer (however important) of some wider combination or arrangement which and
which alone is the subject matter of the claim." (See page 82, lines 27 to 30.)
sThe 1949 Act introduced this phrase 44 the invention so far as claimed in any claim"
not only in section 14 (l)(c) but elsewhere in the Act and in particular in section
14(1)(b) (prior publication), section 14(l)(d) (prior user) and section 14(l)(e)
(obviousness). The acceptance of the principle of multiple priorities required some
such introduction, so that it cannot be assumed that Parliament in phrasing the
alteration as it did was intending 5 to do more than to adjust the Act to accord with
this principle. It would be a matter of surprise if, in purporting to do this, the
legislature had made a fundamental alteration in the principles by which the validity
of claimed monopolies has hitherto been determined.
xxx xxx xxx
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There would appear to be no ground for construing the phrase "the invention so far
as claimed in any claim" in different senses in the sub-divisions of section 14(1), so
that, if the cited prior claim on its fair construction can be seen to grant as a
manner of manufacture that which the later claim on its fair construction would re-
monopolise, the objection of prior claiming is established, and this despite the
inclusion in the later claim of variants of the manner of manufacture to which no
objection can properly be raised. The later circumstance will of course be of concern
in the determination of the relief to be accorded if and when the plea is established,
but it cannot shield a vulnerable embodiment of the invention claimed from attack on
the ground of preclaiming any more effectively than it can from the other objections
available at the opposition stage."
[Emphasis is mine]
22.9 In my view, the facts in the instant suit action are closer to those which
obtain in Merck & Co. (Macek's) case. As noticed above, in the Daikin Kogyo
case, the Court found that the features were different.
23. The plaintiffs also cited the decision of U.S. Court of Customs and Patent
Appeals [CCPA] rendered in Application of Virgil W. Vogel and Paul W.
Vogel, 422 F.2d 438 (C.C.P.A. 1970) in support of their stand.
23.1 This appeal arose from a decision of the Patent Office Board of Appeals
whereby rejection of claims 7, 10 and 11 in the appellant's patent application
for "Process of Preparing Packaged Meat Products for Prolonged Storage" was
affirmed. In this case, the sole ground of rejection of claims 7, 10 and 11 was
that they were unpatentable over appellant's co-pending patented claims in
Vogel et al in view of Ellies.
23.2 It was typically a double patenting type of rejection. The CCPA viewed
the matter from two angels. First, was it the same invention i.e. identical subject
matter? Second, whether the claim in the application, defined merely an obvious
variation of an invention disclosed and claimed in the patent. Insofar as the first
aspect was concerned, the CCPA observed as follows.
"The first question is: Is the same invention being claimed twice? The answer is no.
The patent claims are limited to pork. Appealed claims 7 and 10 are limited to meat,
which is not the same thing. Claims 7 and 10 could be infringed by many processes
which would not infringe any of the patent claims. Claim 11 is limited to beef. Beef is
not the same thing as pork."
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23.3 As regards the other aspect which is whether the appeal claim defined
merely an obvious variation of the invention disclosed, the CCPA noted that the
appeal Claim 11 recited beef which did not read on the pork process disclosed
and claimed in the patent. The CCPA, thus, concluded that Claim 11 did not
define merely an obvious variation of the pork process. It found that the specific
time and temperature consideration concerning pork might not apply to beef.
Accordingly, it held that Claim 11 did not present any kind of double patenting
situation. However, in the case of Claim 10, it made the following pertinent
observations.
"Appealed claim 10, supra, will now be considered. It recites a process to be
performed with "meat." "Meat" reads literally on pork. The only limitation appearing
in claim 10 which is not disclosed in the available portion of the patent disclosure is
the permeability range of the packaging material; but this is merely an obvious
variation as shown by Ellies. The answer to the second analysis question, therefore, is
yes, and the claim is not allowable in the absence of a terminal disclaimer. The
correctness of this conclusion is demonstrated by observing that claim 10, by reciting
"meat," includes pork. Its allowance for a full term would therefore extend the time of
monopoly as to the pork process. It is further noted that viewing the inventions in
reverse order, i. e. as though the broader claims issued first, does not reveal that the
narrower (pork) process is in any way unobvious over the broader (meat) invention
disclosed and claimed in the instant application. The same considerations and result
apply to claim 7.
The decision of the board is affirmed as to claims 7 and 10 and reversed as to claim
11."
24. Furthermore, qua the arguments advanced on behalf of the plaintiffs that
DAPA, though, covered in IN 147, was not disclosed therein, is answered, to
my mind, by the judgement of the United Kingdom Supreme Court [UK SC] in
Regeneron Pharmaceuticals Inc (Respondent). vs. Kymab Ltd. (Appellant),
(2020) UKSC 27 [Majority view 4:1].
24.1 This was a case where a dispute related to two patents obtained by
Regeneron Pharmaceuticals Inc. [RPI] with a priority date of 16.02.2001 and
each with substantially the same disclosure to justify different claims. The two
patents were briefly referred to as "287 patent" and "163 patent". The 163 patent
was divisional of 287 patent.
24.2 The challenge to the validity arose because RPI alleged infringement by
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Kymab Ltd. of Claim 1 in 163 patent and Claim 5 and 6 of 283 patent by
offering to the pharmaceutical industry its own transgenic mouse i.e.
"Kymouse" with reverse chimeric locus some of which included the whole of
the human variable segments in both the heavy and the light chain loci. The UK
SC was faced with a challenge to the aforementioned patents which sought to
confer monopoly over the creation of a range of transgenic mouse.
24.3 The Court observed that "in order to patent an inventive product the
patentee must be able to demonstrate (if challenged) that a skilled person can
make the product by the use of teachings disclosed in the patent coupled with
common general knowledge which is already available at the time of priority
date without having to undertake undue experimental burden or apply any
inventiveness on their own". This requirement, according to the UK SC, is
labelled as sufficiency. Applying this test, the Court culled out certain principles
which are set out in paragraph 56 of the judgement. A couple of principles that
the Court adverted to reads as follows.
