Indirect Aggrenox buyers reached a $54 million settlement agreement over allegations Teva Pharmaceutical and Boehringer Ingelheim blocked generic alternatives from coming to the market.

H&S garners major settlement for purchasers of Aggrenox

Law360, New York (January 9, 2018, 5:09 PM EST) -- A proposed class of indirect Aggrenox buyers told a Connecticut federal judge on Monday that they have reached a $54 million settlement agreement with Teva Pharmaceutical and Boehringer Ingelheim over allegations the companies blocked generic alternatives to the stroke-prevention drug from coming to the market.

The putative class, which is represented by 16 union health and welfare funds, reached the deal with several subsidiaries of Teva Pharmaceutical Industries Ltd. and Boehringer Ingelheim Pharmaceuticals Inc. in late December, according to the agreement. Their claims are part of a sprawling multidistrict litigation accusing Boehringer and Teva unit Barr Pharmaceuticals of orchestrating a $120 million pay-for-delay deal to keep generic versions of Aggrenox off of the market.

In a memorandum supporting a motion for preliminary approval of the settlement on Monday, the indirect buyers said they participated in a mediation session that led to a separate deal between direct purchasers and the companies last year but added that they were unable to reach their own agreement during that session. The sides kept negotiating, however, and attended a second mediation session in September that resulted in a framework for the new deal.

“The second round proved fruitful,” the memorandum said. “In mid-September 2017, the parties successfully hammered out the key terms of a settlement.”

According to the suit, and the other MDL suits, Boehringer received the U.S. Food and Drug Administration's approval for Aggrenox in 1998, and netted a total of $388 million in U.S. sales of the drug by 2008. But when Barr Pharmaceuticals, which was later purchased by Teva, allegedly sought regulatory approval in 2007 for a generic version of Aggrenox, the company was promptly hit with a patent infringement suit by Boehringer.

To settle the infringement suit,Boehringer allegedly agreed to pay Barr Pharmaceuticals $120 million over a period of seven years to delay the introduction of a generic version of Aggrenox until 2015, according to court documents. Meanwhile, Boehringer granted Barr Pharmaceuticals a license to sell an authorized generic version of Aggrenox immediately, further suppressing the market for the generic drug, according to the allegations.

The U.S. Judicial Panel on Multidistrict Litigation combined a slew of Aggrenox suits in Connecticut in 2014.

In December, U.S. District Judge Stefan R. Underhill granted final approval for a $146 million deal between the companies and direct purchasers in the MDL, led by drug wholesalers American Sales Company LLC, Cesar Castillo Inc., Miami-Luken Inc. and Rochester Drug Co-Operative Inc.

Attorneys for the indirect buyers, Boehringer and Teva did not respond to requests for comment Tuesday about the latest settlement agreement.

Boehringer and its affiliates are represented by Peter J. Carney, Matthew S. Leddicotte, J. Mark Gidley, Jack E. Pace III and Ross E. Elfand of White & Case LLP and Richard P. Colbert of Day Pitney LLP.

Teva and its affiliates are represented by Christopher T. Holding, Robert D. Carroll and Sarah Frederick of Goodwin Procter LLP and James T. Shearin of Pullman & Comley LLC.

The indirect purchasers are represented by Marvin A. Miller of Miller Law LLC, Renae D. Steiner of Heins Mills & Olson PLC, and Steve Shadowen of Hilliard & Shadowen LLP

The MDL is In re: Aggrenox Antitrust Litigation, case number 3:14-md-02516, in the U.S. District Court for the District of Connecticut.