On 25 July 2025, the High Court of Delhi issued an interlocutory judgment in ongoing patent infringement litigation brought by Roche to prevent Zydus from launching Sigrima®, biosimilar to Roche’s Perjeta® (pertuzumab), in India.
One of Roche’s patents in suit, IN464646, claims a process for making a composition comprising pertuzumab. Roche had sought disclosure, on a confidential basis, of Zydus’ manufacturing process for Sigrima®. Roche invoked section 104A of India’s Patents Act 1970, under which a defendant may carry the burden of proving non-infringement of a patent that claims a process for producing a product, if the defendant’s product is shown to be “identical” to one produced by the patented process.
The Court found that Roche had not proved that Sigrima® was “identical” to the product of the patented process. Roche’s only evidence was the use by Zydus of Perjeta® as the reference drug for Sigrima®. This was only sufficient to prove that Sigrima® met the regulatory guidelines for biosimilarity but not that it was “identical” to Perjeta®. It remains open to Roche to prove the products are identical by other means in the substantive trial.
Zydus is also facing infringement proceedings in India alleging that Zydus’s ZRCr-4276, biosimilar nivolumab, infringes BMS’ patent IN340060, which protects Opdivo® (nivolumab, branded as Opdyta® in India).