Pfizer and a class of direct purchasers who allege the drugmaker used fraudulent patents to delay generic competition for its anti-inflammatory drug Celebrex have agreed to a $94 million settlement. U.S. District Judge Arenda L. Wright Allen certified a class of 32 direct purchasers in August who claim Pfizer Inc. cost Celebrex buyers hundreds of millions by abusing the courts and the U.S. Patent and Trademark Office (USPTO) to extend its exclusive window to sell the drug. The parties filed a joint motion for preliminary approval of the settlement on Nov. 22. They told the court the agreement came after discovery in the case had already resulted in the production of 800,000 documents, 28 depositions of party witnesses and reports from 20 separate experts, in addition to discovery obtained from outside parties.
According to the July 2014 suit, the issue dates to 2008, when the Federal Circuit invalidated U.S. Patent No. 5,760,068, finding it not distinct enough from two other Celebrex patents also owned by Pfizer. The decision was said to have pushed up the expiration of Pfizer’s patent exclusivity on the drug from December 2015 to May 2014. In order to extend that exclusivity period, the company asked the USPTO to reissue the patent, claiming that its earlier applications had contained “unintentional” errors “needing” correction. The suit alleged that Pfizer provided “false information, deflective arguments and voluminous irrelevant materials.”
The request was granted by the USPTO in 2013 under U.S. Patent No. RE44,048. The Celebrex purchasers allege the reissued patent was then asserted to initiate lawsuits against competing drugmakers working toward approval for generic forms of the drug. Even though a Virginia federal court invalidated the reissued patent in March 2014, Pfizer settled with the generic-drug makers before a final judgment was issued.
Through the settlements, the competitors agreed not to sell their Celebrex generics until December 2014, six months after Pfizer’s exclusivity period would have expired. The direct purchasers have argued that Pfizer’s alleged anti-competitive scheme violated federal antitrust laws by delaying generic competition for Celebrex, and claimed they are entitled to the difference between the price they paid for Celebrex and the price they would have paid for a generic equivalent.
A proposed class of health benefit plans, suing as indirect purchasers of Celebrex, had their claims dismissed in February and are appealing to the Fourth Circuit Court of Appeals.
The direct purchasers are represented by lawyers from Glasser & Glasser PLC, Hagens Berman Sobol Shapiro LLP, Radice Law Firm PC, Berger & Montague PC, Faruqi & Faruqi LLP, Taus Cebulash & Landau LLP, and Nussbaum Law Group PC. The case is In re Celebrex (Celecoxib) Antitrust Litigation, (case number 2:14-cv-00361) in the U.S. District Court for the Eastern District of Virginia.