Hagens Berman filed an amended complaint on behalf of a direct purchaser of blockbuster cancer drug Revlimid and its generic equivalent lenalidomide, alleging that Celgene Corporation and its parent Bristol-Myers Squibb Company paid generic manufacturers through patent settlements to delay the launch of their generic lenalidomide, allegedly resulting in billions in overcharges. The amended complaint adds as defendants some of the generic manufacturers and their successor companies: AbbVie Inc., Dr. Reddy’s Laboratories Ltd., Natco Pharma Limited, and Teva Pharmaceuticals USA, Inc.
According to the complaint, Celgene’s (and later Bristol-Myers’s) anticompetitive conduct to exclude generic entry included entering into unlawful reverse payment agreements with the generic manufacturers to delay entry of generic Revlimid until March 2022. Although generic entry commenced in March 2022, it is subject to single-digit volume caps until 2026, resulting in ongoing supracompetitive pricing and harm to purchasers.
ABOUT THE REVLIMID LAWSUIT
This is a direct suit by Cigna Corporation; it opted out of a class action brought against Celgene Corporation (see In re Thalomid and Revlimid Antitrust Litigation, 2:14-cv-06997 (D.N.J., 2014)). As in the class action, this suit alleges the same monopolistic scheme, wherein Celgene took various anticompetitive steps to monopolize the market for generic versions of Revlimid (generic, “lenalidomide”). The present suit further alleges that Celgene and subsequently its parent Bristol-Myers (which acquired Celgene in November 2019) entered into unlawful reverse payment agreements with generic manufacturers when settling the underlying patent litigations.
As would-be competitors sought FDA approval to market generic versions of Revlimid, the suit alleges that the defendants took a series of anticompetitive actions to block or delay those generics from coming to market.
Upon the generic manufacturers’ filing of their lenalidomide Abbreviated New Drug Applications (“ANDAs”) with the FDA, Celgene responded by filing flimsy patent infringement lawsuits. According to the complaint, Celgene settled its lawsuit against first-filer Natco by entering into an anticompetitive reverse payment agreement. The agreement was structured to ensure there would not be generic competition based on price nor the launch of an authorized generic, thus inducing the first-filing generic manufacturer to accept a later date to market its generic product. This was accomplished through provisions such as volume limits on how much product Natco can sell until 2026 and both a most-favored entry clause (also referred to as an acceleration clause) and a most-favored quantity clause that deterred later-filing generics from challenging Celgene’s patents. The agreement amounts to hundreds of millions of dollars in payment to that first-filing generic manufacturer.
Celgene and Bristol-Myers later settled with at least 9 other generic manufacturers, allocating the generic market through volume limits that allowed all generic manufacturers to charge supracompetitive prices. Those anticompetitive settlements have delayed robust generic competition until at least January 21, 2026.
