WASHINGTON _ The patentability of gene therapy survived anunexpected edit of previously negotiated terms for the medicalpatents ban Wednesday during the House/Senate conferencecommittee. Efforts by the conference committee to simplify wordingin the legislative record were stymied when representatives from thebiotechnology industry voiced their opposition to any changes thatcould threaten the patentability of biotechnology innovations.

"There are always unexpected obstacles when you are dealing withlegislation," said Lisa Raines, vice president for government relationsat Genzyme Corp., in Cambridge, Mass., who was involved inWednesday's negotiations.

The original medical patents ban, which was sponsored by Rep. GregGanske (R-Iowa) and supported by the American MedicalAssociation, was intended to prevent patents on procedures, such assurgery, that could limit their availability. However, biotech industryrepresentatives opposed the wording of the legislation as vagueenough to allow the patent ban to be applied to biologic drugs andgene therapy.

Industry leaders and the Biotechnology Industry Organization (BIO)negotiated changes to the bill and the legislative record that wouldprotect current biotechnology patent rights.

However, Wednesday it became clear that during the process oftaking the appropriations bill into conference committee, keywording in the legislative record had been omitted and edited in orderto shorten the document. As a result, the wording once again placedthe patentability of gene therapy into question. The report languagehas been restored as negotiated, and the bill now awaits finalapproval by both the House and Senate before being signed into lawby the president.

"We have been following this thing very closely because it is in theclosing days and it is very hard to keep track of," said ChuckLudlum, vice president of government relations of BIO, who alsotook part in the negotiations. "We are on the right track here but weare going to follow it until Congress is gone." n

-- Lisa Seachrist Washington Editor

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