"iii) Patentees are free to choose how widely to frame the range of products for which
they claim protection. But they need to ensure that they make no broader claim than is
enabled by their disclosure.
iv) The disclosure required of the patentee is such as will, coupled with the common
general knowledge existing as at the priority date, be sufficient to enable the skilled
person to make substantially all the types or embodiments of products within the
scope of the claim. That is what, in the context of a product claim, enablement means.
v) A claim which seeks to protect products which cannot be made by the skilled
person using the disclosure in the patent will, subject to de minimis or wholly
irrelevant exceptions, be bound to exceed the contribution to the art made by the
patent, measured as it must be at the priority date.
vi) This does not mean that the patentee has to demonstrate in the disclosure that
every embodiment within the scope of the claim has been tried, tested and proved to
have been enabled to be made. Patentees may rely, if they can, upon a principle of
general application if it would appear reasonably likely to enable the whole range of
products within the scope of the claim to be made. But they take the risk, if
challenged, that the supposed general principle will be proved at trial not in fact to
enable a significant, relevant, part of the claimed range to be made, as at the priority
date."
25. Applying these principles, it would have to be said that the arguments of
the plaintiffs that DAPA was not claimed in IN 147 seem to be untenable at this
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stage. The Regeneron Pharmaceuticals decision, in my opinion, has a greater
persuasive value than the decisions rendered in Eli Lily, Apotex, 2010 FCA 214
and Dr. Reddy's Laboratories (UK) Ltd vs. Eli Lilly and Co Ltd. (2009) EWCA
1362 cited on behalf of the plaintiffs, which are, distinguishable on facts.
25.1 It must be stated that it was portrayed on behalf of the plaintiffs that the
genus patent i.e. IN 147 ringfenced certain compounds which were disclosed
only when the species patent i.e. IN 625 was granted, which would, essentially,
mean that the written description/complete specification of IN 147 covered
DAPA but did not disclose it. To my mind, such written
descriptions/specifications would be flawed as it would prevent third parties
from carrying out research in future. The Federal Court, in an en banc decision
in Ariad Pharmaceuticals, Inc. vs. Eli Lilly and Company, 598 F.3d 1336,
made some pertinent observations in this behalf.
"The written description requirement also ensures that when a patent claims a genus
by its function or result, the specification recites sufficient materials to accomplish
that function--a problem that is *1353 particularly acute in the biological
arts.5 See Guidelines for Examination of Patent Applications Under the 35 U.S.C.
112, 1, "Written Description" Requirement, 66 Fed.Reg. 1099, 1105-1106 (Jan. 5,
2001). This situation arose not only in Eli Lilly but again in University of Rochester
v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed.Cir.2004). In Rochester, we held
invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by
administering a non-steroidal compound that selectively inhibits the COX-2
enzyme. Id. at 918. We reasoned that because the specification did not describe any
specific compound capable of performing the claimed method and the skilled artisan
would not be able to identify any such compound based on the specification's function
description, the specification did not provide an adequate written description of the
claimed invention. Id. at 927-28. Such claims merely recite a description of the
problem to be solved while claiming all solutions to it and, as in
Eli Lilly and Ariad's claims, cover any compound later actually invented and
determined to fall within the claim's functional boundaries--leaving it to
the pharmaceutical industry to complete an unfinished invention.
Ariad complains that the doctrine disadvantages universities to the extent that basic
research cannot be patented. But the patent law has always been directed to the
"useful Arts," U.S. Const. art. I, § 8, cl. 8, meaning inventions with a practical
use, see Brenner v. Manson, 383 U.S. 519, 532-36, 86 S.Ct. 1033, 16 L.Ed.2d 69
(1966). Much university research relates to basic research, including research into
scientific principles and mechanisms of action, see, e.g., Rochester, 358 F.3d 916, and
universities may not have the resources or inclination to work out the practical
implications of all such research, i.e., finding and identifying compounds able to
affect the mechanism discovered. That is no failure of the law's interpretation, but its
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intention. Patents are not awarded for academic theories, no matter how
groundbreaking or necessary to the later patentable inventions of others. "[A] patent
is not a hunting license. It is not a reward for the search, but compensation for its
successful conclusion." Id. at 930 n. 10 (quoting Brenner, 383 U.S. at 536, 86 S.Ct.
1033). Requiring a written description of the invention limits patent protection to
those who actually perform the difficult work of "invention"--that is, conceive of the
complete and final invention with all its claimed limitations--and disclose the fruits of
that effort to the public.
That research hypotheses do not qualify for patent protection possibly results in some
loss of incentive, although Ariad presents no evidence of any discernable impact on
the pace of innovation or the number of patents obtained by universities. But claims to
research plans also impose costs on downstream research, discouraging later
invention. The goal is to get the right balance, and the written description doctrine
does so by giving the incentive to actual invention and not "attempt[s] to preempt the
future before it has arrived." Fiers, 984 F.2d at 1171. As this court has repeatedly
stated, the purpose of the written description requirement is to "ensure that the scope
of the right to exclude, as set forth in the claims, does not overreach the scope of the
inventor's *1354 contribution to the field of art as described in the patent
specification." Rochester, 358 F.3d at 920 (quoting Reiffin v. Microsoft Corp., 214
F.3d 1342, 1345 (Fed.Cir.2000)). It is part of the quid pro quo of the patent grant and
ensures that the public receives a meaningful disclosure in exchange for being
excluded from practicing an invention for a period of time. Enzo, 323 F.3d at 970."
26. In my opinion, given the aforesaid discussion, a credible defence to the
infringement action is set up by the defendants.
27. This takes me to the other aspect i.e. challenge laid to IN 625 on the
ground that it was anticipated by what was published or publicly known from
IN 147. Concededly, the PCT publication date of IN 147 is 19.04.2001 which is
well before, as noted above, the priority date of IN 625, that is, 20.05.2002. It is
contended on behalf of the defendants that since DAPA is both claimed and
"fully and particularly described" as required under Section 10(4)(a) of the Act
as a part of its complete specification, there is a credible case that DAPA was
known and, therefore, vulnerable under Section 64(1)(e).
27.1 In this behalf, reference was made to the judgement of the Supreme Court
in Monsanto Company vs. Coromandel Indag Products, (1986) 1 SCC 642. It
was contended on behalf of the defendants that the expression publicly known is
to be understood from the point of view of a person engaged in the pursuit of
knowledge of the patented product which in this case would be a man of science
dealing with organic/medicinal chemistry.
