Novartis’s top-selling medicine is safe from generics — for now
US consumers lose out after judge stops rivals from making cheaper versions of multiple sclerosis drug Gilenya
Zurich — Novartis has won a US federal court order preventing rival generic makers from selling versions of the Swiss drugmaker’s top-selling multiple sclerosis medicine Gilenya in the US, at least until a patent dispute is resolved.
Novartis had asked for a preliminary injunction to halt generics makers including Dr Reddy’s Laboratories, Mylan Pharmaceuticals, Torrent Pharma and Aurobindo Pharma, among others, from making or selling a Gilenya copy in the US until a final decision on a Novartis patent for the medicine.
The judge said letting generics makers sell their versions before the patent dispute was decided would damage the Swiss drugmaker more than those wanting a piece of Gilenya’s market.
“Defendants stand to lose the opportunity to earn ... $50m collectively by not being able to compete over approximately the next year, whereas Novartis will irreparably lose a market in which they sell approximately $1.8bn of drugs each year,” US district judge Leonard Stark wrote in a nine-page opinion published on Monday. “To me, that balance clearly favors Novartis.”
Worldwide, Gilenya revenue totalled $3.3bn in 2018, making the decade-old multiple sclerosis drug Novartis’s top-selling medicine. While a patent term extension expires in 2019, Novartis is arguing that a patent on how the drug is dosed — is due to expire in 2027 —should extend its exclusivity.
Stark’s decision ends uncertainty over whether the generics makers would start selling their Gilenya versions in the US before the patent case was resolved.
A trial on the patent case is still pending.
Gilenya has a list price of $95,594 annually in the US. While consumers would benefit from the lower prices that are likely to accompany generics, Stark said Novartis has a good chance of succeeding in its claims.
“Novartis has met its burden to demonstrate a likelihood of success on the merits,” Stark, based in Delaware, wrote. “The public has an interest in protecting valid patent rights and in maintaining incentives for the massive investments required for drug development.”