- Generic competitors to Novartis' blockbuster multiple sclerosis pill Gilenya will be put on hold while Novartis resolves a patent dispute, under a court injunction published Monday.
- Novartis has won challenges to its Gilenya intellectual property estate and extended patent protection to as late as 2027, but a dosing patent is still subject to challenge.
- Gilenya had sales of $3.3 billion in 2018, but as competition grows Novartis is turning to its similarly acting new drug Mayzent to shore up its multiple sclerosis business.
Gilenya (fingolimod) was the first oral drug for the relapsing-remitting form of multiple sclerosis and made Novartis one of several major players in multiple sclerosis. The treatment was Novartis' biggest seller in 2018, eight years after its first approval in the U.S.
The Swiss pharma recently won a regulatory OK for a follow-on drug called Mayzent (siponimod) acting on the same target, the sphingosine 1-phosphate (S1P) receptor, but it treats a more severe form of the disorder and thus may not fully replace Gilenya.
Novartis is therefore keen to stretch out market exclusivity as long as possible. At one point, the main patents looked set to fall as early as this August, but subsequent court victories have reinvigorated Gilenya's intellectual property.
After the dust had settled on that dispute, which centered on a patent for a dose-escalation regimen, Novartis sued for patent infringement those generic manufacturers that had submitted Food and Drug Administration applications for Gilenya copycat pills.
The generic drugmakers, which include Mylan, Dr. Reddy's Laboratories and Aurobindo, had sought to market their products before the courts could decide on the validity of that patent. Monday's court decision stops those companies from doing so.
That dose-escalation patent could yet fall, as the courts may decide against Novartis. Meanwhile, it also has implications for Celgene and its pending acquisition by Bristol-Myers Squibb. Celgene's S1P ozanimod, a drug Bristol-Myers pointed to when the transaction was announced, relied on a similar regimen in clinical trials, and some observers have questioned whether the two companies will end up in court.
Ozanimod has been rejected once by the FDA, and Celgene resubmitted its application at the end of March.