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27.2 Thus, based on the comparison of written descriptions of WO'128 and IN
625, it was contended that to the man of science of ordinary skill but otherwise
interested in the field of organic/medicinal chemistry having reasonable
experience, DAPA was not new and was known prior to the priority date of IN
625.
27.3 In support of this contention, the counsel of the defendants laid stress on
the fact that the person skilled in the art, ultimately, would filter down to a small
class of compounds since the prior publication set out a series of preferred
claims. Thus, according to the defendants, even if the prior art referred to
infinite number of molecules, a person skilled in the art would be able to narrow
it down to 8 molecules. In support of this submission, the defendants have, to a
large extent, relied upon the affidavit of their expert witness i.e. one, Dr.
Stephen F. Martin.
27.4 The plaintiffs, on the other hand, have relied upon an affidavit of one, Dr.
Easwaran dated 18.10.2020 to contend that WO'128 which is the PCT
equivalent of the suit patent IN 147 would have structures which would cover
millions of compounds and, therefore, going by the Markush formula they
would have to be taken down and made one by one. This would take a lifetime.
It was also contended that substitutions indicated by Dr. Martin, such as, A, CH-
2, R1 had no obvious logic and, therefore, could only be carried out by
hindsight wisdom.
28. Having heard arguments of both sides on this aspect of the matter, in my
view, while counsel for the defendants, based on the affidavit of Mr. Martin, did
try to convey that a person skilled in the art could iterate the claims and arrive at
8 molecules based on prior publication and not hindsight, this is an aspect which
would be required to be tested in a trial. Therefore, on this score, the defendants'
defence, at this stage, in my opinion, does not inject vulnerability.
29. This brings me to the ground for revocation taken under Section 64(1)(f)
i.e. that IN 625 is vulnerable as it does not involve any "inventive step". It is
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required to be noticed that the expression "inventive step" has been defined
under Section 2(1)(ja) as follows.
"(ja) "inventive step" means a feature of an invention that involves technical advance
as compared to the existing knowledge or having economic significance or both and
that makes the invention not obvious to a person skilled in the art;"
29.1 A plain reading of the definition would show that it has two parts to it and
both are inextricably linked with the other. In other words, if a patentee is
unable to measure up to the ingredients of either of the two parts, the invention
claimed is not construed under the Act as an inventive step.
29.2 First part involves patentee to show that the invention claimed in any
claim involves "technical advance" as compared to the existing knowledge or
has "economic significance" or both. The second part of the definition alludes to
the fact that the invention should not be obvious to the person skilled in the art.
29.3 A comparison of the complete specifications/descriptions of Indian genus
patent i.e. IN 147 and Indian species patent i.e. IN 625 shows that there is no
technical advance of the latter over the former. This is clearly evident if one
were to peruse the following extracts from Indian genus patent i.e. IN 147 and
Indian species patent i.e. IN 625.
Extracts from Indian Patent 147 [internal page Extracts from Indian Patent 625 [internal page
number 11 of the complete specification] number 7 of the complete specification]
... The compound of formula I possesses activity as ... The compound of formula I possesses activity
inhibitors of the sodium dependent glucose as inhibitors of the sodium dependent glucose
transporters found in the intestine and kidney of transporters found in the intestine and kidney of
mammals and is useful in the treatment of diabetes mammals and is useful in the treatment of diabetes
and the micro- and macrovascular complications of and the micro- and macrovascular complications
diabetes such as retinopathy, neuropathy, of diabetes such as retinopathy, neuropathy,
nephropathy, and wound healing. ... nephropathy, and wound healing. ...
29.4 The plaintiffs sought to get over this by seeking to rely upon Dr.
Washburn's affidavit of April 2020 which was filed on 12.10.2020 to show
technical advance. The data pertaining to technical advance is set out in Dr.
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Washburn's affidavit under the following broad headings.
"A. Enhanced selectivity for SGLT2 versus SGLT1
B. Enhanced ability to reduce blood glucose at 5 hours after oral administration to
diabetic STZ rats (short-term animal model)
C. Enhanced ability to reduce plasma glucose over a 15-day period after oral
administration to ZDF rats (longer-term animal model)"
29.5 Based on the data set out in the affidavit, Dr. Washburn made the
following conclusions.
"29. In my opinion, the increased selectivity and the reduction of glucose levels
obtained with dapagliflozin compared to Example 12 of WO '128 in the STZ and ZDF
rat models were surprising and unexpected.
30. In my opinion, the glucose reductions in STZ and ZDF rats are particularly
surprising considering that, in the in vitro experiments, the SGLT2 inhibitory
potential (EC50) of dapagliflozin was seemingly similar to the SGLT2 inhibitory
potential of Example 12 of WO '128."
30. In my opinion, if this information was not available at the time the
application for grant of patent was filed, then, this cannot be taken into account,
at this juncture, by the plaintiffs in support of their plea that IN 625 involved an
inventive step. There is no clue in IN 625 of an unknown technical effect on its
priority date. Dr. Washburn's affidavit, who professes to be the co-inventor of
DAPA, could have come to the rescue of the plaintiffs to demonstrate technical
advance if, at least a seed of that nature had been planted in IN 625, on its
priority date.
30.1 The plaintiffs' argument that post filing data relating to the invention is
admissible is based on two grounds.
i. First and foremost, the applicant may not be fully aware of the advances
and properties of the subject invention, in this case, the compound
DAPA, on the priority date. In this behalf, it is stated that DAPA's
properties for treatment of heart failure came to be known only
subsequently.
ii. Second, there is no requirement in law that all properties, advantages, and
characteristics should be stated on the filing date of the patent application.
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In support of their plea, the plaintiffs relied upon Genetics institute, LLC,
vs. Novartis vaccines, 655 F.3d 1291 (2011); and Knoll Pharm. Co. vs.
Teva Pharms. USA, Inc., 367 F.3d 1381, 1385. It was argued that the
plaintiffs had complied with the best code rule as engrafted in Section
10(4) of the Act which is qualified by the expression "known to the
applicant". It was also contended that they had satisfied the examiner on
the aspect of inventive step and factually the examiner had raised no such
objection in his examination report of October 2007. The plaintiffs also
sought to contend that they met the plausible unknown technical effect
test as formulated in Generics (UK) Limited vs. Yeda Research and
Development Company Limited, (2017) EWHC 2629 (Pat).
