There has been another development in ER Squibb v Zydus, at the center of which is Nivolumab, an anti-cancer drug. Readers will remember that on 12th January 2025, a division bench of the Delhi HC had allowed Zydus to launch their biosimilar product, ZRC-3276, in the market.(here) The bench had refused to grant an interim injunction against Zydus’s launch because the Patentee had not mapped the product against their claims. As a result, the Court held, it could not arrive at a finding of prima facie finding of infringement. Also, since Nivolumab was a life-saving drug, it allowed the launch. For a detailed overview, please read this post.
On 11th Feb, the SC has allowed the Petitioners to map their claims against Zydus’s product, available in the market as ‘Tishtha’, and approach the DB for appropriate interim directions. It directed Zydus to provide a sample of their product to the Patentee within 24 hours.
As I wrote in an earlier post, a similar biologic “only needs to be of comparable quality to the reference biologic in terms of identity, purity and potency.” That whether the similar biologic is of ‘comparable’ quality is not decided using mapping exercise. To equate proof of biosimilarity with infringement, thus, is erroneous and unfounded. The SC order, keeping in mind this context, is a welcome development.
The case was first heard on 08-05-2024. Then, the Court had said- “till the next date of hearing, defendant shall not place its products in the market without the prior permission of the Court.” At the time, the patentee’s strategy was simple- to keep Zydus from launching and cause market share. In July, the strategy had nearly paid off when an injunction was granted despite absence of claim-mapping. In January, however, it all came undone when the DB, in plain words, held that biosimilarity alone is not proof of infringement. Rather, claim-mapping is essential to arrive at a prima facie finding of infringement.(here)
Will the present SC order lead to closure? Maybe yes or maybe not. It will depend on the outcome of the mapping exercise. If a significant overlap of essential elements of the claims is found, ER Squibb is likely to move the DB for relief as soon as possible. Zydus’s product has been available for nearly a month at approximately a quarter of the price charged by the patentee. Any further delay continues to chip away their market share. Remember, the patent on Nivolumab expires on 2nd May 2026, giving the patentee nearly 2 and a half months to extract profits.
Other important questions, however, continue to loom- what strategy will ‘first-movers’ in the biologics market adopt moving ahead? Would they continue to file for quia timet injunctions without a product to map against? Or will they wait for a launch and risk significant erosion of market share? Will sec. 104A come to the aid of biologic manufacturers in the future? Most importantly, for life-saving biologics, how will the courts balance it against patent rights?