Policy ForumIntellectual Property

Turning Patent Swords into Shares

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Science  17 Dec 2010:
Vol. 330, Issue 6011, pp. 1630-1631
DOI: 10.1126/science.1189592

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The decision earlier this year in the U.S. District Court to deny patent protection for isolated human genes and associated diagnostic methods (1) shocked the biotech community. The case related to genetic tests for familial breast and ovarian cancer developed by the company Myriad Genetics. The product claims (used to describe the compound in question) were directed to isolated DNA containing human BRCA1 and BRCA2 gene sequences. The method claims (used to describe the activity exercised upon the compound) covered the process of identifying certain mutations in the BRCA genes. The court held that the claimed isolated DNA “is not markedly different from native DNA as it exists in nature” and constitutes unpatentable subject matter (1). The court also ruled that the claimed method is “directed only to the abstract mental process of comparing or analyzing gene sequences,” fails the so-called “machine or transformation test” (2), and is unpatentable as well (1).