Fingolimod - USA

On Apr 12, 2017,  The Federal Circuit affirmed the Patent Trial and Appeal Board's decision invalidating a patent (US 8,324,283 expiring on Mar 29, 2026) covering Novartis' multiple sclerosis drug Gilenya (Fingolimod), in a win for generics makers Apotex, Mylan and Torrent pharma. The ‘283 patent covers a solid combination of a sphingosine-1 phosphate (S1P) receptor agonist (fingolimod) and a sugar alcohol (mannitol). The drug – sold under the trade name Gilenya – is used to treat multiple sclerosis

This was an appeal from the Final Written Decision of the United States Patent and Trademark Office, Patent Trial and Appeal Board (Board) in two consolidated inter partes review (IPR) proceedings of US’283 patent, owned by Novartis AG and Mistubishi Tanabe Pharma Corp. (collectively, Novartis). The Board instituted IPRs on all claims of the ’283 patent based on petitions filed by Torrent Pharmaceuticals Limited, Apotex, Inc. and Mylan Pharmaceuticals Inc. (collectively, Petitioners). After reviewing the claims, receiving extensive briefing, and hearing oral argument, the Board found all original claims of the ’283 patent and Novartis’ proposed substitute claims unpatentable as obvious.

On appeal, the court noted that the board considered the negative properties of using mannitol (teaching-away), but was not convinced, and sufficient evidence supported the Board’s decision.  The patentee also focused on the fact that the Board’s written decision did not expressly consider all of the patentee’s teaching-away arguments.  On appeal, the Federal Circuit rejected that argument – holding that “there is no requirement that the Board expressly discuss each and every negative and positive piece of evidence lurking in the record to evaluate a cursory argument.”

The court concluded that substantial evidence supports the Board’s finding that, despite mannitol’s potentially negative characteristics, it was nevertheless a valid consideration as an excipient for solid oral pharmaceuticals and a person of skill in the art would have been motivated to combine fingolimod and mannitol in the manner claimed by the ’283 patent. Indeed, the Board cites to multiple pieces of evidence establishing mannitol as one of a handful of excipients used in solid oral compositions and its primacy as a non-hygroscopic and compressible diluent which makes it particularly valuable in tableting. We, therefore, find no legal error in the Board’s treatment of the motivation to combine evidence nor do we find a lack of substantial evidence supporting its conclusion.