Vifor (International) Ltd. & Anr. v. MSN Laboratories Pvt. Ltd. & Anr.

Relevant Acts and provisions

Patents Act, 1970

Section 10Section 48

Provisions considered: Section 48 of the Patents Act, 1970, and the construction of product-by-process claims for infringement purposes.

Brief facts

Vifor held an Indian patent claiming Ferric Carboxymaltose, an iron-replacement drug, in product-by-process terms using obtainable by language. When generic manufacturers sought to market the drug, the Single Judge declined an interim injunction, holding that a product-by-process claim is infringed only if the defendant uses the identical or an equivalent claimed process, and that Vifor had not shown the generics used that process. Vifor appealed to a Division Bench, arguing that its patent protected the novel product itself, independent of the manufacturing process recited in the claim.

Issues before the Court

1. Does a product-by-process claim protect only products made by the recited process, or the novel product itself regardless of process?
2. What is the significance of obtainable by as opposed to obtained by language in such claims?

Court's findings

The Court held that product-by-process claims exist because the applicant is unable to define the novel product by its structural attributes alone, and resorts to process language for that limited descriptive purpose; the invention being protected is the product, not the process. It held that where the claim uses obtainable by rather than the narrower obtained by, the process language is illustrative and non-limiting, so infringement analysis must focus on whether the accused product possesses the same novel characteristics as the claimed product.

The Court held that the Single Judge had erred in treating process identity as a threshold requirement for infringement, since the drug was itself a new product not disclosed in the prior art, so any manufacture or sale of it would prima facie fall within the claim irrespective of the process used.

The Court clarified that patentability and infringement of product-by-process claims should be assessed on a consistent standard directed at the product's novelty and inventive step, and set aside the finding that had denied interim relief on the process-identity ground.

Decision

Appeals allowed; the Single Judge's order was set aside and the matter remanded for fresh consideration of interim relief applying the product-focused test.

Keywords

Claim Construction Interim Injunction Novelty Pharmaceutical Patent Product-By-Process Claim