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."