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M/s Genentech Inc. & Ors. v. Drugs Controller General of India & Ors.

Civil Appeal · 2019 INSC 1391Decided 17 Dec 2019
Civil Appeal No. 9491 of 2019
Justice R. Banumathi · Justice A.S. Bopanna · Justice Hrishikesh Roy

Background

Genentech and its Indian marketing partners, who market the cancer drug Trastuzumab under brand names like HERCEPTIN, sued Reliance Life Sciences before the Delhi High Court to stop it from marketing its own version, "TrastuRel," as biosimilar to their drug, alleging inadequate trials. A Single Judge had earlier imposed interim conditions restricting how Reliance could describe and market TrastuRel pending trial. A Division Bench of the High Court later stayed those conditions and let Reliance market freely on par with two other manufacturers, prompting Genentech's appeal to the Supreme Court.

Decision Breakdown

The Supreme Court found that the Division Bench had failed to comply with this Court's own earlier direction to hear the appeals and interim applications of both sides together, and had instead decided only Reliance's application while shutting out Genentech's. The Court held that the arrangement under the Single Judge's 2016 interim order had operated without disruption for over three years and should not have been disturbed without a final decision in the underlying suit. It set aside the Division Bench's order, restored the Single Judge's interim conditions, and directed the High Court to dispose of the main suit expeditiously (preferably within 12 months), while permitting Reliance to participate in government tenders using the generic drug name in the meantime.

Lesson Learnt

When a court directs that competing parties' applications be heard and decided together, an appellate forum cannot selectively decide only one side's application, doing so can itself be a ground for the higher court to step in, even at the interim stage, without touching the final merits of the underlying suit.

Official source (sci.gov.in)View Judgment (PDF)

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