Shares of Lupin Ltd and Zydus Lifesciences Ltd shares fell 4% and 7%, respectively, on Wednesday, 16 April, after losing a patent case in the US Federal Court involving Myrbetriq, a prescription medicine used to treat overactive bladder, to Astellas Pharma, which could mean the Indian pharma players have to withdraw their drug from the market.
Myrbetriq would have contributed approximately $30 million to both pharma companies’ quarterly sales.
“The Court concludes the Generics Manufactures did not prove their asserted invalidity defenses by clear and convincing evidence,” the Delaware District Court’s ruling dated 15 April said. In this case, the ‘Generics Manufactures’ are Zydus and Lupin.
The order goes on to state that any damages will be litigated in the subsequent jury trial. “Having rejected the invalidity theories posited by the Generics Manufactures in this litigation, the Court finds in Astellas’s favor on the validity issue. Infringement, damages, and any additional invalidity theories will be litigated at the consolidated jury trial in 2026.”
Astellas filed an appeal with the Delaware District Court, seeking a ruling that pharmaceutical companies’ generic versions of Myrbetriq violated the ‘780 Patent.
When a product covered by the Patent’s claims is manufactured, sold, or imported without the patent holder’s permission, it is deemed an infringement of the ‘780 Patent.
“The Court concludes that the Generics Manufacturers did not meet their burden of showing, by clear and convincing evidence, that the ‘780 Patent is invalid for lack of enablement, lack of written description, or indefiniteness,” Delaware District Court said.
Both Zydus and Lupin have filed a ‘Motion to Clarify’, attempting to assert additional validity theories that will be heard next year at trial.
At 3:30 pm, the shares of Lupin closed 3.87% lower at Rs 1,935 whereas shares of Zydus Lifesciences closed 6.47% lower at Rs 826 on NSE.
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