Recently, the U.S. Patent and Trademark Office (PTO) upheld Novartis’ patent on its multiple sclerosis blockbuster Gilenya (fingolimod). With the decision, the exclusivity on Gilenya has been extended from 2019 to 2027.
Several companies continue to develop generic alternatives to Gilenya, however, and some have filed their own patent lawsuits that are still pending. Armed with the recent decision, Novartis is fighting back. The company has filed four lawsuits of its own, naming generic companies Apotex, Mylan, Torrent Pharma, Teva, Sun pharma and Accord Healthcare, among others.
The exclusivity argument upheld by the PTO is based on a Gilenya dose patent. In its new lawsuits, Novartis is asking the Delaware District Court to block the commercial manufacture or sale of any generic versions of Gilenya before 2027 and require companies that do so to pay damages.
Analysts believe that the other patent challenges to Gilenya will not be resolved until the early 2020’s at the earliest, so Gilenya should be protected until then. If Novartis wins its latest lawsuits, analysts also believe it will benefit other makers of branded MS drugs, including Teva and Biogen. Celgene could also benefit, because the launch of its new MS drug ozaminod, which it claims is safer than Gilenya, has been delayed due to the need for the company to provide more complete pharmacology information to the US Food and Drug Administration.