Association for Molecular Pathology v. Myriad Genetics
Citation and Court
569 U.S. 576 (2013), Supreme Court of the United States
Facts
Myriad Genetics held patents on the BRCA1 and BRCA2 genes, mutations in which are associated with hereditary breast and ovarian cancer. Myriad isolated these naturally occurring DNA sequences and obtained patents covering both isolated genomic DNA and complementary DNA (cDNA) synthesized in the laboratory. A coalition of medical associations challenged the patents as covering non-patentable subject matter.
Issue
Whether isolated naturally occurring DNA sequences and synthetically created cDNA sequences are patentable subject matter under 35 U.S.C. § 101.
Holding
The Supreme Court unanimously held that isolated naturally occurring DNA segments are products of nature and thus not patentable, but that cDNA — which does not occur naturally and is created in the laboratory — is patentable subject matter.
Rule / Doctrine
Under § 101, laws of nature, natural phenomena, and abstract ideas are excluded from patent protection. Merely isolating a gene that exists in nature does not create a new composition of matter — the genetic information encoded in the DNA sequence is the same as in nature. However, cDNA is not naturally occurring (it lacks introns) and thus may qualify as patentable subject matter if it meets the other requirements for patentability.
Significance
Association for Molecular Pathology v. Myriad Genetics resolved a critical question in biotechnology patent law by distinguishing natural DNA sequences from laboratory-synthesized cDNA. The decision has significant implications for the scope of gene patents and for access to genetic testing.