FDAnews Drug Daily Bulletin

PTAB Invalidates Patent for Novartis MS Drug

Oct. 6, 2015

The Patent Trial and Appeal Board has invalidated a patent for Novartis’ multiple sclerosis drug Gilenya, in one of the first successful uses of the inter partes review process by generics drugmakers.

The decision — which clears the way for Torrent, Apotex and Mylan to pursue generic versions of Gilenya (fingolimod) — maintains that the Novartis’ ’283 patent is obvious because a person with basic knowledge of drugmaking could come up with the formulation. To get an inter partes review, patent challengers must show there is reasonable likelihood they will prevail.

Torrent’s petition for inter partes review of Novartis was heard by the board last December. Apotex and Mylan filed a separate petition, which the board took up in February. The cases were subsequently joined.

The three judges in this case are all lawyers with decades of patent law experience, and two of them hold biochemistry PhDs, says Dennis Crouch, associate professor of law at the University of Missouri. As a result, the patent challengers were able to present highly technical evidence that the judges understood — a situation that just doesn’t happen in a jury trial. He notes that the generics makers collectively submitted testimony from eight different technical experts.

Novartis spokeswoman Elizabeth Power stresses that the decision affects Gilenya’s formulation patent and not the compound patent. The company is considering an appeal to the Federal Circuit.

Read the decision here: www.fdanews.com/9-15-PTAB-FinalDecision.pdf. — Jonathon Shacat