On Thursday, June 14, 2013, the United States Supreme Court unanimously ruled that the isolated form of naturally occurring DNA molecules does not rise to the level of patent-eligible subject matter. The ruling likely invalidates numerous issued patent claims directed to isolated DNA sequences. However, the Court also held that claims directed to complementary DNA (cDNA) molecules are patent-eligible because cDNA is not naturally occurring.
The decision, Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ____ (2013), was appealed to the Supreme Court after two decisions by the Court of Appeals for the Federal Circuit affirming the patent eligibility of Myriad’s claims to isolated DNA sequences encoding the human breast cancer genes BRCA1 and BRCA2. The second decision of the Federal Circuit resulted from a remand by the Supreme Court following the unanimous Prometheus v. Mayo decision, holding that a natural correlation between blood metabolite levels and patient health was not patent-eligible. The Federal Circuit panel decided, 2-1, that the act of isolating a specific sequence of nucleotides from a chromosome was an inventive act that entitled Myriad to patent protection for claims directed to the isolated DNA molecule.
In overruling the Federal Circuit, and finding Myriad’s claims to the isolated form of naturally occurring DNA molecules invalid as a product of nature, the Supreme Court focused on the informational content of the isolated DNA. The Court stated, “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.” The Court found that the information contained in the isolated DNA molecule was not markedly different from that naturally found in the human chromosome. As a result, the Justices were unable to identify a difference between the naturally occurring form of the breast cancer genes and the corresponding isolated form that met the standards of patent eligibility.
Myriad argued that isolating DNA from chromosomes creates a structurally different DNA molecule that does not exist in nature, and that should be available for patent protection. Although Justice Thomas, writing for the Court, recognized that the isolated form of DNA is not a naturally occurring molecule, he dismissed this distinction, stating that the claims do not rely on chemical changes resulting from the isolation of DNA. Instead, the opinion of the Court again pointed out that the informational content of the naturally occurring BRCA1 and BRCA2 molecules is the same as that of the isolated form of the molecules. Thus, the Court did not consider the structural differences between isolated and naturally occurring DNA, a distinguishing feature that would remove isolated DNA molecules from the “product of nature” exclusion of patent-eligible subject matter.
In holding isolated cDNA molecules patent-eligible, the Court recognized the differences between human chromosomal DNA and the corresponding cDNA. Because the non-coding regions of naturally occurring chromosomal DNA have been removed in cDNA, the Court accepted that cDNA is not a product of nature and, therefore, patent-eligible subject matter. However, the Court pointed out that cDNA is only patenteligible insofar as it is different from the corresponding chromosomal DNA. Thus, cDNA from species not having introns (i.e., bacteria) will now likely be outside of the scope of patent-eligible subject matter.
Although the Myriad decision limits the ability of applicants to broadly claim the isolated form of naturally occurring DNA sequences, other claiming options remain available for protecting gene-based inventions. In fact, the Court specifically points out that other claiming strategies for isolated DNA and applications of knowledge about the BRCA1 and BRCA2 genes were not considered in the opinion. However, an important consequence of this ruling might be a limitation on claiming isolated polypeptides having the same sequence as the corresponding naturally occurring equivalent.
Myriad represents the third Supreme Court decision in recent years narrowing the scope of patent-eligible subject matter under §101. With the recent enactment of the America Invents Act, it is unlikely that the United States Congress will revisit patent reform anytime soon. While the ruling restricts the protection of isolated DNA molecules, claims drawn to the use of DNA molecules and transgenic organisms remain patent-eligible.
To view the Myriad opinion, please go to the Supreme Court’s website.