U.S. Supreme Court dismisses Vanda Pharmaceuticals case involving sleep-drug patents, Reuters reports

U.S. Supreme Court dismisses Vanda Pharmaceuticals case involving sleep-drug patents, Reuters reports

By Blake Brittain

WASHINGTON (Reuters) – The U.S. Supreme Court on Monday refused to hear Vanda (NASDAQ:) Pharmaceuticals’ request to reinstate patents for its sleep disorder drug Hetlioz that were found invalid in the part of a dispute with generic drug manufacturers Teva and Apotex.

The justices rejected Vanda’s appeal of a lower court’s ruling against the company, which in 2018 sued Teva and Apotex in Delaware for patent infringement after applying to make generic versions of Hetlioz. Vanda, a circadian rhythm-based medication used to treat rare sleep disorders. .

In this case, the Supreme Court refused to consider, for the first time since 2007, cases in which a patent can be invalidated on the grounds that it is “obvious” based on prior publications describing the same invention.

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 lifted a hurdle for generics in 2022. Connolly declared Vanda’s patents invalid based on clinical trial results, state Food and Drug Administration guidelines -United States and other documents which, when combined, would have made the patented inventions obvious. to a scientist in the field.

The U.S. Court of Appeals for the Federal Circuit, which specializes in patents, upheld the decision in 2023. Vanda asked the Supreme Court in January to hear her appeal.

Vanda told the justices that the Federal Circuit had “charted its own path” and adopted a lower standard than that imposed by the Supreme Court for determining obviousness.

“The most important thing here is that this threatens to make many advances in drug development unpatentable,” Vanda said. “This is a particularly pernicious outcome for rare diseases, where patent-based incentives are crucial to getting innovators to invest the billions needed to develop effective new treatments.”

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Israeli company Teva and Canadian company Apotex responded that Vanda was simply trying to extend its patent monopoly on Hetlioz and that the case “involves nothing more than the routine and factual application of established patent law.” obvious.”

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