Case Note & Summary
The dispute arose from an appeal against an interim order of the Delhi High Court concerning the marketing of a biosimilar drug 'TrastuRel' by M/s Reliance Life Sciences Pvt. Ltd., which was challenged by M/s Genentech Inc. and its associates. The appellants claimed to be the innovators of the drug 'Trastuzumab', which had its patent expire in 2013. They sought to restrain the respondent from launching 'TrastuRel', arguing that it had not undergone the necessary trials as per the Drugs and Cosmetics Act, 1940. The High Court initially imposed conditions on the marketing of 'TrastuRel', but the Division Bench later granted interim relief to the respondent, allowing them to market the drug under certain terms. The appellants contended that the Division Bench did not adequately consider their application and failed to comply with the Supreme Court's earlier directions for analogous consideration of both parties' appeals. The Supreme Court found that the Division Bench had erred in not considering the appellants' application and in granting relief to the respondent without addressing the balance of convenience. The Court reinstated the Single Judge's interim order and directed the High Court to expedite the final disposal of the suit, while allowing the respondent to participate in government tenders for 'TrastuRel' without impediment. The appeal was allowed without costs.
Headnote
A) Intellectual Property Law - Patent Rights - Expiry of Patent - Patent rights of the appellants on 'Trastuzumab' lapsed in 2013, impacting their enforceable rights against the biosimilar 'TrastuRel' - The court noted that the suit was not a trademark action but an extended passing off action to prevent misuse of data - Held that the expiry of patent does not directly affect the suit's core issues (Paras 24-25). B) Regulatory Compliance - Approval of Biosimilar Drugs - The court emphasized the need for compliance with the Drugs and Cosmetics Act, 1940 and the 2012 Guidelines for biosimilar drugs - The interim order allowed respondent no.3 to market 'TrastuRel' under specific conditions to ensure public safety pending final resolution of the suit - Held that the approval process must adhere to statutory provisions (Paras 7-8, 28). C) Interim Relief - Balance of Convenience - The court found that the Division Bench failed to consider the balance of convenience and the prevailing situation for three and a half years before unsettling the interim order - The appeal was allowed, reinstating the Single Judge's interim order and directing expeditious disposal of the suit (Paras 27-28).
Issue of Consideration
Whether the Division Bench of the High Court erred in granting interim relief to the respondent without considering the appellants' application.
Final Decision
The Supreme Court set aside the impugned order of the Division Bench, reinstated the interim order of the Single Judge, and directed the High Court to expedite the final disposal of the suit within 12 months.
Law Points
- Interim relief
- patent rights
- biosimilar drugs
- compliance with regulatory guidelines
- balance of convenience
