Pfizer has been sued in a putative class action in the Southern District of New York by a group of health and welfare benefit plans who claim that Pfizer filed sham patent applications and colluded with Ranbaxy Inc. to delay the introduction of generic competitors to its cholesterol treatment Lipitor.
The complaint alleges that Pfizer and its subsidiary Warner-Lambert delayed the date on which generics could have entered the market by (1) fraudulently obtaining a second, duplicative patent for the same compound covered by its first patent; (2) filing a sham “citizen petition” with the U.S. Food and Drug Administration; and (3) engaging in an anticompetitive scheme with generics maker Ranbaxy, costing indirect purchasers billions of dollars. This suit follows a similar one filed by eleven California pharmacies.
The New York case alleges that in order to make the second patent appear novel, Warner-Lambert falsely asserted that the new compound was 10 times more effective in inhibiting cholesterol production than an alternate compound. After Ranbaxy — the first company to challenge Pfizer’s patents on Lipitor — filed its abbreviated new drug application in August 2002, Pfizer sued for infringement of both the ‘893 and ‘995 patents, triggering a 30-month delay required by the FDA’s approval of Ranbaxy’s ANDA.
When the stay was about to expire, the complaint alleges, Pfizer sent a letter to the FDA and later refiled as a citizen petition, asking the FDA to take into account information that allegedly lacked any regulatory, scientific or medical relevance to Ranbaxy’s ANDA in order to further delay the introduction of a generic version of Lipitor.
The putative class claims that Pfizer brought Ranbaxy into the anticompetitive scheme, reaching a settlement in its patent infringement suits that took advantage of Ranbaxy’s entitlement, as the first filer of an ANDA for generic Lipitor, to market the drug exclusively for 180 days. To avoid paying damages, plaintiffs allege, Ranbaxy promised not to compete directly with Pfizer by launching its generic Lipitor or to allow others to compete by relinquishing its marketing exclusivity until Nov. 30, 2011.
A spokesman for Pfizer noted that the Federal Trade Commission had reviewed the terms of the companies’ settlement.