Direct Purchaser Class Plaintiffs allege that Defendants violated federal antitrust laws by engaging in unlawful conduct to delay and impair competition of generic versions of the diabetes medication Glumetza® (metformin hydrochloride) extended release tablets (in both 500mg and 1000mg strengths). Direct Purchaser Class Plaintiffs allege that in February 2012, the defendants agreed in writing to delay the sale of the first generic competitor to Glumetza (by Defendant Lupin) until February 1, 2016 at the earliest and that in exchange, the Brand Defendants agreed to pay (and did pay) Defendant Lupin in the form of reimbursement of attorneys’ fees and an agreement to delay the launch of an authorized generic product. Direct Purchaser Class Plaintiffs allege that this payment included: (a) an agreement not to compete with Lupin’s generic with a Brand-authorized generic for twelve months, and (b) an agreement not to grant a license that would allow any other generic manufacturer to market a generic competitor to Lupin’s generic any earlier than August 1, 2016.
As alleged, the “pay for delay” scheme outlined by Direct Purchaser Class Plaintiffs allowed the Brand Defendants to greatly increase the price of Glumetza, protected Lupin from generic competition from the Brand and other generics, and made members of the Class pay more for brand or generic Glumetza.
Defendants deny these allegations, and deny that any Class member is entitled to damages or any other relief. Defendants also deny that any of their conduct violated any applicable law or regulation. Specifically, Defendants assert that no provision in the settlement agreement is properly characterized as a “payment” in exchange for a delayed generic launch. Defendants also assert that the settlement agreement, which permitted licensed generic entry more than four years prior to the expiration of the latest-expiring Glumetza® patent at issue in the patent litigation, constituted a lawful resolution of patent litigation, that the licensed entry date for when Lupin could begin selling generic Glumetza was a reasonable and lawful procompetitive outcome, and that the settlement and license agreement accelerated and enhanced 5 competition. Defendants deny that Direct Purchaser Class Plaintiffs have sustained any injury or damages as a result of Defendants’ conduct.
No court has determined whether Direct Purchaser Class Plaintiffs’ position or Defendants’ position is correct, and no trial has been held.
