Yesterday, the U.S. Supreme Court issued its anxiously awaited decision in Association for Molecular Pathology et al. v. Myriad Genetics, Inc., No. 12-398 (U.S. June 13, 2013). The Court addressed whether an isolated naturally occurring piece of DNA and/or synthetically created DNA called "cDNA" (corresponding to protein-coding parts of the DNA) are products of nature and thus ineligible for patent protection. The Court unanimously held that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," but agreed with the Federal Circuit that cDNA is patent eligible because "it is not naturally occurring."
At issue in the case were certain patent claims directed to the BRCA1 and BRCA2 genes — the discovery of which was an undeniable medical breakthrough. Because mutations in these genes strongly correlate with risk of breast and ovarian cancer, the identification of the BRCA1 and BRCA2 genes provided a simple and effective way to test, for the first time, whether patients were at hereditary risk for developing the disease. Myriad, the patent holder in the case, is the company that first successfully isolated and sequenced these genes and brought a diagnostic product to market. Myriad obtained a series of patents, including claims to the isolated BRCA1 and BRCA2 genes, which in turn allowed Myriad to exclude others from isolating or using the genes and to set itself up as the only provider of BRCA testing. The underlying suit was brought by medical doctors, medical agencies, and patient advocacy groups, who argued that isolated DNA and cDNA are not patentable subject matter. The district court agreed, but the Federal Circuit reversed, including after remand in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ____ (2012).
In its unanimous decision, the Supreme Court continued to look at the specific language of the claims as a whole in determining patent eligibility. In reviewing Myriad’s patent, the Court found the isolated DNA claims as drawn to the genetic code to be the same as native DNA, and it therefore concluded that they fell within the "law of nature" exception under which laws of nature, natural phenomena, and abstract ideas are not patentable. The Court held that although Myriad found an important gene, it did not create anything in doing so and therefore these claims were not patentable.
In reaching its decision, as in its recent Bowman decision in another complex biotechnology case, the Court was equally careful to state what it was not holding:
First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. . . .
Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. . . .
Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. . . .
Slip Op. at 17, 18. The Court concluded: "We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material." Id. at 18.
A corollary aspect of the Court’s opinion is that, in sharp contrast to Judge Newman’s recent dissent in CLS Bank, International v. Alice Corp. Pty. Ltd., No. 2011-1301 (Fed. Cir. May 10, 2013) (en banc), the Court’s Myriad decision suggests that a patent eligibility analysis under §101 of the Patent Act may be an issue for district courts to determine, separate from the "other statutory requirements of patentability. See 35 U.S.C. §§ 102, 103, and 112." Myriad, Slip Op. at 17 n.9. If so, one wonders whether we will soon be having Myriad hearings to determine patent eligibility prior to Markman hearings for claim construction.
There is little doubt the ramifications of this decision will be substantial. For example, although the Court said it was "merely hold[ing]" that only "genes and the information they encode" are not patent eligible, its reasoning suggests a broader reach. At minimum, it would seem that any isolated forms of naturally occurring compounds will be ineligible for patent protection. And the decision is also likely to have significant ramifications on the novelty and obviousness of biotech patents, such as those claiming recombinant genes that rely on the isolated gene, or an isolated chemical compound that demonstrates certain activity.
To read a full copy of the opinion, click here.