Delhi High Court
Boehringer Ingelheim ... vs The Controller Of Patents & Anr. on 12 July, 2022
$~14
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Date of Decision: 12th July, 2022
+ C.A. (COMM.IPD-PAT) 295/2022 & I.As.10369-70/2022
BOEHRINGER INGELHEIM INTERNATIONAL
GMBH ..... Appellant
Through: Mr. Debashish Banerjee and Mr.
Ankush Verma, Advs.
(M:9810948290)
versus
THE CONTROLLER OF PATENTS & ANR. ..... Respondents
Through: Mr. Harish Vaidyanathan Shankar,
CGSC with Mr. Srish Kumar Mishra,
Mr. Sagar Mehlawat and Mr.
Alexander Mathai Paikaday,
Advocates. (M:7204711976)
CORAM:
JUSTICE PRATHIBA M. SINGH
Prathiba M. Singh, J. (Oral)
1. The present appeal arises out of the impugned order dated 25th
March, 2022 by which the Controller of Patents (hereinafter "Controller")
has rejected the request of the Appellant-Applicant (hereinafter
"Applicant") for pursuing a divisional application bearing no.20178031279
dated 4th September, 2017, titled 'A medicament of a DPP inhibitor'. The
Controller, while rejecting the divisional application has stated that the
divisional application had similar claims, as had already been proffered in
the refused amendment applications and the divisional application does not
fall within the scope of the parent application.
Factual background
2. The background of this appeal is that the Applicant had filed a
National Phase PCT Application on 14th November, 2008, for 'Use of DPP
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
IV Inhibitors'. The patent specification had a total of 1 to 18 Claims, with
two claims numbered as 15. For the sake of clarity, the same are re-
numbered as 15 and 15A at the outset. The First Examination Report
(hereinafter "FER") was issued on 24th March, 2014, in response to which
the Applicant amended its Claims on 24th October, 2014 (hereinafter
"Amendment No.1"). In the said Amendment No.1, the Applicant sought to
delete all Claims except Claims 14, 15 & 15A.
3. Thereafter, the application remained pending. Sometime in 2015-2016
i.e., on 20th March, 2015 and 18th February, 2016, two Forms-13 were filed
by the Applicant seeking two further amendments (hereinafter "Amendment
No.2" and "Amendment No.3" respectively). These two amendments were,
thereafter, sought to be converted into a divisional application filed on 4th
September, 2017. This application has been rejected by the impugned order.
4. In Amendment No.2 dated 20th March, 2015, the Applicant sought to
expand from three Claims to Claims 1 - 11 and in Amendment No.3 dated
18th February, 2016, the Applicant amended the Claims to 1 to 15, i.e.,
added four new Claims. On 5th July, 2017, a hearing notice was issued by
the Patent Office and the following objections were raised:
"2. The examination report is based on the claims
filed on 24/10/2014 as form-13 filed on 23/02/2015
and 19/02/2016 not allowed as amendments carried
out in claims, via said forms, goes beyond the scope
of claims as on record before the amendments.
Claims 1-3 lack novelty and inventive step under
section 2(1)(j) of Patents Act,1970. The following
documents are considered for the examination.
D1: WO 2004/018468 A (2004-03-04)
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
D2: WO 2004/050658 A (2004-06-17)
D3: WO 2005/085246 A (2005-09-15)
D4: WO 2006/029769 A (2006-03-23)
Novelty under section 2(1)(j) of Patents Act,1970.
D1, D2, D3 and D4 discloses the use of specific
DPP-IV inhibitors which in each case fall under the
Markush formula of the present application, for the
treatment of, inter alia, diabetes mellitus type 1 and
type 2, prediabetes, reduction of the glucose
tolerance or changes in the fasting blood sugar,
diabetic complications, insulin resistance, metabolic
syndrome or dyslipidaemia. The use of the DPP-IV
inhibitors as combination medicament with other
antidiabetics (including metformin), with
antilipemics (including atorvastatin) or with agents
which lower blood pressure is also disclosed.
So novelty cannot be acknowledged for the present
set of claims 1-3
Inventive step under section 2(1)(ja) of Patents
Act,1970.
Each of the documents D1-D4 represents per se the
closest prior art, since the use of specific DPP-IV
inhibitors for the treatment of diabetes mellitus in
various facets is disclosed and it appears that there
is no technical advancement achieved with the
compounds of the present application with respect to
its closest prior art documents.
Claims 1-3 don't contain any technical feature
except DPP inhibitors which is already known from
the above-cited documents D1-D4.
So inventive step cannot be acknowledged for the
present set of claims 1-3."
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
5. The objections in the FER included lack of novelty and inventive step.
Pursuant to this hearing notice, the objections raised were contested by the
Applicant. The hearing on the objections was held in August, 2017. The
decision on the said parent application and the Amendments was rendered
finally in January, 2018.
6. Notably, after the hearing on the Amendments to the original patent
application was held on 28th August, 2017 and prior to rendering of the
decision on 4th January, 2018, the Applicant sought to file a divisional
application on 4th September, 2017 by creating an amalgam of Claims 1 to
11 and Claims 1 to 15, which Claims also formed part of Amendment Nos.
2&3.
7. The Controller vide decision dated 4th January, 2018, passed the
decision on all three Amendments. Insofar as Amendment No.1 restricting
the original patent to Claims 14, 15 & 15A is concerned, a decision was
rendered on merits. Insofar as Amendment Nos. 2&3 are concerned, the
Controller held as under:
"Subsequent to FER reply two form-13 filed on
23/03/2015 and 19/02/2016 for making amendment in
claims. The amended claims 1-11 as filed on
23/03/2015 relates to a medicament combination of a
DIPP IV inhibitor with metformin and the amended
claims as filed on 19/02/2016 further contains 4 new
claims (claims 12-15), in addition to claims as filed on
23/03/2015, which relate to a medicament combination
of a DIPP IV inhibitor with telmisartan.
The scope of protection of original filed claims, i.e. use
of DPP IV inhibitor of formula I or formula II alone or
in combination with other active substances, cannot be
extended to the protection of a medicament
combination of a DIPP IV inhibitor with
metformin/telmisartan as such such change in contents
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
of amended claims does not wholly fall within the
scope of original filed claims. Further said
amendments cannot be considered to be done by way of
disclaimer, correction, clarification or explanation as
there is clear change in category of claims wherein
"use claims" were amended to "product claims".
...
Based on the above facts and circumstances of the
case, it is observed that the objections raised in
paragraphs 2 and 3 the hearing notice are still pending
and not met. Therefore, the instant application No.
09501/DELNP/2008 is hereby refused for grant of
patent u/s 15 of the Patents Act, 1970."
8. Thus, the Controller applied Section 59 of the Patents Act, 1970
(hereinafter "the Act") and held that the said amended claims i.e., Claims 1
to 11 and Claims 1 to 15 are beyond the scope of originally filed Claims and
rejected the same. Accordingly, vide this order dated 4th January, 2018, the
Patent Application 9501/DELNP/2008 which was the parent application,
was refused under Section 15 of the Act. Amendment Nos. 2&3 were also
rejected by the Controller, but by the time this order was passed, the
Applicant had filed a divisional application qua those very claims.
