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Synopsis

The Delhi High Court recently rejected an application by pharmaceutical giant Bayer Healthcare against Natco Pharma for a suit patent that contained the same chemical compound, “Regorafenib” as found in the genus patent that expired on 12.01.2020.

Justice Navin Chawla, while dismissing the application for interim injunction by the plaintiff, held, “Section 53(4) of the Act specifically provides that on expiry of the term of patent, the subject matter covered by the said patent shall not be entitled to any protection. The plaintiff having admitted that the Suit Patent is covered by genus patent, though qualifying such admission by use of the word ‘technically’, whose term has admittedly expired, at least prima facie is not entitled to an interim order at this stage.”

On principles applicable to consideration of an interim application, the court summarized as follows:

1. Every ground on which the patent may be revoked under Section 64 of the Patent Act shall be available as a ground for defence;

2. There is no presumption with respect to validity of a patent;

3. The defendant, in opposition to the prayer for interim relief is only to show ‘vulnerability of the patent’ and not prove ‘actual invalidity of the patent’.

Reliance was inter-alia placed on BP Radhey Shyam v. Hindustan Metal Industries, (1979) 2 SCC 511 and F. Hoffmann-LA Roche Ltd. v. Cipla limited, 2008 SCC OnLine Del 382 in this regard.

With respect to genus v. species patent and the related aspect of ‘disclosure’ and ‘coverage’ in a patent, Court reiterated, “Attempt of ever-greening of the patent is to be discouraged and denounced. It is only truly new product or process involving an inventive step and capable of industrial application, that would be entitled to protection under a subsequent patent.”

Reliance was placed on Novartis AG v. Union of India, AIR 2013 SC 1311 and Astrazenca AB & Anr. v. Intas Pharmaceuticals Ltd., 2021 SCC OnLine Del 3746.

On affordability v. accessibility, the court added, “The public interest would also demand that such injunction be refused inasmuch as it is claimed that there is a huge disparity between the price of the product offered by the plaintiff and the defendant for a disease which is life-threatening. In the present case, the Plaintiffs are selling their product at the rate of Rs. 36,995/- by importing the same into India, whereas, the Defendants are manufacturing the product in India and selling the same at a cost of Rs. 9,900/-.”

Brief Background

The plaintiff in the present case, was part of the Bayer Group of companies, with holding company being Bayer AG.

IA 8878 of 2019 in CS (COMM) 343 of 2019 and IA 15573 of 022 in CS (COMM) 660 of 2022 were sought by the plaintiff against the defendant, with respect to a molecule REGORAFENIB. The plaintiff stated that REGORAFENIB is not specifically disclosed in the genus patent by way of either a chemical name, chemical formula, or chemical structure, however, technically covered within the generic scope of the numerous compounds included in the Markush Formula disclosed in the patent.

The defendants inter-alia stated that the plaintiff had prior knowledge of compound REGORAFENIB at the time of filing of genus patent IN ‘758. At the time of filing, the genus patent captured numerous compounds under its formula, however, later during prosecution, many such compounds, including REGORAFENIB were deleted by amending the description of IN ‘758, only to claim them separately, the defendants added. 

Case Title: Bayer Healthcare v. Natco Pharma | CS (COMM) 343 of 2019