Himachal Pradesh High Court
) Boehringer Ingelheim Pharma vs Vee Excel Drugs And ... on 2 June, 2022
Bench: Ajay Mohan Goel
IN THE HIGH COURT OF HIMACHAL PRADESH AT SHIMLA
.
ON THE 2nd DAY OF JUNE, 2022
BEFORE
HON'BLE MR. JUSTICE AJAY MOHAN GOEL
OMP No. 85 of 2022 IN COMS No. 07 of 2022
OMP No. 89 of 2022 IN COMS No. 08 of 2022
OMP No. 93 of 2022 IN COMS No. 09 of 2022
OMP No. 97 of 2022 IN COMS No. 10 of 2022
Between:-
OMP No. 85 of 2022 in COMS No. 07 of 2022
1) BOEHRINGER INGELHEIM PHARMA
GMBH & CO. KG, D-55216, INGELHEIM
AM RHEIN GERMANY THROUGH ITS
POWER OF ATTORNEY HOLDER.
2) BOEHRINGER INGELHEIM (INDIA) PVT.
LTD. UNIT NO. 202 AND PART OF UNIT
NO. 201, 2ND FLOOR, GODREJ 2,
PIROJSHA NAGAR, EASTERN
EXPRESS HIGHWAY, VIKHROLI (E),
MUMBAI-400079, THROUGH ITS
POWER OF ATTORNEY HOLDER
..PLAINTIFFS/APPLICANTS
(BY M/S ASHOK AGGARWAL AND VINAY
KUTHIALA, SENIOR ADVOCATES WITH M/S
ATUL JHINGAN, SHILPA SOOD, SANJAY
KUMAR, ARPITA SAWHNEY, DHANANJAY
SINGH, PRIYANK SHARMA, ABAY TANDON,
AND PRIYANK SHARMA, ADVOCATES)
AND
1) MSN LABORATORIES PRIVATE
LIMITED 22-23, INDUSTRIAL AREA,
MEHATPUR, UNA, HIMACHAL
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PRADESH, 174315 THROUGH ITS
MANAGING DIRECTOR.
ALSO AT
.
MSN LABORATORIS PRIVATE LIMITED
MSN HOUSE, PLOT NO. C-24, SANATH
NAGAR INDUSTRIAL ESTATE SANATH
NAGAR, TELANGANA 500018.
ALSO AT
MSN CORPORATE, H. NO. 2-91/10 &
11/MSN WHITEFIELDS, KONDAPUR,
HYDERABAD 500084 TELANGANA.
2) ERIS LIFESCIENCES LIMITED AF-10
KANCHAN PHARMA HOUSE NATIONAL
HIGHWAY NO.
r 8, ASLALI,
AHMEDABAD-382 427, GUJARAT
THROUGH ITS MANAGING DIRECTOR.
.......DEFENDANTS/NON-APPLICANTS
(BY MR. BIPIN CHANDER NEGI, SENIOR
ADVOCATE WITH M/S GURU NATRAJ &
SHRADHA KAROL, ADVOCATES FOR
DEFENDANT/RESPONDENT NO.1.
M/S MIHIR THAKORE & NEERAJ GUPTA,
SENIOR ADVOCATES, WITH M/S RAJESHWARI,
SWAPNIL GAUR, ABHINEETA CHATURVEDI,
ANUJ GUPTA, ZAINAB BHARMAL, SAINAB
BHARMAL ADVOCATES, FOR
DEFENDANT/RESPONDENT NO. 2).
OMP No. 89 of 2022 in COMS No. 08 of 2022
1) BOEHRINGER INGELHEIM PHARMA
GMBH & CO. KG, D-55216, INGELHEIM
AM RHEIN GERMANY THROUGH ITS
POWER OF ATTORNEY HOLDER.
2) BOEHRINGER INGELHEIM (INDIA) PVT.
LTD. UNIT NO. 202 AND PART OF UNIT
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NO. 201, 2ND FLOOR, GODREJ 2,
PIROJSHA NAGAR, EASTERN
EXPRESS HIGHWAY, VIKHROLI (E),
MUMBAI-400079, THROUGH ITS
.
POWER OF ATTORNEY HOLDER
..PLAINTIFFS/APPLICANTS
(BY M/S ASHOK AGGARWAL AND VINAY
KUTHIALA, SENIOR ADVOCATES WITH M/S
ATUL JHINGAN, SHILPA SOOD, SANJAY
KUMAR, ARPITA SAWHNEY, DHANANJAY
SINGH, PRIYANK SHARMA, ABAY TANDON,
AND PRIYANK SHARMA, ADVOCATES)
AND
1) MSN LABORATORIES PRIVATE
LIMITED 22-23, INDUSTRIAL AREA,
MEHATPUR,
UNA, HIMACHAL
PRADESH, 174315 THROUGH ITS
MANAGING DIRECTOR.
ALSO AT
MSN LABORATORIS PRIVATE LIMITED
MSN HOUSE, PLOT NO. C-24, SANATH
NAGAR INDUSTRIAL ESTATE SANATH
NAGAR, TELANGANA 500018.
ALSO AT
MSN CORPORATE, H. NO. 2-91/10 &
11/MSN WHITEFIELDS, KONDAPUR,
HYDERABAD 500084 TELANGANA.
.......DEFENDANT/NON-APPLICANT
(BY MR. BIPIN CHANDER NEGI, SENIOR
ADVOCATE WITH M/S GURU NATRAJ &
SHRADHA KAROL, ADVOCATES).
OMP No. 93 of 2022 in COMS No. 09 of 2022
1) BOEHRINGER INGELHEIM PHARMA
GMBH & CO. KG, D-55216, INGELHEIM
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AM RHEIN GERMANY THROUGH ITS
POWER OF ATTORNEY HOLDER.
2) BOEHRINGER INGELHEIM (INDIA) PVT.
.
LTD. UNIT NO. 202 AND PART OF UNIT
NO. 201, 2ND FLOOR, GODREJ 2,
PIROJSHA NAGAR, EASTERN
EXPRESS HIGHWAY, VIKHROLI (E),
MUMBAI-400079, THROUGH ITS
POWER OF ATTORNEY HOLDER
..PLAINTIFFS/APPLICANTS
(BY M/S ASHOK AGGARWAL AND VINAY
KUTHIALA, SENIOR ADVOCATES WITH M/S
ATUL JHINGAN, SHILPA SOOD, SANJAY
KUMAR, ARPITA SAWHNEY, DHANANJAY
SINGH, PRIYANK SHARMA, ABAY TANDON,
AND PRIYANK SHARMA, ADVOCATES)
AND
1) MSN LABORATORIES PRIVATE
LIMITED 22-23, INDUSTRIAL AREA,
MEHATPUR, UNA, HIMACHAL
PRADESH, 174315 THROUGH ITS
MANAGING DIRECTOR.
ALSO AT
MSN LABORATORIS PRIVATE LIMITED
MSN HOUSE, PLOT NO. C-24, SANATH
NAGAR INDUSTRIAL ESTATE SANATH
NAGAR, TELANGANA 500018.
ALSO AT
MSN CORPORATE, H. NO. 2-91/10 &
11/MSN WHITEFIELDS, KONDAPUR,
HYDERABAD 500084 TELANGANA.
2) EMCURE PHARMACEUTICALS
LIMITED SHOP NO. 15, 2ND FLOOR, CO.
DUTTA MARKETINGS, SANJAULI,
SHIMLA, THROUGH ITS MANAGING
DIRECTOR.
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ALSO AT:
PLOT NO. P2, IT-BT PARK, PHASE II,
MIDC HINJAWADI, PUNE 411057.
.
.......DEFENDANTS/NON-APPLICANTS
(BY MR. BIPIN CHANDER NEGI, SENIOR
ADVOCATE WITH M/S GURU NATRAJ &
SHRADHA KAROL, ADVOCATES).
OMP No. 97 of 2022 in COMS No. 10 of 2022
1) BOEHRINGER INGELHEIM PHARMA
GMBH & CO. KG, D-55216, INGELHEIM
AM RHEIN GERMANY THROUGH ITS
POWER OF ATTORNEY HOLDER.
2)
BOEHRINGER INGELHEIM (INDIA) PVT.
LTD. UNIT NO. 202 AND PART OF UNIT
NO. 201, 2ND FLOOR, GODREJ 2,
PIROJSHA NAGAR, EASTERN
EXPRESS HIGHWAY, VIKHROLI (E),
MUMBAI-400079, THROUGH ITS
POWER OF ATTORNEY HOLDER
..PLAINTIFFS/APPLICANTS
(BY M/S ASHOK AGGARWAL AND VINAY
KUTHIALA, SENIOR ADVOCATES WITH M/S
ATUL JHINGAN, SHILPA SOOD, SANJAY
KUMAR, ARPITA SAWHNEY, DHANANJAY
SINGH, PRIYANK SHARMA, ABAY TANDON,
AND PRIYANK SHARMA, ADVOCATES)
AND
1) OPTIMUS PHARMA PRIVATE LIMITED
C/O CURETECH SKINCARE, PLOT NO.
3-33/34, PHASE IV, HIMUDA,
BHATOLIKALAN, SOLAN, HIMACHAL
PRADESH-173205, THROUGH ITS
MANAGING DIRECTOR.
ALSO AT
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SECOND FLOOR, SY. NO. 37/A & 37/P,
PLOT NO. 6P, SIGNATURE TOWERS,
KOTHAGUDA, KONDAPUR,
HYDERABAD 500 084, TELENGANA.
.
.......DEFENDANT/NON-APPLICANT
(BY MR. BIPIN CHANDER NEGI, SENIOR
ADVOCATE WITH M/S GURU NATRAJ &
SHRADHA KAROL, ADVOCATES).
Pronounced on: 02.06.2022
Whether approved for reporting? Yes.
These applications coming on for pronouncement of order
this day, Hon'ble Mr. Ajay Mohan Goel, passed the following:-
O R D E R
This order shall dispose of applications preferred under Order
XXXIX, Rules 1 and 2 read with Section 151 of the Code of Civil
Procedure, 1908 by the applicants/plaintiffs, praying for interim directions
during the pendency of the suits, i.e., OMP No. 85 of 2022 in COMS No.
07 of 2022, OMP No. 89 of 2022 in COMS No. 08 of 2022, OMP No. 93
of 2022 in COMS No. 09 of 2022 & OMP No. 97 of 2022 in COMS No. 10
of 2022. The prayers made in the said applications in the respective suits
are as under:-
OMP No. 85 of 2022 in COMS No. 07 of 2022
"a) Restrain the respondents, by themselves,
their directors, partners, licensees, stockists and
distributors, agents and/or anyone claiming through any
of them, jointly and severally from infringing the patent
rights of Applicant No. 1 under Indian Patent No.
243301 by advertising, launching, making, using,
offering for sale, selling, importing and/or exporting the
medicinal product, Linagliptin in any form whatsoever
including Linagliptin API, Linagliptin formulation,
.
"Linagliptin Tablet" and/or "Linagliptin + Metformin
Hydrochloride Tablets" or any "generic version" thereof
or any product sold under the trade marks/brand names
"LINARES" and "LINARES M" or any other trade
mark(s)/brand name(s), whatsoever, or any other
product covered by the subject patent granted by the
Controller of Patents on October 5, 2010 in favour of
Applicant No. 1 subsists;"
OMP No. 89 of 2022 in COMS No. 08 of 2022
"a) Restrain the respondent, by itself, its
directors, partners, licensees, stockists and distributors,
agents and/or anyone claiming through any of them,
jointly and severally from infringing the patent rights of
Applicant No. 1 under Indian Patent No. 243301 by
advertising, launching, making, using, offering for sale,
selling, importing and/or exporting the medicinal
product, Linagliptin in any form whatsoever including
Linagliptin API, Linagliptin formulation, "Linagliptin
Tablet" and/or "Linagliptin + Metformin Hydrochloride
Tablets" or any "generic version" thereof or any product
sold under the trade marks/brand names "LINANEXT"
and "LINANEXT-M" or any other trade mark(s)/brand
name(s), whatsoever, or any other product covered by
the subject patent granted by the Controller of Patents
subsists;"
OMP No. 93 of 2022 in COMS No. 09 of 2022
"a) Restrain the respondents, by themselves,
their directors, partners, licensees, stockists and
.
distributors, agents and/or anyone claiming through
any of them, jointly and severally from infringing the
patent rights of Applicant No. 1 under Indian Patent No.
243301 by advertising, launching, making, using,
offering for sale, selling, importing and/or exporting the
medicinal product, Linagliptin in any form whatsoever
including Linagliptin API, Linagliptin formulation,
"Linagliptin Tablet" and/or "Linagliptin + Metformin
Hydrochloride Tablets" or any "generic version" thereof
or any product sold under the trade marks/brand
names "EMLINZ 5" and "EMLINZ M 500" or any other
trade mark(s)/brand name(s), whatsoever, or any other
product covered by the subject patent granted by the
Controller of Patents on October 5, 2010 in favour of
Applicant No. 1 subsists;"
OMP No. 97 of 2022 in COMS No. 10 of 2022
"a) Restrain the respondent, by itself, its
directors, partners, licensees, stockists and
distributors, agents and/or anyone claiming through
any of them, jointly and severally from infringing the
patent rights of Applicant No. 1 under Indian Patent No.