9. After this decision was rendered, in so far as the pending divisional
application was concerned, the FER was issued on 16th July, 2019. A
response dated 16th January, 2020 was filed to the said FER and a pre-grant
opposition dated 27th January, 2021, was also filed qua this divisional
application. The reply statements, etc. were completed in the pre-grant
opposition and after hearing the pre-grant opponent and the Applicant, by
the impugned order dated 25th March, 2022, the divisional application was
refused. The reasoning given by the Controller in the impugned decision is
that the division itself could not have been permitted as the Amendments
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
were rejected in the parent application. Since the current Claims had been
already examined and refused, the same Claims cannot be allowed in
another application. The Controller also reproduced various other objections
raised by the pre-grant opponent. The findings in the impugned order dated
25th March, 2022 are as under:
"c) I have analysed the amended claims of the parent
application (9501/DELNP/2008) were refused under
section 15 due to the reason that none compliance of
section 57 and 59. As well as the parent refusal order
clearly indicates the lack of Novelty and inventive step as
well.
The applicant replicated amended claims of the parent
application in the Divisional application (present), since,
there were three set of claims was filed/amended until
refusal of the parent application, the first set was
original claims ( 18 claims ) and second set of claims (
11 claims ) amended in the year 2015 in response to FER
and the third set of claims (15 claims in 2016) all above
three set of claims have been examined, finally an
opportunity of hearing was also offered followed by
written submission, based on argument and /or written
submissions, the refusal order was issued in the parent
application refusing all the claims. The three set of
claims are distinguished as under in tabular format to
make it clear understanding, and all three set of claims
are reproduced above.
Claims of Exactly similar Claims of Remarks
present parent
application application9501/DELNP/2008
(201718031279)
Claims 1, 2 Claims 1, 2 Amended Exactly similar
dt.25/03/2015 claims have
been examined
in Parent
application
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
Claims 3, 4 Claims 3, 4 Exactly similar
claims have
been examined
in Parent
application
Claims 5,6,7,8 Claims 5,6,7,8 Exactly similar
claims have
been examined
in Parent
application
Claim 9, 10 Refer claims 5 to 8 Exactly similar
claims have
been examined
in Parent
application
Claim 11 Claim 7, 11 Exactly similar
claims have
been examined
in Parent
application
Claim 12, 13 Covered under claims 7-11 Exactly similar
claims have
been examined
in Parent
application
Claim 14,15 Covered under claims 5 & 2 Exactly similar
claims have
been examined
in Parent
application
Claim 16, 17 Covered under claims 14 of Exactly similar
new claims in 2016 , and 12 claims have
claim in 201515, been examined
in Parent
application
Claim 13 Claim 18, examined in 2015 Only wordings
(Method claims) and 2016 of claims 7 to 13 rearranged no
changes in
technical
parameters
Claim 20 Claim 5 of 2015 Exactly similar
claims have
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
been examined
in Parent
application
Claims 24 and repetitions of
25 the old parent
application
claims
From the above analysis, it is observed that the claims
amended at various point of time during prosecution of
the parent application which are exactly similar to that
of present claims pending with alleged divisional patent
application.
d) It is to be noted that the claims which are amended in
the Parent application for grant of patent, at various
stages that includes in response to First Examination
report, in response to hearing notice and as well in post
hearing written submission as well. Those claims were
refused with a due process under section 15. The reason
for refusal can be seen in the order of parent application,
however, the applicant submitted before the hearing
officer that previous amendments carried out in the
claims on March 23, 2015 and February 19, 2016 are
allowable. The amendments made in claims were based
on original claims 10-12 and the description in the
specification and are therefore allowable under Section
59(1) of Act. In this regard, the attention is invited to last
paragraph page 12, which reads as 'The DPP IV
inhibitors mentioned above may also be used in
conjunction with other active substances, by means of
which improved treatment results can be obtained Such a
combined treatment may be given as a free combination
of the substances or in the form of a fixed combination,
for example in a tablet or capsule. Paragraph 2 of page
13 reads as Examples of antidiabetic combination
partners are metformin. The last paragraph of page 20
reads 'A particular preferred example of an antidiabetic
combination partner is metformin. The last paragraph of
page 22 recites telmisartan as a combination partner.
Further, Examples 13 and 16 of the specification relate
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
to combinations with metformin and telmisartan
respectively.
The learned Controller's attention is further invited to
the provisions under Section 59 of the Act which lays
down the conditions for allowance/disallowance of
amendments. Section 59 is reproduced below:
Section 59(1)- No amendment of an application for a
patent or a complete specification or any document
relating thereto shall be made except by way of
disclaimer, correction or explanation, and no
amendment thereof shall be allowed, except for the
purpose of incorporation of actual fact, and no
amendment of a complete specification shall be allowed,
the effect of which would be that the specification as
amended would claim or describe matter not in
substance disclosed or shown in the specification before
the amendment, or that any claim of the specification as
amended would not fall wholly within the scope of a
claim of the specification before the amendment. Under
Section 59(1), the amendments made by the Appellant
should not fall outside the scope of the unamended
specification. This has also been affirmed by the
Honorable Board in its order Solvay Fluor GmBH v E.l
Du Pont de Nemours and Company & others (ORDER
No.111 of 2010). The relevant paragraphs 18 and 19 of
the order are reproduced below:
18. We have heard the arguments of both the counsel and
have gone through the petitions and the replies filed
thereon. The amendments suggested must comply with
the requirements of section 59 of the Act. 19. Hence from
the above section 59 of the Act, what are permissible
amendments are as follows:- 1. Amendment must be by
way disclaimer, correction, clarification or explanation;
2. The amendment must be for incorporation of actual
fact; 3. The effect of amendment should not enable the
specification as amended to describe any matter not in
substance disclosed or shown in the specification before
amendment; All the three above-identified conditions are
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
fulfilled by the amended claims submitted by the
Applicant in the present application.
The amendments were carried out by way of correction
and explanation. Further, as the medicament
combinations are clearly disclosed in the specification,
the amendments pertained to incorporation of actual
fact. The third condition was also complied with since
the amendments made by the Appellant pertain to the
matter already disclosed in the specification and do not
fall outside the scope of the unamended specification. In
view of the above, it was requested to allow the
amendments carried out on March 23, 2015 and
February 19, 2016.
e) The Applicant submits that the amended claims are
novel and inventive over the cited prior art documents
and do not fall under Section 3(e). In this regard, the
Applicant submits the following: Beneficially, as stated
in the application was filed, the DPP IV inhibitors as
included in the present claim set "are distinguished from
structurally comparable DPP IV inhibitors, as they
combine exceptional potency and a long-lasting effect
with favourable pharmacological properties, receptor
selectivity and a favourable side-effect profile or bring
about unexpected therapeutic advantages or
improvements when combined with other pharmaceutical
active substances" (page 11 of the description).
