Association for Molecular Pathology Et Al.  vs. Myriad Genetics, Inc., Et Al.

Patentability of BRCA genes


The case involved patents filed by Myriad. Myriad discovered the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes. Mutations in these genes can dramatically increase an individual’s risk of developing breast and ovarian cancer. The case involved claims from three of them and question before the Court was whether a naturally occurring segment of deoxyribonucleic acid (DNA) is patent eligible under 35 U. S. C. §101 by virtue of its isolation from the rest of the human genome.

 Also the question of the patent eligibility of synthetically created DNA known as complementary DNA (cDNA), which contained the same protein-coding information found in a segment of natural DNA but omit portions within the DNA segment that do not code for proteins. Before Myriad’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. Myriad identified the exact location of the BRCA1 andBRCA2 genes on chromosomes 17 and 13. Within those chromosomes, the BRCA1 and BRCA2 genes are each about 80,000 nucleotides long. Knowledge of the location of the BRCA1 and BRCA2 genes allowed Myriad to determine their typical nucleotide sequence. That information, in turn, enabled Myriad 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. Once it found the location and sequence of the BRCA1and BRCA2 genes, Myriad sought and obtained a number of patents. Nine composition claims from three of those patents were at issue in the present case.

 The Supreme Court observed that Myriad’s patents would, if valid, 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 Myriad the exclusive right to synthetically create BRCA cDNA. In Myriad’s view, manipulating BRCA DNA in either of these fashions triggers its “right to exclude others from making” its patented composition of matter under the Patent Act. 35 U. S. C. §154(a)(1).

But the Supreme Court observed that isolation is necessary to conduct genetic testing, and Myriad was not the only entity to offer BRCA testing after it discovered the genes. The University of Pennsylvania’s Genetic Diagnostic Laboratory (GDL) and others provided genetic testing services to women. Petitioner Dr. Harry Ostrer, then a researcher at New York University School of Medicine, routinely sent his patients’ DNA samples to GDL for testing. After learning of GDL’s testing and Ostrer’s activities, Myriad sent letters to them asserting that the genetic testing infringed Myriad’s patents. In response, GDL agreed to stop testing and informed Ostrer that it would no longer accept patient samples. Myriad 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. Myriad, thus, solidified its position as the only entity providing BRCA testing.

Some years later, petitioner Ostrer, along with medical patients, advocacy groups, and other doctors, filed the present lawsuit seeking a declaration that Myriad’s patents are invalid under 35 U. S. C. §101. Citing the Supreme Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U. S. 118 (2007), the District Court denied Myriad’s motion to dismiss for lack of standing. Association for Molecular Pathology v. United States Patent and Trademark Office, 669 F. Supp. 2d 365, 385–392 (SDNY 2009). The District Court then granted summary judgment to petitioners on the composition claims at issue in the case based on its conclusion that Myriad’s claims, including claims related to cDNA, were invalid because they covered products of nature. The Federal Circuit reversed, Association for Molecular Pathology v. United States Patent and Trademark Office, 653 F. 3d 1329 (2011), and the Supreme Court granted the petition for certiorari, vacated the judgment, and remanded the case in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc.

On remand, the Federal Circuit affirmed the District Court in part and reversed in part. All three judges agreed that only petitioner Ostrer had standing. They reasoned that Myriad’s actions against him and his stated ability and willingness to begin BRCA1 and BRCA2 testing if Myriad’s patents were invalidated were sufficient for Article III standing.

With respect to the merits, the court 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 agreed that patent claims relating to cDNA met the patent eligibility requirements of §101.

 The Supreme Court observed that it is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. 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. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether it rendered the genes patentable.

Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry [Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127 (1948)].

Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, did not render the BRCA genes “new compositions of matter,” §101, that are patent eligible.

Myriad sought to import extensive research efforts into the §101 patent ¬eligibility inquiry. But extensive effort alone is insufficient to satisfy the demands of §101. Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a non naturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule. The Supreme Court also rejected Myriad argument that the PTO’s past practice of awarding gene patents is entitled to deference.

 Regarding cDNA, the Court observed that cDNA did not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Creation of a cDNA sequence from mRNA result in an exons-only molecule that is not naturally occurring.  Petitioners conceded that cDNA differed from natural DNA in that “the non-coding regions have been removed.” But they argued that cDNA is not patent eligible because “the nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” That may be so, but the lab technician unquestionably created something new when cDNA is made. cDNA retained the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

The Supreme Court thus held that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material. The judgment of the Federal Circuit was thus affirmed in part and reversed in part.