30.2 In this context, I may refer to the judgement in Generics (UK) Limited vs.
Yeda Research and Development Company Limited, (2017) EWHC 2629 (Pat)
cited on behalf of the defendants. In this case, Generics, which was the
claimant, sought revocation of a European patent [entitled low-frequency
glatiramer acetate therapy] of which the defendant i.e. Yeda was the registered
proprietor and a third party [i.e. Teva] was the exclusive licensee. One of the
issues which arose for consideration before the Court concerned the lack of
inventive step for want of technical contribution and insufficiency.
30.3 On behalf of Generics, it was contended that the claimed inventions made
no technical contribution to the art and, therefore, did not involve inventive
steps as summarized in another judgement i.e. Generics (UK) Ltd vs Yeda
Research and Development Co Ltd, [2013] EWCA Civ 925 Alternatively, it
was argued that the technical contribution was insufficient as per principles
summarised by Kitchin LJ in Idenix Pharmaceuticals Inc vs. Gilead Sciences
Inc, [2016] EWCA Civ 1089. The Court after discussing the issue made the
following crucial observations.
197. In case this case goes further, I must briefly address the Defendants'
reliance upon evidence which post-dates the priority date of the Patent. It is
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common ground that such evidence can only be relied upon to confirm the
existence of a technical effect which is plausible in the light of the specification and
the skilled person's common general knowledge, and not to establish the existence
of a technical effect for the first time.
[Emphasis is mine]
30.4 Therefore, what emerges is this: that post priority date evidence which
has been furnished in Dr. Washburn's affidavit to show technical advance can
only be taken into account to confirm the existence of technical effect which is
found embedded in the specification of IN 625 and is capable of being
understood by a skilled person having common general knowledge and not to
rely upon the same to establish its effect for the first time.
30.5 The plaintiffs have not been able to demonstrate, at least at this stage, the
existence of such technical effect in the specifications. The plaintiffs' argument
that the examiner should have been conscious of the inventive step objection or
that evidence of technical advance could be placed before the Court even at this
juncture fails to take into account the plain language of Section 64(1)(f) read
with Section 2 (1)(ja) of the Act. The defendants are entitled, as noted above, to
submit, in support of their challenge, that there is no demonstrable technical
advance as on the date of priority of IN 625.
30.6 Whether or not the examiner raised this issue, the defendants are certainly
entitled to raise the same in defence to an infringement action. The plaintiffs'
submissions, to my mind, would only buttress the stand of the defendants that
there is a credible challenge to IN 625. The reference by the plaintiffs to some
of the attributes which, according to them, are referred to in IN 625 does not
demonstrate, at least at this stage, technical advance.
31. On the last aspect, which is, as to whether the plaintiffs failed to make a
complete disclosure in terms of Section 8 of the Act, the following facts need to
be noticed.
i. The plaintiffs had, vide a letter dated 10.01.2005, filed the
corresponding US patent with the Indian Patent Office. The Indian
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Patent Office, while issuing its first examination report on 12.10.2007,
against serial no. 13 concededly sought the following information.
ii. In response thereto, the plaintiffs on 08.10.2007, stated the following.
"Regarding paragraph 13 of the official letter, we have the honour to submit herewith
copies of the EPO decision to grant and the EP granted patent, which in turn meets
with the requirement of Section 8(2)"
iii. Clearly the plaintiffs did not provide to the Indian Patent Office, the
office action/examination report dated 30.07.2002 issued by the
USPTO in connection with US 117 which corresponds to IN 625. In
the examination report of 30.07.2002, the USPTO inter alia stated the
following.
"1. Claims 1-17 are rejected under the judicially created doctrine of double patenting
over claims 14-30 of U. S. Patent No. 6,414,126 since the claims, if allowed, would
improperly extend the "right to exclude" already granted in the patent. The subject
matter claimed in the instant application is fully disclosed in the patent and is covered
by the patent since the patent and the application are claiming common subject
matter, as follows:
Although the conflicting claims are not identical, they are not patentably distinct from
each other because the present claims are directed towards glucoside structures
characterized by specific stereochemistry and further these compounds are
characterized by biaryl substitution (SGLT2 inhibitor compounds), their
pharmaceutical acceptable salts and a method of treatment of diabetes employing an
SGLT2 Inhibition (i.e. C-Aryl glucoside compounds) which encompass the invention
cited in claims in 14-30 of '126 which are directed toward the (SGLT2 inhibitor
compounds), their pharmaceutical composition and a method of treatment of diabetes
with an SGLT2 inhibitor.
The issued patent '126 differ from the present application in that it does not include
the acetyl derivatives of glucoside structures characterized by specific
stereochemistry in a C-Aryl glucoside compounds (22 claim 17).
Furthermore, there is no apparent reason why applicant was prevented from
presenting claims corresponding to those of the instant application during
prosecution of the application which matured into a patent. See In re Schneller, 397
F.2d 350, 158 USPQ 210 (CC)A 1968). See also MPEP 804."
iv. It is in response to the same that the plaintiffs, on 19.08.2002
voluntarily sought to limit the term of US 117 [equivalent to IN 625]
to the date when the US genus patent 126 was to expire. It was only
after terminal disclaimer was filed by the plaintiffs, which was
accepted by USPTO, that US 117 was granted on 20.09.2002, albeit,
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with the caveat that it would expire on the same date as the US genus
patent i.e. US 126. This information was not furnished to the Indian
Patent Office.
31.1 In this behalf, the plaintiffs contend that the Indian Patent Office was
aware of the fact that the continuation- in- part application had been moved
before the USPTO which, according to the plaintiffs, would have indicated to
the Indian Patent Office that the corresponding US patent was to terminate on
the same date.
31.2 Second, the fact that USPTO had already granted patents, it was not
incumbent upon the plaintiffs to file the examination reports generated by the
USPTO. It was also contended that the error, if any, was bona fide and,
therefore, could not lead to revocation under Section 64(1)(m) of the Act. In
support of their plea, the plaintiffs placed reliance on judgement dated
07.11.2014, passed in FAO (OS) No. 16/2014, titled Maj. (Retd.) Sukesh Behl
& Anr. vs. Koninklijke Phillips Electronics.
32. In my view, the judgement in Chemtura Corporation vs. Union of India
(UOI) and Ors., 2009 (41) PTC 260 (Del) sets the tone as to what all needs to
be provided to the patent office when a prospective patentee seeks grant of
patent.
