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Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al.

Supreme Court of the United States
569 U.S. (2013)
ELI5:

Rule of Law:

A naturally occurring segment of DNA is a product of nature and is not patent-eligible merely because it has been isolated from its natural environment. However, complementary DNA (cDNA) is patent-eligible because it is synthetically created and not a naturally occurring molecule.


Facts:

  • Myriad Genetics, Inc. discovered the precise location and sequence of two human genes, BRCA1 and BRCA2.
  • Mutations in these genes are associated with a substantially increased risk of developing breast and ovarian cancer.
  • Based on this discovery, Myriad developed and marketed medical tests to detect these specific mutations.
  • Myriad obtained several patents that claimed the isolated BRCA1 and BRCA2 genes themselves, including both full sequences and shorter fragments of 15 or more nucleotides.
  • Myriad's patents also claimed synthetically created complementary DNA (cDNA), which is made in a laboratory and contains only the protein-coding portions (exons) of the natural genes.
  • Myriad sent letters to other laboratories and researchers, including the University of Pennsylvania's Genetic Diagnostic Laboratory (GDL) and Dr. Harry Ostrer, asserting its patent rights and demanding they cease all BRCA testing.
  • As a result of Myriad's enforcement actions, other institutions stopped their BRCA testing services, solidifying Myriad's position as the sole provider of such tests.

Procedural Posture:

  • The Association for Molecular Pathology, Dr. Harry Ostrer, and others sued Myriad Genetics, Inc. in the U.S. District Court for the Southern District of New York, seeking a declaration that Myriad's patents were invalid.
  • The District Court granted summary judgment to the plaintiffs, invalidating the patent claims for both isolated DNA and cDNA as improper attempts to patent products of nature.
  • Myriad, as appellant, appealed to the U.S. Court of Appeals for the Federal Circuit, which reversed the District Court and held that both isolated DNA and cDNA were patent-eligible.
  • The plaintiffs, as petitioners, sought a writ of certiorari from the U.S. Supreme Court, which granted the petition, vacated the judgment, and remanded the case to the Federal Circuit for reconsideration in light of Mayo v. Prometheus.
  • On remand, the Federal Circuit reaffirmed its prior holding that both isolated DNA and cDNA were patent-eligible subject matter.
  • The plaintiffs again petitioned the U.S. Supreme Court for a writ of certiorari, which was granted.

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Issue:

Is a naturally occurring, isolated segment of DNA patent-eligible subject matter under 35 U.S.C. § 101, and is synthetically created complementary DNA (cDNA), which omits non-coding regions, patent-eligible under the same statute?


Opinions:

Majority - Justice Thomas

No, as to the isolated DNA; Yes, as to the cDNA. A naturally occurring DNA segment is an unpatentable product of nature, and merely isolating it from the human genome is not an inventive act that renders it patent-eligible under § 101. Laws of nature, natural phenomena, and abstract ideas are implicit exceptions to patent law. Myriad did not create or alter the genetic information encoded in the BRCA genes; it only discovered their location. This act of discovery, even if groundbreaking, is not invention. The Court distinguished this from Diamond v. Chakrabarty, where scientists created a new bacterium with 'markedly different characteristics.' In contrast, isolated DNA's primary utility—its genetic information—is identical to that of DNA in the body. The chemical changes from severing bonds are insufficient to make it patentable because the claim's focus is on the information, not the chemical structure. However, cDNA is patent-eligible because it is created in a laboratory from messenger RNA (mRNA) and the process removes non-coding introns. The resulting exons-only molecule is not found in nature and is therefore a human-made invention distinct from its naturally occurring counterpart.


Concurring - Justice Scalia

I join the judgment and the Court's opinion, except for the detailed discussion of molecular biology. It is sufficient to decide this case that the isolated portion of DNA sought to be patented is identical to that portion of DNA in its natural state. Conversely, complementary DNA (cDNA) is a synthetic creation that is not present in nature, which makes it patent-eligible.



Analysis:

This landmark decision significantly narrowed the scope of patentable subject matter in biotechnology, invalidating thousands of existing patents on isolated human genes. The ruling clarified the critical distinction between unpatentable discovery and patentable invention, holding that a product of nature cannot be patented unless it is fundamentally altered by human ingenuity to possess 'markedly different characteristics.' By invalidating gene patents, the Court opened the door for competition in genetic testing and research, leading to more accessible and affordable diagnostic services. However, by upholding the patentability of cDNA, the decision preserved patent protection for synthetic biological creations, thus maintaining incentives for certain innovations in the biotechnology industry.

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