Patent Conflict
Delhi HC lifts bar on sale, marketing of Sigrima by Zydus Lifesciences
This story was originally published at 13:02 IST on 10 October 2024
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NEW DELHI – The Delhi High Court has lifted the bar on the sale and marketing of Sigrima by Zydus Lifesciences Ltd., which was allegedly biologically similar to F-Hoffmann-LaRoche AG's "Perjeta/Pertuzumab". The high court has rejected F-Hoffmann-LaRoche AG's plea seeking an interim injunction against Zydus Lifesciences for Sigrima.
"Under the aforesaid circumstances, to the mind of this Court, the plaintiffs are not entitled for the reliefs prayed for in the present application. Accordingly, the present application under Order XXXIX rules 1 & 2 CPC of the plaintiffs is dismissed in the above terms and the ad interim order dated Jul. 9, 2024, passed by the predecessor bench is vacated," said the court.
"...however, since there is no 'claim mapping' qua the two patents IN '646 and IN '632 of the plaintiffs with the impugned product 'Sigrima' of the defendant, this Court is unable to pass any order in favour of the plaintiffs merely because the composition comprising Pertuzumab is same or they are biosimilar," said the court.
As per the petition, Zydus Lifesciences had procured 480 vials of the original innovator biologic reference product Pertuzumab (Perjeta) from F-Hoffmann-LaRoche AG's affiliate, Roche Products (India) Pvt. Ltd. Thereafter, Roche Products supplied 478 vials of Perjeta for clinical trials of Zydus Lifesciences.
In February, F-Hoffmann-LaRoche came across the recommendation of the Subject Expert Committee (Oncology) of the Central Drugs Standard Control Organization, whereby Zydus had filed an application for grant of permission to manufacture new drug formulation for sale or the distribution of Pertuzumab as per New Drugs and Clinical Trials 2019. The committee had recommended for grant of permission to manufacture and market Pertuzumab 30 milligram/millilitre concentrate solution for infusion (420 mg 14 ml single-dose vial) to Zydus. Against this backdrop, F-Hoffmann-LaRoche filed the permanent injunction suit in the high court.
F-Hoffmann-LaRoche also filed an interim injunction after it found that Zydus had entered into a semi-exclusive licensing agreement with Dr. Reddy's Laboratories Ltd. for co-marketing the alleged Pertuzumab biosimilar 'Sigrima'.
At 1156 IST, shares of Zydus Lifesciences traded down 0.7% at INR 1,057.85 on the National Stock Exchange, while those of Dr. Reddy's Laboratories were down 1% at 6,597.70 rupees. End
IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT
Reported by Surya Tripathi
Edited by Manisha Baxla
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