243301 by advertising, launching, making, using,
offering for sale, selling, importing and/or exporting the
medicinal product, Linagliptin in any form whatsoever
including Linagliptin API, Linagliptin formulation,
"Linagliptin Tablet" and/or "Linagliptin + Metformin
Hydrochloride Tablets" or any "generic version" thereof
or any trade mark(s)/brand name(s), whatsoever, or
any other product covered by the subject patent
granted by the Controller of Patents on October 5,
.
2010 in favour of Applicant No. 1 subsists;"
2. The suits of the plaintiffs are for passing of a decree of
restraint and permanent injunction against the defendants/non-applicants
by themselves or through their directors, partners licenses, stockiest and
distributors, agents etc. from infringing the patent rights of plaintiff No.1
under Indian Patent No. 243301 by advertising, launching, making, using,
offering for sale, selling, importing and/or exporting the medicinal product
Linagliptin in any from whatsoever or any other product covered by the
subject patent granted by the Controller of Patents on October 05, 2010,
in favour of plaintiff No 1. In addition, the plaintiffs are also praying for a
decree of damages. According to the plaintiffs/applicants, plaintiff No. 1 is
a company incorporated under the laws of Germany and plaintiff No. 2 is
a company registered under the Companies Act. Plaintiff No. 1 is the
owner of plethora of patents worldwide, including Indian Patent No.
243301 (hereinafter to be referred as 'subject patent or IN' 301 for short).
The subject patent was granted in favour of plaintiff No. 1 on 05.10.2010
as per Section 43 of the Indian Patents Act 1970, under IN' 301 for
pharmaceuticals product titled "8 (3-AMINOPIPERDIN-1YL)-XANTHINE
COMPOUNDS", for a term of 20 years from the date of filing.
3. The arguments on behalf of the plaintiffs/applicants were
advanced by M/s Ashok Aggarwal and Vinay Kuthiala, learned Senior
.
Counsel. Arguments on behalf of the defendant/non-applicant No. 1 in all
the suits were advanced by Mr. Bipin Chander Negi, learned Senior
Counsel and Mr. Guru Natarajan, learned counsel and in COMS No. 7 of
2022 arguments on behalf of defendant/non-applicant No. 2 were
addressed by M/s Mihir Thakore & Neeraj Gupta, learned Senior Counsel.
4. Learned Senior Counsel appearing for the plaintiffs/applicants
argued that for the purpose of grant of interim relief, three primary
ingredients, i.e., prima facie case, balance of convenience and irreparable
loss are all in favour of the plaintiffs/applicants. In addition, they argued
that as the defendants/non-applicants have not been able to lay any
credible challenge to the 'subject patent', therefore, this application be
allowed by granting ad-interim injunction in favour of the
plaintiffs/applicants.
5. On the other hand, learned counsel for the defendants/non-
applicants have submitted that as the defendants/non-applicants have laid
a credible challenge to the 'subject patent' therefore, the application filed
under Order XXXIX, Rules 1 and 2 of the Code of Civil Procedure be
dismissed.
6. To substantiate their contention that all ingredients exist in
favour of the plaintiffs/applicants for grant of interim order, learned Senior
Counsel argued that in the present case, the patent in issue, i.e. Indian
Patent No. 243301 (hereinafter to be referred as 'IN' 301') was granted to
the applicants on 5th October, 2010 and as its international date of filing
.
was 18th August, 2003, the term of the patent being 20 years, the patent is
still alive and is to expire on 18 th October, 2023. As per learned counsel,
the patent was granted to the applicants after following the procedure
prescribed in the Patents Act, 1970, as amended from time to time and
the Rules framed thereunder. There was no opposition to the grant of
patent at any stage after the application was filed for the grant of the
patent and after the patent was granted on 5th October, 2010, by anyone,
including the respondents in terms of statutory provisions of the Patent
Act, 1970. The patent in issue is a commercially successful patent. The
medicinal product "Linagliptin Tablet and Lenagliptin + Metformin
Hydrochloride Tablets" covered by the said patent were introduced and
launched in the Indian market under the brand name "Trajenta/Trajenta
Duo" on 27.05.2012 and 21.06.2014, respectively. Learned Senior
Counsel stressed that no party, including the respondents have filed any
pre-grant opposition, post-grant opposition or a revocation petition against
the subject patent especially against the quality and strength of the
subject patent. They further submitted that the respondent-Company is an
Indian Pharmaceutical Company and it had recently come within the
knowledge of the applicants that the respondents-Companies have made
preparation to launch and thereafter had launched infringing
product Linagliptin 5mg tablets under the respective brand names.
As per learned Senior Counsel, the product Linagliptin tablets now being
offered for sale by the respondents, are covered by the subject patent and
.
manufacturing of the said product by the respondent-Company is an act of
infringement of the exclusive rights of the subject patent of applicant No.
1. It was argued that as admittedly the respondent-Company neither has
any patent nor it has got a licence to manufacture and sell the products
covered by the subject patent from the applicants nor the respondents
have applied for or have been granted compulsory licence to manufacture
and sell the product, therefore, during the pendency of the suit, the
respondents be restrained from manufacturing and selling the product in
issue which are covered by the subject patent. According to the
plaintiffs/applicants, the following points demonstrate that there exists a
good case in their favour for grant interim order:-
"(a) 'subject patent' is old and well established;
(b) 'subject patent' is commercially highly
successful and extensively useful;
(c) admittedly, no party, including the defendant,
raised any pre-grant opposition, post-grant
opposition, including against the quality and
strength of the 'subject patent';
(d) the patent was granted in favour of the
plaintiffs after following the substantive
provisions of the The Patents Act, 1970;
(e) the patent has had a successful
commercial run in India for more than eleven years,
without any challenge, including that from the
defendant;
(f) the Central Government has not filed
.
any revocation for the 'subject patent' in terms of
Section 64 of the Patents Act, 1970;
(g) the Central Government has not made
any declaration for revocation of the 'subject patent'
in public interest in terms of Section 67 of the
Patents Act;
(h) none, including the defendant, applied
under Section 84 of the Patents Act for grant of
compulsory licence of the 'subject patent' on the
grounds as mentioned therein;
(i) no challenge was ever put forth by the
defendants to the 'subject patent' except
immediately before the commercial launch of its
infringing product in the month of February 2022,
when a revocation petition was filed by the
defendants under Section 64 of the Patents Act."
7. It was argued that above facts clearly and categorically
demonstrate that there exists a prima facie case in favour of the
plaintiffs/applicants and balance of convenience is also in their favour and
in this backdrop, in case, ad-interim order is not granted and the
defendants/non-applicants are permitted to infringe the 'subject patent' of
the plaintiffs/applicants, then, the plaintiffs/applicants shall suffer
irreparable loss, which cannot be compensated monetarily as all the hard
work that has gone into the invention of the product in issue and getting it
patented would be washed away. Learned Senior Counsel further
stressed that admittedly the defendants/non-applicants neither have any
.
patent in their name nor did they lay any challenge at the time when the
plaintiffs/applicants had applied for the 'subject patent' or even after the
patent was granted in favour of the plaintiffs/applicants. They also
submitted that the filing of a revocation petition by the defendants/non-
applicants in COMS No. 7 of 2022, in close proximity with the launch of
the infringing product was nothing but an afterthought to hold out that in
lieu of their having filed a revocation petition, they have laid a credible
challenge to the 'subject patent'.
8. Opposing the application, learned Counsel for the non-
applicant/defendant No. 1 Sh. Bipin Chander Negi, Senior Advocate and
Mr. Guru Natrajan, Advocate, argued that the applicants, in fact, have not
approached the Court with clean hands as fact of the matter is that the
applicants had obtained two patents, i.e. Patent No. 227719 (hereinafter
to be referred as 'IN' 719') for the "Markush" formula being the 'genus'
patent, which expired on 21st February, 2022 and subject patent IN' 301,
which is a 'species' patent and both patents were granted for the same
invention as it is nowhere disclosed either in the plaint or in the application
as to what was the inventive step capable of industrial application, which
distinguished patent IN301 from IN719. The Court was apprised by them
that the non-applicants MSN Laboratories had filed a revocation petition
against the patent in issue under Section 64 of the Patents Act, 1970 in
this High Court, in which, notices to the present applicants have been
issued. It was argued that the non-applicants have rightly challenged the
.
'species' after the 'genius' has expired and as the plaint is conspicuously
silent with regard to the difference between the 'genius' patent and the
'species' patent, therefore, the applicants are not entitled for any relief. It
was argued that as a credible challenge stood made to the patent in issue
by the respondent, therefore, no interim relief be granted. As per them, it
is settled law that mere grant of patent does not lend a presumption of
validity to the patent. The scheme of the Patents Act is to provide multi-
layer challenges, which are available to a non-patentee to challenge and
question the validity of a patent at any time and such validity has to be
tested on the anvil of the provisions of the The Patents Act, 1970. It was
argued that the provisions of Section 13(4) of the The Patents Act
expressly set out the absence of any presumption of validity due to mere
grant. It was also argued that in the case of pharmaceutical patents, which
have been recognized as a specific species of patent infringement
litigation, the overwhelming factor is that of public interest-namely the
need to provide for affordable and accessible healthcare products. It was
argued that in addition to the settled principles of prima facie case,
balance of convenience and irreparable loss, the plaintiffs also have to
satisfy that there is no credible challenge to the 'subject patent' which in
the present case, the plaintiffs have not been able to demonstrate and in
this view of the matter, prayer of the applicants/plaintiffs for interim
injunction is liable to be dismissed. Learned Counsel have submitted that
the genus patent 'IN 719' has expired on 21 st February, 2022, whereas the
.
specie patent 'IN301'is to expire on 18th August, 2023. According to them,
it is apparent and evident from the record that the plaintiffs/applicants
themselves have held out on more than one occasions that the 'genus'
patent and 'species' patent are the same. Learned Counsel drew the
attention of the Court to the order passed by Hon'ble High Court of Delhi
in Civil Suit (Comm.) No. 239 of 2019 with I.A. No. 6797 and I.A. No.
6798/2019, titled as Boehringer Ingelheim Phara GMBH & Co. KG vs.
Vee Excel Drugs and Pharmaceuticals Private Ltd. & Ors., dated
10.05.2019 and by referring to para-10 thereof, they have argued that the
plaintiffs/applicants cannot wriggle out from the admissions which have
been made by them, as are borne out from the said order that the
plaintiffs themselves have claimed to be owners of two patents, the first
patent being IN719 and the second patent being IN301 and it stood
submitted on behalf of the plaintiffs/applicants before the said Court that
these two patents both cover Linagliptin and all its forms. It was argued
that in the entire plaint, the plaintiffs/applicants have very conveniently
concealed this fact that except a vague and short reference somewhere
in between has been made that the plaintiffs were also holding patent
ÍN719', which as per defendants in fact was for the same product for
which subsequently the plaintiffs obtained patent ÍN'301. The difference
between the same has not at all been explained by the
plaintiffs/applicants in the plaint. Learned Counsel for the defendant also
submitted that the defendants are not infringing the suit patent as the
.
product of the defendants is based on the teaching of IN' 719 after the
expiry of the term of said patent and therefore, their act does not amount
to an act of infringement. As per them, in terms of the provisions of
Section 146(2) of the Patents Act, 1970, read with Rule 131 of the Patents
Rules 2003, the plaintiffs/applicants have filled in Form-27, perusal
whereof would demonstrate that the same product was being reflected in
the said statutory Form under both genus patent and specie patent. Thus,
they prayed that the interim order be not granted in favour of the
plaintiffs/applicants. Learned Senior Counsel have further argued by
referring to paras-30 & 33 to 41 of the reply filed to the application by non-
applicant/defendant No. 1 that descriptions of IN' 719 and IN719 are
identical in large portions and according to them, the averments so made
in the reply were not controverted in the rejoinder. They have further
submitted that the stand taken by the plaintiffs/applicants in the present
suit was totally contrary to the stand which was taken by them in the suits
filed in the High Court of Delhi. Learned Senior Counsel also relied upon
the following judgments:-
1. Dhanpat Seth & others Vs. Nil Kamal
Plastic Crates Ltd., 2006 SCC OnLine HP 98
2. Dhanpat Seth & Ors. Vs. M/s. Nil Kamal
Plastic Crates Ltd., AIR 2008 Himachal
Pradesh 23.
3. AIIMS Vs. Sanjiv Chaturvedi and others
(2020) 17 Supreme Court Cases 602
4. Mumbai International Airport Private Limited
.
Vs. Golden Chariot Airport and another,
(2010) 10 Supreme Court Cases 422.
9. Shri Mihir Thakore, learned Senior Counsel appearing for
non-applicant/defendant No. 2, in addition, while referring to the present
plaint and the plaints filed by the plaintiffs/applicants before the Delhi High
Court and the Gujarat High Court submitted that in other cases,
plaintiffs/applicants never claimed IN' 301 as an improvement of IN'719.
As per learned Senior Counsel, the subject patent was never claimed as
an advancement of the genus patent and further the research was not
pleaded in the earlier suits and this pleading was introduced in the present
suit for the first time in para-15 thereof. By referring to the provisions of
Section 10(4) of the Patents Act, 1970 learned Senior counsel argued that
only part specifications were given in the application of subject patent by
the plaintiffs/applicants, which violated Section Section 10(4) of the
Patents Act, 1970. Linagliptin was squarely covered by IN' 719, but the
genus patent was neither disclosed nor volunteered at the time of
applying for the subject patent and this was also evident from the
objections which were raised by the Examiner of the Patent Controller.
Learned Senior Counsel also submitted that IN'719 was never claimed by
the plaintiffs/applicants as a 'prior art' and product covered by the suit
patent IN' 301 was squarely covered/disclosed by a prior granted patent
IN'719, which expired on 21.02.2022. He further submitted that suit patent
.
IN' 301 was invalid due to anticipation by prior claiming in IN' 719. By
referring to the averments made in para-9 of the preliminary
submissions/objections to the reply filed to the application under Order
XXXIX, Rules 1 & 2 of the Code of Civil Procedure, learned Senior
Counsel argued that comparing the same with para-10 thereof clearly
proved and demonstrated that the subject matter (Linagliptin), which was
claimed by IN'719 was once again been claimed by IN'301. Learned
Senior Counsel by referring to pages No. 918, 920 onwards, 962, 964
onwards, 998, 1013, 1062, 1064, 1065, 1066 onwards up to 1070 of the
documents filed by defendant No. 2, which included copy of First
Examination Reports of IN' 719 and IN' 301, argued that the same clearly
demonstrated that Linagliptin was claimed under IN' 719 also by the
plaintiffs/applicants, especially in Claim 3. In addition, Mr. Neeraj Gupta,
learned Senior Counsel appearing for defendant No. 2 argued that taking
into consideration the fact that there is public interest involved in the
matter, as defendants are making available a drug to the public at large at
a much lower price, on this count also, the plaintiffs are not entitled for any
injunction. Learned Senior Counsel also relied upon the following
judgments:-
1. F. Hoffmann -LA Roche Ltd. & Anr. Vs. Cipla
Ltd. 2009 (110) DRJ 452 (DB).
2. Astrazeneca AB and another Vs. Intas
Pharmaceuticals Ltd. 2021 SCC OnLine Del
3746.
.
10. In rejoinder, learned Senior Counsel appearing for the
plaintiffs argued that there was no concealment of any fact either from the
Patent Authorities or from the Courts. It was argued that in terms of
Section 64(1)(a) of the Patents Act, a revocation petition was maintainable
on the ground that 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 India.
It was stressed that what was important was the 'priority date'. Learned
Senior Counsel for the plaintiffs/applicants argued that if one day before
the filing of the application for the grant of IN' 301, a person trained in the
art without knowing the disclosures and teachings of IN' 301 could say on
the basis of disclosures of IN' 719 that he can solve the problem solved
by IN' 301, then evergreening could be claimed, but this, the defendants
had failed to demonstrate. He submitted that the onus is to prove what
was being alleged by the defendants/non-applicants by assessing the fact
situation as it existed one day prior to the 'priority date' of IN' 301, which in
this case was 21.02.2022. Learned Senior Counsel further argued that
provisions of Section 64(1)(a) of the Patents Act were supreme and
contents thereof were the touchstone for seeking revocation of a patent
and not the contents of the pleadings of the parties or Form 27. As per
him, the innovative steps which were taken and the scientific research
which was undertaken while claiming IN' 301 were placed on record and
queries whatever raised by the Patent Authorities were duly answered to
.
their satisfaction, resulting in the grant of IN' 301. He further submitted
that here was a case where the genus patent had millions and trillions of
compound, which was not in dispute and IN' 301 was a result of further
inventive steps as well as scientific research. Learned Senior Counsel
further argued that in the present suit, it was clearly mentioned in para-15
that Indian Patent No. 227719, i.e., IN' 719 granted to plaintiff No. 1, titled
"XANTHINE COMPOUNDS" for the "Markush" formula being the 'genus'
patent, the term thereof expired on February 21, 2022 and IN' 301 is the
'species' patent covering the specific commercial embodiments being
marketed by plaintiff No. 1 through plaintiff No. 2 in India. In this para of
the plaint, it stood specifically mentioned that the compound Linagliptin
"covered and claimed" by the subject patent was invented upon further
research carried out subsequent to the filing date of IN' 719 being the
'genus' patent and before the earliest priority date of the subject patent.
Learned Senior Counsel has also placed reliance upon the affidavit
deposed by Dr. Matthias Eckhardt, being the co-inventor of the inventions
covered by IN' 719 and IN' 301, which is available on record with the
documents of the plaintiffs/applicants, as Annexure-E. He submitted that
whereas in the present case, the plaintiffs/applicants clearly stated that
'compound Linagliptin was covered and claimed' by the subject patent,
whereas in the earlier suit, for example the suit filed by the plaintiffs in the
High Court of Delhi, i.e., CS(COMM) No. 240 of 2019, it was clearly
mentioned that Linagliptin, as mentioned in the carton of the infringing
.
product is a compound claimed and covered in Claim 1 of IN' 301,
whereas, with regard to IN' 719, it was mentioned that Linagliptin, as
mentioned in the carton of the infringing product was a compound
"claimed and encompassed" in Claim 1 of IN' 719. Learned Senior
Counsel by taking the Court through the plaint, which has been filed by
defendant/non-applicant No. 2 stated that in more than 10 places, it was
averred by the plaintiffs/applicants that whereas Linagliptin was a
compound "claimed and encompassed" in Claim 1 of IN' 719, the same,
i.e., Linagliptin was a compound claimed and covered in Claim No. 1 of
IN' 301. On these bases, it was submitted that it was never held out at any
stage by the plaintiffs that Linagliptin was a compound "covered in Claim
of IN' 719" and plaintiffs/applicants have always claimed Linagliptin to be
covered in Claim 1 of IN' 301. On these bases, he submitted that as there
was no merit in the contentions of the defendants/non-applicants, the
interim prayer being prayed for, be granted. Learned Senior Counsel has
also relied upon the following judgments:-
1. Novartis AG and another Vs. Natco Pharma
Limited, 2021 SCC OnLine Del. 5340.
2. Merck Sharp and Dohme Corporation and
another Vs. Glenmark Pharmaceuticals, 2015
SCC On Line Del. 8227.
11. I have heard learned Counsel for the parties and I have also
gone through the application filed under Order 39, Rules 1 and 2 of the
.
Code of Civil Procedure as well as response(s) filed thereto.
12. Before proceeding further, I will refer to, two judgments of the
Hon'ble Supreme Court and some of the case law that has been relied
upon by learned Counsel for the parties.
13. In M/s Bishwanath Prasad Radhey Shyam Vs. Hindustan
Metal Industries, (1979) 2 Supreme Court Cases 511, Hon'ble Supreme
Court has been pleased to hold that 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.
Hon'ble Supreme Court further held that the 'validity of a patent is not
guaranteed by the grant', was also expressly provided in Section 13(4) of
the Patents Act, 1970.
14. Hon'ble Supreme Court of India in Dalpat Kumar and
Another Vs. Prahlad Singh and Others, (1992) 1 Supreme Court Cases
719 has held that it is settled law that the grant of injunction is a
discretionary relief and exercise thereof is subject to the Court satisfying
that (1) there is a serious disputed questions to be tried in the suit and that
an act, on the facts before the Court, there is probability of his being
entitled to the relief asked for by the plaintiff/defendant; (2) the Court's
interference is necessary to protect the party from the species of injury. In
other words, irreparable injury or damage would ensue before the legal
right would be established at trial' and (3) that the comparative hardship or
.
mischief or inconvenience which is likely to occur from withholding the
injunction will be greater than that would be likely to arise from granting it.
In para-5 of the judgment, Hon'ble Apex Court has been further pleased to
hold as under:-
"5. Therefore, the burden is on the plaintiff by
evidence aliunde by affidavit or otherwise that there is
"a prima facie case" in his favour which needs
adjudication at the trial. The existence of the prima facie
right and infraction of the enjoyment of his property or
the right is a condition for the grant of temporary
injunction. Prima facie case is not to be confused with
prima facie title which has to be established, on
evidence at the trial. Only prima facie case is a
substantial question raised, bona fide, which needs
investigation and a decision on merits. Satisfaction that
there is a prima facie case by itself is not sufficient to
grant injunction. The Court further has to satisfy that
non-interference by the Court would result in
"irreparable injury" to the party seeking relief and that
there is no other remedy available to the party except
one to grant injunction and he needs protection from the
consequences of apprehended injury or dispossession.
Irreparable injury, however, does not mean that there
must be no physical possibility of repairing the injury,
but means only that the injury must be a material one,
namely one that cannot be adequately compensated by
way of damages. The third condition also is that "the
balance of convenience" must be in favour of granting
injunction. The Court while granting or refusing to grant
.
injunction should exercise sound judicial discretion to
find the amount of substantial mischief or injury which is
likely to be caused to the parties, if the injunction is
refused and compare it with that it is likely to be caused
to the other side if the injunction is granted. If on
weighing competing possibilities or probabilities of
likelihood of injury and if the Court considers that
pending the suit, the subject-matter should be
maintained in status quo, an injunction would be issued.
Thus the Court has to exercise its sound judicial
discretion in granting or refusing the relief of ad interim
injunction pending the suit."
15. In F. Hoffmann-LA Roche Ltd. & Anr. Vs. Cipla Ltd. 2009
(110) DRJ 452 (DB), Hon'ble Division Bench of High Court of Delhi was
dealing with an appeal filed by the plaintiffs against the judgment passed
by learned Single Judge whereby the prayer for grant of interim injunction
to restrain the defendant from manufacturing, offering for sale etc. the
drug in issue was rejected. In the said judgment, Hon'ble Division Bench
held as under:-
"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 weigh-
tage, 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. M/s Hindustan
Metal Industries AIR 1982 SC 1444, Standipack Pvt. Ltd.
v. Oswal Trading Co. Ltd. AIR 2000 Del 23, Bilcare Ltd. v.
Amartara Pvt. Ltd. 2007 (34) PTC 419(Del), Surendra
Lal Mahendra v. Jain Glazers (1979) 11 SCC 511. In
BeechamGroup Ltd. v. Bristol Laboratories Pty Ltd. (1967-
68) 118 CLR 618 and Australian Broadcasting Corporation
v. O'Neill (2006)229 ALR 457 it was held that the defen-
dant 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 as-
serting invalidity to show that want of validity is a triable
question." In Abbot Laboratories v. Andrx Pharmaceuticals
Inc. (decision dated 22 nd June 2006 of the U.S.Court of
Appeals for the Federal Circuit 05-1433) the Court of Ap-
peals followed its earlier ruling in Helifix Ltd. v. Blok-Lok
Ltd. 208 F.3d 1339 where it was held (at 1359): "In resist-
ing 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 invalid-
ity 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 infringe-
ment 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 ques-
tion" and a triable issue. Without indulging in an exercise
in semantics, the Court when faced with a prayer 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."
16. It is pertinent to mention herein that in the above matter, the
Court was dealing with a life saving drug relating to the treatment of Can-
cer. In this context, in para-84 of the judgment, Hon'ble Division Bench
further held as under:-
"84. Even while considering this aspect, the Court
is conscious that the defendant has been able to demon-
strate prima facie that the plaintiffs do not hold a patent yet
for the drug Tarceva, which is the Polymorph B form of the
substance for which they hold a patent. Secondly, the de-
fendant has raised a credible challenge to the validity of
the patent held by the plaintiffs. In such circumstances, the
public interest in greater public access to a life saving drug
will have to outweigh the public interest in granting an in-
junction to the patent holder."
17. Learned Single Judge of Hon'ble High Court of Delhi in
Glaverbel S.A. versus Dave Rose & Ors. 2010 SCC Online Del 308,
while dealing with an application filed under Order 39, Rules 1 and 2 of
the Code of Civil Procedure, held as under:-
.
"68. There is no res integra to the question that
the grounds of challenge of the patent which are available
to the defendant in revocation of the patent are also
available to the defendant by way of challenging the
validity of the same in an infringement suit. The same
exposition of law has been discussed in Bishwanath
Prasad Radhey Shyam‟s case (supra) which has been the
authority on the point and also discusses in detail the tests
of patentability.
69. There are other authorities which reiterate the
said exposition of law from time to time and discuss the
grant of injunction at the interlocutory stage, however, the
recent one which encapsulates the law on the subject and
lays down the parameters within which this court has to
scrutinize the patents and the challenge thereto is decided
by a Division Bench of this Court in F. Hoffmann- La Roche
Ltd Vs. Cipla Ltd; 159(2009)DLT243 wherein the division
bench while dealing with a similar issue of the grant of
injunction laid down the extent of examination by the court
for the grant of injunction which is stated as under :
" Notwithstanding the above, assuming that the
plaintiff held a valid patent for the product which has been
subject matter of the suit for infringement, the grant of
such patent to the plaintiffs will not ipso facto entitle them
to an interim injunction if the defendant is able to satisfy
the court that there is question to be tried as to the validity
of the patent. In the present case, the defendant has
raised a credible challenge to the validity of the patent by
raising the serious triable and substantial question that
renders it vulnerable to challenge."
