U.S. Supreme Court rebuffs Novartis, allows generic versions of MS drug (updated)

Yichang Hec Changjiang Pharmaceutical Co

13/10/2022 22:35

(Adds case details)
    By Blake Brittain
       WASHINGTON, Oct 13 (Reuters) - The U.S. Supreme Court on
Thursday turned down Novartis'  NOVN.S  bid to block the launch
of generic versions of the company's blockbuster multiple
sclerosis drug Gilenya in a dispute with China's HEC Pharm Co
Ltd  1558.HK  and other generic drugmakers.
    Novartis had asked the justices to suspend a lower court's
ruling that lifted a ban on generic versions of Gilenya, the
Switzerland-based company's third highest-selling drug last year
with $2.8 billion in sales.
    Representatives for the companies did not immediately
respond to requests for comment.
    Novartis sued HEC and more than a dozen other generic
drugmakers, accusing them of patent infringement, in Delaware
federal court after they applied for U.S. Food and Drug
Administration (FDA) approval of Gilenya generics. 
    Novartis settled with some of the drugmakers it had sued,
allowing for some Gilenya generics before a key patent's 2027
expiration. Companies that settled with Novartis included
India-based Aurobindo Pharma Ltd  ARBN.NS , Dr. Reddy's
Laboratories  REDY.NS  and Sun Pharmaceutical Industries Ltd
 SUN.NS , Pennsylvania-based Viatris Inc's  VTRS.O  Mylan
Pharmaceuticals and privately held Canada-based Apotex Inc.
    The FDA in 2010 approved Gilenya, a once-daily pill used to
treat relapsing forms of multiple sclerosis, a chronic disease
that affects the central nervous system. Novartis said in
September that it expects to lose $300 million in sales for the
rest of 2022 if the Gilenya generics are launched. 
    The patent-focused U.S. Court of Appeals for the Federal
Circuit ruled in June that a key Novartis patent for Gilenya was
invalid. 
        U.S. Chief Justice John Roberts, granting a request by
Novartis on Sept. 29, prevented the Federal Circuit from issuing
a mandate as planned on Oct. 4 to lift a federal judge's
injunction that blocked generic versions of Gilenya based on the
Novartis patent claims.
    Roberts acted after Novartis said that green-lighting the
generics would hurt the company in "ways that could be
impossible to calculate at an after-the-fact damages trial" and
that it was likely to win a Supreme Court appeal of the
underlying case.
    HEC told the Supreme Court that Novartis makes $3.8 million
per day from Gilenya sales in the United States alone.
    "If Novartis does not prevail in this Court, it will
improperly extract $3.8 million from payors and patients every
day its requested stay remains in effect," HEC said. "And not
one penny of those improper monopoly revenues will be
recoverable from Novartis by anyone."
 (Reporting by Blake Brittain in Washington and Nate Raymond in
Boston; Editing by Chris Reese and Grant McCool)
 ((Nate.Raymond@thomsonreuters.com and Twitter @nateraymond;
347-243-6917; Reuters Messaging:
nate.raymond.thomsonreuters.com@reuters.net))