Delhi HC restores temporary ban on sale of Sigrima by Zydus Lifesciences
This story was originally published at 17:56 IST on 16 October 2024
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NEW DELHI – A division bench of the Delhi High Court on Wednesday restored the temporary ban on the sale and marketing of Sigrima by Zydus Lifesciences Ltd. based on a plea by F-Hoffmann-LaRoche AG. Setting aside an order by a single bench, the division bench also restored the Swiss multinational Roche's plea to seek an interim injunction against Zydus Lifesciences before the single bench till the main suit is decided.
Roche claims that Sigrima, an injection used to treat breast cancer, is biologically similar to its Perjeta/Pertuzumab.
On Jul. 9, a single bench of the high court restrained Zydus Lifesciences from selling Sigrima till the next date of hearing. However, the ban was lifted by another single bench on Oct. 9.
The division bench said the single bench's order to lift the ban was "totally unstainable" and there was "not even one point in the order which can be said to be correct." The single bench, despite taking the position that it had not gone into the validity of the July order of ad-interim injunction, could not have lifted the temporary ban, the division bench said.
As per the petition, Zydus Lifesciences had procured 480 vials of the original innovator biologic reference product Pertuzumab/Perjeta from Roche's affiliate, Roche Products (India) Pvt. Ltd. Roche Products also supplied 478 vials of Perjeta for clinical trials by Zydus Lifesciences.
Roche filed a permanent injunction suit in the high court after it found out that Zydus Lifesciences had applied for permission to manufacture and market Pertuzumab. An expert committee of the Central Drugs Standard Control Organisation had recommended granting permission to Zydus Lifesciences to manufacture and market Pertuzumab 30 milligram/millilitre concentrate solution.
Roche also filed an interim injunction after it found that Zydus Lifesciences had entered into a semi-exclusive licensing agreement with Dr. Reddy's Laboratories Ltd. for co-marketing Sigrima.
On Wednesday, shares of Zydus Lifesciences ended 3.6% lower at INR 1,020.10 on the National Stock Exchange, while those of Dr. Reddy's Laboratories closed 1.5% higher at 6,710.90 rupees. End
Reported by Surya Tripathi
Edited by Saji George Titus
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