70. Thus, this court has to examine the challenge
.
made to the patent as to whether there is any serious,
triable dispute which is made out and the same renders
the patent vulnerable to challenge or not.
71. The another thing which requires discussion
at this juncture is that novelty, inventive step and industrial
application are the three trinity tests of patentability and
the same are to be satisfied independently of each other
although r it is separate issue that they may be
interdependent upon each other as novelty promotes
invention which enhances its applicability in the industry.
Thus, the challenge which in the present case is raised
has to be looked into from the perspective of novelty or
newness as well as inventive step or obviousness wherein
the criterion is that the same invention cannot be known to
the person skilled in the art. Discussion on submissions by
the parties"
18. Hon'ble Division Bench of High Court of Delhi, in
Astrazeneca AB and Another versus Intas Pharmaceuticals Ltd., 2021
SCC Online Del 3746, held as under:-
"41. During the hearing, we also enquired from the
counsel for the appellants/plaintiffs, that if DAPA was not
disclosed in IN 147 and was in fact not known to the ap-
pellants/plaintiffs also, what would have been the situation
if someone other than the appellants/plaintiffs had discov-
ered DAPA, even if from IN 147, before the
appellants/plaintiffs.
46. In our opinion, a single formulation as DAPA,
.
is incapable of protection under two separate patents
having separate validity period. The appellants/plaintiffs, in
their pleadings, are not found to have pleaded the
difference, save for pleading that DAPA was discovered by
further research. From the field of the invention subject
matter of the two patents being verbatim same, at this
stage, it also appears that there is no enhancement of the
known efficacy, within the meaning of Section 3(d) of the
Act, between the product subject matter of IN 147 and the
product subject matter of IN625."
19. In Novartis AG Vs. Natco Pharma Ltd., 2021 SCC Online
Del 5340, after taking into consideration the authorities referred to therein
on the principles of grant of interim injunction in the patents matter,
learned Single judge, inter alia, held as under:-
"173. Several stellar principles emanate from a
reading of the afore- quoted judicial authorities. So pivotal
are these principles to assessment of infringement, and
the aspect of vulnerability of the "(5) The claim of claims of
a complete specification shall relate to a single invention,
or to a group of inventions linked so as to form a single in-
ventive concept, shall be clear and succinct and shall be
fairly based on the matter disclosed in the specification."
Patent alleged to be infringed, that, at the cost of repeti-
tion, I deem it appropriate to enumerate the principles,
thus:
(i) On patentability
a) Inventions, alone, are entitled to patents.
b) An invention must (i) be new, i.e. not anticipated,
(ii) involve an inventive step, (iii) be capable of industrial
.
application, i.e. of being made or used in the industry and
(iv) entail technical advance over existing knowledge, or
have economic significance, rendering the invention not
obvious to a person skilled in the Art.48
(c) The triple test of patentability is, therefore, novelty, the
existence of an inventive step and industrial applicabil-
ity. In Merck v. Glenmark16, it was held that these tests
stood satisfied by the SFB disclosed in the Markush
patent.
(d)
The claim in a patent could conceivably encompass
embodiments to be invented in future without particularly
advantageous properties, provided such inventions em-
ploy the technical contribution made by the invention.49
(e) "Patentability" requires that the product (a) must be
an invention within the meaning of Section 2(j) and
(b) must not fall within the exceptions in Section 3.50
(f) Section 3(d) is not an exception to Section 2(1)(j).
While assessing patentability of a claim for grant of patent,
it had to be examined, in the first instance, whether the
product was disentitled to patent on any of the grounds en-
visaged by Section 3(d). The patentability of products
would then have to be assessed, for determination of their
patentability on the basis of Section 2(1)(j) read with
Section 2(1)(j)(a).51
(g) A mere claim, without enabling disclosure, as would
enable a person skilled in the art to work the invention, is
not patentable.52
(h) The role of the complete specification accompany-
ing a patent application is to teach what the invention was,
how it was to be made, and how it was to be used.53
(i) One invention is entitled only to one patent. One
patent may, however, cover more than one invention, pro-
vided all inventions involved the same inventive steps.
(j) Grant of repeated patents for the same invention re-
sults in the malaise of evergreening of a patent beyond its
life, which is impermissible.55
(ii) Mere grant of a patent is not necessarily a prima fa-
.
cie indicator of its validity.56
(iii) Infringement:
(a) Examination of any claim of infringement requires
(i) determination of the meaning and scope of the claims in
the suit patent and (ii) comparison of the claim so
interpreted with the allegedly infringing product of the
defendants. The comparison has to be of the defendants'
product vis-a-vis the plaintiffs' patent and not product-to-
product.57
(b) This has to be determined on the basis of claim
construction. The plea of a defendant that the plaintiff may
have itself applied for grant of patent in respect of the
allegedly infringing product, and abandoned the claim
later, was held, in Merck v. Glenmark16, to be irrelevant. In
a visible departure, however, where the claim of the
plaintiff was rejected, Roche v. Cipla held this to be an
indicator, prima facie, that the defendant's product
infringed the suit patent.
(iv) Section 3(d)
(a) Once a patent was granted to an Active Pharmaceu-
tical Ingredient (API), Section 3(d) protects all products of
such API, in any form, from grant of a subsequent patent.
The manufacture or marketing by any third party of any
product-derivative of a patented API would amount to in-
fringement.58 The API is the molecular entity which exerts
the therapeutic effect of medicine and is biologically active.
Patent protection is ordinarily granted to the API59.
(b) In the case of pharmaceutical products, the deriva-
tives envisaged by Section 3(d) would include (a) pro-
drugs, which are not active, but are metabolized in the
body so as to result in pharmaceutically active substances,
(b) combinations of more than one APIs or the combina-
tion of an API with an inert carrier and (c) drug delivery
systems, which are compositions enabling the constituents
to be administered in a particular fashion.60
(c) In Novartis9, examining the vulnerability of Imatinib
Mesylate to invalidity on the ground of Section 3(d), the
Supreme Court held that (i) the obtaining of Refer Roche v.
Cipla Ltd17 Refer Roche v. Cipla Ltd17 Refer Roche v.
.
Cipla Ltd17 approval for Imatinib Mesylate on the basis of
Zimmerman patent, (ii) the obtaining of patent term exten-
sion for the Zimmerman patent on the ground of pendency
of regulatory approval for Imatinib Mesylate,
(iii) the obtaining, by Novartis, of injunction against mar-
keting of Imatinib Mesylate by any third party on the basis
of the Zimmerman patent and (iv) the view of the Board of
Patent Appeals that the Zimmerman patent had the teach-
ing to convert Imatinib to Imatinib Mesylate, in conjunction,
indicated that Imatinib Mesylate was not a "new product",
within the meaning of Section 3(d), vis-à- vis the Zimmer-
man patent, but merely a "known substance".
(d) "Efficacy" in Section 3(d) refers to the function, utility
and purpose of the product under consideration. Hence,
for pharmaceutical products, "efficacy" would mean "thera-
peutic efficacy". "Therapeutic efficacy" was required to be
judged strictly and narrowly.61
(e) Enhanced properties, which were inherent to the
forms of the known substance, visualized in the explana-
tion to Section 3(d) would not imply enhanced efficacy. En-
hanced therapeutic efficacy was a must.62
(f) "Enhanced solubility" is no indicator of enhanced ef-
ficacy in pharmaceutical products.63
(g) Applying this principle, the admission, by Novartis,
that "all indicated inhibitory and pharmacological effects of
the β-crystalline form of Imatinib Mesylate are present in
the free base", was held by the Supreme Court in Novar-
tis9, to indicate that the β- crystalline form of Imatinib Me-
sylate did not possess enhanced efficacy vis-à-vis the Ima-
tinib free base.
(h) As no research data had been placed by Novartis
on record to indicate enhanced therapeutic efficacy of the
β-crystalline form over the Zimmerman patent, except in
respect of properties already possessed by the Zimmer-
man patent, the Supreme Court, in Novartis, that the β-
crystalline form of Imatinib Mesylate did not possess en-
hanced therapeutic efficacy vis-à-vis the free base or the
non crystalline form of Imatinib Mesylate.
(i) Whether increased bioavailability would or would
not, result in enhanced therapeutic efficacy had to be de-
.
cided on the basis of research data, and had to be specifi-
cally claimed.64
(v) Coverage, claim construction and disclosure
(a) The coverage of a claim, for the purposes of deter-
mination the scope of protection under Section 48 of the
Patents Act65 had to be determined by claim construction.
Claim construction involved reading of the wording of the
claim with its enabling disclosures as contained in the
complete specifications, as understood by a person skilled
in the art, acquainted with the technology in question. A
product could be treated as covered by the claim, for the
purposes of patent protection if, on the basis of the word-
ing of the claim read with the enabling disclosures in the
complete specifications, the person skilled in the art would
be in a position to work the invention so as to make it
available to the public by the expiry of the patent term.66
(b) The qualities of an enabling disclosure were well de-
lineated in the Wands tests33. They involved (i) the quan-
tity of experimentation necessary, (ii) the amount of guid-
ance available in the patent, (iii) the presence/absence of
working examples, (iv) the nature of invention, (v) the state
of prior art, (vi) the related skill of those in the art, (vii) the
predictability/unpredictability of
48. Rights of patentees -
Subject to the other provisions contained in this Act and
the conditions specified in section 47, a patent granted
under this Act shall confer upon the patentee -
(a) where the subject matter of the patent is a product,
the exclusive right to prevent third parties, who do not
have this consent, from the act of making, using, offering
for sale, selling or importing for those purposes that
product in India;
(b) where the subject matter of the patent is a process
the exclusive right to prevent third parties, who do not
have his consent, from the act of using that process, and
from the act of using, offering for sale, selling or importing
for those purposes the product obtained directly by that
process in India."
ReferMerck v. Glenmark16 the art and (viii) the
breadth of the claims.67
.
(c) Some of the principles of claim construction are that
(I) the claim defines the scope and territory of the
patent, (ii) claims in a patent may be dependent or
independent, (iii) different claims in one patent define
different embodiments of the same inventive concept,
(iv) invalidation must be of each claim separately and
independently, (v) where the claim was worded using the
expression "comprising of" various elements, the addition
of another element would infringe the patent, (f) where,
however, the claim was "consisting of" various elements,
infringement would require the subsequent patent to have
all the elements in the claim and non other, with the
addition of any other element defeating infringement and
(g) claims were not to be construed on the basis of prior
material or subsequent conduct68.
(d) In this context, in my opinion, demystification of the
concept of "coverage", when used in the concept of claim
construction and claim protection in patent law, is
essential, as there is considerable debate on this issue in
nearly every case, with Counsel, relying on the same
decisions, adopting near irreconciliable stances. There is,
in my view, a distinction between the "broad coverage"of a
claim in a patent, and the "protected coverage", i.e. Refer
Merck v. Glenmark16 Refer Roche v. Cipla Ltd17 the
coverage which would be entitled to patent protection
under Section 48. The following passage from Merck v.
Glenmark16 is important in this regard:
"Construction of the patent by this court, to
verify its coverage is fundamental. This coverage depends
on the nature of the claims made (and enabling
disclosures specified) by MSD in its 'Complete
Specification' under Form 2 of the Act. The words used to
describe the claims - as read by a person of ordinary skill
in the art - determine the breadth of the monopoly granted
by the patent, for which the substantive (and indeed,
substantial) rights under Section 48 of the Act are
triggered."
(Emphasis supplied) Judgements are not to
be read like statutes.69 While referring to a precedent, it is
necessary to discern, with care, what exactly the court
seeks to convey. The reference to "coverage", in the afore-
extracted passage from Merck v. Glenmark16, is, in my
view, to be understood as referring not to the "broad
coverage" of the claim, but to that coverage which would
be entitled to patent protection under Section 48. The
.
Division Bench holds that the coverage encompassed by
the claim, as worded, read with the enabling disclosure,
would be entitled to protection under Section 48. A case in
point is SPM, which was subject matter of consideration
in Merck v. Glenmark16. The claim in IN 816, as worded,
encompassed "Sitagliptin with its pharmaceutically
acceptable salts". Sitagliptin Hydrochloride was specifically
exemplified in the complete specifications in Bharat
Petroleum Corporation Ltd v. N.R. Vairamani, (2004) 8
SCC 579. The SFB, and Sitagliptin Hydrochloride,
therefore were, on a plain reading, entitled to patent
protection. Paras 38 and 39 of the report in Merck v.
