In re Aggrenox Antitrust Litigation

Updated: August 21, 2016
Status: Ongoing Case

Labaton Sucharow challenges pay-for-delay agreement for Aggrenox

On June 12, 2014, Labaton Sucharow filed a class action complaint on behalf of consumers and third party payors who purchased, paid for or were reimbursed for prescriptions of combination aspirin and extended-release dipyridamole, a drug manufactured by global pharmaceutical company Boehringer Ingelheim under the brand name Aggrenox. Aggrenox is typically used to lower the risk of stroke in people who have suffered a transient ischemic attack (mini-stroke) or stoke due to a blood clot.

The plaintiff alleges that absent the Aggrenox pay-for-delay agreements, generic versions of Aggrenox would have been on the market as early as August 14, 2009. This pay-for-delay agreement caused the plaintiff and the class to continue paying supracompetitive prices for Aggrenox throughout the class period, beginning August 14, 2009.

The court granted in part and denied in part the defendants’ motions to dismiss the end payor plaintifs’ claims in August 2016. The court also ruled in August 2016 that the market is limited to the market of Aggrenox and its generic equivalents. The case continues for end payor plaintifs on injunctive relief and various state antitrust law claims. Fact discovery is set to close in April 2017.

The case is In re Aggrenox Antitrust Litigation. The plaintiff is Pipefitters Union Local No. 537 Health & Welfare Fund. The defendant is Boehringer Ingelheim Pharma GmbH.

Aggrenox was a core drug for Boehringer Ingelheim, generating several hundred million dollars a year. Generic manufacturer Barr Pharmaceuticals (now Teva) wanted to enter the market with lower-priced generic alternatives to the brand-named drug, which would provide significant cost savings to consumers. Barr challenged the validity and enforceability of the patent covering Aggrenox. The plaintiff alleges that rather than risk a court determination that the Aggrenox patent was invalid or unenforceable, Boehringer agreed to pay Barr with up to $120 million in one-time and annual royalty payments for co-promotional services relating to the sale of Aggrenox in exchange for Barr agreeing to abandon its patent challenge and refrain from launching a generic version of Aggrenox until at least July 2015. This agreement substantially delayed entry of low-cost generic alternatives into the market, thereby reducing competitive options to consumers and maintaining high Aggrenox prices. The payment agreement that the defendants entered into are typically referred to as reverse payment or pay-for-delay agreements.