Novartis named in pay for delay class action involving Gleevec

Posted on: September 4th, 2015 by Steve Larson

medicineAccording to a complaint filed in a federal court in Massachusetts, Novartis Pharmaceutical Corp. conspired to improperly withhold generic versions of Gleevec — a blockbuster leukemia medication — from the consumer market.  Two employee welfare funds, United Food & Commercial Workers Unions & Employers Midwest Health Benefits Fund and Laborers Health & Welfare Trust Fund for Northern California, filed the complaint on behalf of a proposed class of direct purchasers. The complaint alleges that Novartis has engaged in “patent gamesmanship and frivolous litigation” in order to extend the period in which it maintains the exclusive right to profit from patents describing the chemical compound imatinib mesylate, which it markets under the brand name Gleevec.

A full course of Gleevec, which costs close to $9,000 per month, has been a significant source of revenue for Novartis, grossing, according to the complaint, $13.5 billion for the company since it began marketing the drug in 2001.

The patents describing Gleevec have been the source of contention between Novartis and Sun Pharmaceutical Industries, since at least 2001, when Sun filed its original Abbreviated New Drug Application, seeking the right to manufacture a generic version of Gleevec once the exclusivity period for Novartis’ patent patent expired on July 4, 2015.

Since then, the two companies have engaged in several lawsuits, as Novartis has attempted to stall Sun’s ANDA application. The most relevant of those suits ended on May 15, 2014, when the parties reached a settlement according to which Sun would delay its release of a generic Gleevec until February 1, 2016, in exchange for an undisclosed sum.

The complaint contends that this settlement violates the Sherman Antitrust Act.