Delhi High Court
Novartis Ag & Anr. vs Msn Laboratories Private Limited on 26 May, 2022
$~2
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Date of decision: 26th May, 2022.
+ CS(COMM) 305/2022 & I.As. 7317-18/2022
NOVARTIS AG & ANR. ..... Plaintiffs
Through: Mr. Hemant Singh, Ms. Mamta Rani
Jha, Mr. Saif Rahman Ansari and Mr.
Siddhant Sharma, Advocates.
(M:7409531351)
versus
MSN LABORATORIES PRIVATE LIMITED ..... Defendant
Through: Ms. Rajeshwari H., Ms. Swapnil Gaur
and Mr. Deepanshu Nagar, Advocates
forD-1. (M:8826968200)
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.237430, damages, rendition of
accounts, delivery up etc. The details of the said patent are as under:
Patent No. : IN 237430
Title : Inhibitors of Tyrosine Kinases
Date of filing : 04th July, 2003
Date of Expiry : 04th July, 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
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By:DEVANSHU
JOSHI
any other provision of the Patents Act, 1970.
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
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By:DEVANSHU
JOSHI
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
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. Defendant No.1 - MSN Laboratories Private Limited has handed over
the original affidavit deposed by Mr. Srinivasan Thirumalai Rajan, Head -
Intellectual Property & Technical of the Defendant No.1. Let the same be
taken on record. The relevant extract of the said affidavit reads as under:
"I say that the Defendant has been granted
manufacturing Licence in respect of product Nilotinib
and the copy thereof is submitted as Document 1.
The Defendant submits that Government of India was
collecting information with respect to the capability of
various manufacturers. The Defendant has responded
to the same."
9. As per the above affidavit, the Defendant No.1 has been given a
manufacturing licence on 26th August, 2019 for commercial manufacture
and sale of Nilotinib. The suit patent is due to expire on 4th July, 2023.
10. Ms. Rajeshwari, ld. Counsel for the Defendant No.1 submits that the
Defendant No.1 has no intention to undertake manufacture and sale of
Nilotinib, at this stage. However, since the Defendant No.1 has a
manufacturing licence, as and when the Defendant No.1 decides to
manufacture the said product on a commercial scale, she submits that it shall
give notice to the Plaintiff of at least four weeks.
11. The above statement made on behalf of the Defendant No.1 is taken
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By:DEVANSHU
JOSHI
on record and accepted by the Court. It is accordingly directed that if the
Defendant No.1 takes a decision to undertake commercial production or sale
of pharmaceutical preparations of Nilotinib, it shall give advance intimation
to the Plaintiff of at least four weeks. At that stage, the Plaintiff is permitted
to avail of his remedies in accordance with law. This would, however, not
prejudice the rights of the Defendant No.1 to undertake permissible
activities, in terms of Section 107A of the Act.
12. The present suit is decreed in the above terms.
13. It is made clear that the Court has not considered the merits of the
case, either in respect of infringement or validity of the suit patent.
14. Decree sheet be drawn accordingly. The next date of hearing stands
cancelled. All pending applications are disposed of.
PRATHIBA M. SINGH
JUDGE
MAY 26, 2022
dj/ad
Signature Not Verified
By:DEVANSHU
JOSHI