Glenmark16 goes on to suggest that, possibly, enabling
disclosure, in respect of SPM, was also to be found in IN
816 (though, later, the judgement leaves this issue open
for more detailed analysis). The paragraphs (to the extent
relevant) read thus:
"38. ... The section 'Detailed Description of
the Invention', which discloses Formula 1 (reproduced
below), corresponds to claim 1 of the patent specification,
discloses the following compound structure:
39. This is the Sitagliptin free base. Each element of this
structure, and selection of particular elements to reach this
structure, is further detailed at pages 5 and 6 of the
specification. Page 10 further details the separation of
racemix mixtures of the compound to isolate individual
enantiomers, including the R form of the compound that is
ultimately used in Januvia and Janumet. The term
"pharmaceutically acceptable salts"
- it is stated - "refers to salts prepared from
pharmaceutically acceptable non-toxic bases or acids
including" inter alia phosphoric acid, which is the second
element in SPM (i.e. the P in SPM). The M - or
monohydrate - is indicated by stating that "salts... may also
be in the form of hydrates" (page 10 of the Form 2 filing)."
If, thus, the disclosure contained in IN 816 enabled the
person skilled in the cart to arrive at SPM, SPM would also
be covered by IN 816 so as to be entitled to patent protec-
tion under Section 48." This, then, would, as held in para
38 of Merck v. Glenmark16, be the "coverage" which
would trigger the protection provided by Section
(e) As against this, the "broad coverage" of the claim in
the patent, as worded, may include products for which
.
there is no enabling disclosure. For example, in IN 816, all
pharmaceutically acceptable salts of Sitagliptin are within
the "broad coverage" of the claim as worded. Assuming,
however, that there is, in the complete specifications in IN
816, no enabling disclosure (arguendo) except in respect
of SPM - excepting Sitagliptin Hydrochloride, which is
claimed by exemplification, such pharmaceutically accept-
able salts, which are not disclosed in IN 816, but are,
nonetheless, within the coverage of the claim as worded,
would not be entitled to patent protection under Section
48. "Coverage", in this sense, is, therefore, wider than
"disclosure".
(f) While this distinction between "coverage" of a claim,
as understood in absolute terms, and the "disclosures" in
the complete specifications relating thereto does exist, the
gap between coverage and disclosure could not be so
wide as to enable an artful draftsman to so draft a claim as
to escape coverage by the prior art70.
(g) Applying this principle, the contention of Novartis
that the Zimmerman patent covered, but did not disclose
Imatinib Mesylate, was rejected by the Supreme Court in
Novartis9. The Supreme Court held that (a) as the Imatinib
free base was covered and disclosed in the Zimmerman
patent, (b) the Zimmerman patent also claimed pharma-
ceutically acceptable salts of the Zimmerman free base,
(c) Imatinib Mesylate was a "known substance" from the
Zimmerman patent and (d) Imatinib Mesylate was a phar-
maceutically acceptable salt of the Imatinib free base, Ima-
tinib Mesylate was claimed and disclosed in the Zimmer-
man patent.71
(h) Similarly, in Merck v. Glenmark16, even while ex-
pressing no final opinion in that regard, it was observed
that (a) the disclosure, in the prior art, of the method of iso-
lation of the Sitagliptin free base, (b) the identification of
pharmaceutically acceptable salt of Sitagliptin, in the prior
art, as including salts made from phosphoric acid and (c)
the suggestion, in the prior art, that pharmaceutically ac-
ceptable salts of the Sitagliptin free base may also be in
the form of hydrates, indicated that SPM was disclosed in
the prior art.
(i) Where the attached salt radical was a mere in-
ert Refer Novartis9 career, and pharmaceutical activity
.
was attributable to the free base, the disclosure of the free
base in prior art would imply disclosure of the salt, as nov-
elty existed in the free base, even if the combination with
the inert salt radical was useful for effective administration
of the drug72.
(vi) Obviousness:
(a) "Prior disclosure", for the purposes of obviousness,
meant disclosure which, if performed, would infringe the
patent73.
(b) Prior art, for the purposes of obviousness, was re-
quired to have been published before the priority date of
the suit patent74.
(c) The test of obviousness was whether, if the prior art
document was placed in the hands of a competent drafts-
man endowed with common general knowledge at the pri-
ority date, faced with the problem which the patentee
solved in the suit patent, but not endowed with the knowl-
edge of the patented invention, the draftsman would have
said "this gives me what I want."75
(d) In Roche v. Cipla-I17, various combination
tests have been approved by the Division Bench, to as-
sess "obviousness". These are the following:
(i) The first is the triple test of obviousness, involving
determination of the scope and content of the prior art,
difference between the prior art and the claims and issue
and the level of ordinary skill in the pertinent art resolved.
Against this background, the obviousness or non-
obviousness of the subject matter is determined. Such
secondary considerations as commercial success, long felt
but unsolved needs, failure of others, etc., might be
utilized to give light to the circumstances surrounding the
origin of the subject matter sought to be patented.
(ii) The second test involves the following four steps:
(a) identifying the inventive concept
embodied in the patent;
(b) imputing to a normally skilled but
unimaginative addressee what was commongeneral
knowledge in the art at the priority date;
(c) identifying the differences if any
.
between the matter cited and the alleged
invention; and
(d) deciding whether those differences,
viewed without any knowledge of the alleged invention,
constituted steps which would have been obvious to the
skilled man or whether they required any degree of
invention.
(iii) The third test involves the following five steps:
"Step No. 1 - To identify an ordinary person skilled in the
art, Step No. 2 - To identify the inventive concept
embodied in the patent, Step No. 3 - To impute to a normal
skilled but unimaginative ordinary person skilled in the art
what was common general knowledge in the art at the
priority date.
Step No. 4 - To identify the differences, if any, between the
matter cited and the alleged invention and ascertain
whether the differences are ordinary application of law or
involve various different steps requiring multiple,
theoretical and practical applications, Step No. 5 - To
decide whether those differences, viewed in the
knowledge of alleged invention, constituted steps which
would have been obvious to the ordinary person skilled in
the art and rule out a hideside (sic hindsight) approach."
(e) The reason or motivation for making the choices
which would lead the persons skilled in the art to arrive at
the suit patent from the prior art, must be apparent in the
prior art, i.e. in the claim in the prior art read with its
enabling disclosure, for "obviousness" to exist. The
"motivation" must include the motivation to select and the
motivation to combine.76
(f) The suit patent is obvious from the prior art if the
invention claimed in the suit patent, as a whole, would
have been obvious, prior to the priority date of the suit
patent, to a person skilled in the art, from the claim in the
prior art read with its enabling disclosures. In this, the first
step is the selection of the prior art as the lead compound.
(g) Clear differences in molecular structure would militate
against any inference of obviousness77.
(h) In assessing obviousness, hindsight analysis is im-
permissible. In other words, while assessing whether the
suit patent is vulnerable to invalidity on the ground of obvi-
ousness, the teachings in the suit patent cannot be used
as a guide. If the teachings in the suit patent are required
to be referred, it would imply that the exercise is one of
.
hindsight analysis.78
(i) The simple test to ascertain whether the suit patent
is obvious from the prior art, is, therefore, to arm the mythi-
cal person skilled in the art with the complete specifica-
tions of the prior art, and the objective which the suit
patent ultimately achieved. If the person is able to use the
teaching in the prior art to arrive at the suit patent, the suit
patent is obvious. If he is not able to do so, it is not.
(j) The "person skilled in the art" is "a person who prac-
tices in the field of endeavor, belongs to the same industry
as the invention, possesses average knowledge and ability
and is aware of what was common general knowledge at
the relevant date".79
(k) A claim of infringement, by the product of the defen-
dant, of the suit patent as well as the prior art, would itself
defeat, prima facie, the allegation of infringement, as it
would imply that the suit patent is obvious from the prior
art80.
(l) In the case of a Markush patent, and a subsequent
patent for a specific entity, where the Markush does not
contain any precise enabling disclosure teaching the way
to the subsequent patent, the question to be addressed
while examining the vulnerability of the subsequent patent
as obvious from the Markush, would be as to how far the
subsequent patent is subsumed in the earlier Markush
patent81.
(m) Where the inventor of the prior art and the suit
patent is the same, the appropriate test to be applied
would be that of "a person in know, rather than a person
skilled in the art.82"
(vii) Industrial applicability and commercial utility:
(a) On the aspect of industrial applicability, in Merck v.
Glenmark16, it was held that, once the SFB had been
disclosed, alongwith disclosure of its usefulness in treating
diseases and the mode of administration of the drug
resulting from the free base, the SFB was capable of
industrial application.
(b) Capability of industrial application has to be decided
on the basis of the API, not on the basis of the particular
.
salt. The requirement of combination of the API with an
inert career, for its administration, was irrelevant to the
issue of industrial application83.
(c) The inert career is not the crux of the invention, as
the therapeutic efficacy is attributable to the API alone84.
Refer Astrazeneca v. Intas20 Refer Merck v. Glen-
mark16 Refer Merck v. Glenmark16
(d) The criteria to assess industrial application are (i)
that the patent must disclose its practical application and
be of profitable use, (ii) the use of the patent in industrial
practice must be derivable directly from the description in
the complete specifications read with common general
knowledge, (iii) speculative use is insufficient in this regard
and (iv) the complete specification, read with common
general knowledge, was required to be sufficient to enable
a person skilled in the art to exploit the invention without
undue burden and without having to carry out a research
programme85.
(e) In pharmaceutical compounds, generally, a patent is
capable of industrial application if (i) the function of the en-
tity is disclosed in the patent and (ii) the function disclosed
relates to usefulness of the entity in the medical indus-
try86.
(f) Breakthrough inventions, even if not commercially
viable at the time of their conceptualization, or invention,
are nonetheless useful and industrially applicable. In this
context, "commercial utility" must be distinguished from
"patentable utility". "Commercial utility" is not a sine qua
non for patentability.87 Refer Merck v. Glenmark16 Refer
Merck v. Glenmark16 Refer Roche v. Cipla Ltd17
(g) Any challenge to the validity of a patent on the
ground of want of commercial utility, in order to succeed,
would require the challenger to show that the later com-
mercially successful patent owed nothing to the original
patent88.
(h) A patent could be treated as lacking commercial util-
ity only if, even if worked as suggested by the complete
specifications, it would not yield the promised result. If it
does, commercial utility is established.89
.
(viii) Section 8:
(a) The requirement of compliance with Section 8 of the
Patents Act is mandatory.
(b) As violation of Section 8 renders the patent vulnera-
ble to revocation, the provision is required to be strictly
construed.90
(c) Section 8 is applicable only to foreign patents.91
(d) The use of the word "may" in Section 8 indicates
that, breach does not automatically result in revocation of
the patent and that revocation is discretionary.
(e) At the interlocutory stage, it is normally not advis-
able to reject a request for injunction on the ground of vio-
lation, in obtaining the suit patent, of Section 8.93
(f) The failure, by the plaintiff, to disclose the earlier ap-
plication filed by the plaintiff for the patent in respect of the
allegedly infringing product later released by the defen-
dant, would not be fatal where, at the time of applying for
the suit patent, the plaintiff was of the opinion that the al-
legedly infringing product was a separate invention. This
principle was applied in Roche17, in the context of Er-
lotinib Hydrochloride vis-à-vis polymorph B thereof.
174. Infringement admitted: The defendant acknowl-
edges the fact that it is manufacturing and dealing in El-
trombopag Olamine. If the suit patent is valid, therefore, in-
fringement is admitted. What is required, therefore, to be
seen, is whether the defendant has set up a credible chal-
lenge of vulnerability of the suit patent to invalidity. The
grounds urged by Mr. Sai Deepak in this regard would
have to be examined in the light of the principles delin-
eated hereinabove.
175. It is made clear that the observations/findings that
follow are prima facie, and intended only for deciding the
application for interlocutory injunction under Order XXXIX
Rules 1 and 2 of the CPC. The Supreme Court has, time
and again, cautioned Courts, especially in intellectual
property matters, not to give detailed findings on merits, as
would exhibit a final opinion regarding the rival contention
.
of the parties."
20. In Merck Sharp and Dohme Corporation and Anr. vs.
Glenmark Pharmaceuticals, 2015 SCC Online Del 8227, Hon'ble Divi-
sion Bench of Delhi High Court in paras 84 to 89 held as under:-
"84. At this stage, the Court must address the is-
sue of public interest in respect of access to drugs. In the
Hoffman La Roche case (supra) at the interlocutory stage,
both at the stage of the Single Judge and the Division
Bench, considerable attention was given to the nature of
the drug and the price differential. The Court also con-
cluded prima facie that the defendant, a generic manufac-
turer, had made out a credible defence and a credible
challenge to the validity of the patent. The Court located
the public interest concern in the debate on balance of
convenience and noting that the price differential was
about 300% in relation to a life-saving drug (one which
treated lung cancer), held that balance of convenience did
not lie in favour of grant of injunction as the possibility of
several thousands using the generic product being denied
access, and consequently their lives, was real. Such con-
sequence was an in-compensable eventuality. Here, no
such startling consequences are discernible. Diabetes is
more of a lifestyle disorder, which requires management
and treatment. The new line of treatment offered by MSD
improves efficient management of the condition FAO (OS)
190/2013 Page 74 which cannot be termed as life threat-
ening, so as to characterize the patented product as a life-
saving drug (without going into what are life-saving drugs,
.
because of an element of subjectivity and fact depen-
dence, but recognizing a broad distinction which is suffi-
cient for the purposes of this case). In this context, it would
be useful to notice that in the World Health Organization's
(WHO's) Model list of Essential medicines, besides three
forms of insulin, "Glibenclamide Tablet: 2.5 mg; 5 mg" and
"Metformin Tablet: 500 mg (hydrochloride)" no other drug-
including none with any Sitagliptin combination has been
shown.15
85. This leads us to the second principle, which is
whether the Court can overlook the public interest in main-
taining the integrity of the patent system itself, so that a le-
gitimate monopoly is not distorted. As this Court noted in
Bayer Corporation and Ors. v. Cipla, Union of India (UOI)
and Ors., 162 (2009) DLT 371 "[i]f, after a patentee, re-
warded for his toil - in the form of protection against in-
fringement - were to be informed that someone, not hold-
ing a patent, would be reaping the fruits of his efforts and
investment, such a result would be destructive of the ob-
jectives underlying the Patents Act.".
