New Delhi: US-based Bristol Myers Squibb (BMS) failed to get any relief against Indian drugmaker Zydus Lifesciences whom the Supreme Court refused to restrain from manufacturing and selling a version of its anti-cancer medication Nivolumab in the country.
A bench of Chief Justice of India (CJI) Surya Kant and Justice Joymalya Bagchi declined to overturn a Delhi High Court order of January that permitted Zydus to market its biosimilar, ZRC-3276, in “public interest.”
Nivolumab is a monoclonal antibody-based immunotherapy used in the treatment of several cancers, including lung and head-and-neck cancers. It is used in situations where chemotherapy is ineffective or shows limited benefit. The American company sells the life-saving drug under the brand names, Opdiva and Opdyta.
Noting that Squibb’s patent is due to expire on 2 May, the HC had said withholding such therapy from the public could cause irreparable prejudice to lakhs of lives who had started their treatment with ZRC-3276.
Without weighing into the merits of the case, both the CJI and Justice Bagchi aligned with the HC’s reasoning. It told Squibb’s legal team, represented by senior advocate Mukul Rohatgi, that the company’s loss, if any due to sale of Zydus product, is not irreversible.
“You can be compensated. But suppose someone loses a life for want of medicine, then nothing can compensate for that,” the CJI said.
Justice Bagchi suggested Squibb to conduct a mapping exercise of Zydus product with their claimed patent to ascertain the infringement, if any. He said when the Delhi HC heard and decided the matter there was no direct evidence available then because Zydus drug was not in the market then.
“Now there is direct evidence. Let there be mapping of the marketed product to find whether it is in violation of the patented claim,” the judge said.
The bench gave 15 days to Squibb to conduct the said exercise and re-approach the Delhi HC to pursue further legal remedies. To enable this, it directed Zydus to supply the drug within 24 hours to Squibb.
Objecting to Squibb’s appeal against the HC order, senior advocates Abhishek Manu Singhvi and Neeraj Kishan Kaul argued that their client’s product did not map onto their own claim for patent.
Zydus’s ZRC-3276 binds on a different protein when compared to that of Squibb’s, they told the bench. Moreover, they said, Squibb’s drug was not an inventive step and, importantly, did not match with the claim it filed. Further, they added, while Squibb sold its vial for Rs 1 lakh each, Zydus sold it for Rs 70,000, making cancer treatment through this drug more affordable for the patients.
Zydus, according to Rohatgi, was a “copycat” and violated the law. He questioned its hurried approach, saying that Squibb’s patent was expiring in May and that Zydus could have waited until then to launch its product.
Rohatgi further added that if Zydus had to develop a drug such as the one manufactured by his client, it should have taken Squibb’s drug as a reference.
At this, the CJI said that Rohatgi was presuming that the Zydus product was similar to that of his client’s.
“Their product is in the market, get an expert report. If the ingredients are found to be substantially same, then seek compensation. Injunction cannot be granted on presumption. Unfortunately, it’s not a car. There has to be a scientific analysis of the substance,” the CJI told the senior counsel.
Through its January order, a division bench of the HC had overturned a July 2024 injunction granted in favor of Squibb by a single judge. At the same time, the two-judge bench clarified that products which infringe patents of others cannot be permitted to circulate in the market.
Hence, to balance the interest of the two sides, the court ordered Zydus to maintain and file audited accounts of all revenues earned from the sale of the allegedly infringing product until Squidd’s patent expiry.
Such an arrangement, the HC said, would preserve the patent holder’s right to claim damages in case it is able to establish infringement against Zydus.
(Edited by Tony Rai)
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