US Supreme Court rebuffs Novartis bid to revive MS drug Gilenya patent (updated)

Yichang Hec Changjiang Pharmaceutical Co

17/04/2023 14:48

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    By Blake Brittain
       WASHINGTON, April 17 (Reuters) - The U.S. Supreme Court
on Monday declined to hear Novartis Pharmaceuticals Corp's
 NOVN.S  bid to revive a key patent on its blockbuster multiple
sclerosis drug Gilenya that was invalidated amid a legal dispute
with China's HEC Pharm Co Ltd  1558.HK .
    The justices turned away an appeal by Novartis of a lower
court's decision to cancel the patent, a ruling that paved the
way for some generic versions of Gilenya.
    Novartis sold $1.1 billion worth of Gilenya in the U.S. last
year, a 19% drop from 2021 that was caused in part by generic
competition, according to a company report.
    The U.S. Food and Drug Administration in 2010 approved
Gilenya to treat relapsing forms of multiple sclerosis, a
chronic disease that affects the central nervous system. 
    Novartis sued HEC and more than a dozen other generic
drugmakers for patent infringement in Delaware federal court
after they applied for FDA approval of Gilenya generics.
Novartis settled with some of the drugmakers, allowing for some
Gilenya generics before a key patent's 2027 expiration.
    The U.S. Court of Appeals for the Federal Circuit determined
last year that the patent was invalid, in a 2-1 reversal of its
own previous split decision to uphold the patent.

 (Reporting by Blake Brittain. Editing by Will Dunham)
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