US court upholds patent validity for Novartis' drug Gilenya

A US district court upheld the validity of Novartis' patent for its top-selling multiple sclerosis (MS) drug Gilenya, rejecting a lawsuit from generic drug maker HEC.

Gilenya is the Swiss drugmaker's No. 2 revenue generator at $738 million in the second quarter.

HEC had sought approval to make a generic copy of Gilenya before the expiration of Novartis' patent with the US Food and Drug Administration (FDA).

The Swiss drugmaker said it continued the injunction against the marketing and sale of Gilenya and other generics granted to it in June 2019.

The FDA approved three generic versions of the Novartis MS treatment in December.

Novartis had settlement agreements with other manufacturers to allow them to launch generic versions of Gilenya before the patent expires in 2027.