A Bench comprising Chief Justice of India (CJI) Sanjiv Khanna and Justice PV Sanjay Kumar emphasized the practical implications of judicial orders, observing, “At times, the practical impact of orders is more important than the case itself.”
![[Roche vs Zydus] Apex Court Refuses To Revoke Injunction Against Sale Of Zydus Lifesciences' Breast Cancer Drug](https://i0.wp.com/lawchakra.in/wp-content/uploads/2024/11/Zydus-Lifesciences_-Zydus-barred-from-selling-cancer-biosimilar-for-now-The-Economic-Times.png?resize=420%2C315&ssl=1)
NEW DELHI: The Supreme Court on Monday(18th Nov) directed the Delhi High Court to decide on the issue of interim injunction in a patent dispute over the latter’s manufacture of a breast cancer drug, ‘Sigrima’.
This direction followed Zydus’ appeal to the Supreme Court against the Delhi High Court’s restoration of an interim injunction order that barred the company from manufacturing, selling, or marketing ‘Sigrima.’
A Bench comprising Chief Justice of India (CJI) Sanjiv Khanna and Justice PV Sanjay Kumar emphasized the practical implications of judicial orders, observing,
“At times, the practical impact of orders is more important than the case itself.”
The Court, without issuing a formal notice, remitted the matter back to the High Court, instructing it to hear the case on December 2 and decide expeditiously.
Roche has alleged that ‘Sigrima’ infringes on its patent for Pertuzumab (marketed as Perjeta), a breast cancer drug. The High Court had earlier reinstated a single-judge order restraining Zydus, prompting Zydus to approach the Supreme Court.
During the hearing, Senior Advocate Dushyant Dave, representing Zydus, criticized the High Court proceedings, stating,
“What is happening in the High Court, it is shocking!” The CJI also expressed concerns, remarking that the High Court’s order “did not go into the question” and appeared flawed.
However, Senior Advocate Mukul Rohatgi, representing Roche, argued there was no justification to lift the interim injunction. The High Court had deferred its hearing to December 2 due to the pendency of the matter before the Supreme Court. Until then, the interim injunction against Zydus remains in effect.
Legal representation for Roche included Senior Advocates Mukul Rohatgi, Sandeep Sethi, and Arvind Nigam, along with advocates Pravin Anand, Shrawan Chopra, Archana Shankar, and others.
Zydus was represented by Senior Advocates Dushyant Dave and Rajiv Nayar, supported by advocates Bitika Sharma, Vrinda Pathak, Sandhya Kukreti, and others.
Patent Infringement Case
Zydus Lifesciences’ biosimilar, Sigrima, has faced multiple legal challenges. In July 2024, the Delhi High Court issued a temporary injunction preventing Zydus from selling the biosimilar. Although this was vacated in October, the injunction was soon reinstated, prompting Zydus to approach the Supreme Court to seek relief and reintroduce the product to the market. The Supreme Court has now directed the matter back to the Delhi High Court, and responses from the involved parties are awaited.
In June 2024, Zydus signed a co-marketing agreement with Dr. Reddy’s Laboratories (DRL) Ltd for Sigrima. Developed in-house at the Zydus Research Centre (ZRC), DRL was granted semi-exclusive rights to co-market the biosimilar in India under the brand name Womab. Zydus was to receive upfront licensing fees and milestone payments contingent on achieving predefined goals.
Chilling Effect on Generics
An industry insider revealed that DRL has refrained from marketing the product since the initial injunction. Leena Menghaney, an intellectual property lawyer focused on healthcare access, remarked that such legal developments could have a “chilling effect” on other generic companies exploring this market.
“Courts must balance intellectual property enforcement with public interest,” she noted, highlighting the role of generic competition in making expensive biotech drugs more accessible to patients.
A Roche spokesperson welcomed the decision, emphasizing the importance of strong intellectual property protections.
“As a company committed to delivering innovative medicines worldwide, we believe robust IP protection, including patents, is crucial for fostering medical innovation and addressing global healthcare challenges,” the representative stated.
Case Title: Zydus Lifesciences Ltd v. F. Hoffmann-La Roche AG and Anr
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