Case Note & Summary
The Supreme Court of India heard an appeal against an interim order of the Delhi High Court Division Bench dated 18.09.2019. The dispute involved M/s Genentech Inc. and its affiliates (appellants), who are innovators of the monoclonal antibody drug 'Trastuzumab' marketed under brand names HERCEPTIN, HERCLON, and BICELTIS. The patent for Trastuzumab had lapsed on 03.05.2013. The appellants had filed a suit (CS(OS) No. 3284/2015) seeking to restrain respondent no.3, M/s Reliance Life Sciences Pvt. Ltd., from launching its biosimilar version 'TrastuRel', and also challenging the approval granted by the Drug Controller General of India (DCGI) for that drug. The appellants alleged that respondent no.3 had not conducted the requisite chemical trials and had not generated adequate data to establish safety, efficacy, and immunogenicity as required under the Drugs and Cosmetics Act, 1940 and applicable guidelines. Respondent no.3 contended that the appellants had no enforceable right due to patent expiry and that they could rely on the appellants' data in the public domain. The Single Judge of the Delhi High Court, on 25.04.2016, passed an interim order permitting respondent no.3 to launch and market 'TrastuRel' but with several conditions, including that it cannot be called 'biosimilar' or claim similarity to the appellants' products, and cannot use the appellants' data. Respondent no.3 appealed to the Division Bench, which on 18.09.2019 allowed respondent no.3's application and stayed the Single Judge's order, allowing marketing of 'TrastuRel' on the same terms as were granted to Biocon and Mylan in a separate case. The Supreme Court noted that the Division Bench did not independently assess the prima facie case, balance of convenience, and irreparable injury specific to the case of respondent no.3, but merely relied on the orders in the Biocon and Mylan cases. The Supreme Court held that the Division Bench's order was unsustainable and set it aside, remanding the matter to the High Court for fresh consideration of the interim application, with a request to dispose of the appeals expeditiously.
Headnote
A) Civil Procedure - Interim Orders - Appellate Court's Power - The Division Bench, while hearing an appeal against an interim order, must independently assess the prima facie case, balance of convenience, and irreparable injury, and cannot merely adopt the reasoning of another case without considering the specific facts of the case before it. (Paras 14-17) B) Drugs and Cosmetics Act, 1940 - Biosimilar Drug Approval - Regulatory Compliance - The approval of a biosimilar drug by the Drug Controller General of India (DCGI) must be in accordance with the Drugs and Cosmetics Act, 1940 and the Guidelines of 2012; the court must examine whether the requisite trials and data have been generated before granting interim relief. (Paras 4-7) C) Intellectual Property - Patent Expiry - Locus Standi - The expiry of a patent does not automatically deprive the innovator of locus standi to challenge the marketing of a biosimilar drug on grounds of non-compliance with regulatory requirements, especially when the innovator's data and reputation are involved. (Paras 5, 12) D) Interim Injunction - Biosimilar Drug - Conditions - The Single Judge had imposed conditions to prevent the biosimilar from being marketed as 'biosimilar' to the innovator's product; the Division Bench's order lifting those conditions without adequate reasoning was set aside. (Paras 7, 12, 17)
Issue of Consideration
Whether the Division Bench of the Delhi High Court was justified in granting interim relief to respondent no.3 (M/s Reliance Life Sciences Pvt. Ltd.) to market its biosimilar drug 'TrastuRel' without the restrictions imposed by the Single Judge, pending final disposal of the appeal.
Final Decision
The Supreme Court allowed the appeal, set aside the impugned order of the Division Bench dated 18.09.2019, and remanded the matter to the High Court for fresh consideration of the interim application (C.M. Appln. No.22510/2016) in FAO (OS) No.181/2016. The High Court was requested to dispose of the appeals expeditiously, preferably within four months.
Law Points
- Interim relief
- biosimilar drug approval
- Drugs and Cosmetics Act
- 1940
- patent expiry
- locus standi
- regulatory compliance
- balance of convenience
- prima facie case
