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Supreme Court of India 2019-12-17 allowed

M/S GENENTECH INC vs DRUGS CONTROLLER GENERAL OF INDIA

Bench: 3 — D.Y. Chandrachud, Hrishikesh Roy, R. Banumathi, A.S. Bopanna

In Brief

M/s Genentech Inc., the innovator of Trastuzumab, challenged a High Court order allowing competitor Reliance Life Sciences to market the biosimilar drug 'TrastuRel'. Although Genentech's patent had expired in 2013, they sought to prevent Reliance from using the generic name and marketing the product as a biosimilar. The Supreme Court allowed the appeal, setting aside the Division Bench's interim order, and restored conditions imposed by the Single Judge requiring Reliance to qualify the drug name and avoid claiming bio-similarity. The Court held the Division Bench erred by failing to simultaneously consider both parties' applications as earlier directed, and should not have disturbed an arrangement that had worked satisfactorily for three-and-a-half years pending final trial.

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Pharmaceutical Law Biosimilar Drugs Intellectual Property Passing Off Patent Expiry Regulatory Approval Interim Relief Civil Procedure

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