F. Hoffmann-La Roche AG & Anr. v. Natco Pharma Limited

Relevant Acts and provisions

Patents Act, 1970

Section 107Section 2(1)(ja)Section 48(a)Section 64(1)(e)Section 64(1)(f)

Provisions considered: Sections 2(1)(ja), 48(a), 64(1)(e), 64(1)(f) and 107 of the Patents Act, 1970, on obviousness and interim injunction.

Brief facts

Roche held an Indian patent claiming Risdiplam, a drug for spinal muscular atrophy, and sued Natco Pharma for infringement when Natco sought to launch a generic version. The Single Judge declined an interim injunction, accepting Natco's defence under Section 107(1) read with Section 64(1) that the compound was obvious over a compound disclosed in Roche's own earlier genus patents, given that the modification involved a standard bioisosteric substitution and both patents shared common inventors. Roche appealed, arguing that structural proximity to a genus-patent compound did not establish obviousness.

Issues before the Court

1. Does coverage by an earlier genus patent, by itself, render a later species compound obvious under Section 64(1)(f)?
2. Was the validity challenge credible enough to defeat an interim injunction under Section 48(a)?

Court's findings

The Court held that infringement analysis and validity analysis serve different inquiries: infringement turns on whether the accused product falls within claim coverage, whereas invalidity for lack of inventive step turns on whether the claimed compound was rendered obvious by what was already disclosed to a person skilled in the art. It held that mere theoretical coverage of a compound by a broad genus claim does not amount to an enabling disclosure defeating novelty, but a credible showing that the specific modification from a disclosed lead compound was a routine, predictable substitution can support a strong prima facie case of obviousness.

The Court found that replacing a specific ring atom in the earlier disclosed compound with nitrogen was a well-known bioisosteric substitution within the ordinary skill of a medicinal chemist, and that common inventorship across both patents reinforced the inference that the later compound was an obvious development rather than an inventive leap.

The Court reiterated that patent monopolies cannot be extended over life-saving medicines through obvious structural modifications once the substance of the invention was already disclosed.

Decision

Appeal dismissed; the Single Judge's refusal of an interim injunction was upheld, allowing Natco to continue manufacturing and selling the generic pending trial.

Keywords

Evergreening Genus-Species Patent Interim Injunction Inventive Step Obviousness Pharmaceutical Patent