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Executive Summary

GPIA's ALTERNATIVE TO REP. BOUCHER's BIOTECHNOLOGY BILL is an administrative declaration in lieu of legislation. Instead of amending patent law, like title I of the measure sponsored by the Virginia Democrat, the Generic Pharmaceutical Industry Association has proposed "a simple administrative action" by the Patent & Trademark Office "to make it clear that a patent applicant is entitled, under existing law, to claim the process for using a patentable essential material in the same patent application which claims the essential material." Such a "minor" administrative declaration, the GPIA proposal states, "would close the alleged loophole which permits unfair foreign competition without any impact on U.S. competition or expansion of U.S. patent law." On the other hand, the association maintained, HR 3957 constitutes unnecessary "additional process patent legislation" to fashion a remedy "already available under existing law." Boucher's biotech bill was introduced Feb. 6 with Rep. Moorhead (R-Calif.) as principal cosponsor ("The Pink Sheet" Feb. 12, T&G-2). It is supported by the Industrial Biotechnology Association, although the biotech group is pushing an amendment to the legislation ("The Pink Sheet" June 4, T&G-7). In an April 30 letter to House Judiciary/Intellectual Property Subcommittee Chairman Kastenmeier (D-Wis.), GPIA President Dee Fensterer said the association also opposes the Boucher bill on the grounds that "it opens the door to patent 'evergreening.'" The measure would create "the possibility that multiple patents with different expiration dates will be granted on essentially the same invention," GPIA President Fensterer said. * "The legislation creates a risk that separate patents with different expiration dates will be granted on (1) the essential material and (2) the process of using the essential material, thereby wrongfully extending patent life and postponing competition between American manufacturers," the association contended. GPIA also opposes the legislation's retroactivity, maintaining that it "would upset the carefully crafted process patent amendments" enacted in the Omnibus Trade Act of 1988.

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