Novartis got a reprieve last week when the U.S. Patent and Trademark Office upheld a patent on its multiple sclerosis blockbuster Gilenya. Now, the Swiss pharma intends to use that win in court against generics makers in the hopes to block copycats from entering the U.S. market until 2027.
In the days that followed the PTO ruling, Novartis fired back at some previous challengers to its Gilenya patent. It filed four lawsuits that name multiple generic makers, including Apotex, Mylan, Torrent Pharma, Teva, Sun pharma and Accord Healthcare, among others, all of which are seeking to make copies of the drug.
Novartis’ exclusivity argument rests on a Gilenya dose patent that the PTO just backed following inter partes review. That patent is slated to expire in 2027, and Novartis is asking the Delaware District Court to block commercial manufacturing or selling any generic versions of Gilenya before that or face damages.
Gilenya, currently approved for relapsing MS, was Novartis’ best-selling medicine in 2017. Over half, or $1.71 billion, of the drug’s sales came from the U.S.
Novartis had previously lost a fight to fend off Gilenya generic challenges. Last April, a formulation patent that would have protected Gilenya until 2026 was ruled invalid by the U.S. Federal Circuit, following the same ruling in 2015 at the PTO. If the current dose patient fails, Gilenya will lose exclusivity in 2019 when a patent term extension expires.
If it prevails, it will be a win not just for Novartis, but for other branded oral MS drugmakers as well. A generic version to Teva’s injectable MS stalwart Copaxone has already landed in the U.S., but the entry of Gilenya copies would also put pressure on prices of oral MS drugs like Biogen’s Tecfidera, RBC Capital Markets analyst Brian Abrahams wrote in a note last week.
Another less obvious beneficiary of a Novartis win is Celgene, whose ozanimod in February was rejected by the FDA due to “incomplete” pharmacology information. That pushed a potential launch to 2019. If those generics were delayed, Celgene would have more time to reap top sales.
Novartis also faces other Gilenya patent challenges, but Abrahams noted that, with the favorable PTO ruling, “a generic Gilenya will likely be unable to launch until the resolution of these cases in the early-2020s,” even in the worst-case scenario. That leaves the brand-name drugmakers to fight among themselves. Celgene, for example, touts that ozanimod is safer than Gilenya.