Novartis Sues Over Generics for Gilenya After Favorable PTO Ruling

In the latest move by Novartis to protect its top selling multiple sclerosis drug Gilenya (fingolimod) from generic competition, the Swiss drugmaker filed lawsuits against dozens of drugmakers seeking to market Gilenya copies.

Just days after winning a Patent and Trademark Office case, Novartis filed complaints against challengers of the Gilenya patent (including Sun Pharma, Acord Healthcare, Teva, Apotex and Mylan) trying to block them from marketing their generics in the U.S. until the patent expires in 2027.

The PTO ruling followed two previous setbacks for Novartis. In 2016, the PTO ruled that a formulation patent for Gilenya set to expire in 2026 was invalid; a federal court upheld that ruling last year.  The current dose patent at issue in the new lawsuits is set to expire in August 2019 if the generic companies come out on top.