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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) 305 of 2022 & I.As. 7317-18 of 2022
Decided On : 26-05-2022




The Government's Public Notice regarding local drug manufacturers does not imply authorization to infringe patent rights, clarifying its non-involvement under the Patents Act.

Headnote:(A) Patents Act, 1970 - Section 100 - Permanent injunction sought for infringement of Indian Patent No. 237430 regarding inhibitors of tyrosine kinases. The Department of Pharmaceuticals clarified that their Public Notice does not authorize infringement of patent rights and is only for collating local manufacturers. No further orders were required against the Government in this context. (Paras 5, 7, 9, 10, 11)

(B) Patent Rights - The Court emphasized that neither the Plaintiff nor the Defendant has the right to interpret the Department's Public Notice as a means to infringe patent rights. (Paras 6, 17, 18)

Facts of the case:
The suit was initiated by a pharmaceutical company against another entity alleging infringement of a patent concerning a cancer treatment drug. The Government issued guidelines to increase local production, but these were misinterpreted by the Defendant as infringing on patent rights.

Findings of Court:
The Government was not invoking any provisions of the Patents Act for procurement, thus no further orders against them were necessary. The Defendant must notify the Plaintiff at least four weeks in advance if they intend to manufacture the drug commercially.

Issues: The primary questions addressed included whether the Government's guidelines constituted infringement of patent rights and the conditions for further production by the Defendant.

Ratio Decidendi: The court underscored the distinction between the Government's advisory role versus the protection of patent rights, asserting that the Defendant misread the Government's Public Notice as an authorization to infringe.

Result: Suit decreed as per the terms stated.

Table of Content
1. clarification of the dop's intent and compliance with patent laws. (Para 2 , 3 , 4 , 5 , 6)
2. defendant's manufacturing license status and implications. (Para 8 , 9)
3. defendant's obligation to notify the plaintiff before commencing manufacturing. (Para 10 , 11)
4. decree issued based on current terms without merit consideration. (Para 12)
5. court's ordering of next procedural steps and case closure. (Para 13 , 14)

JUDGMENT

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

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 Authorizatio

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