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Executive Summary

PATENT OFFICE's ROLE IN ANDA PATENT CERTIFICATION is being debated by PMA (Pharmeceutical Mfrs. Assn.) and GPIA (Generic Pharmaceutical Industry Assn.) in a comment dialogue with FDA regarding implementing regs for the Waxman/Hatch Act. PMA wants FDA to establish a review procedure for patent certification statements that would permit the NDA holder on a pioneer product to request review of a generic mfr.'s patent certification by the Patent Office. GPIA believes that all patent discussions occasioned by the certification notices should take place exclusively in the courts. In April 4 comments to FDA, PMA urged that NDA holders be permitted to ask the Patent Office to review patent certification statements by generic sponsors. According to PMA's plan, an NDA holder would have 15 days to ask FDA to refer the patent certification statement to the Patent Office. Under Waxman/Hatch, the Patent Office has no specific role in the patent certification process. In a July 23 response to PMA's comments, GPIA criticized the Patent Office review proposal as an attempt to add an extra layer of procedural review. "By statute (28 U.S.C. Sec.1338)," GPIA said, "the District Courts have original and exclusive jurisdiction over controversies relating to patents. There is nothing in the Act which remotely suggests any modification of that exclusive jurisdiction, or which gives the FDA power to confer jurisdiction on the Patent Office to examine a certification notice for any purpose. What is at stake in the debate over the Patent Office's participation as a first layer of review for certification notices is a de facto extension of a 45-day deadline in Waxman/Hatch. That deadline sets the time limit in which NDA holders must initiate patent infringement legal challenges to ANDA applications. PMA would set a 15-day deadline for the petition to FDA for Patent Office review. The Patent Office would subsequently have 30 days to decide on the adequacy of the generic sponsor's patent certification. PMA would then have the 45-day challenge deadline begin after the Patent Office notifies FDA that a certification is acceptable. Thus, the 45-day deadline in Waxman/Hatch would be extended: (1) by 15 days for the petition process; (2) by whatever period of time FDA takes to review the petition; and (3) by the Patent Office's review of up to 30 days. If a generic sponsor's patent certification were found insufficient by the Patent Office, PMA would have FDA require a new filing -- - with the start of a new timeclock for the challenge procedures. GPIA maintained that Waxman/Hatch "does not vest the FDA with the authority to modify or extend the 45-day period within which a litigation must be commenced following a certification notice." The generic trade group declared that the Patent Office "is not in a position to make any meaningful review. There is no way in which the Patent Office can determine that the notice contains all the facts and theories on which the certifier relies without examing the party making the certification." GPIA further contended that the requirement to take patent infringement allegation to court was fully intended by Waxman/Hatch."The examination of the legal sufficiency of the certification is precisely the purpose of the lawsuit," GPIA said.

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