32.1 In the instant actions, specific details were sought by the Indian Patent
Office concerning search and examination report. What was submitted by the
plaintiffs to the Indian Patent Office via the letter dated 10.01.2005 were the
corresponding US patents and not the examination reports. It is not denied by
the plaintiffs that the examination report dated 30.07.2002 issued by the USPTO
qua US species patent 117 was not furnished.
32.2 It is also not denied by the plaintiffs that their response of 19.08.2002,
whereby, the validity period of US 117 was voluntarily aligned with the US
genus patent i.e. US 126 was not placed before the Indian Patent Office. These
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were vital documents which ought to have been furnished to the Indian Patent
Office.
32.3 The submission advanced on behalf of the plaintiffs that the terminal
disclaimer is an obviation and not an admission of obviousness is not an answer
to the provisions of Section 8(2) of the Act which is mandatory. Assuming,
under the USA patent law, it is construed as an obviation, even then, in my
view, it was incumbent upon the plaintiffs to furnish the examination report of
the USPTO. As to what would have followed from there, would obviously be
within the ken of the examiner at the Indian Patent Office. The scope of Section
8 of the Act has been captured in Chemtura Corporation case. The relevant
observations are replicated hereafter for the sake of convenience.
"Non-compliance with Section 8
36. Section 8 of the Act is titled 'Information and undertaking regarding foreign
applications'. Section 8 (1) (a) requires an applicant for a patent to file along with his
application a statement setting out the detailed particulars of the application filed by
such applicant "in any country outside India in respect of the same or substantially
the same invention". Section 8 (1) (b) requires such applicant to also furnish an
undertaking that up to the date of the grant of patent in India he will keep the
Controller of Patents informed in writing "from time to time" of detailed particulars
as required under clause (a) in respect of such application made in a country outside
India. The corresponding rule is Rule 12 (1) of the Rules which states that the
statement and undertaking to be filed in terms of Section 8 (1) of the Act will be in
Form 3. Prior to the making of the present Rules in 2003, the earlier relevant Rule
was Rule 13 which was to the same effect with slight changes in Form 3.
xxx xxx xxx
40. As far as Section 8(2) is concerned, the Controller on his own may also require
the applicant to furnish details "relating to the processing of the application in a
country outside India, and in that event the applicant shall furnish to the Controller
information available to him within such period as may be prescribed." That
requirement is mandatory as has been further emphasised by the wording of
Section 64(1) (j) ["that the applicant has failed to disclose to the Controller the
information required by Section 8 or has furnished information which in any manner
was false to his knowledge"] which indicates the non-compliance with such directive
of the Controller as a ground for the revocation of the patent. The obtaining of a
patent, "on a false suggestion or representation" is a further ground of revocation
under Section 64 (1) (m).
xxx xxx xxx
43. It is not possible to agree with the submission of Mr. Shanti Bhushan that the
search and the examination report is required to be furnished only if it has resulted in
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the allowing of the Plaintiff's claim by the Patent Office in a foreign country. The
word "including" only means that the Plaintiff has to additionally furnish the search
and the examination report where applications have been allowed. It was incumbent
on the Plaintiff therefore to furnish to the Controller of Patents any search or/and
examination report that may have been issued by the Patent Office either in US or
Europe as on the date of their reply i.e. 17th October 2005. What is significant is that
initially by the letter dated 17th October 2005 to the Patent Controller, the Plaintiff
did not adhere to the requirements of paras 7 and 8 at all. Later after the telephonic
conversation it submitted that a letter dated 19th October 2005 where it simply stated
that "there has been no further development subsequent to Form 3 which was filed at
the time of filing the application in India." This statement, as will be seen hereafter,
was not true.
xxx xxx xxx
45. It is not possible to accept the submission, made by referring to the Halsbury's
Laws of England, that since the omission to furnish particulars is not serious
enough to affect the grant of the patent, it did not impinge on its validity. Section 64
(1) (j) and (m) indicate to the contrary. Further under Section 43 (1) (b) a patent
can be granted only when the application has been found not to be contrary to any
provision of the Act. It cannot be said that the omission to comply with the
requirement of Section 8 (2) was not serious enough to affect the decision of the
Controller to grant the patent to the Plaintiff. The information, if provided, would
have enlightened the Controller of the objections raised by the US patent office and
the extent to which the Plaintiff had to limit its claims to the torus shape of the
compression spring, which was a key feature of the subject device. Had the Controller
been informed of the Plaintiff's own patent No.3932005 dated 13th January 1976, he
would have been called upon to examine if that patent taught the use of a toroidal
shape of a compression member and whether therefore the subject device was an
inventive step within the meaning of the Act.
xxx xxx xxx
48. Under the amended Section 48 (1) of the Act, the patent granted shall, where the
subject matter of the patent is a product, give the patentee the exclusive right to
prevent third parties, who do not have his consent, from the act of making, using,
offering for sale, selling or importing for those purposes that product in India.
Likewise, where the subject matter of the patent is a process, the patentee would have
the exclusive right to prevent third parties, who do not have his consent, from the act
of using that process, as well as from the act of using, offering for sale, selling or
importing any product obtained directly by that process in India. The change is
therefore, that under the amended Section 48 a right is given to the patent holder
Plaintiff, to prevent third parties from making, selling or offering for sale, the product
for which such patent has been granted without the prior consent of the patent holder.
The amended Section 48, however, does not in any manner change the position as
regards the validity of the patent itself. It would still be vulnerable to challenge in
terms of Section 13 (4) read with Sections 64 and 107 of the Act. A similar
conclusion has been arrived at in Bajaj Auto Ltd. v. TVS Motor Company
Ltd. (supra).
49. This Court holds that for the aforementioned reasons, in view of the prima
facie non-compliance by the Plaintiff with the requirement of Sections 8 (1)(b) and
8(2) of the Act, the ground for revocation as contained in Section 64 (1) (m) is prima
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facie attracted. ..."
