Hagens Berman filed an amended complaint on behalf of a direct purchaser alleging that Celgene Corporation and its parent Bristol-Myers Squibb Company engaged in extensive anticompetitive conduct to delay generic competition for Celgene’s blockbuster cancer drug Revlimid. 

Case Status
Active
Court
U.S. District Court for the District of New Jersey
Case Number
21-cv-11686
Defendant(S)
Celgene Corporation
Bristol-Myers Squibb Company
File Date

ABOUT THE REVLIMID LAWSUIT

According to the complaint, Celgene’s anticompetitive conduct to exclude generic entry included obtaining invalid patents, blocking generic manufacturers’ access to samples (which are needed to conduct the testing necessary for FDA approval), filing baseless Citizen Petitions, and pursuing sham patent litigation.

Subsequently, Celgene and later Bristol-Myers entered into an unlawful reverse payment agreement 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.

RELATED LITIGATION VS. CIGNA

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) and/or Thalomid (generic, thalidomide). The present suit further alleges that Celgene and subsequently its parent Bristol-Myers entered into an unlawful reverse payment agreement with generic manufacturers when settling the underlying patent litigation. Bristol-Myers acquired Celgene in November 2019.

CALGENE FIGHTING GENERICS

To prevent generic entry, the suit alleges, Celgene first wrongfully obtained various patents from the U.S. Patent and Trademark Office for Revlimid and Thalomid. Those patents are subject to strong invalidity, unenforceability, and non-infringement challenges, as well as those for improper listing in the Orange Book (an FDA publication entitled, “Approved Drug Products with Therapeutic Equivalence Evaluations”).

Subsequently, as would-be competitors sought FDA approval to market generic versions of Revlimid and/or Thalomid, the suit alleges that the defendants took a series of anticompetitive actions to block or delay those generics from coming to market. Those steps included Celgene using pretextual safety concerns to refuse to sell necessary samples of Revlimid and Thalomid to generic manufacturers for testing. That refusal served to delay the generic manufacturers from obtaining approval of the generic products by the FDA.

Plaintiffs allege Celgene not only refused to sell samples to generic competitors, but also that it schemed to execute exclusive contracts with ingredient suppliers, designed to delay competitors from obtaining needed resources to file for approval of the competitor generics.  

Celgene, the suit alleges, also filed baseless citizen petitions with the FDA, questioning the safety of the Revlimid and Thalomid generics. Those petitions were other brazen attempts to delay generic approval.

Upon the generic manufacturers’ filing of their lenalidomide Abbreviated New Drug Application with the FDA, Celgene responded by filing patent infringement lawsuits. The suit alleges that those patent infringement lawsuits were shams, designed simply to delay bringing competitors’ products to market.

According to the complaint, later, Celgene settled its lawsuit against first-filer Natco by entering into an anticompetitive reverse payment agreement. The agreement provides for volume limits on how much product Natco can sell until 2026 and also provides Natco with a royalty-free license. That agreement amounts to hundreds of millions of dollars in payment to that first-filing generic manufacturer. The agreement also contained a most-favored entry clause (also referred to as an acceleration clause) that deterred later-filing generics from challenging Celgene’s patents and induced the first-filing generic manufacturer to accept a later date to market its generic product.

Celgene later settled with at least 4 other generic manufacturers. Those anticompetitive settlements have delayed robust generic competition until at least January 21, 2026.

TOP PHARMA LAW FIRM

Hagens Berman is one of the most successful litigation law firms in the U.S. taking on pharmaceutical companies and has achieved more than $320 billion in settlements against Big Pharma largest sellers and manufacturers for antitrust schemes, pay-for-delay, IP shams and other forms of wrongdoing that drive up the costs of prescription drugs for consumers and others.

Case Timeline
Description

Following the court’s denial of defendants’ motion to dismiss in a related action, Hagens Berman and co-counsel filed an amended complaint on behalf of Cigna Corporation.

Date
Description

The Honorable Michael Hammer ordered defendants to file a single consolidated motion to dismiss no later than Aug. 26, 2022.

Date

CASE TIMELINE

The Honorable Michael Hammer ordered defendants to file a single consolidated motion to dismiss no later than Aug. 26, 2022.

Following the court’s denial of defendants’ motion to dismiss in a related action, Hagens Berman and co-counsel filed an amended complaint on behalf of Cigna Corporation.

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