Another REMS Antitrust Lawsuit: Mylan Sues Celgene Over THALOMID and REVLIMID to Obtain Drug Product Sample

April 4, 2014

By Kurt R. Karst –      

In a 17-count, 84-page Complaint filed earlier this week in the U.S. District Court for the District of New Jersey, Mylan Pharmaceuticals Inc. (“Mylan”) alleges that Celgene Corporation (“Celgene”) has violated federal and state antitrust laws by preventing generic competition for Celgene’s drug products, THALOMID (thalidomide) Capsules and REVLIMID (lenalidomide) Capsules.  Both drug products are the subject of a Risk Evaluation and Mitigation Strategies (“REMS”) – here and here – providing for restricted distribution of the products because of safety concerns – a so-called ETASU (Elements To Assure Safe Use) REMS.  

According to Mylan:

Celgene, a branded drug manufacturer, has used REMS as a pretext to prevent Mylan from acquiring the necessary samples to conduct bioequivalence studies, even after the FDA determined that Mylan’s safety protocols were acceptable to conduct those studies.  In furtherance of its scheme to monopolize and restrain trade, Celgene implemented certain distribution restrictions that significantly limit drug product availability.  Indeed, Mylan had contacted known wholesale distributors throughout the years, in an effort to obtain Thalomid and Revlimid samples, however, those efforts were unsuccessful.  Throughout this entire period, Celgene has engaged in a scheme . . . to continuously prevent and/or stall all of Mylan’s efforts to obtain samples of Thalomid and Revlimid.  In so doing, Celgene prevented Mylan from obtaining any of the drug products necessary to conduct required bioequivalence testing.

Among other things, Mylan is seeking preliminary and permanent mandatory injunctive relief to compel Celgene to sell Mylan sufficient quantities of THALOMID and REVLIMID at market prices for purposes of bioequivalence testing and ANDA submission, and compensatory damages for Mylan’s lost sales of generic THALOMID and REVLIMID (and profits on those sales) determined to be caused by the delay in Mylan’s ability to submit an ANDA to FDA.

Issues concerning ETASU REMS, restricted distribution programs, and generic competition have previously been debated in court.  As we previously reported, in September 2012, Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. preemptively sued prospective ANDA applicants Apotex Corp. and Roxane Laboratories, Inc. in a Complaint filed in the U.S. District Court for the District of New Jersey seeking declaratory relief that Actelion is under no duty or obligation to supply ANDA applicants with TRACLEER (bosentan) Tablets, approved with an ETASU REMS, for purposes of bioequivalence testing and ANDA submission.  That lawsuit was ultimately dismissed after a settlement between the parties, but not before the Federal Trade Commission filed an amicus brief in the case (see our previous post here) asking the court to “carefully consider the unique regulatory framework governing the pharmaceutical industry and the potential ramifications for consumers of prescription drugs.”

Another lawsuit going back to early 2008 brought by Lannett Company, Inc. against Celgene involving THALOMID, restricted distribution, and generic competition issues was also dismissed after a settlement between the parties.  (See our previous post here.)