Association For Molecular Pathology v. Myriad Genetics, Inc.

133 S.Ct. 2107 (2013)

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Nature of the Case

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Facts

Myriad (D) discovered the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes. Mutations in them can dramatically increase an individual's risk of developing breast and ovarian cancer. Before D's discovery of the BRCA1 and BRCA2 genes, scientists knew that heredity played a role in establishing a woman's risk of developing breast and ovarian cancer, but they did not know which genes were associated with those cancers. Knowledge of the location of the BRCA1 and BRCA2 genes allowed D to determine their typical nucleotide sequence. That allowed D to develop medical tests that are useful for detecting mutations in a patient's BRCA1 and BRCA2 genes and thereby assessing whether the patient has an increased risk of cancer. D sought and obtained a number of patents. The claims assert a patent on the DNA code that tells a cell to produce the string of certain amino acid. D's patents give it the exclusive right to isolate an individual's BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual's genome. The patents would also give D the exclusive right to synthetically create BRCA cDNA. D sent letters to those it claimed infringed its patents. D also filed patent infringement suits against other entities that performed BRCA testing, resulting in settlements in which the defendants agreed to cease all allegedly infringing activity. Association (P) filed this lawsuit seeking a declaration that D's patents are invalid under. The District Court granted summary judgment to Ps on the composition claims at issue based on its conclusion that D's claims, including claims related to cDNA, were invalid because they covered products of nature. The Federal Circuit reversed. The Supreme Court granted the petition for certiorari, vacated the judgment, and remanded the case. The Federal Circuit affirmed the District Court in part and reversed in part, with each member of the panel writing separately. All three judges agreed that only Ostrer (P) had standing. The court then held that both isolated DNA and cDNA were patent eligible under § 101. The central dispute among the panel members was whether the act of isolating DNA - separating a specific gene or sequence of nucleotides from the rest of the chromosome - is an inventive act that entitles the individual who first isolates it to a patent. Each of the judges on the panel had a different view on that question. Although the judges expressed different views concerning the patentability of isolated DNA, all three agreed that patent claims relating to cDNA met the patent eligibility requirements of § 101. P appealed and the Supreme Court once again granted certiorari.