Linagliptin (BI 1356), a particularly preferred DPP-4
inhibitor of the present application (page 7 of the
description, last paragraph, first species) inhibits DPP-4
more effective and longer lasting than the other major
DPP-4 inhibitors vildagliptin, sitagliptin, saxagliptin and
alogliptin, and is thus potent at low therapeutic doses
and long-acting. The low dose amount is a particular
feature for the provision of combinations of the present
DPP IV inhibitor species according to the present claim
set, constituting a contribution of the invention over the
art. The low oral dose such as recited in the claims
reflects said exceptional potency and long lasting effect,
and is for at least this reason remarkable and valuably
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
enriching the art. Further, Linagliptin is characterized
by unique pharmacokinetics, such as with nonlinear
profile (less than dose-proportional exposures). Other
gliptins have dose-proportional (fairly linear) oral
pharmacokinetie properties. Accordingly, optimization
for therapeutic dose of linagliptin is not necessarily
trivial. Further beneficially, the combination of
linagliptin and metformin was shown to be well tolerated
and improved glycemic control more than either
monotherapy. For example: Combination of linagliptin
and metformin improves glycemic control in type 2
diabetes: A randomized trial with an open-label arm in
patients with poor glycemic control: Progression to
combination of oral glucose-lowering drugs in patients
with type 2 diabetes mellitus (T2DM) is recommended
when monotherapy fails to reach treatment targets. This
24-week, double-blind, placebo controlled study
randomized 791 T2DM patients. The 6 treatment groups
included 2 arms receiving free combinations of
linagliptin 2.5 mg bid+ either low- or high-dose (500 or
1000 mg) metformin (MET) bid.
Four monotherapy arms received linagliptin 5 mg q,d,
MET 500 or 1000 mg bid, or placebo. Patients with a
baseline HbAIc ≥11% received open-label combination
therapy with linagliptin 2.5 mg bid+ MET 1000 mg bid
(n=66). Mean baseline HbA1c was between 8.5% and
8.7%, and 11.8% in the open-label arm. Placebo-
corrected, adjusted mean HbAIc changes after 24 weeks
are shown in the figure [figure 1]. For the combination
of linagliptin 2.5 +MET 500 or 1000, the placebo
corrected reduction in HbAIc was -1.3% and -1.7%,
respectively. Both combination regimens were superior
to the monotherapy arms. In patients with poor glycemic
control, mean change in HbA1c from baseline was -
3.7%. Adverse event rates were similar across treatment
arms. The total number of hypoglycemic events during
combination treatment was low (in total, 5 [1.8%]
randomized patients receiving linagliptin 2.5 + MET 500
or 1000). The difference in body weight after treatment
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
with linagliptin 2.5 +MET 1000 compared with MET
1000 was -0.23 kg. The combination of linagliptin and
MET was well tolerated and improved glycemic control
more than either monotherapy. Combination of
linagliptin with MET significantly improves glycemic
control towards treatment targets without weight gain
and with a very low risk of hypoglycaemia Figure 1,
Therefore, e.g., a particularly suitable and
beneficial/positive therapeutic combining effect and
usability (e.g. significant efficacy and/or favourable
safety) can be achieved by the combinations according to
the present invention, thus valuably enriching the art.
The above Figure 1 clearly shows the effects of
linagliptin (5 qd) alone, metformin (500 bid, 1000 bid)
alone, as well as the effects of various
linagliptin+metforrnin combinations, particularly the
considerable effect in the most right bar in Figure 1 as to
the combination linagliptin+metformin in patients with
poor glycemic control. The combination of linagliptin
and metformin provides significant improvements in
glycemic control compared to placebo, to metformin
alone, and to linagliptin alone. Thus, the combination
therapy of linagliptin with metformin relates to a
particular embodiment of the present invention.
Furthermore beneficially, in type II diabetes patients
who are not adequately controlled on another oral anti-
hyperglycemic drug, the combination of a DPP-IV
inhibitor of this invention with such other anti-
hyperglycemic drug provides a therapeutic benefit to
such patients. Especially, in type II diabetes patients who
are not adequately controlled on metformin, the add-on
combination of linagliptin (which is a DPP-IV inhibitor
of this invention) to existing metformin therapy results in
a significant and clinically meaningful improvement in
glycemic control, without weight gain or increased risk
of hypoglycemia; thus such combination provides indeed
a "synergistic" (cooperative, complementary or
improving) effect. One skilled in the art would not have
plainly and inevitably predicted that the specific dosage
amount of the DPP-IV inhibitor species in a combination
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
with metformin would provide the (clinically and
therapeutically) significant improvements in glycemic
control (AI C and FPG) as outlined above.
f) With reference to paragraph 2 of the hearing notice
the agent for the applicant submitted that the
amendments previously carried out in the claims on
March 23, 2015 and February 19, 2016 are not found to
be persuasive as amended claims so filed goes beyond
the scope of originally filed claims. It may be noted that
the subject matter of originally filed claims relate to USE
of DPP IV inhibitor of formula I or formula II alone
(claims 1-9) or in combination with other active
substances (claims 10- 13), isolation or storage medium
for islets of Langerhans or beta cells (claims 14-15),
method of enhancing the vitality and secretion capacity
of islets of Langerhans or beta cells and method of
treating a patient with a DIPP IV inhibitor (claims 16-
18).
The said claims were restricted to three claims relating
to isolation or storage medium for islets of Langerhans
or beta cells and method of enhancing the vitality and
secretion capacity of islets of Langerhans or beta cells in
response to FER filed on 24/10/2014. Subsequent to FER
reply two form-13 filed on 23/03/2015 and 19/02/2016
for making amendment in claims.
g) The amended claims 1-11 as filed on 23/03/2015 (are
most similar to the present patent application) "relates
to a medicament combination of a DIPP IV inhibitor with
metformin and the amended claims as filed on
19/02/2016 ( are most similar to the present patent
application) further contains 4 new claims (claims 12-
15), in addition to claims as filed on 23/03/2015, which
relate to a medicament combination of a DIPP IV
inhibitor with telmisartan. The scope of protection of
original filed claims, i.e. use of DPP IV inhibitor of
formula I or formula II alone or in combination with
other active substances, cannot be extended to the
protection of a medicament combination of a DIPP IV
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
inhibitor with metformin/telmisartan as such change in
contents of amended claims does not wholly fall within
the scope of original filed claims. Further said
amendments cannot be considered to be done by way of
disclaimer, correction, clarification or explanation as
there is clear change in category of claims wherein "use
claims" were amended to "product claims" entirely
changes in the scope. The submission given by the agent
for the applicant w.r.t. section 3(e) of the Patents Act is
in reference to the amended claims, relating to
medicament combination, which were not allowed hence
said submission is irrelevant. Further no submission filed
by the agent for the applicant for the objections raised in
paragraphs 2 and 3 of hearing notice, regarding lack of
novelty and inventive step of claims 1-3 (as filed on
24/10/2014) w.r.t. cited prior art documents D1-D4 and
claims 1-3 falling under section 3(e), 3(i) and 3(j) of the
Patents Act, therefore said objections still stands. Based
on the above facts and circumstances of the case, the
parent application application No. 9501/DELNP/was
refused for grant of patent u/s 15 of the Patents Act, 1970
as per as the parent application concerned.
