The Supreme Court has held that “a naturally occurring DNA segment” in isolated form is a product of nature and is, therefore, not patent eligible under 35 U.S.C. § 101, whereas cDNA is patent eligible because it is not naturally occurring. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___ (June 13, 2013) (“Myriad”).
Myriad Genetics, Inc. (Myriad), discovered the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer and obtained a number of patents based upon its discovery. Claims from three of these patents were at issue, requiring the Court to resolve whether (i) a naturally occurring segment of deoxyribonucleic acid (DNA) (also known as genomic DNA) is patent eligible by virtue of its isolation from the rest of the human genome and (ii) synthetically created DNA known as complementary DNA (cDNA), which only contains the protein-coding sequences (exons) found in a segment of natural DNA but omits the intervening portions within the natural DNA segment that do not code for proteins (introns) is also patent eligible.
An assortment of medical organizations, researchers, genetic counselors, and patients challenged the patents. The U.S. District Court for the Southern District of New York granted summary judgment that isolated DNA molecules were not patent eligible under 35 U.S.C. § 101. Myriad appealed, and the Federal Circuit reversed. The Association for Molecular Pathology (“AMP”) petitioned for a writ of certiorari to the Court, which remanded the case back to the Federal Circuit for further consideration in light of Mayo Collaborative Services v. Prometheus, Inc., 132 S. Ct. 1289 (2012). The Federal Circuit again held that claims to isolated DNA molecules, including isolated genomic DNA, cDNA, and short DNA probes, fall within the scope of 35 U.S.C. § 101. AMP again petitioned for certiorari with respect to the second Federal Circuit decision, and the Court’s decision arises from the grant of the second certiorari.
The Court held that Myriad’s isolated genomic DNA claims fall within the law of nature exception to 35 U.S.C. § 101, i.e., they are unpatentable, because those DNAs are present naturally in cells. According to the Court, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes; Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. Further, in the Court’s opinion, Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together. Finally, Myriad’s argument that the Patent and Trademark Office’s (PTO’s) past practice of awarding gene patents is entitled to deference failed in the Court’s eyes because Congress has not endorsed the views of the PTO in these matters, and, in fact, the United States, in its brief, argued that isolated DNA was not patent eligible under §101.
The Court, however, also held that cDNA is not a “product of nature,” and is thus patent eligible under §101. According to the Court, creation of cDNA results in an “exons-only molecule,” which is not naturally occurring and thus is patent eligible under §101 (except insofar as a cDNA molecule may have the same chemical sequence as a naturally occurring DNA segment (i.e., when there are no introns in the naturally occurring DNA)).
The Court stressed that this decision is limited in scope and does not implicate method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.
Impact of the Decision
It is estimated that approximately 12,000 U.S. patents owned by private commercial companies, government, universities, and non-profit organizations have claims to naturally occurring DNA molecules, and about 8,700 of these patents remain in force as of May 2013. These estimates do not account for other patents that, for example, claim isolated proteins, and that may be affected by this decision as well. These patents are in fields as diverse as human medicine, veterinary medicine, agriculture, food and beverage manufacturing, biochemicals and enzyme manufacturing, and bioenergy. Interestingly, in humans, it is estimated 94% of the genes are interrupted by, on average, seven introns. In contrast, however, only 5% of the genes are interrupted by introns in yeast, a unicellular organism that is utilized extensively in the biotechnology industry. Accordingly, human cDNA claims may have an easier time getting over the patent eligibility hurdle as compared to yeast cDNA claims. Thus, while the scope of the Court’s decision may be broad, its impact may be variable.
In addition, as a consequence of the Court’s decision, there may be an up-tick in reissue filings by patent holders attempting to obtain narrower cDNA coverage and inter partes review requests by competitors/licensees seeking to invalidate previously issued genomic DNA claims (particularly in view of the recent first decision by the USPTO’s new Patent Trial and Appeal Board under the America Invents Act invalidating business method claims also under 35 USC § 101).