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REP. BOUCHER's PROCESS PATENT BILL WILL PREVENT IMPOSITION OF HIGHER PATENTABILITY STANDARDS

Executive Summary

REP. BOUCHER's PROCESS PATENT BILL WILL PREVENT IMPOSITION OF HIGHER PATENTABILITY STANDARDS on biotechnology inventions, PMA maintained in testimony to the House Judiciary/intellectual Property Subcommittee on May 15. Pharmaceutical Manufacturers Association President Gerald Mossinghoff told the House panel that the association "supports a change" in patent law as proposed by Rep. Boucher (D-Va.) so that "patent claims directed to a process of making a biotechnology product are not subjected to a higher standard of patentability than are other inventions." The bill was introduced in the House as HR 1417 by Boucher and Rep. Moorhead (R-Calif.) and in the Senate as S 654 by Sens. Deconcini (D-Ariz.) and Hatch (R-Utah) ("The Pink Sheet" March T&G-1). Identical to Boucher's second process patent bill of 1990, HR 1417/S 654 would allow patent protection for a production process when the starting compound is novel and thus patentable. The bill does not contain a provision of Boucher's first bill proposed last year that would have empowered the International Trade Commission to block imports of products made using any process employing U.S.-patented starter material such as host cells. That provision was caught up in Amgen's patent battle with Genetics Institute over recombinant erythropoietin and was omitted from the current version. PMA opposed process patent legislation last year. The association said a key change permitting its support of the current bill is that the measure does not contain provisions that were seen as applying the measure retroactively. The present, more streamlined bill would apply to patents granted on or after the legislation's enactment and patent applications pending on the date of enactment. The earlier bill contained similar language for the process patent provision. However, the earlier bill's now-deleted ITC provision would have stopped the sale of products already imported into the U.S., beginning 90 days after the bill's enactment ("The Pink Sheet" Feb. 12, 1990, T&G-2). Mossinghoff also told the subcommittee that the "availability of process protection in this country will enable a patentee to remedy the unfair situation which is now occurring in the biotechnology field in which a competitor can make or use a patented intermediate in a foreign country and import into the U.S. the final but unpatented product." The House subcommittee and its Senate counterpart have yet to schedule markups on the current legislation.
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