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U.S. Supreme Court rejects Vanda Pharmaceuticals case over sleep-drug patents
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U.S. Supreme Court rejects Vanda Pharmaceuticals case over sleep-drug patents
Apr 22, 2024 7:20 AM

WASHINGTON, April 22 (Reuters) - The U.S. Supreme Court

on Monday declined to hear a bid by Vanda Pharmaceuticals ( VNDA )

to revive patents for its sleep-disorder drug Hetlioz

that were previously declared invalid in a dispute with generic

drugmakers Teva and Apotex.

The justices turned away Vanda's appeal of a lower court's

ruling against the company, which in 2018 had sued Teva and

Apotex in Delaware for patent infringement after they applied to

make generic versions of Vanda's Hetlioz, a circadian-rhythm

drug used to treat rare sleep disorders.

In the case, the Supreme Court declined a chance to consider

for the first time since 2007 when a patent can be invalidated

as "obvious" based on earlier publications describing the same

invention.

Washington-based Vanda earned more than $100 million

from sales of Hetlioz in 2023, according to a company report.

U.S. District Judge Colm Connolly ruled against Vanda and

cleared a hurdle for the 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 patent-focused U.S. Court of Appeals for the Federal

Circuit upheld the decision in 2023. Vanda asked the Supreme

Court in January to hear its appeal.

Vanda told the justices that the Federal Circuit has

"charted its own course" and adopted a lower standard than the

Supreme Court mandated for determining obviousness.

"Most relevant here, it threatens to render many

advancements in drug development unpatentable," Vanda said.

"That is an especially pernicious result for rare diseases,

where patent-based incentives are crucial for innovators to

invest the billions required to develop new, successful

treatments."

Israel-based Teva and Canada-based Apotex responded that

Vanda was merely trying to extend its patent monopoly on Hetlioz

and that the case "involves nothing more than the routine,

fact-bound application of settled obviousness law."

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