Zydus Lifesciences Limited appealed a single judge's order restraining its anti-cancer biosimilar drug ZRC 3276 (claimed 70% cheaper than respondent's 5C4/Nivolumab/Opdivo under IN 340060) as allegedly infringing the respondent's patent for an isolated monoclonal antibody binding specifically to PD-1 with specified amino acid sequences in a quia timet suit filed before commercial launch.
No direct product-to-claim mapping existed; single judge relied on indirect biosimilar-to-reference biologic comparison assuming identical sequences and non-exclusive "specifically," overlooking appellant's evidence of statistically significant binding.
Division bench found flawed reasoning on biosimilar identity, "specifically" per prosecution history requiring no significant cross-binding, and mapping standards under Patents Act.
Absent conclusive mapping or irrefutable prima facie infringement amid technical triability, public interest in life-saving cancer therapy outweighed absolute injunction despite patent protection needs, especially with patent expiry on 2 May 2026.
Modifying order to vacate injunction conditioned on appellant filing audited sales accounts till expiry.
Law Point:
In patent infringement suits, product-to-claim mapping is indispensable to establish prima facie case under S.48 Patents Act; its absence requires overwhelming, unbroken circumstantial evidence sans presumption.
For life-saving drugs like anti-cancer therapies, public interest paramount in interlocutory injunctions alongside prima facie case/balance of convenience; absolute restraint unjustified if triable issues/expert evidence needed—secure via accounts instead.
Case Detail:Zydus Lifesciences Limited Vs E.R. Squibb and Sons:12.01.2026:FAO(OS) (COMM) 120/2025:2026:DHC:178:DB: Justice C. Hari Shankar, Justice Om Prakash Shukla
[Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation]
[Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi]
