FTC Submits Amicus In Mylan v. Celgene, Citing Potential Refusal To Deal Concerns

The FTC has submitted an amicus brief in Mylan Pharmaceuticals Inc. v. Celgene Corp., 2:14-CV-2094 (D.N.J.), offering support in favor of Mylan's claims. Mylan sued Celgene in April 2014, bringing claims related to its attempts to develop generic versions of Revlimid and Thalomid, brand drugs used to treat certain forms of cancer. Due to safety concerns, the FDA required Celgene to adopt Risk Evaluation and Mitigation Strategies ("REMS") that limit their distribution. As a result, Mylan claims that it cannot purchase any of the drugs through distributors, and that Celgene has refused to sell any amounts of the drugs directly. Without samples, Mylan cannot perform the bioequivalence testing necessary for Abbreviated New Drug Applications. Mylan alleges that Celgene's use of REMS to deny it access to the drugs is pretextual, and are designed to prevent any generic entrants. Mylan's complaint contains claims for violation of Section 2 of the Sherman Act by Celgene under