Delhi High Court
Novartis Ag & Anr. vs Msn Laboratories Private Limited on 26 May, 2022
$~4
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Date of decision: 26th May, 2022
+ CS(COMM) 307/2022 & I.A. 7325-26/2022
NOVARTIS AG & ANR. ..... Plaintiffs
Through: Mr. Hemant Singh, Ms. Mamta Rani
Jha, Mr. Saif Rahman Ansari and Mr.
Siddhant Sharma, Advocates.
versus
MSN LABORATORIES PRIVATE LIMITED ..... Defendant
Through: Ms. Rajeshwari H., Ms. Swapnil Gaur
and Mr. Deepanshu Nagar, Advocates
for D-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.
CS(COMM) 307/2022
2. The present suit has been filed seeking permanent injunction
restraining infringement of Indian Patent No.283133, damages, rendition of
accounts, delivery up etc. The details of the said patent are as under:
Patent No. : 283133
Title : PYRROLOPYRIMIDINE
COMPOUNDS AND THEIR
USES
Date of Filing : 24th May, 2007
Date of Expiry : 24th May, 2027
3. Pursuant to the directions issued vide previous orders dated 20th May,
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By:DEVANSHU
JOSHI
2022 and 11th May, 2022, the Department of Pharmaceuticals, Ministry of
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 the said notice, Ribociclib was mentioned at Serial No.163.
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
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By:DEVANSHU
JOSHI
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.
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. On merits of the present suit, Defendant No.1 - MSN Laboratories
Private Limited has handed over the original affidavit dated 25th May, 2022
deposed by Mr. Srinivasan Thirumalai Rajan, Head - Intellectual Property &
Technical of the Defendant No.1. Let the same be taken on record.
9. In the said affidavit, the stand of the Defendant No.1 is that the
Plaintiff had filed a separate application bearing No.1014/DELNP/2011
dated 20th August, 2009. The said application was opposed by Natco Pharma
Ltd. One of the grounds of the opposition was that Ribociclib was
anticipated by the suit patent IN'283133. In response thereto, the Plaintiff -
NOVARTIS AG is stated to have taken a stand that Ribociclib is not
covered by IN'283133. The relevant extract of the said reply to the
opposition is set out below:
"23. The Applicants submits that a person skilled in the
art on the priority date of the instant application would
not selectively identify the particular substituents from
the Markush definition as pointed out the Opponent.
24. The Applicants submits that Markush structure /
formula is used in the field of chemical art to cover large
number of chemical compounds. The generic / Markush
formula covers a class of compound defined by the
invention. A general formula with multiple substituents
would not take away the novelty of a subsequent claim to
an individual compound. A prior generic disclosure does
not take away the novelty of a claim to a specific
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JOSHI
compound unless the compound is disclosed in
"individualized form" (Reddy vs Eli Lilly, 2008 EWHC
2345).
25. The Applicants submits that the cited document D1
discloses more than 400 exemplified compounds.
However, there is no disclosure of the specific
compound, i.e., Ribociclib, claimed in IN '1014
application, in an "individualized form" in the cited
prior art document D1. None of the compounds disclosed
in D1 contains all the structural features of the claimed
compound, Ribociclib.
"
10. In view of the above submissions made on behalf of the Defendant
No.1, the Defendant No.1 may file its written statement within 30 days.
I.A. 7325/2022 (for stay)
11. Ld. counsel for the Defendant submits that insofar as Ribociclib is
concerned, the Defendant No.1 does not have a manufacturing licence yet.
Further, it is submitted that it may even take six months for such a licence to
be issued.
12. It is made clear that if a manufacturing licence is issued in respect of
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By:DEVANSHU
JOSHI
Ribociclib, before taking any further steps for the commercial
manufacture/launch of any product or pharmaceutical preparation in respect
of Ribociclib, the Defendant No.1 shall move an application before the
Court, informing the Court of the said licence having been granted. At that
stage, the Court would consider if any further orders have to be passed.
Accordingly, I.A. 7325/2022 is disposed of.
13. It is made clear that if the Defendant No.1 obtains a manufacturing
licence on a commercial scale, the Plaintiff is permitted to seek restoration
of the present application seeking interim injunction.
14. Insofar as the manufacture and sale of the product as permitted under
Section 107A of the Patents Act, 1970 is concerned, there would be no
impediment for the Defendant No.1 to carry out such permissible activity, in
accordance with law.
15. List the suit before the Joint Registrar on 28th July, 2022.
16. List before Court on 22nd September, 2022.
I.A. 7326/2022(seeking appointment of LC)
17. This is an application seeking the appointment of Local
Commissioner. The same is disposed of as not pressed.
18. Accordingly, I.A. 7326/2022 is disposed of as not pressed.
PRATHIBA M. SINGH
JUDGE
MAY 26, 2022
dj/ad
Signature Not Verified
By:DEVANSHU
JOSHI