h) The above analysis made on the original claims as
well as on amended claims affected in 2015 and 2016
itself. Consequently the refusal order issued on the
amended claims, and the refused claims are most similar
with pending claims in the alleged patent application. It
is to be noted that the parent refusal order clearly
stipulates the reasons that the amended claims how it
goes beyond the scope of the invention under section 57
and 59, and the amended claims subsequently were not
allowed.
i) Because of non - allowance of the amended claims
followed by refusal under section 15 would not be a case
for divisional application. Perhaps, the amended claims
could have been allowed in the parent application itself
even If there was any little chance for allowance, The
order also clearly indicates original and amended claims
lacking Novelty and obviousness, regarding Novelty and
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
inventive step the Parent refusal order has already been
considered and examined during prosecution of the
parent application. Thus, the current claims on record
absolutely do not have any merits for the purpose of
divisional application. The entire specification directed
for use of the compound, but nowhere in the
specification relates to the medicaments. The agent of
the applicant made attempts to get a patent on the
amended claims in the parent application, after refusal of
the parent application claims (original, amended claims
in 2015, amended claims in 2016) the three set of claims
are similar to the present divisional application claims.
Therefore, failure to get patent on the parent
application is not eligible criteria for divisional
application. Very important to note that in case, if the
amended claims are allowable in the present
application then the same claims could have been
allowed in the parent application itself if meeting all
criteria.
Therefore, the objection raised in the hearing notice i.e
Invention u/s 2(1)(j) 1. Objections as mentioned in this
office communication letter dated on 16/07/2019 is still
maintained and applicant reply to objections on
31/12/2019 have been fully considered but they are not
persuasive in view of the following reasons. Applicant
argument that Section 16{1} clearly and expressly allows
at any time before grant to voluntarily to file a divisional
application in respect of any invention disclosed in the
complete specification. But Section 16{1} of the Act
illustrates that an applicant can file for a further
application, if the complete specification related to more
than one invention. Before the grant of patent that has
been already been filled for which is referred to as the
first mentioned application. "If he so desires" is not
unconditional and it does not give the applicant an
unjustified liberty to file a divisional application even
when there is no multiple invention in the parent
application. A divisional has to satisfy the test of Section
16 of the Act which means that more than one invention
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
in the parent application has to be shown. 1. Claims of
the parent application 9501/delnp/2008 filed on
14/11/2008 did not contain any plurality of invention u/s
10(5) of the patent act 1970. Therefore the current
divisional application is invalid and the current
application is not allowed u/s 16(1) of the patent act
1970. Thus novelty and inventive step of the current
divisional application is not examined.
Claims 1-25 of the current divisional application were
already examined and refused in the parent application,
and therefore same claims cannot be allowed in another
application.
The above objection exhaustively discussed during the
course of hearing followed by analysis of post hearing
written submission made, the findings of the case are
clearly enumerated above, in view of above findings the
patent application bearing no. 201718031279 divisional
of a refused PCT National Phase Application No.:
9501/DELNP/2008 95 is refused under section 15."
10. The present appeal challenges the above impugned order.
Submissions
11. At the outset, Mr. Banerjee, ld. counsel for the Applicant, submits that
in the Amendments, which were sought in 2015 and 2016, i.e., Amendment
Nos. 2&3, the Applicant's claims were for various medicaments of DPP IV
Inhibitors, which were disclosed in the original National Phase PCT
application. Thus, they were within the scope of the parent
application.
12. As for the divisional application, ld. Counsel for the Applicant
submits that Claims 1 to 25 are clearly based out of the original
specification and thus, since the scope of the parent specification includes
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
the claimed products and formulations, the same can be the subject matter of
the divisional application in terms of the Section 16 of the Act.
13. He further relies upon the judgement of the IPAB in Milliken &
Company v. Union of India [OA/61/2012/PT/MUM, decided on 5th
January, 2016] to argue that in the said case, the rejection of the second
divisional application was set aside by applying Section 16 of the Act and
holding that the applicant has a right to divide the inventions into separate
divisional applications. He submits that the fact situation in the present case
is similar, inasmuch as in Milliken (supra), in the first divisional
application, Form 13 was filed seeking amendments and after the
amendment was refused, a second divisional application was filed and was
permitted.
14. On the other hand, Mr. Harish Vaidyanathan, ld. CGSC appearing for
the Controller, submits that the impugned order does not deserve to be
interfered with, inasmuch as the parent application, was for use of DPP IV
inhibitors and not for the inhibitor/medicament itself. The manner in which
the Amendments were sought to be made for seeking exclusivity qua the
inhibitor was contrary to Section 10(4) of the Act. Once the Amendments
were refused as being beyond the scope of claims, Section 16 of the Act
cannot be invoked by the Applicant for filing a divisional application for the
same claims. He further seeks to distinguish Milliken (supra) by holding
that in the said case, the Controller himself had raised an objection that there
was a plurality of inventions and multiple independently worded claims in
the parent application, which was not allowable, as they fall beyond the
scope of the main claims. Hence, the division was allowed in a completely
different fact situation.
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
15. In response, Mr. Banerjee, ld. Counsel seeks to distinguish paragraph
16 of Milliken (supra) on the ground that the said paragraph deals with the
parent application and not the relationship between the first divisional and
the second divisional applications, whereas the issue in that matter concerns
only the first and second divisional applications.
Findings and Analysis
16. Heard ld. counsels for the parties.
17. The present appeal is a case where the patent Applicant is seeking to
file a divisional application to claim a monopoly in respect of DPP IV
Inhibitors, which were originally not claimed in the parent application at
all. A perusal of the Claims in the parent application shows that all Claims
including Claim 1 which is the main claim, relate to 'Uses of DPP IV
inhibitors' of formula 1 or formula 2 along with certain substitutions at R1
and R2. The said original Claims illustratively, are demonstrated as below:
"1. Use of a DPP IV inhibitor of formula (I)
and one of the salts thereof, characterised in that
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
R1 denotes ([1,5]naphthyridin-2-yl)methyl,
(quinazolin-2-yl)methyl], (quinoxalin-6-yl)methyl,
(4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl,
(3-cyanoquinolin-2-yl)methyl, (3-cyano-pyridin-2-
yl)methyl, (4-methyl-pyrimidin-2-yl)methyl, or
(4,6-dimethyl-pyrimidin-2-yl)methyl and R2
denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-
methyl-propyl)-methylaminoor(2-(S)-amino-
propyl)-methylamino,
for preparing a medicament for the therapeutic
treatment of a patient who has been diagnosed
with a physiological functional disorder selected
from among pre-diabetes, glucose intolerance,
pathological fasting glucose, diabetic foot,
diabetes-associated ulcer, diabetic
hyperlipidaemia, diabetic dyslipidaemia, newly
diagnosed type 1 diabetes, gestational diabetes,
hyperglycaemia, adrenergic postprandial
syndrome and heart failure, or for the therapeutic
treatment of a patient with transplanted islets of
Langerhans or beta cells.