[Emphasis is mine]
32.4 The reliance placed on behalf of the plaintiffs on a judgement of the
Division Bench i.e. in Maj. (Retd.) Sukesh Behl case, in my view, misses a
vital distinction between this case and the judgement rendered in Chemtura
Corporation case. In this context, it is required to be noticed that the judgement
in Maj. (Retd.) Sukesh Behl case was rendered in the context of Order XII Rule
6 of the Code of Civil Procedure, 1908 [in short "CPC"] whereas the judgement
in Chemtura Corporation case was foregrounded in the provisions of Order
XXXIX Rule 1 and 2 of the CPC [See paragraph 39 in Maj. (Retd.) Sukesh
Behl case].
32.5 Furthermore, in Maj. (Retd.) Sukesh Behl case, the Court ruled that
because the power to revoke patent was discretionary [on account of the
expression 'may' inserted in subsection (1) of section 64 of the Act], a decision
in the matter could be reached only after a trial in view of absence of an
unequivocal and/or unambiguous admission by the plaintiff in that case.
32.6 A careful perusal of the facts found in Maj. (Retd.) Sukesh Behl case
would show that the plaintiffs' attorney while furnishing information concerning
foreign applications had missed out some part of the information. However, the
plaintiffs' attorney on their own, albeit after a lapse of time, had filed a letter
with the Indian Patent Office whereby the information which was missed out
was furnished. In the letter, it was indicated that the documents received by the
attorney had some part of the information incorporated on the reverse side of the
said documents. It was stated that the paralegal who was assisting the attorney
had inadvertently left out the said information.
32.7 Construing these facts, the Court ruled that it was not a case of a clear and
unambiguous admission, thus, triggering the provisions of Order XII Rule 6 of
the CPC. Pertinently, the Court agreed with the judgement rendered in
Chemtura Corporation case that the provisions of Section 8 were mandatory.
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32.8 As indicated above, the plaintiffs in support of their submission that filing
of terminal disclaimer was only an obviation and not admission of obviousness
and double patenting had relied upon the judgement of the US Federal Court in
Quad Environment vs. Union Sanitary, 946 F2d 870. The defendants, on the
other hand, relied upon the judgement of the US Supreme Court in Festo Corp.
vs. Shoketsu Kinzoku3, 535 U.S 722 (2002); and another judgement of the US
Court of Appeals for the Federal Circuit SimpleAir, Inc. vs. Google LLC,
Appeal Number: 16-2738, United States Court of Appeals for the Federal
Circuit.
32.9 A perusal of these judgements would show that while terminal
disclaimers are not treated as admissions, they are taken into account to
ascertain the prosecution history of the patent i.e. the reason as to why the
patentee chose to narrow down its claim. Thus, while terminal disclaimer filed
by a patentee is not treated as a complete bar against the defence of non-
obviousness, depending on facts, it can operate as estopped by conduct.
33. The point to be stressed here is that under our Act, was the examiner
under the Indian Patent Office not entitled to know as to what was the
prosecution history of the plaintiffs qua the corresponding patents in US. In my
opinion, the answer to this has to be in the affirmative. Chemtura Corporation
case, while interpreting the provisions of Section 8 of our Act, in a sense, in its
own language, brings to fore this seminal point.
33.1 Therefore, to my mind, as to whether or not the Court would, ultimately,
revoke the suit patents for failure to furnish information, as sought for by the
"... When the patentee is unable to explain the reason for amendment, estoppel not only
applies but also "bar[s] the application of the doctrine of equivalents as to that element."
Ibid. These words do not mandate a complete bar; they are limited to the circumstance where
"no explanation is established." They do provide, however, that when the court is unable to
determine the purpose underlying a narrowing amendment--and hence a rationale for
limiting the estoppel to the surrender of particular equivalents--the court should presume
that the patentee surrendered all subject matter between the broader and the narrower
language."
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Indian Patent Office, would be ruled upon after the trial. It, nevertheless, is an
important factor to be taken into account at a preliminary injunction stage; at
which point, the Court exercises equitable jurisdiction.
34. This brings me to the arguments raised concerning the balance of
convenience, and irreparable harm. In my view, if, as held by me above, the
defendants have been able to set up a credible challenge and/or establish, at
least at the preliminary injunction stage, the vulnerability of the suit patents,
even if the balance of convenience is in favour of the plaintiffs, the injunction
cannot be granted.
34.1 On the other hand, if the plaintiffs had established a strong prima facie
case for grant of a preliminary injunction, they would still have to satisfy the
Court as to whether or not balance of convenience was in their favour and that
denial of interim relief would cause irreparable damage. In this background, let
me examine the rival contentions made on behalf of the parties before me.
34.2 The plaintiffs claim that the Indian genus patent i.e. IN 147 survived its
full validity period and the Indian species patent i.e. IN 625 is in 18 th year of its
lifecycle. The plaintiffs' product is being sold in India since 2015 at reasonable
prices. The defendants, according to the plaintiffs, should be asked to "clear the
way" as contemplated in Merck Sharp and Dohme Corporation and Ors. vs.
Glenmark Pharmaceuticals, MANU/DE/0852/2015 by following any of the
following rules i.e.
i. Seeking voluntary license;
ii. Seeking compulsory license;
iii. Filing revocations;
iv. Filing pre-grant opposition and post-grant opposition; and
v. Filing a declaratory action for non-infringement.
34.3 The suit patents i.e. IN 147 and IN 625 were published in 2005 and were
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granted nearly 13 and 11 years ago respectively. Besides this, the plaintiffs have
obtained injunctions in several pending suit actions which have been instituted
in this Court. Furthermore, if the injunction is not granted, it would destroy the
plaintiffs' market qua their product. Besides this, doctors have expressed
concerns about the quality of the products that the defendants may launch. It is
also contended that the damages are difficult to compute. Monetary
compensation, according to the plaintiffs, will not be adequate. It is emphasized
that the plaintiffs are interested in a real and not a pyrrhic victory by having
their rights enforced under the Act.
34.4 The defendants, on the other hand, say that the plaintiffs' suit actions are
abusive which are intended to re-monopolise their rights that admittedly came to
an end on 02.10.2020. It is emphasized by the defendants that grant of an
injunction would not only impact the defendants' rights to enter the market but
would deprive the public at large to obtain their drug at relatively cheap prices.
It is contended that since the plaintiffs are interested in licensing their product to
third parties, the damage if any caused is compensable in monetary terms in
accordance with the mandate of the law.
34.5 As against this, if an injunction is granted, the opportunity lost by the
defendants to market their products cannot be quantified in monetary terms.
