Gene Patenting: Federal Circuit Upholds Patents to Isolated DNA


On Friday, the Federal Circuit issued its highly anticipated decision in Association for Molecular Pathology, et al. v. Myriad Genetics. The Federal Circuit held that isolated DNA sequences (both genomic DNA and cDNA) are patentable subject matter, while Myriad's claims for "comparing" or "analyzing" DNA sequences to identify mutations in patients' genes only required abstract mental steps and were ineligible for patent protection. The decision rejects the position of the Obama administration, which had filed an amicus brief arguing that isolated genomic DNA should not be patentable, and conforms with the settled expectations of the biotechnology industry and long-standing practice of the Patent Office to issue patents to isolated DNAs.

The case involved Myriad's claims to isolated BRCA1 and BRCA2 genes, two genes involved in human breast cancer, and method claims directed to "comparing" or "analyzing" a patient's BRCA1/2 gene sequences with "normal" BRCA1/2 gene sequences to identify the presence of mutations known to correlate with an increased risk of breast cancer. The district court found both types of claims unpatentable under 35 U.S.C. § 101. According to the district court, isolated human genes possess the same information as genes in their native state and are not patentable subject matter because they are not "markedly different" from what exists in nature. The district court further found the method claims unpatentable because they claimed only abstract mental steps....

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