US Supreme Court rejects Vanda Pharmaceuticals case over sleep drug patents

By Blake Brittain

WASHINGTON (Reuters) – The U.S. Supreme Court on Monday declined to hear a bid by Vanda Pharmaceuticals to revive patents on its sleep disorder drug Hetlioz, which were previously declared invalid in a dispute with generic drug makers Teva and Apotex.

The justices rejected Vanda’s appeal of a patent-focused U.S. Court of Appeals for the Federal Circuit ruling against the company, which in 2018 sued Teva and Apotex in Delaware for patent infringement after they applied to produce generic versions of Vanda’s Hetlioz. a circadian rhythm medicine used to treat rare sleep disorders.

In this case, the Supreme Court declined the opportunity to consider, for the first time since 2007, when a patent may be invalidated as “obvious” based on prior publications describing the same invention.

“The Federal Circuit’s obviousness standard departs materially from the Supreme Court’s long-standing positions,” said Vanda’s attorney, Paul Hughes. “While we are disappointed that the Supreme Court declined to review this case, we remain hopeful that the court will ultimately correct the governing standard.”

“Doing so is imperative in the pharmaceutical context to ensure that life-changing therapies are developed in a timely manner and reach underserved patients,” Hughes added.

A Teva spokesperson said the company was pleased with the Supreme Court’s action. Apotex representatives did not immediately respond to a request for comment.

Washington-based Vanda earned more than $100 million from Hetlioz sales in 2023, according to a company report.

U.S. District Judge Colm Connolly ruled against Vanda and cleared a hurdle for generics in 2022. Connolly found Vanda’s patents invalid based on clinical trial results, U.S. Food and Drug Administration guidance and other documents that, when combined , would have made the patented inventions obvious to a scientist in the field.

The Federal Circuit upheld the decision in 2023. Vanda asked the Supreme Court in January to hear her appeal.

Vanda told the justices that the Federal Circuit “charted its own path” and adopted a lower standard than that required by the Supreme Court to determine obviousness.

“The most relevant thing here is that it threatens to make many advances in drug development unpatentable,” Vanda said. “This is an especially pernicious outcome for rare diseases, where patent-based incentives are crucial for innovators to invest the billions needed to develop new and successful treatments.”

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Israel-based Teva and Canada-based Apotex responded that Vanda was merely seeking to extend its patent monopoly over Hetlioz and that the case “involves nothing more than the routine, fact-based application of the law of established obviousness”.

(Reporting by Blake Brittain in Washington; Editing by Will Dunham)