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High Court of Delhi Declines to Order Zydus to Disclose Pertuzumab Biosim Manufacturing Process

Jul 25, 2025

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).