ANDA Time Limit Expiration Did Not Foreclose Preliminary Injunction

In Pfizer, Inc., et al. v. Teva Pharmaceuticals USA, Inc., et al (Fed. Cir.; November 22, 2005), the court affirmed the grant of the preliminary injunction against Teva and Ranaxby, finding that Ranbaxy failed to rebut the presumption of irreparable harm.

On December 27, 2002, Ranbaxy sought FDA approval to market its own generic version of Accupril® by filing its own ANDA and certifying that its product would not infringe the ’450 patent. Ranbaxy sent Warner-Lambert a paragraph IV certification letter on April 7, 2003, explaining why Ranbaxy believed its product would not infringe the ’450 patent. Ranbaxy’s letter indicated that it had adopted and relied upon the construction of "saccharide" Warner-Lambert had previously stipulated to in its case against Teva. Warner-Lambert did not respond to Ranbaxy’s letter or sue Ranbaxy within forty-five days of receiving the letter, which would have triggered a thirty-month stay of approval of Ranbaxy’s ANDA. See 21 U.S.C. § 355(j)(5)(B)(iii) (2000).

According to the appellate court, the district court did not abuse its discretion by not faulting co-plaintiff Warner-Lambert for its decision not to bring suit within forty-five days of receiving Ranbaxy’s paragraph IV certification letter.

Ranbaxy is correct to point out that evidence that a patent owner unduly
delays in bringing suit against an alleged infringer negates the idea of
irreparability. And Ranbaxy is also correct that the relevant statutory
provisions would have triggered the thirty-month stay of FDA approval of
Ranbaxy’s ANDA had Warner-Lambert sued. But there is no requirement that a
patent owner take advantage of the statutory carrot of a thirty-month stay, and
certainly no statutory stick for choosing not to. Moreover, Teva, as the first
party to file an ANDA, held exclusive generic rights. There was therefore no
immediate need for Warner-Lambert to sue Ranbaxy. And the fact that
Warner-Lambert filed suit against Ranbaxy within two months of the launch of
Ranbaxy’s quinapril formulation supports the district court’s rejection of the
idea that Warner-Lambert unduly delayed in bringing suit against Ranbaxy. Thus,
the district court did not clearly err or otherwise abuse its discretion in determining
that Ranbaxy did not meet its burden of rebutting the presumption of irreparable
harm.

For the reasons discussed, we conclude that the district court did not abuse its discretion in its analysis of the harm to Warner-Lambert.