Friday, January 21, 2005

Pfizer defeats Teva in Zoloft case

In this Hatch-Waxman case, Teva filed a paragraph III certification as to US 4,356,518 (composition of matter of sertraline hydrochloride) and a paragraph IV certification as to US 5,248,699 (novel crystalline form of sertraline hydrochloride). Pfizer failed to sue Teva for infringement of the '699 patent within 45 days, and Teva filed a DJ action for a declaration of noninfringement or invalidity. The district court dismissed Teva's case for lack of jurisdiction. Teva appealed to the CAFC and lost.

The CAFC gave some background on the Hatch-Waxman Act, background of relevance not only to this case but also to Merck v. Integra. Ivax submitted an amicus brief on behalf of Pfizer and the FTC, the AARP, and the Generic Pharmaceutical Association filed on behalf of Teva. The court noted that the ANDA of a generic may rely on safety and efficacy studies in an NDA provided information establishing bioequivalence is presented. The court discussed certifications described at 21 USC 355(j)(2)(A)(vii)(I-IV).

A legal issue was a 2004 amendment codified at 21 USC 355(j)(5)(C) and a factual nuance was that Ivax (then Goldline) had filed a paragraph IV certification as to the '699 in 1999, prior to Teva's filing. Pfizer did file suit against Ivax. In 2002, Pfizer and Ivax cut a deal, wherein Ivax would get a license to the '699 and begin marketing on the expiry of the '518 patent (June 30, 2006).

The CAFC discussed the two part test for DJ jurisdiction (citing, among others, EMC, 89 F3d at 811): explicit threat by patentee and present activity by DJ plaintiff. Reasonable apprehension based on threat by patentee was the issue in this case. The CAFC noted an absence of reasonable apprehension of IMMINENT suit. Along this line, the CAFC also noted that Teva could not receive FDA approval until AFTER the 180 day exclusivity period granted to Ivax, so Pfizer had no immediate need to sue Teva.

Teva argued that the reasonable apprehension test was prudential, rather than constitutional, in nature, citing to among other cases Arrowhead, 846 F2d at 736 and Ewen, 123 F3d 1466. The CAFC rejected this.

Judge Mayer dissented.


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