Supreme Court grants Novartis request to halt Gilenya patent cancellation

The U.S. Supreme Court on Thursday agreed to halt the cancelation of a key patent for Novartis’ multiple sclerosis drug Gilenya, staving off a wave of competition from at least a dozen generic versions.

Novartis asked the court for an emergency stay on Wednesday after the U.S. Court of Appeals for the Federal Circuit said it would allow an injunction blocking the generics to end on Oct. 4. The same panel of judges last week rejected Novartis’ bid for a rehearing of a June ruling that declared its patent invalid.

Chief Justice John Roberts ordered the mandate of the lower court stayed until further notice and generic maker HEC Pharma to file a response by Oct. 5.

HEC Pharma is one of a dozen companies with U.S. regulatory approval to launch generic versions of Gilenya, and as many as 20 others could follow, Novartis wrote in its application. “Without a stay of mandate, [a Supreme Court] review will come too late to avoid irreparable harm,” the company wrote.

Gilenya is one of Novartis’ top sellers, with revenues of $2.8 billion in 2021. The company last week warned it could lose $300 million in sales this year if generics are launched. But Novartis does not expect to forestall generics for long; it has told analysts it expects generic competition in 2024 under settlements reached with other generic makers.

Novartis is defending its US Patent No. 9187405 that sets out a treatment for multiple sclerosis with a lower 0.5 mg daily dose of Gilenya. Because the patent does not state that a higher loading dose is initially given to patients, at issue is whether the patent is described clearly enough to be valid.

The federal circuit “is deeply divided on the question” as shown by the lower court’s rare reversal of itself after the retirement of the judge who voted in favor of Novartis. The judge’s replacement flipped the original 2-1 ruling, a decision that “prompted a wave of criticism, in part because it is exceptionally rare for a court of appeals to reverse itself” in such a manner, Novartis wrote in its petition.

Bristol-Myers Squibb’s Juno Therapeutics has also asked the Supreme Court to review a lower court’s reversal of its patent infringement case against Gilead Sciences’ Kite Pharma.

That case also hinges on the same question over clarity of a patent description. Novartis said if the Supreme Court intervenes in the Juno case, it means “there is at least a fair chance of reversal” in its case.

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