In a significant legal turn, the Delhi High Court has reinstated an injunction preventing Indian pharmaceutical company Zydus Lifesciences from manufacturing or selling ‘Sigrima,’ a breast cancer treatment alleged to be a biosimilar of the Swiss-origin drug Perjeta, developed by F. Hoffmann-La Roche AG. This move follows a legal challenge by Roche, which claims ‘Sigrima’ infringes upon its patent for Pertuzumab.
The Division Bench of Justice Yashwant Varma and Justice Ravinder Dudeja overturned a prior single-judge decision that had lifted the initial injunction from July, asserting that the judge’s actions contradicted earlier indications that the injunction’s validity would not be questioned. Citing this inconsistency, the Bench stated in an October 16 order that lifting the injunction was “wholly unsustainable.”
The initial injunction had temporarily barred Zydus from marketing ‘Sigrima,’ but on October 9, it was vacated, only to be extended until October 23, allowing Roche time to appeal. On October 16, the Division Bench renewed the restriction, prohibiting Zydus from promoting ‘Sigrima’ while directing the single judge to re-evaluate the case.
As the legal standoff continues, Zydus has escalated the matter to the Supreme Court, challenging the reinstatement. In response, the single judge has deferred any further hearings on the injunction until December 2. This case showcases the persistent clash between innovative drug patents and biosimilar entries into the pharmaceutical market, with substantial legal backing on both sides.
