(Adds background to case, paragraphs 4-10)
By Blake Brittain
WASHINGTON, June 21 (Reuters) - The U.S. Supreme Court on
Monday rejected a bid by an Amarin Corp PLC subsidiary
to revive patents on its heart drug Vascepa in a legal battle
against generic drugmakers Hikma Pharmaceuticals PLC and
Dr. Reddy's Laboratories Ltd.
The justices declined to hear Dublin-based Amarin Pharma's
appeal of a lower court ruling that affirmed that the patents
were invalid following a challenge by Hikma and Dr. Reddy's. The
lower court found that the patents were invalid as "obvious"
based on "prior art," which means that earlier publications had
already disclosed their innovations.
A federal judge's decision last year to invalidate the
patents cost Amarin Corp nearly 70% of its stock price.
Vascepa is an omega-3 oil used to lower fat levels in
patients' bloodstreams. Amarin sued London-based Hikma and
Hyderabad, India-based Dr. Reddy's in Las Vegas in 2016,
alleging that their proposed generic versions of the drug would
infringe six of its patents.
Nevada-based U.S. District Judge Miranda Du ruled in March
2020 that the patents were obvious and unenforceable, finding
that earlier publications including a reference to the omega-3
drug Lovaza previously disclosed the patents' innovations.
The decision opened the door to generic versions of Vascepa
and wiped out $3.5 billion of Amarin's market capitalization.
The Washington-based U.S. Court of Appeals for the Federal
Circuit, which specializes in patent law, affirmed the decision
in September.
Hikma launched its generic version of Vascepa in November.
Amarin told the Supreme Court in February that Du failed to
consider secondary indications that the patents were not
obvious, including Vascepa's commercial success and its meeting
of a long-standing need for a drug to treat severe
hypertriglyceridemia - high amounts of a type of fat found in
the blood called triglycerides - that does not elevate "bad"
cholesterol.
Hikma had urged the court not to hear the appeal, arguing
among other things that Amarin "relied exclusively on prior-art
studies" to develop Vascepa.
(Reporting by Blake Brittain; Editing by Will Dunham)
Hikma Pharmaceuticals (HIK)
