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Case 11.2
ASSOCIATION FOR MOLECULAR PATHOLOGY V. MYRIAD GENETICS, INC.
Supreme Court of the United States
133 S.Ct. 2107; 186 L.Ed. 2d 124; 2013 U.S. LEXIS 4540 [June 13, 2013]
FACTS:
Myriad Genetics, Inc. (Myriad) produced a true research breakthrough when it identified the
location and sequence of two genes related to breast and ovarian cancer.
Myriad obtained several patents after discovering the precise location and sequence of the BRACA1
and BRACA2 genes, mutations of which can dramatically increase breast and ovarian cancer.
This knowledge allowed Myriad to determine the genes’ typical nucleotide sequence, which, in turn
enabled it to develop medical test useful for detecting mutations in these genes in a particular
patient to access the patient’s cancer risk.
If valid, Myriad’s patents would give it the exclusive right to isolate an individual’s BRACA1 and
BRACA 2 genes, and would give Myriad the exclusive right to synthically create BRACA cDNA.
Myriad filed for patents on the full genes and the smaller segment.
The effect of the patents was to give Myraid the right to exclude others from isolating BRACA 1 and
BRACA2 from the human body. That would preclude the use of isolated genes in test kits useful for
detecting breast and ovarian cancer.
The Association for Molecular Pathology (AMP) and various other public interest groups objected
to Myriad’s patent claims on the basis that they claimed ownership over a natural phenomenon
(DNA). AMP asked the court to declare the claims invalid.
PROCEDURE: The District Court granted summary judgment to petitioners, concluding that Myriad’s
claims were invalid because they covered products of nature. The Federal Circuit initially reversed, but
on remand found both isolated DNA and cDNA patent eligible.
ISSUE: Whether Myriad’s patents claim any “new and useful composition of matter,” or if the patents
claim naturally occurring phenomena?
RULE: “The Patent Act permits patents to be issued to ‘whoever invents or discovers any new or
useful…composition of matter,’ but ‘laws of nature, natural phenomena, and abstract ideas’ ‘are basic
tools of scientific and technological work’ that lie beyond the domain of patent protection.’”
REASONING:
1. Laws of nature, natural phenomena, and abstract ideas are not patentable. Without this exception,
3. The location and order of the nucleotides existed in nature before Myriad found them; nor did
Myriad create or alter the genetic structure of DNA.
ADDITIONAL INFORMATION:
The Court’s decision retroactively affects existing patent claims covering natural DNA – they are
now invalid.
cDNA is not a “product of nature,” so it is patent eligible under Section 101. cDNA does not present
