Zydus, Lupin shares fall over US court ruling in Myrbetriq patent case

Companies say they are in process of assessing impact of order on operations

Lupin and Zydus Lifesciences shares fell by almost 7 per cent on Wednesday after losing a patent case in a US federal court involving Myrbetriq, a prescription medicine used to treat overactive bladder, to Tokyo-based Astellas Pharma.

 

Astellas had sued both the pharmaceutical companies, alleging that their generic versions of a sustained-release formulation of mirabegron, which is marketed in the US as Myrbetriq, infringed its patent rights.

 

The ruling may imply that Indian pharma players will have to withdraw their drug from the market.

 

“The Court concludes the Generics Manufacturers (Zydus and Lupin) did not prove their asserted invalidity defences by clear and convincing evidence,” the Delaware District Court's ruling dated April 15 said.

 

The order added that the generics manufacturers also 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.

 

On Wednesday, Zydus and Lupin stocks fell by 7.02 per cent and 3.79 per cent, respectively, with the exchanges asking the companies for a clarification.

 

While both companies said that they are in the process of evaluating the potential impact of the order on their operations and the legal remedies available to them, Zydus added that the material price movement in the equity shares of the company was due to the announcement of the order.

 

Some analyst estimates, however, project Myrbetriq to contribute around $30 million each to the quarterly sales of both the pharma companies.

 

“No negotiations were taking place in this matter, as this was a patent litigation matter,” Zydus added.