The Court must be mindful - especially in a case where a
strong case of infringement is established, as here - there
is an interest in enforcing the Act. It may be argued that
despite this no injunction should be granted since all dam-
ages from loss of sales can be compensated monetarily
ultimately if the patentee prevails. This argument though
appealing, is to be rejected because a closer look at the
market forces reveal that the damage can in some cases
be irreparable. This in turn leads to the third principle,
.
which is where an infringer is allowed to operate in the in-
terim during the trial, it may result in a reduction in price by
that infringer since it has no research and development ex-
penses to recoup - most revenue becomes profit. The
patentee however can only do so at its peril. Importantly,
prices may not recover after the patentee ultimately pre-
vails, even if it is able to survive the financial setback (or
"hit") during the interim, which may take some time. The
victory for the patentee therefore should not be pyrrhic but
real. This irreparable market effect in cases of a sole sup-
plier of a product has also triggered the decisions in
SmithKline Beecham v. Generics, (2002) 25(1) IPD 25005
and Smithkline Beecham Plc (2) Glaxosmithkline UK Ltd v.
Apotex, [2003] EWCA Civ L37, where in granting an in-
terim injunction, it was held that damages would not be an
adequate remedy for the plaintiff since it was the sole sup-
plier of the product. New entrants to the market would be
likely to cause its prices to go into a downward spiral, and
Smith Kline‟s prices may not recover even if it wins even -
tually. Equally, granting the injunction would not prejudice
Glenmark to an equal extent since - if the suit is dismissed
- it may return to a market that is largely variable.
86. In the present case, given the size of the dia-
betes drug market in India, and the sheer number of pa-
tients, from all economic strata of society, the demand for
low-priced medicines will remain, rather than any distortion
of demand due to brand loyalty or a first mover‟s advan -
tage to MSD. As noticed earlier, the price differential be-
tween MSD‟s drug and the infringing products is 30%, a
significant portion of which is due to the customs duty paid
.
by MSD. Learned senior counsels appearing for MSD had
stated that it FAO (OS) 190/2013 Page 76 would compen-
sate Glenmark for loss of earnings if the suit were to be
dismissed. Thus this arrangement not only ensures that
Glenmark will - if successful - be able to return to the mar-
ket without any handicap, but moreover, it will be compen-
sated at market value for the period for which it was ex-
cluded. The balance of convenience thus clearly lies in
favour of MSD.
87. A related concern that this Court heeds - the
fourth principle operative in this case - is that of the
chronology of events and Glenmark‟s decision to release
Zita without first challenging Januvia or Janumet. Undoubt-
edly, the Act creates a right to oppose patents even after
grant. There is no obligation to only utilize the pre or post
grant opposition mechanisms. Neither does a patent bene-
fit from a presumption of validity if it is challenged in the
course of an infringement suit. However, if a defendant is
aware that there may be a possible challenge to its prod-
uct, but still chooses to release the drug without first invok-
ing revocation proceedings or attempting to negotiate, that
is surely a relevant factor. The defendant‟s legal right to
challenge the patent at any point in time is intact, but that
does not mean that this factor cannot determine the in-
terim arrangement. This is more so where Glenmark today
argues that MSD ought to have disclosed international
patent applications for SPM and Sitagliptin plus Metformin
since they were the "same or substantially the same" as
the suit patent under Section 8. That is Glenmark‟s stated
position. Such being the state of things, it is surely reason-
.
able for Glenmark to detect the possibility to challenge,
when a US patent application for SPM filed by it was op-
posed by MSD. Despite this, Glenmark released the drug
without initiating revocation proceedings under the Act,
which is also a right vested FAO (OS) 190/2013 Page 77
in Glenmark that would have obviated the need for the in-
terim arrangement we are today considering. This does
not mean that Glenmark‟s right to question the validity of
the patent in an infringement is affected, but the manner of
challenge is a relevant factor against it at the interim
stage. As Justice Jacob noted in both Smithkline Beecham
cases (supra):
"I remain of the same opinion that I was in the Generics
case. Where litigation is bound to ensue if the defendant
introduces his product he can avoid all the problems of an
interlocutory injunction if he clears the way first. That is
what the procedures for revocation and declaration of non-
infringement are for."
Similarly, in the Australian decision of Pharmacia Italia
S.p.A v. Interpharma Pty Ltd, [2005] FCA 1675, the Court
noted the fact that Inter- pharma had acted in full
knowledge of Pharmacia‟s patent and the possible
consequences flowing from that. This consideration that
the patentee is already in the market and has been
operating the patent has found favour in Indian Courts as
well. In K. Ramu v. Adayar Ananda Bhavan and
Muthulakshmi Bhavan, 2007 (34) PTC 689 (Mad), Bajaj
Auto Ltd. v. TVS Motor Company Ltd., 2008 (36) PTC417
(Mad) and National Research Development Corporation of
India v. The Delhi Cloth and General Mills Co. Ltd. and
.
Others, AIR 1980 Del 132, the fact that the patentee was
already dealing in the market on the basis of the patent
weighed in as a factor in granting the interim injunction.
88. Ultimately, the Court must look to the combi-
nation of the three primary factors. A strong case can in
some instances offset an equal balance of conveniences
between parties. In this case, MSD has established a
prima facie case of infringement, an interim arrangement
that secures the interests of both parties and which main-
tains the public interest involved is available, FAO (OS)
190/2013 Page 78 which also ensures that the possibility
of irreparable harm to the patentee is removed.
89. Accordingly, for the above reasons, this Court
holds that the order of the learned Single Judge dismissing
the application for grant of an interim injunction is liable to
be and is set aside. The interim injunction claimed for by
the plaintiff MSD in IA 5167/2013 is granted. Additionally,
the following directions are issued:
i) MSD shall furnish an affidavit undertaking (to be filed by
its director duly authorised by its Board of Directors) in the
pending suit, that in the event the suit is dismissed, it
would compensate Glenmark for the damage or loss
caused, including but not limited to loss of earnings. The
affidavit shall be filed in two weeks.
ii) Glenmark shall furnish an undertaking to comply with
the injunction within two weeks from today in the suit.
iii) Glenmark shall file a detailed account of its earnings
(including gross turnover figures) from the products, from
the date of the filing of the present suit; the account shall
.
be accompanied by an affidavit of one of its Board of
Directors authorized directors, which shall also undertake
to pay such damages, if any- which may be decided by the
court if the ultimate result of the suit is a decree in favour
of the plaintiff MSD. The statement shall be filed with a
supporting affidavit of its duly authorized director, within
four weeks. The statement of account shall be
accompanied by the certificate of a chartered accountant
verifying its genuineness.
iv) It is clarified that the defendant Glenmark is permitted
to sell the products in question which are already in the
market (i.e. with its FAO (OS) 190/2013 Page 79 distribu-
tors, retailers etc.). However, in compliance with the injunc-
tion granted in favour of the plaintiff/MSD - it shall not
henceforth further sell, distribute or in any manner take
any steps towards placing in the market the drug in ques-
tion, Zita and Zitamet and such of the pharmaceutical
products which are covered by the claim for interim injunc-
tion in the suit. If any stocks of such goods are in its fac-
tory premises or awaiting the distribution channel, a true
and correct account thereof shall be given to the Court
along with the affidavit to be filed in compliance with direc-
tions (iii) above. Likewise, Glenmark shall also indicate in
the said affidavit details of the drug Zita and Zitamet (and
such of the pharmaceutical products which are covered by
the claim for interim injunction in the suit) which are in the
market and have been permitted to be sold.
v) The parties are directed to appear before the Single
Judge in the suit on 10th April, 2015.
This Court was informed during the hearing that the suit is
.
at the stage of trial. The learned Single Judge shall en-
deavour to ensure that parties agree to limited oral evi-
dence of experts and shall also endeavour to appoint a
technical expert in consultation with parties under Section
115 of the Patents Act for better appreciation of the techni-
cal nature of the evidence. All these are aimed at expedit-
21.
ing the final hearing of the trial."
In AIIMS Versus Sanjiv Chaturvedi and others, (2020) 17
Supreme Court Cases 602, Hon'ble Supreme Court held as under:-
"65. It is true that the interim order passed by a
Court does not operate as a precedent and the law
declared by the Supreme Court with regard to the
precedential value of judgments of Benches of larger
strength may not operate as a binding precedent in the
facts and circumstances of this case. The judgments
referred to in the preceding paragraphs lay down the
norms of judicial decorum and propriety which give 11
(1976) 3 SCC 677 12 (2001) 4 SCC 448 precedence to
Benches of higher strength. There is no reason at all why
the same principles should not apply even to interim orders
in pending proceeding."
22. In Mumbai International Airport Private Limited Vs.
Golder Chariot Airport and another, (2010) 10 Supreme Court 422,
Hon'ble Supreme Court has held that a contesting party cannot be
permitted to take a complete volte-face of its previous stand taken before
the Court of law. A litigant cannot be permitted to change and choose its
.
stand to suit its convenience.
23. The principles which could be culled out on the basis of
various pronouncements which have been made by the Courts while
dealing with applications filed under Order 39, Rules 1 and 2 of the Civil
Procedure Code in patents cases are as under:-
"(i) The registration of a patent per se does not entitle
the plaintiffs to an injunction. The certificate does not es-
tablish a conclusive right.
(ii)
There is no presumption of validity of a patent, which
is evident from the reading of Section 13(4) as well as Sec-
tions 64 and 107 of the Patents Act.
(iii) The claimed invention has to be tested and tried in
the laboratory of Courts.
(iv) The Courts lean against monopolies. The purpose of
the legal regime in the area is to ensure that the inventions
should benefit the public at large.
(v) The plaintiff is not entitled to an injunction if the de-
fendant raises a credible challenge to the patent. Credible
challenge means a serious question to be tried. The defen-
dant need not make out a case of actual invalidity. Vulnera-
bility is the issue at the preliminary injunction stage
whereas the 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 estab-
lish invalidity itself.
(vi) At this stage, the Court is not expected to examine
the challenge in detail and arrive at a definite finding on the
question of validity of the patent. That will have to await at
the time of trial. However, the Court has to be satisfied that
a substantial, tenable and credible challenge has been
made.
(vii) The plaintiff is not entitled to an injunction, if the
patent is recent, its validity has not been established and
there is a serious controversy about the validity of the
patent."
24. Let's apply these decisions vis-a-vis the respective
contentions of the parties to decipher as to whether the defendants have
.
laid a credible challenge which has rendered the patent of the plaintiffs to
be vulnerable at this stage to refuse the grant of interim relief or not.
25. This Court is not oblivious to the fact that vulnerability is the
issue at the primary injunction stage while validity is the issue at the stage
of trial and all that this Court has to see at this stage is as to whether the
defendants have raised a credible challenge to the validity of the patent
held by the plaintiffs and whether the patent is vulnerable. The principal
ground which has been urged by the defendants is that subject patent is
evergreening of IN719, and in this view of the matter, there is indeed a
credible challenge to the subject patent which renders the same
vulnerable. All other contentions raised hover around this principal
contention of the defendants. To substantiate their contention, much
stress was laid upon the pleadings of the plaintiffs in the civil suit, which
stands filed by them in the High Court of Delhi, reference of which has
already been made hereinabove, in which suit, as per defendants, the
plaintiffs were claiming the infringement of IN719 and IN301 qua
Linagliptin, and which as per the defendants, makes it amply evident that
IN301 was nothing but evergreening of IN719. Learned Senior Counsel at
length took the Court through the documents filed by the respective
parties to substantiate their contentions. It was also urged that the factum
of IN301 to be evergreening of IN719 was also evident from the queries
which were raised by the Patents Office at the time of the consideration of
.
the application of the plaintiff qua the subject patent.
26. Now, when one peruses the plaint which has been filed by
the plaintiffs in the High Court of Delhi, one finds that what has been
pleaded by the plaintiffs in the said suit, is that whereas Linagliptin is a
compound "claimed and covered" in Claim No. 1 of IN301, Linagliptin
was a compound "claimed and encompassed" in Claim No. 2 of IN719.
Thus, whereas on one hand the plaintiffs claimed Linagliptin as a
compound to have been claimed and encompassed in Claim No. 2 of
IN719, the said compound was stated to be claimed and covered in Claim
No. 1 of IN301. This demonstrates that Linaglipin compound was not
claimed to be covered in patent IN719, as has been urged by the
defendants. In this background, when one peruses the averments, which
have been made in the present plaints, one finds that in these cases the
stand of the plaintiffs is that Linagliptin is a compound covered by the
subject patent IN301. In this backdrop, now the Court would like to refer to
the queries which were raised by the Patent's Office while processing the
application of the plaintiffs for the grant of subject patent. These
documents have been placed on record by defendant No. 2 in COMS No.
7 of 2022. There is on record a communication dated 06.09.2007 issued
by the Patents Office to the plaintiffs on the subject "Examination Report"
of the application of the plaintiffs qua IN301, relevant portion whereof is
quoted herein below:-
.
"To,
REMFRY & SAGARREMFRY HOUSE,
MILLENNIUM PLAZASECTOR 27, GURGAON
122 002, INDIA
SUB: Examination Report
APPLICATION NUMBER: 01092/DELNP/2003
DATE OF FILING 14/07/2003
DATE OF REQUEST FOR EXAMINATION: 16/12/2005
DATE OF PUBLICATION: 12/01/2007
a. With reference to request no.5624/RQ-DEL/2005
dt.16/12/2005 by you for examination, the above quoted
application has been examined under section 12 of the
Patent Act, 1970 as amended and the First Examination
Report containing a statement of objection is forwarded
herewith for compliance thereof.
The documents enclosed shall be resubmitted
within 12(Twelve) months from the date of issue of the said
report together with your observation if any, in connection
with the compliance of the requirements of this First
Examination Report.
The application referred to will be deemed to have
been abandoned under section 21(1) unless all the
requirements imposed by the said Act and the rules there
under are complied with within the above said prescribed
period.
The pages of the complete specification should be
freshly typed wherever corrections of interpolation are
made. The typed pages in duplicate should be on white
pages in order that clear photocopies of the specification
can be prepared. The original pages in that case should
be returned to this office duly cancelled.
It is in the interest of the applicant to comply with the
requirements at the earliest.
a. Encl:
1. Form-1-Application for Grant of Patent
2 Form-2-Provisional/Complete Specification
3. Form-3-Statement & Undertaking
4. Form-5-Declaration as to Inventorship
NOTE: All Communications to be sent to the Controller of
Patents at the above address.
a Observations:
1. Claims I and 18 define a plurality of Distinct inventions.
2 Claim 16 neither process nor product hence does not
constitute an invention u/s 2(1) of Indian Patents Act 3.
Claims not clear in respect of the expression as indicated
.
therein.
4. Claims are not clearly worded as indicated therein. 5.
Claims do not sufficiently define the invention as indicated
therein.
Form 5 should be corrected as indicated therein 7.
Abstract should be prepared in accordance with the
instructions contained in the Rule 13(7) of the Patent
Rules, 2003(as amended in 2006).
8 International application number given on form-1
incorrect. 9. Extraneous matter should be deleted from
complete specification and fresh retyped pages should be
filed.
10. Pages of complete specification should be
renumbered. 11. Form 3 should be corrected as indicated
therein."
27. Response thereto dated 13.06.2008 is also on record filed by
defendant No. 2 in COMS No.7 of 2022 and relevant portion thereof is
reproduced as under:-
"DDB/Ivs/IP: 1092/DELNP/2003
June 13, 2008
THE CONTROLLER OF PATENTS
THE PATENT OFFICE
DELHI
Examiner: Sh. Rohit Rathore Final date: September 06,
Dear Sirs,
Re:BOEHRINGER INGELHEIM PHARMA GMBH & CO.
KG., Indian Patent Application No. 1092/DELNP/2003
Filing date: July 14, 2003
Reference is made to the official letter dated September
06, 2007. Documents received with the official letter are
returned duly amended to meet the objections raised.
Regarding paragraphs 1 to 5, the claims have been
thoroughly revised in light of the objection of the learned
Examiner and in accordance with the claims as allowed in
the corresponding application in EP Le. EP 1368349. It is
submitted that the revised claims are all directed to the
compound of claim 1 and do not relate to distinct
inventions. It is respectfully submitted that the original PCT
claim set has been restricted by deleting original claims 1
.
to 6. Present revised claim 1 results from original claim 7,
in which the definition of heteroaryl in RI is replaced by the
respective definition from original claim 1. Present claim 2
results from original claim 7. Present claims 3 to 9 result
from original claims 8 to 14, in which the back references
have been adapted accordingly. Original composition
claim 15, use claim 16 and process claims 17 and 18 have
been removed form the present claim set.
In light of the submission provided and the revisions
carried out in the claims, the learned Examiner is
requested to reconsider and withdraw the respective
objections.
As regards the objection of the learned Examiner on the
compound claims under Section 3(d), it is respectfully
resisted and submitted that the claimed compounds are
novel and may accordingly not be rejected as mere
derivatives of known substances, In this regard, the kind
attention of the learned Examiner is respectfully invited to
the positive opinion of the International Searching
Authority. Further, we have the honour to enclose a list of
371 additional compounds supporting the scope of the
present claims. All of these 371 compounds show an IC50
value even below 100nM measured on the assay originally
described in the present application: The learned
Examiner is accordingly requested to waive the objection
under Section 3(d).
The amendments carried out to the specification have
necessitated retyping of pages 289 to 362 as fresh pages
290 and 327 respectively. The retyped pages are
submitted herewith in duplicate along with the former
pages duly cancelled. The pages of the specification have
been correspondingly numbered.
Regarding paragraph 7, we have the honour to submit an
abstract of the invention fin duplicate) in accordance with
Rule 13(7) Patent Rules, 2006, Regarding paragraph 8,
we have corrected the International application no. in Form
1.
Regarding paragraph 12, we have already submitted the
details of corresponding foreign applications vide our letter
dated December 27, 2007. Further, we have the honour to
submit the petitions under Rules 137 and 138 for obviating
irregularity and condoning delay in submitting the details of
corresponding foreign applications.
Regarding paragraph 13, we have already submitted the
prosecution details of corresponding applications vide our
.
letter dated February 28, 2008. As and when we received
any further details, we shall submit the same.
We have the honour to submit a substitute power of
authority in favour of our attorneys.
All the remaining requirements have been complied with.
Grant of a patent on this application within the final and in-
extendible period expiring an September 06, 2008, is
respectfully requested.
Before taking any adverse decision on this case, the
Controller is respectfully requested to give an opportunity
to the applicants to be officially heard in this matter.
Yours faithfully,".
28.
The fact that subsequently subject patent was granted to the
plaintiffs demonstrates that the Patents Office was satisfied with the
response so submitted to its queries by the plaintiffs. That being the case,
it cannot be said that by highlighting these very facts or the pleadings of
plaint filed before the Delhi High Court, the defendants could be said to
have had laid credible challenge to the subject patent so as to make it
vulnerable to deny interim relief to the plaintiffs at this stage.
29. This Court hastens to add that the contention of the
defendants that the subject patent is bad cannot be construed so as to
render the subject patent vulnerable at the threshold stage. In other
words, vulnerability of a patent cannot be concluded simply on the
assertions/defence of the defendants which is yet to be proved as per law.
To elaborate it, grant of patent in favour of the plaintiffs is a matter of
record. Though, mere grant of the patent does not means that challenge
cannot be laid to it as per the provisions of the Patents Act, yet, fact of the
matter is that a challenge, which is yet to be proved, cannot be placed at a
.
higher pedestal than the statutorily granted patent until and unless the
challenging party can demonstrate in terms of the provisions of the
Patents Act that the patent is vulnerable so as to refuse grant of interim
relief. This test obviously has to be in terms of grounds of challenge.
Coming back to the facts of these cases, the ground of challenge of the
defendants to the subject patent is in terms of the provisions of Section
64(1)(a) of the Patents Act, 1970. As of now, nothing has been placed on
record from which it can be inferred that the invention claimed in IN301 of
the complete specifications was also claimed in the complete
specifications of IN719 and this was evident a day before the priority date
of IN301, the subject patent to a person skilled in the art.
30. In the case in hand, the patent in issue, i.e. 'IN301' was
granted in favour of the plaintiffs in India on 5 th October, 2010 and the
terms of the patent is 20 years, which is to expire on 5 th October, 2023 as
the international filing date of the patent application in the present case is
August 18, 2003.
31. On the other hand, admittedly, the defendants do not have
any patent qua the infringing product and no challenge, either to the
application filed by the plaintiffs for grant of patent was laid by the
defendant nor any post patent challenge was laid by it. Of course, in light
of law laid down by Hon'ble Supreme Court in M/s Bishwanath Prasad
Radhey Shyam (supra), grant of patent does not guarantee the validity of
a patent, which can be challenged before the High Court on various
.
grounds in revocation or infringement proceedings, but the factum of a
patent being there in favour of the plaintiffs and the factum of no pre or
post grant challenge to the same by anyone, including the defendant,
except recently by way of a revocation petition which was filed in close
proximity to the launch of the infringing product, does creates a prima
facie case and balance of convenience in favour of the plaintiffs. The
Court is observing so for the reason that as per the plaintiffs, since the
patent was granted on 5th October, 2010, the same has had a successful
commercial run till date which continues and there is no serious dispute
qua the same. The patent is an old patent and it has not been granted
recently to the plaintiffs. Therefore, these facts do create prima facie case
and balance of convenience in favour of the plaintiffs vis-a-vis the
defendant, who admittedly does not has any patent qua the infringing
product.
32. In the light of what has been discussed hereinabove, if an
infringer is not restrained from infringing the patent of patent holder, then,
but of course, the patent holder will suffer from irreparable loss and it
cannot be said that the infringer stands on the same pedestal on which
the patent holder is. Of course, the patent of the plaintiffs is vulnerable. It
is open to challenge and now it has also been challenged by the
defendant by way of a revocation petition. But mere filing of revocation
proceedings cannot be treated to be a "credible challenge" to the old and
successful patent of the plaintiffs. As far as the element of public interest
.
is concerned, it may be observed that in the present case, the Central
Government has not invoked the provisions of Section 66 of the Patents
Act and after following the procedure referred to therein, made a
declaration in the Official Gazette to the effect that the patent of the
plaintiffs stand revoked in public interest. Not only this, the defendant has
not approached the competent authority under Section 84 of the Patents
Act after the expiry of three years from the grant of the patent for grant of
compulsory licence of patent on the conditions enumerated therein.
33. At this stage, it is relevant to refer to Section 48 of the
Patents Act as it stood prior to the amendment and also post amendment,
which amendment was carried out in the said section w.e.f. 20.05.2003.
34. Section 48 of the Patents Act, which deals with rights of the
patentees, before amendment provided as under:-
"Section 48. Rights of patentees
(1) Subject to the other provisions contained in
this Act, a patent granted before the commencement
of this Act, shall confer on the patentee the exclusive
right by himself, his agents or licensees to make,
use, exercise, sell or distribute the invention in India.
2) Subject to the other provisions contained in
this Act and the conditions specified in Section 47, a
patent granted after the commencement this Act
shall confer upon the patentee--
(a) where the patent is for an article or substance,
the exclusive right by himself, his agents or li-
censees to make, use, exercise, sell or distribute
.
such article or substance in India;
(b) where a patent is for a method or process of
manufacturing an article or substance, the exclusive
right by himself, his agents or licensees to use or
exercise the method or process in India."
After amendment, said Section now reads as under:-
"Section 48: Rights of patentees.
Subject to the other provisions contained in this Act
and the conditions specified in Section 47, a patent
granted under this Act shall confer upon the
patentee--
(a) where the subject-matter of the patent is a
product, the exclusive right to prevent third parties,
who do not have his consent, from the act of mak-
ing, using, offering for sale, selling or importing for
those purposes that product in India;
(b) where the subject-matter of the patent is a
process, the exclusive right to prevent third parties,
who do not have his consent, from the act of using
that process, and from the act of using, offering for
sale, selling or importing for those purposes the
product obtained directly by that process in India:"
35. It is evident that though subject to other provisions contained
in the Patents Act, including Section 47 thereof, a patent granted under
the Patents Act does confers upon the patentee, where the subject matter
of the patent is a product, the exclusive right to prevent a third party, who
do not have his consent, from the act of making, using, offering for sale
.
etc. of that product in India. Thus, a statutory right, which has been con-
ferred upon the patentee, clothes the patentee with an umbrella of safety
qua the infringement of its patent by a third party.
36. Now this Court will refer to the two judgments of this Court
which have been relied upon by the plaintiffs as well as defendants.
37. In Dhanpat Seth & others Vs. Nil Kamal Plastic Crates
Ltd., 2006 SCC OnLine HP 98, learned Single Judge of this Court while
dealing with an application filed under Order XXXIX, Rules 1 and 2 of the
Code of Civil procedure for grant of temporary injunction with regard to the
infringement of the Patent granted to the plaintiffs therein in respect of a
device of manual hauling of an agricultural produce, after perusing the
Patent device in the Court, observed that the the basket got patented by
the plaintiffs was not a hauling device and the device was made of
synthetic polymeric material, which had been invented long back and that
the process by which the substance was moulded into various articles like
baskets, buckets, mugs, jugs, furniture and so many other articles was
also well known and there was nothing new about the so called device.