2. Use of a DPP IV inhibitor of formula (I)
and one of the salts thereof, characterised in that
R1 denotes ([1,5]naphthyridin-2-yl)methyl,
(quinazolin-2-yl)methyl, (quinoxalin-6-yl)methyl,
(4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl,
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
(3-cyanoquinolin-2-yl)methyl, (3-cyano-pyridin-2-
yl)methyl, (4-methyl-pyrimidin-2-yl)methyl, or
(4,6-dimethyl-pyrimidin-2-yl)methyl and R2
denotes 3-(R)-amino-piperidin-1-yl, (2-amino-2-
methyl-propyl)-methylaminoor(2-(S)-amino-
propyl)-methylamino
for preparing a medicament for the treatment of
patients who have been diagnosed with pre-
diabetes or manifest type 2 diabetes,
characterised in that by using the pharmaceutical
composition the risk of impaired glucose
metabolism despite treatment, an elevated HbA1c
value despite treatment, an impaired fasting
glucose value despite treatment, the need for
insulin treatment, manifest type 2 diabetes, a
diabetic foot, a diabetes-associated ulcer, diabetic
hyperlipidaemia, diabetic dyslipidaemia or a
macrovascular complication is reduced.
...
10. Use of a DPP IV inhibitor of formula (I)
and one of the salts thereof, characterised in that
R1 denotes ([1,5]naphthyridin-2-yl)methyl,
(quinazolin-2-yl)methyl, (quinoxalin-6-yl)methyl,
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
(4-methyl-quinazolin-2-yl)methyl, 2-cyano-benzyl,
(3-cyanoquinolin-2-yl)methyl, (3-cyano-
pyridin~2-yl)methyl, (4-methyl-pyrimidin-2-
yl)methyl, or (4,6-dimethyl-pyrimidin-2-yl)methyl
and R2 denotes 3-(R)-amino-piperidin-1-yl, (2-
amino-2-methyl-propyl)-methylamino or(2-(S)-
amino-propyl)-methylamino,
for preparing a medicament combination with an
active substance selected from among the other
antidiabetics; active substances that lower the
blood sugar level; active substances that lower
the lipid level in the blood; active substances that
raise the HDL level in the blood; active
substances that lower blood pressure; and active
substances that are indicated in the treatment of
atherosclerosis or obesity.
...
14. Isolation or storage medium for islets of
Langerhans or beta cells, characterised in that
the medium contains 1nmol/1 to 1 μmol/1 of a
DPP IV inhibitor for enhancing the vitality and
secretion capacity of the cells.
...
15. Method of enhancing the vitality and
secretion capacity of iselts of Langerhans or beta
cells, characterised in that during the isolation
and transplantation phase of the islets of
Langerhans or beta cells a DPP IV inhibitor is
added to the isolation and storage medium in a
concentration of between 1 nmol/1 and 1nmol/l
and 1 μmol/l."
18. Thereafter, Amendment No.1 filed in response to the FER dated 24th
March, 2014, reduced the Claims to the following:
"We Claim
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
1. Isolation or storage medium for islets of
Langerhans or beta cells, characterised in that the
medium contains 1nmol/1 to 1 μmol/1 of a DPP iv
inhibitor for enhancing the vitality and secretion
capacity of the cells.
2. Medium as claimed in claim 1, wherein the
structure of the DPP IV inhibitor is described by
the formula(1)
3. Method of enhancing the vitality and
secretion capacity of iselts of Langerhans or beta
cells, wherein during the isolation and
transplantation phase of the islets of Langerhans
or beta cells a DPP iv inhibitor is added to the
isolation and storage medium in a concentration of
between 1 nmol/l and 1nmol/l."
19. Two more Amendments were carried out after this. Claim No.1 of
Amendment No.2 reads as under:
"A medicament combination of a DPP IV
inhibitor which is 1- [( 4-Methyl-quinazolin-2-
yl)methyl]-3-methyl-7-(2-butyn-l-yl)-8-(3-
(R)aminopiperidin-l-yl)-xanthine, or one of the
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
therapeutically active salts thereof, in a dosage of
2.5 mg to 10 mg for oral administration, with
metformin."
20. Claim No.12 of Amendment No.3 reads as under:
"A medicament combination of a DPP IV
inhibitor which is 1 -[(4-Methyl-quinazolin-2-
yl)methyl]-3-methyl-7-(2-butyn-I-yl)-8-(3-
(R)amninopiperidin-1-yl)-xanthine, or one of the
therapeutically active salts 1hereof, with
telmisartan."
21. Thus, Amendment Nos. 2 and 3 were for different combinations of
DPP-IV inhibitors with Metformin and Telmisartan respectively in
medicament i.e., product form.
22. A perusal of the original patent application along with its Complete
Specification and of the Amendments filed thereafter, reveals the following
facts:
(i) The title of the parent application itself is 'Use of DPP IV
inhibitors'.
(ii) All the Claims in the parent application i.e., Claims 1 to 18 are
either use claims or method claims. There is not even a single
product claim in the entire set of claims.
(iii) In Amendment No.1, the Applicant sought to restrict Claims 1
to 18 including Claims 15 & 15A to only three claims i.e.,
Claims 14, 15 & 15A. All the other method or use claims were
given up by the Applicant.
(iv) In Amendment Nos. 2&3 however, the Applicant sought to add
new Claims, which were product Claims 1 to 11 and product
Claims 1 to 15. Amendment No.1 discussed a medicament
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
combination of a DPP IV inhibitor with metformin whereas
Amendment No.2 discussed a medicament combination of a
DPP IV inhibitor with telmisartan. Clearly, these product
Claims were not contained in the parent application at all, as the
Markush formula depicted in the parent application itself was
not a 'product claim', but a 'use claim'.
Divisional Application
23. After the Amendments, a divisional application was filed. The Claims
in the divisional application are extracted below:
"1. A medicament of a DPP IV inhibitor which is 1-
[(4-methyl-quinazolin-2-yl)methyl]-3- methyl-7-(2-
butyn-1-yl)-8-(3-(R)-aminopiperidin-1-yl)-xanthine, or
one of the therapeutically active salts thereof, in a
dosage of 2.5 mg to 10 mg for oral administration,
optionally in combination with another antidiabetic or
a blood pressure-lowering active substance.
2. The medicament combination according to claim 1
of a DPP IV inhibitor which is 1-[(4-Methyl-
quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-
(3-(R)-amino-piperidin-1-yl)-xanthine,
in a dosage of 2.5 mg or 5 mg for oral administration,
with metformin, either in a free combination or in a
fixed combination.
