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Hikma claims Amarin used exclusive agreements with
suppliers to
frustrate generic rivals
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Dr. Reddy's filed similar lawsuit in 2021
By Brendan Pierson
(Reuters) - Generic drugmaker Hikma Pharmaceuticals USA
Inc has sued Amarin Pharma Inc, accusing it of using illegal
tactics to delay generic competition for its heart drug Vascepa.
In a complaint filed Tuesday in Trenton, New Jersey federal
court, Hikma claimed that Amarin "deliberately and meticulously
locked up the supply" of the key ingredient needed to make
generic Vascepa in order to maintain a monopoly.
London-based Hikma eventually launched the first generic
version of Vascepa in November 2020, but it said that Amarin's
tactics delayed the launch by months, and initially prevented
Hikma from supplying enough of its generic to compete
meaningfully with the branded version.
New Jersey-based Amarin did not immediately respond to a
request for comment. The company was already facing a similar
lawsuit filed in 2021 in the same court by Indian generic
drugmaker Dr. Reddy's Laboratories Ltd, which remains pending.
Vascepa, derived from fish oil, is approved by the U.S. Food
and Drug Administration to lower so-called "bad" cholesterol and
reduce the risk of cardiovascular disease generally. It is
Amarin's only product.
The drug brought Amarin $598 million in 2020, but sales have
since fallen as generics have entered the market, forcing the
company to cut its workforce last year. The company said in a
2020 statement to investors that Vascepa had been prescribed
more than 8 million times since its 2013 U.S. launch.
Amarin initially sought to block competitors by suing Hikma
and Dr. Reddy's for patent infringement after they sought FDA
approval to sell generic versions of the drug, but lost after a
Nevada judge ruled its patents obvious. The U.S. Supreme Court
in 2021 rejected Amarin's bid to revive the patents.
Hikma said that even after losing the patent case, Amarin
held on to its monopoly by entering into exclusive agreements
with suppliers of the active ingredient, icosapent ethyl, that
prevented the suppliers from selling to any other companies.
Hikma called the agreements an "illegal anticompetitive
strategy to prevent, delay, and frustrate generic competition
and maintain its monopoly power and prices for Vascepa" and said
it ran afoul of the federal Sherman Act and New Jersey antitrust
law.
The case is Hikma Pharmaceuticals USA Inc v. Amarin Pharma
Inc, U.S. District Court for the District of New Jersey, No.
3:23-cv-01016.
For Hikma: Charles Klein of Winston & Strawn and others
For Amarin: not available
Read more:
U.S. Supreme Court denies Amarin’s bid to revive Vascepa
drug patents
Amarin to slash jobs as generic rivals dull U.S. prospects
of heart drug
(Reporting By Brendan Pierson in New York; editing by Alexia
Garamfalvi)