U.S. Supreme Court Rules Human Genes Cannot Be Patented While Approving Patentability of Synthetic Genes in Issuing Key Myriad Decision

The Supreme Court ruled unanimously June 13, 2013 in favor of Plaintiffs/Petitioners in Association of Molecular Pathologists v. Myriad Genetics on the question of whether isolated DNA is patent eligible. The opinion found a distinction between isolated genomic DNA and fragments thereof (including oligonucleotides), which the Court found were not eligible for patenting under Section 101 of the patent statute, and “synthetic” cDNA, which the Court found did not occur in nature and evinced a sufficient degree of the “hand of man” to fall outside the scope of the Court’s exclusions to patent eligibility.

Applying an analysis similar to the one the Court applied in invalidating claims to diagnostic method claims in Mayo v. Prometheus, the unanimous opinion by Justice Thomas found that isolated genomic DNA was one of the “basic tools of scientific and technological work” that should "lie beyond the domain of patent protection" because if they did not, “there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.’” The Court is careful to ensure that its decision is not interpreted as being a categorical ban on “naturally occurring things,” reminding us that “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,” and “too broad an interpretation of this exclusionary principle could eviscerate patent law,” a concept also taken from its Mayo decision.

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