Association for Molecular Pathology v. Myriad Genetics

By:  Steve Kronengold, Simone Wolf and Yehuda Kronengold

© October 2013

All rights reserved


In Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___ (June 13, 2013) Action No. 12-398, the U.S. Supreme Court reversed the Court of Appeals for the Federal Circuit (CAFC) and held that a DNA segment which is isolated from a naturally occurring DNA sequence is patent ineligible, but affirmed the CAFC’s ruling that synthetically created DNA, i.e. complementary DNA (“cDNA”), which contains only the protein-coding nucleotides found in natural DNA, is patent eligible.


The Court in Myriad, after reaffirming the notion that the goal of issuing patents is to encourage innovation and not stifle it, distinguished between the identification of naturally occurring DNA, which is not patentable, and the synthetic creation of an altered version of DNA (cDNA), which is patentable.

Based on the Court’s opinion, for a claimed product or process to be patentable, the claimed product or process must include an act of creation or invention, such as:

  • an innovative method of searching for, isolating, or identifying genes;
  • an innovative method of manipulating genes while searching for those genes;
  • Creating a synthetic version of DNA (e.g. cDNA) which differs from the composition of naturally occurring DNA, which could include altering the nucleotide sequence; or
  • Creating new applications of knowledge about specific genes.


DNA contains sequences of nucleotides; the order of the nucleotides in these sequences directs cells to synthesize  amino acids which the body uses to build proteins.  However, only some DNA nucleotide sequences, the “exons,” code for amino acids; most nucleotide sequences in prokaryotic cells are non-coding “introns”.  Scientists are able to extract DNA from cells and to isolate specific segments of DNA, including the DNA of a particular gene.  Scientists are also able to create DNA synthetically in the laboratory;   cDNA,  one type of such synthetic DNA, contains only exons, which are crucial for, among other applications, cancer testing.

Respondent Myriad Genetics, Inc. (“Myriad”) discovered the precise location and sequence of the genes BRCA1 and BRCA2, mutations of which can substantially increase the risks of breast and ovarian cancer.  Once Myriad discovered the location of these genes, it was able to develop medical tests to detect mutations in these genes, thereby determining whether the patient had an increased risk of certain kinds of cancer.  Upon identifying the location and sequence of these genes, Myriad obtained several patents. Some of the patents were for the sequencing of the BRCA1 and BRCA2 genes; other patents claimed the isolated DNA sequences themselves; while other patents covered the creation of the cDNA and the cDNA per se.  Nine composition claims from three of these patents were at issue in Myriad.

Upholding the validity of Myriad’s patents would have sustained Myriad’s exclusive right to isolate the BRCA1 and BRCA2 genes and to perform testing for these genes.  These patents, if upheld, would also have granted Myriad the exclusive right to create the BRCA cDNA, a synthetic version of the BRCA gene.

Prior to the issuance of these patents to Myriad, entities besides Myriad offered testing for the BRCA genes.  However, after the issuance of patents to Myriad, including the patents at issue, Myriad objected to competitors’ testing activity, claiming that such activity infringed Myriad’s patents. Myriad eventually became the only entity to offer testing for the BRCA genes.  Several doctors, patients, and advocacy groups then filed suit, seeking a declaration that Myriad’s patents were invalid under 35 U.S.C. §101 since the patents covered products of nature, which the petitioners claimed were not patentable under prevailing law.

The CAFC held that both the DNA isolated from cells and the cDNA created in the lab were eligible for patent protection under 35 U.S.C. § 101.


35 U.S.C. §101 provides in part that “[w]hoever invents or discovers any new and useful . . . composition of matter, or any new and useful im­provement thereof, may obtain a patent therefor, sub­ject to the conditions and requirements of this title.”  However, laws of nature and natural phenomena are not patentable since granting patents on such laws and phenomena would inhibit future innovation premised upon them, which would defeat the purpose of patent issuance.  See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (March 20, 2012) and Diamond v. Chakrabarty, 447 U.S. 303 (1980).

At issue in the instant case was whether Myriad’s patents claimed any new and useful composition of matter under 35 U.S.C. §101 or whether the patents claimed only natural phenomena which are not patentable.  In short, did Myriad invent anything?


On appeal, the Supreme Court reversed in part and affirmed in part.

Regarding Myriad’s patent claims relating to isolating and identifying BRCA1 and BRCA2, the Court noted that Myriad did not create or alter genetic information encoded in the BRCA genes or in the genetic structure of DNA.  If Myriad had created a new method for manipulating genes while searching for BRCA1 and BRCA2, or if it had altered the genetic code, Myriad’s discoveries might have been patentable. (The Court did not address these issues.)  However, since Myriad merely isolated and identified the precise location of matter that already exists naturally in the human body, the Court reasoned that although separating the BRCA genes from their surrounding genetic material is an innovative and brilliant discovery, such activity does not constitute an act of invention and is not patentable.  See Funk Broth­ers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127 (1948).

The Court then turned its attention to Myriad’s claims in connection with the creation of cDNA.  The creation of cDNA occurs in the laboratory and results in an exons-only molecule.  The Court noted that the cDNA molecule does not occur in nature and is distinct from the naturally occurring DNA from which it is derived.  Accordingly, the Court concluded that since the cDNA is not a product of nature, but rather is synthetically manufactured, it is a new creation, and therefore patentable under 35 U.S.C. §101.  The Court therefore sustained Myriad’s patent claims regarding the cDNA that Myriad had created.
This article is provided for educational, informational and non-commercial purposes only. The content of this article is not intended to provide legal advice on any subject matter and should not be relied on as such.

Share this post