The legal battle involving Sigrima, Zydus Lifesciences’ biosimilar version of Roche’s breast cancer drug Pertuzumab, has taken a fresh turn, and this could affect further generic competition on the drug, said a section of Intellectual property and industry voices.

According to legal reports, the Supreme Court, on Monday, had refused to grant interim relief to Zydus in its battle against a Delhi High Court injunction that had restrained it from making and selling Sigrima. The issue has been directed back to the Delhi HC, the report added.

Patent infringement

In fact, Sigrima has been through a couple of legal directives, already. In a patent infringement case against it, Zydus was temporarily restrained from selling the biosimilar by the Delhi HC in July 2024. This was vacated in October only to be soon reinstated. Zydus then approached the apex court to get its biosimilar back in the market. With the case now directed back to the Delhi High Court, responses are awaited from the companies to queries from businessline.

In June this year, Zydus had inked a co-marketing agreement on the biosimilar with Dr Reddy’s Laboratories (DRL) Ltd. The biosimilar has been developed in-house by the research team at the Zydus Research Centre (ZRC), the two companies had said.

Under the agreement, DRL was to receive semi-exclusive rights from Zydus to co-market the product in India and it was to market it under the brand name Womab. “Zydus will receive upfront licensing income and is eligible to receive milestone income based on achievement of pre-defined milestones,” the two companies said.

Chilling effect

An industry source said that DRL had not been marketing the product since the first legal injunction. Leena Menghaney, an IP lawyer working on access barriers in health, pointed out the latest development will have a “chilling effect” on other generic companies that may have plans to enter the segment. “Courts have to balance between IP enforcement and public interest,” she said, adding that ordinary patients would not be able to access expensive biotech drugs without generic competition that help bring down prices.

Welcoming the decision, a Roche official said, as a company who is constantly innovating to deliver medicines to people around the world, “we believe that strong IP protection, including patents, is essential for medical innovation and needed to address the healthcare challenges we face today.”

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