FMC Corporation & Anr. v. Natco Pharma Ltd. Anr.

IMPORTANT ISSUE

• Whether Patent IN’307 was liable to revoked as the product was obvious from the genus patent IN’978

FACTUAL MATRIX

1. The Plaintiff was the owner of subsisting patents IN’307 (product patent), IN’ 332 (process patent) and IN’ 978 (genus patent) expiring on 13th August 2022. The dispute was regarding Chlorantraniliprole (also known as “CTPR”) and the preparation process thereof.
2. The dispute arose in October 2019 when the Defendant launched a CTPR based insecticide and also filed an application with the Indian Patent Office for improved preparation of CTPR.
3. The Plaintiff has filed for permanent injunction against the infringement of these patents by the Defendant, and also filed for interlocutory injunction while the case was sub judice.
4. The Defendant in response has raised an argument that the patents were inavlid and liable to be revoked as the “novel compound” in IN’307 is evident in the teachings of the Markush claims in IN’978.

SUBMISSIONS OF PLAINTIFF

1. In the interlocutory stage, the Defendant has to establish a prima facie case against the validity of the patent. So far, they have not placed on record an expert opinion to prove the vulnerability of the subsisting patents and hence, the Defendant has failed to discharge the burden of proof placed on them.
2. Marrkush claims in IN’978 covers millions of compounds and while it is true that CTPR is one of the compounds covered by the Markush claim, it is not obvious for a person skilled in art to synthesize the same without imagination and creativity. If the very fact of being covered in a Markush claim could negate patentability of individual compounds therein, the concept of genus and specie patents as envisaged in Section 10(5) would not exist.

SUBMISSIONS OF DEFENDANT

1. Section 107(1) of the Act states that in a suit for infringement, every ground of revocation under Section 64 shall be available as a defence against infringement. The Defendant contested that the patents were invalid and liable to be revoked and hence, they were not guilty of infringement.
2. Grant of a patent does not raise a presumption of validity. Since the patented product is obvious in the teaching of the genus patent ‘978, the subsisting patent ‘307 is liable to be revoked.
3. The Plaintiff has admitted that CTPR is covered in ‘978 and according to the Novartis judgement by the Supreme Court, there is no difference between disclosure and coverage. Markush claim contained in ‘978 sufficiently discloses CTPR to be synthesized by a person skilled in art.

HELD

1. There is an etymological difference between the terms “guarantee” and “presumption” of validity. Precedents laid down by the Supreme Court states that the grant of a patent does not guarantee its validity meaning that a patent once granted does not become immune to challenge in the future.
2. In the interlocutory stage, while it is true that a credible challenge to the validity of the patent would suffice, it is imperative to place on record substantial material as evidence even if not necessarily expert opinions.
3. Synthesis of CTPR from the Markush claims is possible only because the Defendants cherry picked substitutions. A careful perusal of ‘978 does not discern any teachings of CTPR and hence, there is no obviousness in the patent.
4. Thus, the interlocutory injunction is granted.

Citation: 2021 SCC OnLine Del 3647
Copy of judgement