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IN THE HIGH COURT OF DELHI
Prathiba M. Singh, J.
Novartis AG - Appellant
Versus
MSN Laboratories Private Limited - Respondent
CS(COMM) 307 of 2022 & I.A. 7325-26 of 2022
Decided On : 26-05-2022




The government notice for local manufacturing does not authorize infringement of patent rights, clarifying its intent under the Patents Act, ensuring that specific claims retain their novelty despite general disclosures.

Headnote:(A) Patents Act, 1970 - Section 100 and Section 107A - Permanent injunction sought against infringement of Indian Patent No.283133 regarding Pyrrolopyrimidine compounds - Government clarification that public notice for local manufacturers does not authorize infringement of patent rights - Defendant's misinterpretation of governmental intent noted - No further orders on government necessary as provisions of Patents Act not invoked. (Paras 5-7)

(B) Patent Application - Opposition to patent claims discussed - Claim of novelty regarding Ribociclib challenged - Explanation given that general formula does not undermine specific compound claims unless disclosed individually. (Paras 9-9)

Facts of the case:
The appellant filed a suit for a permanent injunction against the respondent alleging patent infringement concerning a compound patented under Indian Patent No.283133, with the expiry on 24th May, 2027. The Department of Pharmaceuticals clarified their public notice’s purpose regarding local manufacturing was misinterpreted by the defendant as a governmental authorization to infringe the patent.

Findings of Court:
The court found no requirement for further orders on the government regarding the patent issue and noted the defendant's lack of a manufacturing license for the disputed compound.

Issues: The main issues involved whether the public notice from the Department constituted a government direction that would infringe upon patent rights and the interpretation of the opposition to the patent application regarding novelty.

Ratio Decidendi: The court clarified that the Department’s notice does not affect patent rights and emphasized the distinction between governmental authority and patent holder rights under the Patents Act, affirming that general disclosures do not negate specific claims of novelty.

Result: Application for stay disposed of; defendant allowed to seek restoration upon obtaining a manufacturing license.

Table of Content
1. clarification of dop's role and stance on patent. (Para 2 , 3 , 4 , 5 , 6)
2. no further orders needed against the dop. (Para 7)
3. defendant's stance on patent opposition outlined. (Para 8 , 9)
4. conditions for proceeding with manufacturing license. (Para 10 , 11 , 12 , 14)
5. administrative orders and scheduling. (Para 13 , 15 , 16 , 17 , 18)

JUDGMENT

Prathiba M. Singh, J. (Oral)--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, 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 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 Governmen

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