A Pennsylvania federal judge said last month that he would approve a $512 million settlement between direct purchasers and Teva Pharmaceutical Industries Ltd. and its subsidiaries Cephalon Inc. and Barr Pharmaceuticals Inc. in pay-for-delay litigation over Cephalon’s narcolepsy drug Provigil. U.S. District Judge Mitchell S. Goldberg presided over a fairness hearing held Oct. 15 to determine if the proposed settlement agreed to in April should be approved. This is the largest settlement ever in a pay-for-delay case on behalf of direct purchasers. “I’ve never seen a proceeding go this quickly with so much money involved,” Judge Goldberg told the lawyers before advising them to anticipate that he would approve the settlement.
The suit is one of several brought by direct purchasers, end payors and the Federal Trade Commission (FTC) challenging a series of patent infringement settlements that Cephalon reached with generic-drug companies in 2005 and 2006 over Provigil. While Teva, which acquired Cephalon in 2012, and its related entities agreed to pay the direct purchasers $512 million to resolve the dispute in April, the agreement did not include Mylan Pharmaceuticals Inc. and Ranbaxy Pharmaceuticals Inc.
The settlement is factored into a larger, $1.2 billion disgorgement deal between the FTC and Teva, but it doesn’t end the Provigil pay-for-delays claims against Mylan and Ranbaxy. The Third Circuit Court of Appeals has said that it would hear the appeal by those two drugmakers’ of Judge Goldberg’s decision to certify the class of direct purchasers.