On these findings, leaned Single Judge rejected the prayer for grant of
interim relief.
38. In appeal, Hon'ble Division Bench of this Court while up-
holding the order passed by the learned Single Judge in Dhanpat Seth &
Ors. Vs. M/s. Nil Kamal Plastic Crates Ltd., AIR 2008 HP 23 has held
as under:-
.
"11. A bare perusal of the definition of
invention clearly shows that even a process
involving an inventive step is an invention within
the meaning of the Act. It is, therefore, not
necessary that the product developed should be a
totally new product. Even if a product is
substantially improved by an inventive step, it
would be termed to be an Invention. The definition
of 'inventive step' provides that when technical
advances as compared to existing knowledge
take place in an existing product or there is
improved economic significance in the
development of the already existing device and
the invention is not obvious to people skilled in the
art, it would amount to an inventive step.
12. The learned single Judge had seen
the products of the plaintiffs, the defendant and
the traditional Kilta. We also called upon the
parties to produce their respective devices as
well as the traditional Kiltas.
13. A Kilta is a traditional product which
has been used since time immemorial for
carrying produce including agricultural produce in
hill areas especially in the State of Himachal
Pradesh. The traditional Kilta is made of
bamboo. The shape of a kilta is conical having a
wider circular opening on the top and it tapers
and narrows down at the bottom. There is
virtually no difference in the overall design of the
tradition Kilta or the 'devices' developed by the
.
plaintiffs and: the defendant. A visual comparison
of the' three items prima facie establishes that
the articles manufactured by the plaintiffs and the
defendant are virtual copies of the traditional
Kilta. The only difference is that the Kilta is made
of bamboo and the Kilta made by the plaintiffs is
made of polypropylene copolymer (PP). The Kilta
made by the defendant is also made of polymeric
material. The Kilta manufactured by the
defendant is made of high density polyethylene
(HDP). In actual fact, both the materials are
polymers in common parlance known as plastic.
The only visible difference is that device now
being manufactured is having detachable nylon
straps with buckles. The question which arises
for consideration is whether this change of
material from bamboo to plastic and the
development of adjustable nylon straps with
buckles is an inventive step falling within the
meaning of Section 2(ja).
14. Shri Vinay Kuthiala, contended that
by changing the material from bamboo to plastic
there is a great economic gain and there is
technical advance of economic significance.
Though the cost of Kilta made of plastic may be
higher than that of Kilta made of bamboo, its life
is much longer making it more economic. He
further submits that the Kilta is designed in such
a manner as to make it easy to carry heavy load
and, therefore, this is an inventive step.
.
15. After having seen the traditional Kijta
and the devices of the parties and having
examined the same, we are prima facie of the
view that the devices being manufactured by the
parties are only imitations of the traditional Kilta.
Shri Vinay Kuthiala has contended that the
traditional Kilta was only supported by rope on
the forehead. This assertion is in fact incorrect.
The traditional Kilta used in Himachal Pradesh is
by and large supported by adjustable ropes
going over the shoulders. In some cases, the
supporting strap goes over the forehead. Both
types have been in existence for times
immemorial.
16. The Apex Court in M/s. Bishwanath
Prasad Radhey Shyam v. Hindustan Metal
Industries, while dealing with the meaning of the
words 'inventive step' held as follows:
21. It is important to bear in mind that in
order to be patentable an improvement on
something known before or a combination of
different matters already known, should be
something more than a mere workshop
improvement; and must independently satisfy
the test of invention or an "inventive step". To be
patentable the improvement or the combination
must produce a new result or a new article or a
better or cheaper article than before. The
combination of old known integers may be so
.
combined that by their working inter-relation21.
It is important to bear in mind that in
order to be patentable an improvement on
something known before or a combination of
different matters already known, they produce a
new process or improved result. Mere collection
of more than one integers or things, not
involving the exercise of any inventive faculty,
does not qualify for the grant of a patent.
17. The device being manufactured by
the plaintiffs is basically a Kilta but made out of
synthetic polymeric material which is commonly
known as plastic. The process of making
traditional items out of such polymers is a well
known and well established process. This Court
can take judicial notice of the fact that much
prior to the device being manufactured by the
plaintiffs, traditional items made out of woods,
steel, brass, leather and other natural materials
have been replaced by plastic. In this regard
reference may be made to chairs, tables, Jugs,
baskets, shoes and numerous other items which
were traditionally made of natural material but
are now made of plastic. Therefore, in our
opinion, the mere fact that the device is made of
polymeric material instead of bamboo is not an
inventive step involving any novelty. There is
nothing new about the process of manufacturing
the traditional Kilta made of natural material
from synthetic material. Even nylon straps now
.
added are virtually copies of the ropes used in
the traditional Kilta. The ropes in the Kilta can
also be adjusted by the user keeping in view the
height of the person using the Kilta and the
weight being carried by him. The mere
introduction of buckles would not amount to a
new device being called an invention or an
inventive step.
18. Shri Vinay Kuthiala has laid great
emphasis on the order dated 2-7-2007 passed
by the Assistant Controller, Patents and
Designs, whereby he has rejected the
application for revocation filed by the
defendant.
19. At the outset, it would be pertinent
to mention that the Controller before dealing
with the matter did not even take the
traditionally built Kilta into consideration as a
citation. His reasoning in this regard is as
follows:
"Exhibit A is a Bamboo made Kilta with a strap
but there is no proof of date of its publication.
Hence the said document cannot be taken into
consideration as a citation."
20. We fail to understand the reasoning
given by the Assistant Controller, Patents and
Designs in not taking into traditionally built Kilta
into consideration. Even the case set up by the
plaintiffs was not that he had invented an
.
entirely new product but his case was that he
had developed a traditional Kilta by means of
inventive steps in such a fashion that it
amounts to a new invention. The contentions of
both the parties could not have been
appreciated without first taking into
consideration the traditional Kilta. On this short
ground alone we feel that much reliance can
be placed on the aforesaid order.
21. Mere grant of patent in favour of
the plaintiffs by itself does not mean that the
plaintiffs are entitled to any injunction. This is
a factor which may be taken into consideration
and would be a relevant factor but the grant of
patent would not ipso facto entitle the plaintiffs
to grant of an injunction without taking into
consideration other relevant factors. In fact
Section 107 of the Patents Act clearly
provides that in any suit for infringement of a
patent every ground on which it may be
revoked under Section 64 shall be available
as a ground for defence. Therefore, the
defendant is entitled to argue before this Court
that the patent granted is not valid. Reliance
placed upon by the plaintiffs on the judgment
of the Apex Court in Midas Hygiene Industries
(P) Ltd. and Anr. v. Sudhir Bhatia and Ors. is
totally misconceived. The action in the case
was under the Trade Marks Act where the
provisions are different. It may be true that
.
Section 28 of the Trade Marks Act is similar to
Section 28 of the Patents Act but under the
various provisions of the Patents Act, such as
Sections 64 and 107(2) even after the patent
is granted, the same can be challenged in
appropriate proceedings.
22. We also find that the device
manufactured by the plaintiffs has been
termed as hauling device. The learned single
Judge is absolutely right in holding that the so-
called-device is not a device of hauling but
basically a device for carrying the produce.
23. The House of Lords, in (1975) All
England Law Reports 504, American
Cyanamid Co. v. Ethicon Ltd., clearly laid
down that the governing principle with regard
to grant of injunction is that the court should
first consider whether if the plaintiff were to
succeed at the trial in establishing his right to
a permanent injunction he could be
adequately compensated by an award of
damages for the loss he would have sustained
as a result of the defendant's continuing to do
what was sought to be enjoined between the
time of the application and the time of the trial.
If damages in the measure recoverable at
common law would be adequate remedy and
the defendant would be in a financial position
to pay them, no interlocutory injunction should
normally be granted, however, strong the
.
plaintiffs claim appeared to be at that stage. If,
on the other hand, damages would not be an
adequate remedy to the plaintiff in the event of
the success in the trial, the Court can grant
injunction in favour of the plaintiff by ensuring
that the defendant is adequately compensated
in case the trial culminates in his favour. If
damages in the measure recoverable under
such an undertaking would be an adequate
remedy and the plaintiff would be in a financial
position to pay them, there would be no
reason on this ground to refuse an
interlocutory injunction.
24. It also held that where other factors
appear to be evenly balanced the rule of
prudence would be to preserve the status quo.
In the case before the House of Lords, the
defendant had not started manufacturing of
absorbable surgical sutures and it is in these
facts that relief of temporary injunction was
granted. In the present case, the defendant
has already started manufacturing and selling
the Kiltas and has been doing so for a number
of years. In our opinion, at this stage it would
not be appropriate to put the clock back.
25. In respect of the arguments
addressed on the doctrine of anticipation,
even if we discount the production of the
device by the plaintiffs prior to 24-5-2002, it is
clear that prior to this date, the defendant had
.
sent the drawing for production of the Kilta to
Taiwan. At this stage of the suit when
evidence is still to be recorded, the said
material cannot be discarded.
26. Keeping in view the aforesaid
discussion, we are clearly of the view that
the device developed by the plaintiffs is in
fact the result of traditional knowledge and
aggregation /duplication of known products
such as polymers and, therefore, cannot be
said to be an invention. The plaintiffs are,
therefore, not entitled to any injunction."
39. A perusal of the above mentioned judgments of this
Court as well as the judgment of the Hon'ble Supreme Court in
Bishwanath Prasad Radhey Shyam Vs. Hindustan Metal Industries, AIR
1982 SC 1444, which stands taken note by the Hon'ble Division Bench of
this Court demonstrates that in the said two cases, the Patent article was
physically seen by the Court and the same was of such nature that the
Hon'ble Judges were in a position to prima facie conclude as to whether
there was any inventive step involved in the Patent product, as defined in
the Patents Act or not. However, in my considered view, the above
mentioned judgments are of no assistance in the present case, for the
reason that here the Patent is of a drug and infringement is also alleged
by way of a drug being marketed and sold by the defendants based on the
Patent of the plaintiffs. Unlike in the cases referred to above, by no stretch
.
of imagination this Court by comparing the tablet of the
plaintiffs/applicants with the tablet of the defendants/non-applicants with a
naked eye can conclude as to whether any inventive step was involved in
the Patent of the plaintiff or not.
40. Similarly, by referring to the applications and documents
appended therewith, which were submitted by the plaintiffs/applicants for
grant of IN' 719 and IN' 301, this Court cannot conclude even prima facie
that IN' 301 is evergreening of IN'719. Therefore, this Court has no
hesitation in holding at this stage that it cannot be said that the
defendants/non-applicants have been able to lay any credible challenge to
the Patent of the plaintiffs or that they have been able to convince the
Court that the said Patent is vulnerable so as to refuse the grant of interim
protection.
41. There is one more aspect of the matter. Wheras on the one
hand, the plaintiffs/applicants do have a Patent in their favour with regard
to the compound Linagliptin, the defendants/non-applicants do not have
one. Yet knowing fully well that the drug they intended to introduce in the
market was duly covered by the subject Patent, they took a calculated risk
to do so. It is not in dispute that the defendants/non-applicants do admit
that the drug in issue, which is being manufactured by them is covered by
the subject Patent, because if that was not the case, then there was no
occasion for them to have had taken the plea of plaintiffs' evergreening
Patent IN' 719. Now, Patent IN' 719, which has recently expired, was in
.
public domain, yet before manucaturing their respective products and
before marketing the same, the defendants/non-applicants did not seek
revocation of the Subject Patent well in time during the validity of Patent
IN' 719. This also in the considered view of the Court, tilts the balance of
convenience in favour of the plaintiffs.
42. Accordingly, the applications filed by the plaintiffs/applicants
under Order XXXIX, Rules 1 and 2 of the Code of Civil Procedure are
allowed and the defendants/non-applicants in the respective Civil Suits
are restrained either themselves or through their directors, partners
licenses, stockiest and distributors, agents etc., jointly and severally from
infringing the subject Patent, i.e., IN'301 by advertising, launching,
making, using, offering for sale, selling, importing and/or exporting the
medicinal product, Linagliptin in any form whatsoever including Linagliptin
API, Linagliptin formulation, "Linagliptin Tablet" and/or "Linagliptin +
Metformin Hydrochloride Tablets" or any "generic version" thereof or any
other product sold under the trade marks/brand names "LINARES" and
"LINARES M" in COMS No. 07 of 2022, "LINANEXT" , "LINANEXT-M" in
COMS No. 08 of 2022, "EMLINZ 5" and "EMLINZ M 500" in COMS No.
09 of 2022 and generic version of subject patent in COMS No. 10 of 2022
or any other trade mark(s)/brand name(s), whatsoever, or any other
product covered by the subject patent granted by the Controller of Patents
on October 5, 2010 in favour of applicant/plaintiff No. 1 in all the suits. The
applications stand disposed of.
.
A copy of this order be placed in each of the Files.
(Ajay Mohan Goel)
Judge
June 02, 2022
(bhupender/narender)
r to
