Novartis loses patent appeal for Gilenya (fingolimod), opening the US market to generic competition in 2019.

The U.S. Patent Trial and Appeal Board upturned a long-term patent on Gilenya, putting it in line for early generic competition by 2019.

The U.S. Court of Appeals for the Federal Circuit agreed with the U.S. Patent Trial and Appeals Board’s 2015 finding that Gilenya's 2026 formulation patent is invalid. In affirming the PTAB’s decision, the appeals court wrote that it “considered all of Novartis’ remaining arguments,” but concluded “that they are without merit.”

Comment: Gilenya sales for 2016 were $3.1 billion.