Yesterday, the U.S. Supreme Court issued its much anticipated decision in Myriad (Association for Molecular Pathology v. Myriad Genetics). The Court held that naturally occurring DNA segments are products of nature and not patent eligible merely because they have been "isolated." In contrast, the Court held that certain types of synthetic DNA, referred to as cDNA, are patent eligible if distinguishable from natural DNA. Notably, the Court left several questions unanswered by remaining silent on patent eligibility of many commercially relevant forms of synthetic DNA and not addressing the issue of "isolated" molecules more broadly beyond DNA.
The decision is significant, but it does not mean the end for the diagnostics industry and other industries utilizing genomic techniques. The bottom line is: claims to isolated DNA segments that exist in nature are not patent eligible and there likely will be more litigation addressing unresolved issues as to the scope of patent eligibility around synthetic nucleic acids and isolated molecules generally.
In an opinion delivered by Justice Thomas, the Supreme Court addressed whether naturally occurring segments of deoxyribonucleic acid (DNA) are patent eligible under federal statute (35 U.S.C. §101).
The patents at issue, held by Myriad, relate to the discovery of BRCA1 and BRCA2 genes and mutations in these genes that are indicative of an increased risk of breast and ovarian cancers. Myriad offers diagnostic testing in which it evaluates patients' BRCA genes to determine whether they have mutations associated with increased cancer risk. Myriad has essentially been the only entity offering this testing and has leveraged its patents to stop others from practicing similar tests to evaluate the BRCA genes. This lawsuit began when a group of researchers, medical patients, advocacy groups, and doctors interested in Myriad's testing sought a declaration that Myriad's patents are invalid under §101.
In 2010, the U.S. District Court for the Southern District of New York granted summary judgment on Myriad's isolated DNA claims, concluding that the claims were invalid because they covered products of nature. On appeal, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) reversed, taking the view that isolated DNA is not a product of nature because "isolated" indicates that the DNA has been altered from its natural state due, for example, to cleavage of covalent bonds to isolate the DNA from its natural environment. The Federal Circuit acknowledged that the patents at issue contain both claims encompassing isolated DNA having a sequence present within natural genomic DNA and claims encompassing cDNA having a sequence not found within natural genomic DNA. The Federal Circuit took the view that claims covering either DNA or cDNA, in their isolated forms, are patent eligible.
In 2012, the Supreme Court granted a petition by the plaintiffs for a writ of certiorari, vacating the Federal Circuit's judgment and remanding the case for further consideration in light of its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (see our alert here). After rehearing the case, the Federal Circuit reaffirmed its ruling concerning isolated DNA.
The second time around, the Supreme Court disagreed with the Federal Circuit that "isolating" is sufficient to render DNA patent eligible. Citing its decision in Funk Brothers, the Court reiterated that discovery of a natural principle itself does not meet the §101 patent eligibility standard. Rather, as the Court held in Charkrabarty, for a composition to be patent eligible it must be a "product of human ingenuity having a distinctive name, character and use" with "markedly different characteristics from any found in nature." According to the Court, although Myriad discovered the genomic location of an important and useful gene, "separating that gene from its surrounding genetic material is not an act of invention."
Moreover, according to the Court, Myriad's claims were not "saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a non-naturally occurring molecule." Rather, the Court viewed the claims as being "concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule." For example, the Court pointed out that Myriad's claims "are not expressed in terms of chemical compositions or did not rely on chemical changes that results of isolating particular sections of DNA," suggesting that if the claims recited chemical features that distinguish DNA produced in a lab from natural DNA, they might have passed muster under §101.
The Supreme Court also dismissed Myriad's arguments that deference should be given to the U.S. Patent and Trademark Office (PTO) and its long-standing practice of claiming isolated nucleic acids, pointing that Congress had not endorsed the views of the PTO through legislation and that the United States, as Amicus Curiae, holds the position that isolated DNA should not be patent eligible under §101.
With regard to Myriad's isolated cDNA claims, the Court held that, to the extent cDNA is distinguishable from natural DNA, it is not a "product of nature" and thus is patent eligible under §101.
What This Means to You
The decision is significant because it clarifies that mere isolation is not enough to render claims to naturally occurring DNA patent eligible and because, in effect, it upholds the Court's precedent concerning the patent eligibility of compositions of matter as it relates to products of nature.
The decision leaves open the question of patent eligibility of numerous commercially relevant forms of nucleic acids. These unresolved issues likely will be addressed in subsequent litigations. However, primers, probes, therapeutic oligonucleotides, and other nucleic acids that include non-natural chemical modifications, such as sequence tags and modified backbones or nucleotides, are likely to remain patent eligible. It may be a closer call for synthetic nucleic acids that only have naturally occurring sequences and that are not chemically modified in any way or otherwise distinguishable from natural occurring DNA.
Some patent holders having broad claims to isolated DNA may consider having those patents reissued with narrower claims. Prospective licensees may urge for more favorable royalty terms, whereas existing licensees may seek to renegotiate licenses for more favorable terms. Alleged infringers may be more comfortable challenging validity of the patents under § 101 based on the decision. In general, the ruling may embolden companies to offer further genome sequencing or diagnostic tests because they may perceive a reduced risk of patent infringement.
Finally, because the Court emphasized that "isolation" is not sufficient to render natural DNA fragments patent eligible, the implication of this decision on the patent eligibility of other isolated molecules -- such as isolated RNAs, polypeptides (including antibodies and therapeutic proteins), and others -- is unclear and likely will be addressed in future litigations.