Therefore, even from the point of restitution, the balance tilts in favour of the
defendants.
35. Having considered the case from the point of view of facets involving
balance of convenience and irreparable harm, it has to be stated that the fact that
a challenge has been laid at the stage when the plaintiffs seek to enforce their
rights under the patents would not propel the Court [as indicated above] to grant
an injunction if the challenge is credible.
35.1 The provisions of the Act do not provide any shield of inviolability. This
principle is true not only in India but jurisdictions across the world. In no
country, a mere grant of a patent by the patent offices' guarantees their validity.
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It is important to remember that grant of monopoly to the inventor, which is
necessary for her/him to recoup investments and/or derive profits from her/his
inventions, comes with a quid pro quo as noticed in paragraph 38 of Report on
the Revision of the Patents Law by Shri Justice N. Rajagopala Ayyangar
(September, 1959). Paragraph 38 reads thus:
"38. I have already set out the considerations which are said to constitute the quid
pro quo for the grant of the patent monopoly, namely; (1) the working of the
invention within the country so as to result in the establishment in the country of a
new industry or an improvement of an existing industry which would profitably
employ the labour and capital of the country and thus increase the national wealth,
and (2) disclosure to the public of the invention and the manner of its working so
that on the expiry of the life of the patent the public are enabled to work the
invention themselves and in competition with each other. Where the patentee has no
intention of working the invention in this country either because he considers that this
is not profitable or because he prefers to expand the production in his home country
so as to achieve there greater efficiency and more production or is otherwise not
interested in working the invention in India, the grant of the Indian patent might tend
to improve the economy of the patentee's home country but offers little advantage to
us. Unless therefore the law provides for measures to be taken to compel the
patentees to work the invention within the country, and these measures are effective
to achieve their purpose, the social cost involved in the grant of the patent is not
offset by any benefit to the community. As regards the possible advantage which
might result by disclosure it should be noted that most of the inventions patented by
foreigners in this country are also patented abroad and the theory therefore that but
for patent protection the invention would have been worked in secret and that the
public would have been deprived of the knowledge of the invention has no relevance
in the case of the large majority of patents granted in India. As neither of the above
considerations seems to be present in the case of patents granted to foreign nationals
which are not worked in this country the cost to the community by the grant of the
patents is unrelieved by any positive advantage by way of an increase of technical
skill or of national wealth."
[Emphasis is mine]
35.2 The recommendations made therein were a precursor to the enactment of
the Patents Act, 1970. The judgement of the Supreme Court in detail captures
the reasons for the passing of the more recent amendment Acts i.e. 2002
Amendment Act and the 2005 Amendment Act. Broadly, India sought to make
amendments via the said amendments Acts to meet its obligation under TRIPS
which formed part of the agreement which established the World Trade
Organisation [WTO].
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35.3 India, it appears, brought in certain amendments to balance the interests
of the inventors as also those of her citizens. The insertions inter alia of
Sections 2(1)(j), 2(1)(ja), and 2(1)(l); Section 3(d); Section 8; Section 10(5);
Section 53; and Section 107(A) were a step in that direction. The trade-off, it
appears, was between uniformly increasing the validity of patents including
those which were granted for drugs for 20 years as against the right of the local
industries to be able to work the patent to provide the fruits of the invention to
its citizenry at reasonable prices and to embed skills locally.
35.4 This is acutely true when seen in the context of enforcement of patents
concerning drugs. The Court has to be vigilant towards attempts of the patentee
that aims at evergreening an invention which does not inter alia involve an
inventive step i.e. technical advance or economic significance. Therefore,
depriving the defendants, at this stage, from manufacturing and selling their
drugs, when, during the validity period of the genus patent i.e. IN 147 they
largely held themselves in check would, in my opinion, not be appropriate,
especially, when they have set up a credible challenge to the suit patents.
35.5 What persuades me to decline injunction, in addition to what I have stated
above, is also the fact that in this case damages if proved at trial, appear to be
compensable. The defendants have averred that the plaintiffs have, possibly,
licensed their rights under the suit patents to two entities i.e. Sun and Abbott.
The packaging of the products of the drug sold through these entities is
indicative of this aspect. The plaintiffs, however, for reasons best known to
them have not placed on record the agreements arrived at with these entities in
support of their plea. Therefore, it has to be inferred that the said entities are
licensees.
35.6 Besides this, the plaintiffs also aver that they are importing their drug into
the country. Therefore, the plaintiffs seek to monetize their invention. Thus, at
the end of the trial, if they were to succeed, they could be granted damages, if
proved, under the law. Thus, as long as a mechanism can be put in place for
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securing the recovery of damages by the plaintiffs, it would, at this stage,
balance the interest of the parties. [See: Dynamic Manufacturing, Inc. vs.
David A. Craze, and Miller Industries, Inc., 1998 WL 241201]
PUBLIC INTEREST: -
36. The parties have also advanced submissions on the aspect concerning
public interest. The plaintiffs have submitted that the quality of the drug could
be an issue. The plaintiffs have also contended that the drug sold by them is
priced reasonably.
36.1 To my mind, this aspect can be quantitatively verified, to a large extent, if
one were to compare the price of the drugs sold by the plaintiffs both, directly
and/or indirectly, and the prices at which the defendants seek to offer their
drugs.
Price of the Rs. 54.4/- Price of the Rs. 9.90/- Price of the Rs.
plaintiffs' product - INTAS product ALKEM product 13.90/-
5 mg tablet - 5 mg tablet - 5 mg tablet
Price of the Rs. 57.29/- Price of the Rs. 11.90/- Price of the Rs.
plaintiffs' product - INTAS product ALKEM product 17.50/-
10 mg tablet - 10 mg tablet - 10 mg tablet
Cost per patient per Rs. Cost per patient Rs. Cost per patient Rs.490/-
month of the 1523.20/- per month of the 277.20/- per month of the
plaintiffs' product - INTAS product ALKEM product
5 mg - 5 mg - 5 mg
Cost per patient per Rs. Cost per patient Rs. Cost per patient Rs.554.4/-
month of the 1605.80/- per month of the 333.20/- per month of the
plaintiffs' product - INTAS product ALKEM product
10 mg - 10 mg - 10 mg
36.2 Clearly the difference in prices of drugs ranges between 250% to 350%.
Therefore, as is apparent, if defendants were allowed to manufacture and market
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their drugs, it would be far cheaper. Concerns as to quality, at this juncture,
appear to be a self-serving argument. The concerned statutory authority can, in
my view, adequately deal with this issue if and when such a situation arises.
