E.R. Squibb and Sons, LLC & Ors. v. Zydus Lifesciences Limited

Relevant Acts and provisions

Patents Act, 1970

Section 107Section 107ASection 108Section 48Section 64

Provisions considered: Sections 48, 64, 107, 107A and 108 of the Patents Act, 1970, in a quia timet action concerning a biosimilar.

Brief facts

E.R. Squibb and Sons and its group companies, patentees of an Indian patent for monoclonal antibodies used in a cancer immunotherapy drug, filed a quia timet suit against Zydus Lifesciences to restrain manufacture and sale of a biosimilar. The plaintiffs alleged that the defendant had already commenced manufacturing and stockpiling batches of the biosimilar before the patent's expiry, and sought an interim injunction against imminent infringement.

Issues before the Court

1. Did the plaintiffs make out a strong prima facie case of imminent infringement to justify quia timet relief under Section 48?
2. Can biosimilar product manufactured or stockpiled during the term of the patent continue to be restrained even though the patent is due to expire shortly?

Court's findings

The Court held that a quia timet action is maintainable where a party demonstrates a reasonable apprehension of imminent, substantial infringement, and that the plaintiffs had established a strong prima facie case given the defendant's own conduct, including seeking manufacturing approvals for a biosimilar covered by the subsisting suit patent.

The Court further held, in the absence of Indian precedent directly on the point and agreeing with the reasoning of foreign authority, that a product infringing a patent during its term remains tainted by that infringement and can continue to be restrained under Section 48 even after the patent's expiry, insofar as it concerns stock manufactured while the patent subsisted.

The Court accordingly granted an interim injunction restraining dealings in such stock and directed disclosure of the quantities manufactured.

Decision

Interim injunction granted restraining the defendant from manufacturing or selling biosimilar stock made during the patent's subsistence, with disclosure of quantities directed.

Keywords

Biotechnology Interim Injunction Patent Infringement Pharmaceutical Patent Pre-grant Opposition