Zetia Antitrust Litigation

KTMC was counsel for direct purchasers alleging that brand company Merck & Co., and generic company Glenmark Pharmaceuticals, entered into an anticompetitive pay-for-delay agreement over the drug Zetia (“ezetimibe”).  Following Glenmark’s submission of its application to the FDA for approval of a generic version of Zetia, Merck sued Glenmark alleging it had infringed Merck’s patents covering Zetia.  Glenmark was the first generic company to seek FDA approval and had secured the right to a 180-day period without competition from other generic companies.  Merck however had the right to launch its own generic version of Zetia (an “authorized generic”) during the 180-day period of Glenmark’s exclusivity.  In order to resolve its patent infringement case against Glenmark, Merck entered into an unlawful reverse payment settlement with Glenmark in 2010 to delay generic entry until 2016.  In exchange for this significant delay, Merck agreed not to launch an authorized generic to compete with Glenmark’s generic Zetia during the first 180 days Glenmark’s product was on the market.  The direct purchasers paid significantly higher prices as a result of delayed generic entry and the absence of competition from an authorized generic.

During several years of litigation, direct purchasers achieved a number of significant victories leading up to trial.  For example, Judge Rebecca Beach Smith granted the purchasers’ motion for summary judgment as to market power and held that “Simply put, on this record, no reasonable juror could remain faithful to controlling precedent and cast the relevant market as broadly as Defendants suggest. Stretching the ambit to include non-ezetimibe drugs would blunt the procompetitive purpose of antitrust law and render the market power analysis inconsequential.” In addition, the Court denied Defendants’ motion for summary judgment finding there were disputes of material fact about on several key issues in the case.  

On the eve of jury selection, a global settlement for all plaintiff groups (including the indirect purchaser class and several large retailers) of over $600 million was negotiated.