Zydus moves Delhi HC against order restraining manufacture, sale of its cancer drug

Zydus Lifesciences on Thursday moved the division bench of the Delhi High Court against its single judge’s earlier order that temporarily restrained the Ahmedabad-based drug maker from manufacturing, selling biosimilar of US pharma giant E.R. Squibb's patent Nivolumab, a therapeutic antibody used in the treatment of cancer.

The Division Bench while refusing to stay the single judge’s interim order sought response from the US pharma company, which had alleged patent infringement of its blockbuster anticancer drug Opdyta (nivolumab) branded as Opdivo in other countries. In India, Nivolumab is being imported and marketed as Opdyta.

While Squibb alleged that Zydus was conducting clinical trials for nivolumab and had plans to launch it during is valid patent period, the Indian company denied the allegations, saying its product ZRC-3276 does not infringe upon the existing patents, was following the regulatory provisions and had applied for a marketing approval with the central drug regulatory agency.


Zydus argued that its product, ZRC-3276, is bio-similar to Squibb Nivolumab, but bio-similarity by itself does not substantiate infringement as it is based upon product-to-product comparison, whereas, infringement required claim to product mapping.

The generic drug maker claimed that process steps were already known from the prior art and even several techniques for the preparation of human anti-PD1 antibodies were well-known on the priority date of the suit patent.

The post-grant opposition that was filed by its subsidiary Zydus Healthcare led to the recommendation for revocation of the suit patent by the Opposition Board, and the said recommendation clearly showed that such a method was commonly employed to produce antibodies, the Ahmedabad-based drug manufacturer claimed.

On July 18, Justice Mini Pushkarna had noted that E.R. Squibb shall suffer irreparable loss in case an interim relief was not granted. Therefore, the single judge had restrained Zydus from selling a biosimilar of Nivolumab till the main suit was decided.