Trace Your Case


Association of Molecular Pathology v. Myriad Genetics, Inc., S. 576 (2013)


  • Whether isolated DNA sequences, which are human genes, patent eligible under Section 101 of the Patent Act?
  • Whether Myriad’s claimed invention BRCA 1 BRCA 2 and BRCA cDNA, the sequence of certain human genes in both isolated and purified forms, fall within the scope of inventions for which a patent may be granted?
  • Whether the product patents obtained by Myriad Laboratories on the discovery of genes, BRCA 1 and BRCA 2, and BRCA cDNA, on the human genome are valid under the provisions of 35 U. S. Code §101 and in consonance with the relevant jurisprudence on the matter?


  • 35 U. S. Code §101: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”


  • The Association for Molecular Pathology, the Petitioner, sued Myriad Genetics Inc., the Respondent, challenging the validity of Myriad’s patents on the BRCA1 and BRCA2 genes.
  • These genes are associated with an increased risk of developing breast and ovarian cancer.
  • The Respondent had obtained patents on the genes themselves, as well as on methods of using the genes to diagnose and treat cancer.
  • The Petitioner argued that Myriad’s patents were invalid because they covered naturally occurring gene sequences that the genes are products of nature and that they cannot be patented.
  • The Respondent argued that its patents were valid because they covered the isolated and sequenced BRCA1 and BRCA2 genes, which are not naturally occurring.


  • However, the court agreed to grant a patent to the composition of cDNA because, it was clear that this was not a “product of nature”, in the sense that it did not exist in nature, its creation results in an exons-only molecule, which is not naturally occurring.
  • The Supreme Court held that naturally occurring gene sequences are not patent-eligible under Section 101 of the Patent Act.
  • It reasoned that genes are products of nature and that isolating or sequencing them does not create something new or different.
  • The Court also held that genes are not “manufactured” because they are not created by humans.