NDLI: M/s Genentech Inc. & Ors. Vs. Drugs Controller General of India & Ors.

Content Provider	Supreme Court of India
e-ISSN	30484839
Language	English
Access Restriction	NDLI
Subject Keyword	1940 Drugs and Cosmetics Act
Content Type	Text
Resource Type	Law Judgement
Jurisdiction	India
Act(s) Referred	Drugs and Cosmetics Act, 1940 (23 of 1940)
Case Type	Appeal
Court	Supreme Court of India
Disposal Nature	Appeal Allowed
Headnote	Drugs and Cosmetics Act, 1940 – A suit was filed by the appellants before the High Court to restrain respondent No. 3 from launching, marketing or selling ‘TrustuRel’ the biosimilar version of the appellants drug ‘Trastuzumab’ – Prior to this suit, appellants’ had filed a similar suit against ‘B&M’ and High Court had allowed ‘B&M’ to market their drugs – However, respondent no. 3 in its suit was restrained from launching and selling ‘TrustuRel’ and injunction was ordered by the Single Judge of High Court on 25.04.2016 – According to the Single Judge of the High Court, the approvals granted to ‘TrustuRel’ product were not on the basis of the adherence of the guidelines 2012 and rules framed under the Drug Act – However, respondent no. 3 was permitted to launch and market ‘TrustuRel’ on the basis of the approval from the DCGI and without projecting their product as a biosimilar to the appellants’ product – The Division Bench of the High Court granted interim stay of the Single Judge Order dated 25.04.2016 and allowed respondent no. 3 parity of operation with ‘B&M’ – Earlier Supreme Court had in another Special Leave Petition had directed the Division Bench of the High Court to simultaneously take up the appeals and interim applications filed by both sides – Held: As permitted by the interim order dated 25.04.2016, the respondent no.3 had launched its biosimilar product and they were in market with their drug for the last three and a half years – The Division Bench of the High Court had only considered the appeal and application filed by the respondent no.3 on merit without entertaining appellants’ application – The Division Bench of the High Court committed an error – Without analogous consideration of the appellants’ applications, the Court should not have unsettled the prevailing situation for last three and half years, without final conclusion of the respondents’ suit – Therefore, the impugned order passed by the Division Bench of the High Court set aside – The interim direction given by the Single Judge on 25.04.2016 made operational – Further, the High Court directed to dispose of the pending suit expeditiously.
Judge	Hon'ble Mr. Justice Hrishikesh Roy
Neutral Citation	2019 INSC 1391
Petitioner	M/s Genentech Inc. & Ors.
Respondent	Drugs Controller General Of India & Ors.
SCR	[2019] 15 S.C.R. 318
Judgement Date	2019-12-17
Case Number	9491

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