Shares of Orexo closed 30.9 percent higher in Stockholm after the
decision by the U.S. Federal Circuit Court of Appeals in Washington,
D.C., which handles intellectual property cases.
Teva is one of the world's largest makers of generic drugs. Lawyers
for its Actavis Elizabeth unit, the defendant in Orexo's lawsuit,
did not immediately respond to requests for comment.
Opioids, including prescription painkillers and heroin, played a
role in 42,249 U.S. deaths in 2016, according to the U.S. Centers
for Disease Control and Prevention.
Health officials and politicians often characterize opioid abuse as
a serious public health problem or epidemic.
Orexo sued after the Teva unit applied with the U.S. Food and Drug
Administration to market a generic version of Zubsolv, which the
Swedish company said was patent-protected until 2032.
While both sides agreed that the product covered by Orexo's patent
made it easier to treat opioid abuse, a lower court judge found the
patent unenforceable because the ingredients were generally known or
But the appeals court said the Teva unit failed to establish by
"clear and convincing evidence" that Orexo's patent claims were
"obvious" and should therefore be voided.
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Circuit Judge Pauline Newman said Orexo's patent provided a
"significant improvement" for treating opioid addiction, and that
its "novel formulation" allowed patients to reduce dosages and lower
"Although the need to reduce this abuse was known, recognizing a
need does not render the solution obvious," Newman wrote.
The appeals court returned Orexo's case to U.S. District Judge Sue
Robinson in Delaware for further proceedings.
Orexo said the decision does not change its 2018 financial guidance.
The case is Orexo AB et al v Actavis Elizabeth LLC, U.S. Federal
Circuit Court of Appeals, No. 2017-1333.
(Reporting by Jonathan Stempel in New York; Editing by Susan Thomas
and Matthew Lewis)
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