Zydus barred from selling cancer drug Sigrima as Delhi HC restores injunction in favour of Roche
Delhi High Court
New Delhi: Upholding the patent rights of Swiss pharmaceutical giant F-Hoffmann-La Roche AG, the Delhi High Court has once again reinstated an interim injunction issued by a single-judge against Zydus Lifesciences, preventing the drug maker from manufacturing, selling, or marketing its biosimilar drug 'Sigrima', which is allegedly similar to Roche's breast cancer drug 'Perjeta'.
Earlier, a Division Bench of Justice Yashwant Varma and Justice Ravinder Dudeja stated that the single-judge had incorrectly vacated the injunction order of July 9, 2024 despite stating several times that it would not go into the validity of the injunction.
The case centers around a patent infringement suit filed by the Swiss against Zydus, taking objection to the production of 'Sigrima' . It alleged that the product was a biosimilar of the original Pertuzumab (Perjeta).
A single-judge on July 9, 2024 had granted interim injunction in the matter to prevent Zydus from manufacturing or marketing the contested product. However, on 9 October 2024, the Single Judge vacated this injunction, reasoning that Roche had failed to establish a prima facie case, the balance of convenience, or the likelihood of irreparable harm.
While passing the order, the single-judge had extended the interim injunction till October 23 to allow the Swiss company to file an appeal.
On appeal, the Division Bench on October 16 reinstated the interim injunction as per which Zydus stands restrained "from marketing/ selling their product “Sigrima”, which is a biological similar of Plaintiffs’ “Perjeta ®”/ “Pertuzumab".
In its order of October 16, the court had observed;
“Once the learned Single Judge had taken the position that the correctness or otherwise of 09 July 2024 was not being proposed to be gone into, we fail to comprehend or appreciate how the said order could have been ultimately vacated. We consequently have no hesitation in holding that the impugned order is rendered wholly unsustainable.”
Additionally, it directed single-judge to consider the matter afresh.
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Subsequently, when the matter came up for hearing before single-judge on November 5, Senior Advocate Rajshekhar Rao, appearing for Zydus, submitted that it has filed an appeal before the Supreme Court against restoration of the injunction.
Recognizing that Zydus has filed a Special Leave Petition (SLP) before the Supreme Court challenging the Division Bench's reinstatement of the interim injunction, single-judge Justice Amit Bansal decided to defer further hearings on the interim applications. The court emphasized that it would await the Supreme Court's determination on the matter before proceeding with the case.
In light of this, the judge scheduled the next hearing for December 2, 2024. Until that time, the interim order issued on July 9, 2024, which restrains Zydus from marketing or selling its biosimilar drug Sigrima, will remain in effect, Bansal added.
Justice Bansal said;
“Mr Rajshekhar Rao, senior advocate appearing on behalf of the defendants submits that the defendant has filed an SLP against the aforesaid order of the Division Bench which is likely to be listed shortly. Accordingly, it is submitted that the hearing in the present applications be deferred for some time. In view of the fact that an SLP has been filed on behalf of the defendant, I deem it appropriate to defer the hearing in these applications. List on 2nd December, 2024. In the interregnum, the interim order dated 9th July, 2024 shall continue.”
To view July 9, 2024 order, click on the link below:
To view the latest (November 5, 2024 ) order, click on the link below:
