FTC Backs Mylan’s REMS Antitrust Lawsuit Against Celgene
This article was originally published in The Pink Sheet Daily
FTC files second amicus brief saying use of risk management programs to impede generic competition could violate antitrust laws; commission launched an investigation of Celgene four years ago.
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The two agencies are pursuing initiatives to address instances of patents being used improperly to delay competition. FDA may play greater role in PTAB proceedings and training patent examiners.
With full slate of new commissioners FTC may expand focus to FDA regulatory issues; Commission has four cases against pharma companies in federal court and is fighting challenges to its authority to bring pay-for-delay suits.
Patients For Affordable Drugs Founder David Mitchell alleges Celgene's unlawful delay tactics like REMS obstruction kept generic versions of Thalomid and Revlimid off the market, forcing plaintiffs to pay higher costs.