| April 3
April 3 Mylan Inc on Thursday sued
Celgene Corp to stop the latter's effort to keep
generic versions of two drugs that generate $4.5 billion of
annual sales off the market.
The lawsuit accuses Celgene of maintaining unlawful
monopolies over Revlimid, which treats disorders caused by
poorly formed blood cells; and Thalomid, which treats lesions
associated with a variation of Hansen's Disease, or leprosy.
Revlimid is a branded version of lenalidomide, and is a
derivative of thalidomide, a drug introduced in the 1950s for
which Thalomid is a branded version. Mylan said both drugs can
cost more than $100,000 for a year's supply.
In its lawsuit filed in the U.S. District Court in Newark,
New Jersey, Mylan accused Celgene of using federal limits on the
distribution of Revlimid and Thalomid, which were designed to
promote the drugs' safety, as a pretext to keep generic drug
makers from obtaining their own samples.
Mylan said this prevents generic drug makers from conducting
"bioequivalence" tests required by U.S. regulators before
generic drugs can be launched.
"The effect of Celgene's conduct is that no generic
manufacturer, including Mylan, has been able to bring generic
versions of Thalomid and/or Revlimid to market," Mylan said.
"Through its illegal actions, Celgene has foreclosed Mylan from
even attempting to enter the market."
Greg Geissman, a Celgene spokesman, declined to comment.
Celgene is based in Summit, New Jersey, and Mylan is based in
The lawsuit seeks to force Celgene to sell Mylan enough
Revlimid and Thalomid at market prices to allow for
bioequivalence testing. It also seeks compensation for Mylan's
inability to sell generic versions of both, and triple damages.
In a February 13 regulatory filing, Celgene said it sold
$4.28 billion of Revlimid and $244.5 million of Thalomid in
2013, together accounting for nearly 70 percent of all revenue.
Celgene also said its exclusive U.S. rights, whether through
patents or primary regulatory approvals, to Revlimid and
Thalomid expire in 2027 and 2023, respectively.
The case is Mylan Pharmaceuticals Inc v. Celgene Corp, U.S.
District Court, District of New Jersey, No. 14-02094.
(Reporting by Jonathan Stempel in New York; editing by Andrew