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By John Miller
ZURICH - Novartis has won a U.S. federal court order preventing rival generic makers from selling versions of the Swiss drugmaker's top-selling multiple sclerosis medicine Gilenya in the United States, 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 United States 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 ... $50 million collectively by not being able to compete over approximately the next year, whereas Novartis will irreparably lose a market in which they sell approximately $1.8 billion of drugs each year," U.S. District Judge Leonard P. Stark wrote in a nine-page opinion published on Monday.
"To me, that balance clearly favors Novartis."
Worldwide, Gilenya revenue totaled $3.3 billion in 2018, making the decade-old MS medicine Novartis's top-selling medicine. While a patent term extension expires in 2019, Novartis is arguing a patent on how the drug is dosed that is slated to expire in 2027 should extend its exclusivity.
Judge Stark's decision ends uncertainty over whether the generics makers would start selling their Gilenya versions in the United States 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 United States. While consumers would benefit from lower prices 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."
(Reporting by John Miller, editing by Louise Heavens)