37. I may also indicate herein that an argument was raised that diabetes is a
lifestyle disease and, therefore, the concerns generally expressed by Courts qua
drugs which are used to treat life-threatening diseases such as Cancer,
HIV/AIDS etcetera should not impact this matter.
37.1 The defendants on the other hand have emphasised that diabetes is no
longer construed as a lifestyle disease. According to them, given the spread of
Coronavirus, diabetes can cause comorbidity in a patient leading to a potentially
life-threatening situation.
38. On this aspect, judicial notice needs to be taken of the following figures
published by the Government of India and World Health Organisation on
diabetes.
▪ The National Centre for Disease Control, Directorate General of Health
Service, Government of India, in its "Diabetes Special Edition on
Occasion of World Health Day 2016" [April 2016]4 has noted thus:
"India has 6.51 crore diabetes cases which is second highest number of
diabetics in the world and is projected to have 10.9 crore affected persons by
2035.
xxx xxx xxx
Diabetes mellitus is a group of metabolic diseases characterized by
hyperglycemia resulting from defects in insulin secretion, insulin action, or
both. The chronic hyperglycemia of diabetes is associated with long-term
damage, dysfunction, and failure of various organs, especially the eyes,
kidneys, nerves, heart, and blood vessels.
xxx xxx xxx
Type 2 diabetes (non-insulin dependent) is characterised by insulin resistance
[See: https://ncdc.gov.in/WriteReadData/linkimages/cdalert0616262925183.pdf]
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and/ or abnormal insulin secretion. Type 2 diabetes accounts for over 90%
and Type 1 accounts for up to 10% of all diabetes."
▪ The World Health Organisation, in its 'Diabetes Country Profiles, 2016'
concerning India, has noted the following.
38.1 Therefore, if one were to bear in mind the aspect concerning price as also
the nature of the disease which is sought to be treated by the drug-in-issue, the
scales of balance, in my opinion, at this stage, would weigh in favour of the
defendants.
39. Before I conclude [and dehors what has been observed by me
hereinabove], there is literature and scholarly articles available of well-
established academicians which point in the direction that the doctrine of double
patenting needs to be strengthened.
39.1 Some of the academicians in the US, familiar with patent law, decry the
weakening of double patenting doctrine by the Federal Courts in the country by
disregarding the earlier view of the US Supreme Court which held that
"invention of the genus patent is not determined only by the claims but also by
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the embodiments disclosed in the specifications".
39.2 Some of the academicians appear to be of the view [based on the
precedents of the US Supreme Court and also some Federal Circuit Court
judgements] that it must be presumed that the party with genus patent has
invented the full scope of the genus. It is argued that when the same inventor
holds a genus patent for a pharmaceutical product, such an inventor should be
estopped from obtaining a species patent which is within the scope of genus,
whether or not the genus patent constitutes prior art. [See: O'Reilly vs. Morse,
56 U.S. 62, 114 (1853); Singer Mfg. Co. vs. Juune Mfg Co., 163 U.S. 169
(1896); and Schriber-Schroth Co. vs. Cleveland Trust Co., 305 U.S. 47 (1938)]
39.3 In this behalf, see the abstract of the article published in Northwestern
Journal of Technology and Intellectual Property, Volume 14, Issue 3 (Winter
2017) titled Double Patenting: Follow-on Pharmaceutical Patents that
Suppress Competition, authored by Douglas L. Rogers, which is extracted
hereafter.
"ABSTRACT
Prices for pharmaceutical products over the last 10 years have
skyrocketed, increasing far more rapidly than the general cost of living. This
article argues there should be greater competition for the production of
follow-on drugs through the strengthening of the double patenting prohibition:
preventing extending exclusive rights beyond the original patent term by
dressing up part of that invention as a new one. This prohibition against the
same party holding two patents covering the same composition announced by
the Supreme Court in the 1800's has been weakened by lower federal courts to
(1) only considering the claims and not the rest of the specification in
determining if the same invention is being claimed by the inventor in two
patents and (2) only applying the prohibition when the earlier patent did not
satisfy the technical meaning of "prior art" within §102 of the Patent Act. The
rulings weakening the double patenting doctrine have disregarded that the
"invention" of a genus patent is not determined only by the claims, but also by
the embodiments disclosed in the specification, and under Supreme Court and
Federal Circuit precedent it must be presumed that the party with a genus
patent has invented the full scope of the genus. These weakening rulings have
also disregarded that the double patenting doctrine arises from §101 of the
patent statutes, rather than §§102 and 103, which the Federal Circuit models
it double patenting test on, often incorrectly concluding there is no double
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patenting. §§102 and 103 serve different purposes than §101. This article
argues that when the same inventor holds a genus patent for a pharmaceutical
product, it should be estopped from obtaining a patent on a species within the
scope of the genus, whether or not the genus patent constitutes prior art.
Applying this strengthened double patenting doctrine would increase
competition for the development of follow-on pharmaceutical products."
Conclusion: -
40. Thus, for the foregoing reasons I am not inclined to grant an injunction in
favour of the plaintiffs and against the defendants. Consequently, the captioned
applications are dismissed.
41. The defendants will, however, via their respective affidavits, place on
record the details, quantum, and value of drug manufactured and sold as also
indirect and direct taxes paid in that behalf. This information will be placed on
the Court's record every quarter.
41.1 The defendants will also provide details of their assets [encumbered and
unencumbered] which would include their location and current market value.
The information given in the affidavits will be backed by a certificate of a
statutory auditor. The defendants via their affidavits will also undertake to pay
damages as and when called upon to do so by the Court. These affidavits will be
filed within a period of 3 weeks.
CS (COMM) No. 410/2020 & CS (COMM) No. 411/2020
42. List the captioned matters on 15.01.2021.
RAJIV SHAKDHER, J
NOVEMBER 02, 2020
Click here to check corrigendum, if any
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No. 8826/2020 in CS (COMM) No. 410/2020 & I.A. No. 8859/2020 in CS (COMM) No.
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By:VIPIN KUMAR RAI
Signing Date:02.11.2020
15:05:16