3. The medicament combination according to claim 2
of a DPP IV inhibitor which is 1-[(4-Methyl-
quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-
(3-(R)-amino-piperidin-1-yl)-xanthine,
in a dosage of 2.5 mg or 5 mg for oral administration,
with metformin, either in a fixed combination, which is
a tablet or capsule.
4. The medicament combination according to claim 3
of a DPP IV inhibitor which is 1-[(4-Methyl-
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-
(3-(R)-amino-piperidin-1-yl)-xanthine,
in a dosage of 2.5 mg for oral administration, with
metformin, in a fixed combination, which is a tablet.
5. The medicament combination according to claim 3
of a DPP IV inhibitor which is 1-[(4-Methyl-
quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-
(3-(R)-amino-piperidin-1-yl)-xanthine,
in a dosage of 5 mg for oral administration, with
metformin, in a combination, which is a tablet.
6. The medicament combination according to claim 2
of a DPP IV inhibitor which is 1-[(4-Methyl-
quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-
(3-(R)-amino-piperidin-1-yl)-xanthine,
in a dosage of 5 mg for oral administration, with
metformin, in a free combination.
7. The medicament combination according to any one
of the claims 1 to 6, wherein the dose of metformin is
500-2850 mg.
8. The medicament combination according to any one
of the claims 1 to 6, wherein the dose of metformin is
500 mg, 850 mg or 1000 mg.
9. The medicament combination according to any one
of the claims 1 to 6, wherein the dose of metformin is
300 mg to 1000 mg once or twice a day, or delayed-
released metformin in a dose of 500 mg to 1000 mg
once or twice a day or 500 mg to 2000 mg once a day.
10. The medicament combination according to any
one of the claims 1 to 6, wherein the dose of metformin
is 500 mg to 850 mg once or 1000 mg metformin as a
single dose with a totally daily dose of metformin of
500-2850 mg, or 500 mg, 1000 mg, 1500 mg or 2000
mg metformin in a delayed release form.
11. The medicament combination according to any
one of the claims 1 to 10, wherein the oral daily dose
of the DPP IV inhibitor is 5 mg.
12. A method of preparing a combination of a DPP IV
inhibitor which is 1-[(4-methylquinazolin- 2-
yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-
aminopiperidin-1-yl)-xanthine, or one of the
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
therapeutically active salts thereof, with metformin,
said method is characterized by combining the DPP
IV inhibitor in a dosage of 2.5 mg or 5 mg with
metformin in a dosage of 500 mg, 850 mg or 1000 mg.
13. The method according to claim 12, wherein the
daily oral dose of metformin is 500-2850 mg and the
daily oral dose of the DPP IV inhibitor is 5 mg.
14. The medicament combination according to claim 1
of a DPP IV inhibitor which is 1-[(4- methyl-
quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-
(3-(R)-aminopiperidin-1-yl)-xanthine, in a dosage of
2.5 mg to 10 mg for oral administration, with
telmisartan, either in a free combination or in a fixed
combination.
15. The medicament combination according to claim
14, wherein the dosage of the DPP IV inhibitor is 2.5
mg or 5 mg for oral administration.
16. The medicament combination according to 14
or 15, wherein the dosage of telmisartan is 20 mg to
320 mg or 40 mg to 160 mg per day.
17. The medicament combination according to
claim 14, 15 or 16, wherein the oral daily dose of the
DPP IV inhibitor is 5 mg.
18. A medicament of a DPP IV inhibitor which is 1-
[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-aminopiperidin-1-yl)-anthine, or
one of the therapeutically active salts thereof, wherein
the medicament is for oral administration and
contains a dosage of 2.5 mg to 10 mg (such as e.g.2.5
mg, 5 mg or 10 mg) of 1-[(4-methyl-quinazolin-2-
yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-
aminopiperidin-1-yl)-xanthine.
19. A method of preparing a medicament of a DPP IV
inhibitor which is 1-[(4-methylquinazolin-2-
yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-
aminopiperidin-1-yl)-xanthine, wherein the
medicament is for oral administration, said method is
characterized in that the DPP IV inhibitor in a dosage
of 2.5 mg to 10 mg (such as e.g.2.5 mg, 5 mg or 10
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
mg) is formulated together with one or more inert
carriers and/or diluents.
20. The medicament according to claim 18 or the
method according to claim 19, wherein a medicament
is formed which is a galenic preparation selected from
a tablet or coated tablet.
21. The medicament or method according to any one
of claims 18 to 20, wherein the DPP IV inhibitor is
formulated together with mannitol, pregelatinised
starch, maize starch, copovidone and magnesium
stearate.
22. The medicament or method according to any one
of claims 18 to 21, wherein the medicament is in the
form or a film-coated tablet, wherein 1-[(4-methyl-
quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-
(3-(R)-amino-piperidin-1-yl)-xanthine, mannitol,
pregelatinized starch maize starch, copovidone and
magnesium stearate are present in the tablet core
coated with a film-coating of hydroxypropylmethyl-
cellulose, polyethyleneglycol, talc, titanium dioxide
and iron oxide.
23. The medicament or method according to any one
of claims 18 to 22, wherein 1-[(4-methyl-quinazolin-2-
yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-amino-
piperidin-1-yl)-xanthine, mannitol, pregelatinized
starch, maize starch, copovidone are not wet
granulated.
24. The medicament or method according to any one
of claims 18 to 23, wherein the dosage of the DPP IV
inhibitor is 2.5 mg or 5 mg.
25. The medicament or method according to any one
of claims 18 to 24, wherein the oral daily dose of the
DPP IV inhibitor is 5 mg."
24. Thus, the divisional application consists of 25 claims. Claims 1-11,
14-18, 20-25 are all product claims for medicaments which are DPP IV
Inhibitors in various combinations, modes of administration, dosage forms,
etc. Claims 12, 13 and 19 are method claims for some combinations and
dosage forms. Notably, Claims 1-17 of the divisional application were
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
reflected in some form in Amendment Nos. 2&3. Claims 18-25 appear to be
completely new claims in the divisional application.
25. This Court also notes that a hearing was held by the Controller in
respect of the parent application and Amendment Nos. 2&3 in August, 2017.
Pursuant to the said hearing, the Controller appears to have expressed his
opinion that Amendment Nos. 2&3 would not be allowable. After the
hearing in August 2017, the Applicant filed the Divisional Application on 4th
September 2017. One day thereafter, i.e., 5th September 2017, written
submissions were filed in respect of the Amendments and the parent
application. The Controller passed the written order in January 2018,
refusing the amendments as also the parent application. The timing of filing
the divisional application is thus very interesting.
26. In so far as the divisional application itself is concerned, this case
raises an important issue as to whether divisional applications can be filed
for claims, when such claims were not part of the claims in the parent
application. In order to answer this question, a conjoint reading of Sections
10, 15 & 16 of the Act would be needed.
