Shares of Lupin and Zydus Life are sharply lower by 3-4.5 percent on April 16 after losing a US Federal Court patent case involving Myrbetriq - a prescription medicine used in treating overactive bladder - to Astellas Pharma, which may imply the Indian pharma players shall have to withdraw their drug from the market.
In a statement after the closing bell, Zydus Life said, "We are evaluating the potential impact of the said order on the operations of the Company and the legal remedies available with the Company."
Some analyst estimates had projected Myrbetriq to contribute a significant amount close to $30 million each to the quarterly sales of both the pharma companies. Vishal Manchanda, Analyst with the Systematix Group told CNBC-TV18 during a conversation that the FY26 earnings for both Zydus Life and Lupin could see an impact due to the order, and one should expect penalties that Astellas may need to be paid.
"The Court concludes the Generics Manufactures did not prove their asserted invalidity defenses by clear and convincing evidence," Delaware District Court's ruling dated April 15 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 had appealed before the Delaware District Court to seek a ruling that pharmaceutical companies’ generic versions of Myrbetriq infringes the ’780 Patent.
Patent infringement of the '780 patent, particularly in the context of Mirabegron formulations, occurs when someone makes, sells, or imports a product that falls under the scope of the patent's claims without permission from the patent holder.
"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', seeking to assert additional validity theories, which will now come up next year during trial.
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