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The biotechnology industry is urging the Health & Human Services Department (HHS) to reject an advisory panel’s recommendations related to gene patents. The panel has recommended that HHS work with Congress to exempt from infringement liability the use of gene patents for the purpose of developing and commercializing diagnostic tests. It has also recommended that regulations be issued to limit exclusive licensing of federally funded inventions for genetic diagnostic purposes. The HHS Advisory Committee on Genetics, Health & Society says the proposed changes would expand patient access to emerging genetic advances. But the Biotechnology Industry Organization, a lobbying group, says the recommendations, if implemented, would “unravel” the patent system and the Bayh-Dole Act, the 1980 law that helps universities and small businesses commercialize discoveries and move them to the marketplace. “This would do more harm to patients than good, by impairing the research, development, and commercialization of the medicines and diagnostic tests of tomorrow,” BIO says in a letter to HHS.
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