27. The relevant portions of Sections 10, 15 & 16 of the Act are extracted
herein below:
"Section 10. Contents of specifications
(1) Every specification, whether provisional or complete,
shall describe the invention and shall begin with a title
sufficiently indicating the subject-matter to which the
invention relates.
...
(4) Every complete specification shall--
(a) fully and particularly describe the invention and
its operation or use and the method by which it is to
be performed;
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
(b) disclose the best method of performing the
invention which is known to the applicant and for
which he is entitled to claim protection; and
(c) end with a claim or claims defining the scope of
the invention for which protection is claimed.
...
[(5) The claim or claims of a complete specification shall
relate to a single invention, or to a group of inventions
linked so as to form a single inventive concept, shall be
clear and succinct and shall be fairly based on the matter
disclosed in the specification.]
...
(7) Subject to the foregoing provisions of this section, a
complete specification filed after a provisional
specification may include claims in respect of
developments of, or additions to, the invention which was
described in the provisional specification, being
developments or additions in respect of which the
applicant would be entitled under the provisions of
section 6 to make a separate application for a patent.
XXX
Section 15 Power of Controller to refuse or require
amended applications, etc., in certain cases.
15. Power of Controller to refuse or require amended
applications, etc., in certain cases.--Where the
Controller is satisfied that the application or any
specification or any other document filed in pursuance
thereof does not comply with the requirements of this Act
or of any rules made thereunder, the Controller may
refuse the application or may require the application,
specification or the other documents, as the case may be,
to be amended to his satisfaction before he proceeds with
the application and refuse the application on failure to
do so.
Section 16 Power of Controller to make orders
respecting division of application
(1) A person who has made an application for a patent
under this Act may, at any time before the grant of
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
the patent, if he so desires, or with a view to
remedy the objection raised by the Controller on
the ground that the claims of the complete
specification relate to more than one invention,
file a further application in respect of an invention
disclosed in the provisional or complete
specification already filed in respect of the first
mentioned application.
(2) The further application under sub-section (1) shall
be accompanied by a complete specification, but
such complete specification shall not include any
matter not in substance disclosed in the complete
specification filed in pursuance of the first
mentioned application.
(3) The Controller may require such amendment of the
complete specification filed in pursuance of either
the original or the further application as may be
necessary to ensure that neither of the said
complete specifications includes a claim for any
matter claimed in the other.
..."
28. From the above provisions, it is clear that a divisional application
under Section 16 of the Act, has to be an application which arises from a
parent application disclosing a "plurality of inventions". In Section 16(1),
the phrase "the claims of the complete specification relate to more than one
invention" makes this position clear. Section 16(3) also makes it clear that
there cannot be duplication of the claims in the two specifications i.e., parent
specification and the divisional application. This leads us to the question as
to how to determine "plurality of inventions". For this, guidance can be
drawn from Section 10 of the Act which elaborates on the meaning of
complete specification and scope of claims.
29. Importantly, Section 10 of the Act clearly requires the applicant to
define the scope of the invention. It provides that every complete
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
specification has to:
Begin with a title indicating the subject matter of the invention;
Fully and particularly describe the invention;
Fully and particularly describe the operation or use of the invention;
Fully and particularly describe the manner which the invention has to
be to performed;
Disclose the best method of performing the invention, which is known
to the applicant and for which the applicant is entitled to claim
protection;
End with a claim or claims - the claims define the scope of the
invention for which the protection is sought; and
Have an abstract of the invention.
30. A perusal of these conditions as stipulated under Section 10 shows
that the title indicates the subject matter of the invention. The content of the
specification describes the invention. The complete specification also
describes the procedures, processes, methods, including the best methods.
But what is crucial to note, is the fact that the invention itself is defined in
the claims. While such claims do have to be based on the disclosure in the
specification, however even if a person does not read the complete
specification and wishes to identify the invention, the place to look for it is
in the 'Claims'. The Invention thus resides in the Claims. Accordingly,
"unity of the invention"/ "plurality of inventions" and whether they form a
"single inventive concept" has to be gleaned from a reading of the claims.
This position has been examined and held so by the IPAB as well in ESCO
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
Corporation v. Controller of Patents & Designs [OA/66/2020/PT/DEL,
decided on 27th October, 2020], where the IPAB observed:
"10. Therefore, looking at the provisions of law and
the settled practices, we reach the following
conclusions that a patent application can only be
divided, if it claims more than 'one invention'. Now
the question therefore is how "one invention" is
defined. We look at the provisions of "unity of
invention" as provided in section 10(5) of the Patents
Act, 1970. It says 'The claim or claims of a complete
specification shall relate to a single invention, or to
a group of inventions linked so as to form a single
inventive concept". Means if any specification
claims either a single invention or a group of
invention linked so as to form a single inventive
concept, the requirement of "unity of invention" is
satisfied. Hence, if there is no objection on the
ground of 'plurality of distinct inventions' means the
claims of the complete specification, contains either
a single invention or a group of inventions linked so
as to form a single inventive concept and in such a
scenario, no divisional application is allowable."
31. Using this understanding of how an invention is ascertained in a
patent application, it is clear that under Section 16 of the Act, the "plurality
of inventions" should clearly exist in the claims of the original parent
application and within the scope of the specification of the parent
application. Therefore, under Section 16, the question of whether the claims
of the complete specification relate to more than invention i.e., a "plurality
of inventions" has to be seen from the claims of the parent application.
Obviously, the claims in turn, have to be based on the disclosure in the
specification. However, if the invention is not contained in the claims of the
parent application, the divisional application cannot be permitted to be filed
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
solely on the basis of disclosure made in the specification, in respect of
alleged inventions. If applicants are permitted to file such divisional
applications on the basis of disclosure in the complete specification, without
such inventions being claimed in parent applications, it would defeat the
fundamental rule of patent law i.e., 'what is not claim is disclaimed'.1
Similarly, Section 59 also makes it clear that amendments beyond the scope
of the specification and claims would not be permissible. This is the settled
legal position, as also held by this Court in Nippon A&L Inc. v. The
Controller of Patents [C.A. (COMM.IMPD-PAT) 11/2022, decided on 5th
July, 2022]. Thus, the divisional application would be maintainable only
when the claims of the parent application disclose "plurality of inventions".
32. This position of law is also borne out by various decisions of the
IPAB. For instance, most recently in ESCO (supra), the IPAB held as
under:
"10. Therefore, looking at the provisions of law and
the settled practices, we reach the following
conclusions that a patent application can only be
divided, if it claims more than 'one invention'. Now
the question therefore is how "one invention" is
defined. We look at the provisions of "unity of
invention" as provided in section 10(5) of the Patents
Act, 1970. It says 'The claim or claims of a complete
specification shall relate to a single invention, or to a
group of inventions linked so as to form a single
inventive concept". Means if any specification claims
either a single invention or a group of invention
linked so as to form a single inventive concept, the
requirement of "unity of invention" is satisfied. Hence,
if there is no objection on the ground of 'plurality of
Nippon A&L Inc. v. The Controller of Patents [C.A. (COMM.IMPD-PAT) 11/2022, decided on 5th July,
2022]; Manual of Patent Office Practice and Procedure, published by the Office of the Controller General
of Patents, Designs and Trademarks, dated 26th November, 2019.
