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Informist, Thursday, Nov. 21, 2024

 

--Delhi HC sets aside temporary ban on sale of Sigrima by Zydus Lifesciences

 

NEW DELHI – A division bench of the Delhi High Court on Thursday set aside its single-judge bench's Nov. 5 order barring Zydus Lifesciences Ltd. from selling Sigrima till the next hearing on Dec. 2 The division bench asked the single judge to hear F-Hoffmann-LaRoche AG's plea seeking an interim injunction against Zydus Lifesciences for the sale and marketing of Sigrima by the latter and decide it "expeditiously", as stated by the Supreme Court's order of Nov. 18.

 

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. When the case moved to the division bench on Oct. 16, it set aside the single judge order and asked the single judge bench to decide the interim injunction plea of Swiss multinational Roche. Roche claims that Sigrima, an injection used to treat breast cancer, is biologically similar to its Perjeta/Pertuzumab.

 

When the case again moved to the single judge, the court issued notices to the parties on the interim injunction plea and continued its Jul. 9 order of temporary restraint. Challenging this, Zydus Lifesciences moved the division bench on Thursday.

 

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 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. 

 

At 1317 IST, shares of Zydus Lifesciences were down 0.6% at INR 941.60 on the National Stock Exchange.  End

 

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Reported by Surya Tripathi

Edited by Avishek Dutta

 

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