Delhi High Court
Novartis Ag & Anr. vs Centurion Remedies Private ... on 26 May, 2022
$~3
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Date of decision: 26th May, 2022
+ CS(COMM) 306/2022 & I.A. 7321-22/2022
NOVARTIS AG & ANR. ..... Plaintiffs
Through: Mr. Hemant Singh, Ms. Mamta Rani
Jha, Mr. Saif Rahman Ansari and Mr.
Siddhant Sharma, Advocates.
versus
CENTURION REMEDIES PRIVATE LIMITED ..... Defendant
Through: Mr. Bhavik B. Patel, Advocate for D-
1. (M:8238043022)
Mr. Harish Vaidyanathan Shankar,
CGSC with Ms. S. Bushra Kazim,
Mr. Srish Kumar Mishra and Mr.
Sagar Mehlawat, Advocates for D-2.
CORAM:
JUSTICE PRATHIBA M. SINGH
Prathiba M. Singh, J. (Oral)
1. This hearing has been done through hybrid mode.
2. The present suit has been filed seeking permanent injunction
restraining infringement of Indian Patent No.229051, damages, rendition of
accounts, delivery up etc. The details of the said patent are as under:
Patent No. : IN 229051
Title : Pharmaceutical Compositions
Comprising Valsartan and NEP
Inhibitors
Date of Filing : 16th January, 2003
Date of Expiry : 16th January, 2023
3. Pursuant to the directions issued vide previous orders dated 20th May,
2022 and 11th May, 2022, the Department of Pharmaceuticals, Ministry of
Signature Not Verified
By:DEVANSHU
JOSHI
Chemicals and Fertilizers (hereinafter as 'DOP') has filed an affidavit
clarifying its position. As per the said affidavit, for various reasons including
for enhancing supply of local manufactured products and for self-sufficiency
purposes in the case of medicines, drug and medical devices, certain guidelines
were issued by the Government classifying Local Suppliers based on local
value addition or local content as Class I Local Supplier having local content of
more than 80%, Class II Local Supplier having local content of 50-80%, and
Non-Local Supplier having local content less than 50%. Thereafter, it is stated
that the Ministry of Railways and other procuring agencies had requested for
relaxation of the same due to non-availability of local producers. At that stage,
a need was felt for ascertaining local manufacturers in respect of various drugs.
In this background, a list of 209 drugs was published on the website of the
DOP, vide public notice dated 28th February, 2022, seeking details of the local
manufacturers available for these drugs. In response to the said notice, the
Defendant addressed an email dated 15th March, 2022 to the DOP giving
details of its manufacturing capabilities in respect of 44 drugs.
4. The DOP, thereafter, states that a representation was received from
Shri Amitabh Baxi, Head, Country Public Affairs, Novartis India, vide email
dated 13th April, 2022 informing the DOP of the patent which was granted in
their favour.
5. The DOP has now clarified that the effort and intention behind issuing
the Public Notice dated 28th February, 2022 was merely to collate the details
of the local manufacturers of the drugs, as requested by Central Procurement
Agencies. However, the said effort is not, in any manner, to be treated as
directions by the Government under Section 100 of the Patents Act, 1970, or
any other provision of the Patents Act, 1970.
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By:DEVANSHU
JOSHI
6. The relevant portion of the affidavit dated 23rd May, 2022 deposed by
Dr. N Yuvaraj, Joint Secretary (Policy), DOP is set out below:
"15. It is kindly submitted that the defendant always
knew the intention of the Department's Public Notice
dated 28.2.2022 to collate the details of local
manufacturers of the drugs, as requested by the Central
Procurement Agencies, but, un-necessarily brought in
the issue of use of Govt. authorization under the Indian
Patent Act which is in no way related to the guidelines
issued under Public Procurement Order. The defendant
has misinterpreted the Public Notice as if DoP is going
to procure the drugs by issuing any authorization which
is altogether a different power vested with the DPIIT and
issued sparingly under any public health emergency.
xxxx
17. That, as to the issue of patent here, it is clarified that
the Department's Public Notice dated 28.02.2022
nowhere directs or compels anyone to infringe upon the
rights of the patent holders. The Public Notice seems to
have been wrongly interpreted by the Defendant as a
form of Government Authorization to manufacture the
patented drug.
