NYAG forges new ground in scrutiny of pharmaceutical agreements with first-filer exclusivity no-challenge settlement

The New York Attorney General’s (NYAG’s) office has reached a settlement with two generic drug manufacturers regarding allegations that an agreement between the firms not to challenge each other’s eligibility for regulatory exclusivity was anti-competitive. Although not a traditional reverse payment patent settlement agreement between branded and generic drug companies, the settlement reflects a move by antitrust enforcers to apply reverse payment case law and principles to a broader range of agreements in the pharmaceutical space in the wake of FTC v Actavis. Interestingly, the case was brought by the NYAG alone; the FTC, which is typically very active and aggressive on these matters, was not part of the settlement.

The settlement resolves an investigation by NYAG into a 2010 agreement between Ranbaxy Pharmaceuticals and Teva Pharmaceuticals USA related to atorvastatin calcium, the generic version of Lipitor. In 2002, Ranbaxy was the first generic drug company to file an abbreviated new drug application (ANDA) to market atorvastatin calcium. It was expected to be eligible to enjoy the 180-day exclusivity period that is generally granted to the first generic drug company to file an ANDA for a branded product coming off exclusivity. Teva and other generic drug companies also filed ANDAs for atorvastatin calcium. Although Pfizer, the maker of Lipitor, sued Ranbaxy, Teva and other ANDA filers for alleged infringement of the atorvastatin calcium patents, that litigation settled and Ranbaxy received a licence to market atorvastatin calcium. The licence permitted Ranbaxy to enter the market in late November 2011, and Ranbaxy’s first-filer exclusivity would have lasted until late May 2012…

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