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
distinct inventions' means the claims of the complete
specification, contains either a single invention or a
group of inventions linked so as to form a single
inventive concept and in such a scenario, no divisional
application is allowable.
...
13. The issue of divisional applications has drawn
much attention in recent past and we have noted
different practices adopted by the applicants or by the
Patent Office. We, therefore, opine that in the best
interest of justice and in order to bring uniformity of
practices, the following guiding principle may help to
address the issue. Considering the above legal
provisions of Indian Patent law, the Manual Of Patent
Office Practice and Procedure, the PCT to which India
in a member since 1998 and the previous decisions, we
are of the view that the following points need be
adhered to while dealing with divisional applications:
14. Formal Grounds:
14.1 Filing of divisional application
❖ Either by the applicant (suo-moto), if he so desires
or
❖ To remedy the objection raised by the Controller on
the ground of plurality of invention.
❖ In either case the existence of plurality of
invention in the parent application is the sine qua
non for a divisional application.
14.2 The claims of divisional application shall have
their route in the first mentioned (parent) application.
This is true even for divisional to divisional
application as well. The routes of subsequent
divisional application also should be from the first
mentioned application. The divisional application shall
not be filed with the same set of claims as the first
mentioned application.
14.3 The applications need be divided only on the
ground of 'plurality of invention' as envisaged under
section 16. If any claim is held to be non-patentable
due to any other provisions of the law such as the
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
requirements section 3 or otherwise, it should not be
proper for filing a divisional application for such
claims.
14.4 For division of an application, the primary
requirement is that the application shall exist. Meaning
thereby that no divisional application can be filed, if
the application is either "deemed to be abandoned" or
'withdrawn" or "refused". However, the divisional
application once filed, no such subsequent action will
have any bearing on that divisional application, which
shall continue as substantive application.
...
14.7 The complete specification of the divisional
application shall not include any matter not in
substance disclosed in the complete specification of
first mentioned application. The teaching of sub
section (2) of section 16 doesn't refer to the matter
disclosed but not claimed. This relates to the fact that
since both the applications are given the same date of
filing, the latter shall not include any further subject
matter which was not disclosed in the first mentioned
application. Therefore, the contention that some
additional claim(s) can also be allowed, which never
formed part of the originally filed claims, is negated
as the provisions of law need to be read in totality. A
plain reading of sub -section (1) of section 16 reveals
that the very ground to accept divisional application is
"on the ground that the claims of the complete
specification relate to more than one inventions.
Sections 10(5) further qualifies "more than one
invention" to only such invention or group thereof
which cannot be linked to make a single inventive
concept.
Substantive Grounds:
14.8 At the stage of examination, care should be
exercised that merely by the presence of different
embodiments in the specification, which are claimed as
independent set of claims, it does not necessarily
attract the provisions of lack of Unity of invention'. If
the unity of invention is not ascertained, the
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
amendement of the claims can overcome the "scope"
or "definitiveness" requirements, and this option could
well be excercised before hand."
33. This position also finds favour in the IPAB's decision of LG
Electronics, Inc. v. Controller of Patents & Designs [OA/6/2010/PT/KOL,
decided on 10th August, 2011]. The said decision reads as under:
"The concept of divisional application in the
patent law basically addresses the issues of
allowability of protection of multiple inventions
disclosed in one patent application, where these
multiple inventions do not constitute a single
inventive concept. The protection of multiple
inventions through divisional application is
available in the Patents Act 1970 under the
provisions of section 16 and section 10(5)
reproduced below.
...
We agree with the applicants arguments that the
applicant can file an application as divisional
application of his own before the grant of patent.
However Respondent-2 is mandated by the law to
ascertain that the divisional application so filed is
on account of disclosure of plurality of distinct
invention in the parent application. Section 16
pertains to power of the Respondent to make
order respecting division of application. Right to
file divisional application indeed rest with the
applicant but the power to ascertain its
allowability is vested with the Respondent. The
first essential requirement of this provision is the
fact of existence of plurality of invention in the
parent application."
34. Even in Milliken (supra) which has been relied upon by the
Applicant, the parent application had a plurality of inventions in its claims
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
which was then moved to the first divisional application and then to the
second divisional application.
35. In view of the above discussed settled position in law, this Court is
clearly of the opinion that a divisional application in the present case cannot
be filed since there was no "plurality of inventions" in the parent
application. In the present case, the original 'DPP IV inhibitor' arising out of
a Markush formula, in various permutations and combinations describing its
use and method for treatment, which is only mentioned in the examples in
the specification, cannot be permitted to be claimed as separate product
Claims in a divisional application, as there were no product Claims in the
parent application. Clearly, the Claims in the parent application only related
to method or use claims whereas, the Claims in the divisional application
concern "products" i.e., medicaments or their combinations. Once the
product Claims were not sought in the original application and the said
products were clearly disclosed in the content of the complete specification,
the products ought to be treated as having been disclaimed. Thus, the parent
application cannot be interpreted to have included a "plurality of
inventions", i.e., completely new product Claims, patentable by way of a
divisional application.
36. In view of the above findings, this appeal is held to be completely
devoid of any merits. Considering that such long-drawn proceedings
emanated from one parent application, resulting in two separate applications,
three Amendments and the time that has been consumed between 2008 to
2017, and the timing of the divisional application, this Court deems it fit to
reject the appeal along with payment of some costs by the Applicant. Hence,
the appeal is rejected with costs of Rs.50,000/- to be paid by the Applicant
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
within four weeks. Out of this amount, Rs.25,000/- shall be paid to the ld.
Counsel for the Respondent. The remaining Rs.25,000/- shall be paid to the
DHCBA Pandemic Relief Fund [A/c No.15530110152195, IFSC Code-
UCBA0001553, UCO Bank, Delhi High Court]. The said amount shall be
utilised only for the purposes of distribution to lawyers and their families
who have deceased during the pandemic. Hony. Secretary, Delhi High Court
Bar Association to confirm receipt of the said amount, within four weeks.
37. The present appeal is accordingly dismissed. All pending applications
are disposed of.
38. The digitally signed copy of this order, duly uploaded on the official
website of the Delhi High Court, www.delhihighcourt.nic.in, shall be treated
as the certified copy of the order for the purpose of ensuring compliance. No
physical copy of orders shall be insisted by any authority/entity or litigant.
PRATHIBA M. SINGH
JUDGE
JULY 12, 2022/dk/ms
(corrected & released on 20th July, 2022)
Signature Not Verified
Digitally Signed
By:DEVANSHU JOSHI
Signing Date:21.07.2022
10:49:18