18. Further, it is also clarified that the
authorization under section 100 of the Patents Act,
referred by the Plaintiff as well as the Defendant in the
order has no relationship with the Public Notice issued
by the Department since the said provision under the
Patents Act, 1970 has altogether a separate mandate and
process under the administrative powers of the
Department of Industry and Internal Trade (DPIIT)
under the Ministry of Commerce and Industry and the
Department has no authority over the same."
7. In view of this stand of the DOP that the Government has not invoked
any provisions of the Patents Act, 1970 for the procurement of the drugs in
which patent rights are claimed by the Plaintiff, no further orders are
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By:DEVANSHU
JOSHI
required to be passed qua the Government, in respect of the drugs which are
the subject matter of this suit. Accordingly, Defendant No.2 - Department of
Pharmaceuticals, Ministry of Chemicals and Fertilizers, is deleted from the
array of parties.
8. On merits of the present suit, the Defendant No.1- Centurion
Remedies Private Limited has filed an affidavit of Mr. Ambalal V. Patel, the
Managing Director which states as under:
"4) I say that the defendant No.1 has not manufactured
or imported or traded or has not caused to manufacture
or caused to import or caused to trade the
pharmaceutical preparation namely SACUBITRIL +
VALSARTAN, in any manner, either directly or
indirectly.
5) I say that the defendant No.1 is in knowledge of the
fact that the plaintiff is the exclusive proprietor/owner of
the Indian Patent No. 229051 titled 'Pharmaceutical
Compositions Comprising Valsartan and NEP'
(hereinafter referred to as the 'Said Patent').
6) I say that the defendant No.1 has obtained the Export
License/Approval numbered G/25/1325 from FDA, India
to export the pharmaceutical preparation namely
'SACUBITRIL + VALSARTAN'.
7) It is stated that the defendant No. 1 has not exported
or caused to export the pharmaceutical preparation
namely 'SACUBITRIL + VALSARTAN', either directly or
indirectly, or in any other manner. (A Copy of the Export
License obtained from FDA, India is annexed hereto and
marked as Annexure-R3.)
8) I say that the defendant No. 1, with regards to export
or any other activity, has not conducted any activity of
laboratory testing and analysis or caused to conduct any
activity of laboratory testing and analysis in relation to
pharmaceutical preparation namely SACUBITRIL +
VALSARTAN', either directly or indirectly, or in any
other manner.
9)I say that the defendant No. 1, either directly or
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By:DEVANSHU
JOSHI
indirectly, in any manner has not started to use or sell or
import or manufacture or cause to use or sell or import
or manufacture the pharmaceutical preparation namely
'SACUBITRIL + VALSARTAN'.
10) I say that the defendant No.1, either directly or
indirectly, in any manner, does not intend to use or sell
or import or manufacture or cause to use or sell or
import or manufacture the pharmaceutical preparation
namely SACUBITRIL+ VALSARTAN' till the expiration
of said patent."
9. A perusal of the above affidavit shows that the Defendant No.1 has
taken a stand that it has an export licence for exporting of the
pharmaceutical preparation namely Sacubitril + Valsartan. However, the
Defendant has undertaken not to use or sell or import or manufacture or
cause to use or sell or import or manufacture the pharmaceutical preparation
SACUBITRIL+ VALSARTAN, till the expiration of the suit patent.
10. In view of the above categorical stand of the Defendant No.1 it is
directed that the Defendant No.1 shall not undertake or cause commercial
manufacture, sale, use, export or import of any pharmaceutical preparations
consisting of SACUBITRIL+ VALSARTAN, covered by the suit patent IN
229051, till the expiration of the term of the suit patent i.e., 16th January,
2023.
11. The present suit is decreed in the above terms. All pending
applications are also disposed of.
12. Decree sheet be drawn accordingly. The next date of hearing stands
cancelled.
PRATHIBA M. SINGH
JUDGE
MAY 26, 2022
dj/ad
Signature Not Verified
By:DEVANSHU
JOSHI
