The Supreme Court of the United States today issued its opinion in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al., 569 U.S. ____ (2013), concerning the patentability of human genes. The Court ruled that genomic DNA, isolated from the human genome by the breaking of chemical bonds, is not eligible for patent protection. In contrast, the Court held that complementary DNA (“cDNA”), having sequences different to those occurring in nature, is patentable subject-matter.
The domestic context. Given the landmark nature of its novel findings, although Myriad is a decision of a foreign court, under a different legal system, it is certain to be of interest to the Canadian biotechnology industry, the intellectual property profession in Canada, government policy makers, and others.
As in the United States, it has long been understood in Canada that newly discovered genes are patentable on the basis that what is claimed is essentially a new chemical entity that is isolated from its native milieu—it is new and useful and, at least by virtue of its isolation, cannot be considered a product of nature. To the author’s knowledge, no Canadian court has questioned the patentability of isolated DNA, and the Canadian Patent Office has for many years granted claims to isolated gene sequences and continues to do so.
Myriad is nevertheless very interesting from the Canadian perspective given the similarity of the definition of “invention” in section 2 of the Canadian Patent Act to the relevant provisions of the US statute, on which the Court’s findings in Myriad are based. Indeed, the Canadian Patent Act finds its roots in, and is largely modeled on the early US legislation.
In view of these considerations, not only will Myriad be of interest to Canadians with respect to their intellectual property rights in the US, but it may provide important clues for future developments—or prospects to be avoided—here in Canada.
Background. Myriad discovered the precise location and sequence of the BRCA1 and BRCA2 genes, mutations in which can substantially increase a person’s risk of developing breast and ovarian cancer. Myriad obtained patents relating to these genes, and two types of claims were considered by the Court.
Claims of the first type concerned isolated native or genomic DNA encoding BRCA polypeptides—i.e. DNA isolated from the human genome by the breaking of chemical bonds.
Claims of the second type were in contrast directed to cDNA—synthetic DNA produced by the reverse transcription of the messenger RNA (“mRNA”) encoding the BRCA polypeptides. Because mRNA does not contain the non-coding “intron” sequences that are found in genomic DNA, these intron sequences are also absent from the cDNA copy, such that cDNA has a nucleotide sequence different from that found in genomic DNA.
The Court noted that Myriad’s patents would, if valid, give Myriad the exclusive right to isolate an individual’s BRCA genes by breaking the chemical bonds connecting the DNA to the rest of the individual’s genome—this was important, as the Court noted that isolation of DNA is necessary to conduct genetic testing. Myriad’s patents would also give Myriad the exclusive right to synthetically create BRCA cDNA.
The scope of subject matter eligible for patent protection is defined broadly in section 101 of the U.S. Patent Act, which provides, in part, that “[w]hoever invents or discovers any new and useful . . . composition of matter, or any new and useful improvement thereof, may obtain a patent therefor….” However, it has long been held that “laws of nature, natural phenomena, and abstract ideas” are not patentable.
Finding. The Court concluded that Myriad’s claims to isolated DNA were directed to unpatentable naturally occurring phenomena or products of nature, noting that: (1) Myriad did not create or alter the genetic information encoded in the BRCA genes; (2) the location and order of the nucleotides existed in nature before Myriad found them; and (3) Myriad did not create or alter the genetic structure of DNA. In reaching the conclusion that “Myriad did not create anything”, the Court considered that Myriad’s “principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 7 and 13.”
Arguments that isolating DNA from the human genome severs chemical bonds and thereby create a non-naturally occurring molecule were not found persuasive, the Court holding that Myriad’s claims were not expressed in terms of chemical composition, nor did they rely on chemical changes resulting from isolation of a particular section of DNA—rather the claims focused on the genetic information encoded by the BRCA genes.
Myriad argued that the Patent Office’s past practice of awarding gene patents was entitled to deference—indeed, a major point of public commentary has been the effect of a finding of non-patentability on the established expectations of the biotechnology industry. But the Court was not persuaded on this point.
The Court dealt with the cDNA claims in short order, finding that the creation of a cDNA sequence from mRNA results in an exon-only molecule that is not naturally occurring. Accordingly, the Court held that cDNA is not a “product of nature” and consequently is patent eligible.
The Court also noted what was not covered by its decision. No method claims were at issue, and the Court noted that, had Myriad discovered an innovative method of manipulating genes while searching for the BRCA genes, perhaps this could have been patented. Also, the Court’s decision did not involve patents on new applications of knowledge about BRCA1 and BRCA2, the subject of many of Myriad’s unchallenged claims.
Finally, and likely very importantly, the Court emphasized that “[w]e 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.” The patentability of DNA in which the order of the naturally occurring nucleotides has been altered was not at issue.
Looking ahead. Myriad appears to reflect a very dramatic reversal in an important aspect of biotechnology patenting. It is perhaps early to speculate as to the consequences of this decision in the biotechnology industry in Canada or elsewhere, which has developed alongside a longstanding practice of patenting isolated genes. Perhaps it will be of little consequence in areas in which genetic material is indisputably altered from its natural state, such as with cDNA, as exemplified in Myriad. But where a key aspect of an invention or its industrial application involves the original identification and isolation of native DNA itself, the decision may be of greater consequence. Indeed, the Court appears to have acknowledged that Myriad’s isolation of the BRCA genes resulted from “extensive research efforts” and, as mentioned above, that “isolation is necessary to conduct genetic testing”, which appears to be a case in point. More broadly, there is perhaps the prospect that the decision would have relevance in the case of other biomolecules (e.g. proteins) where patentability has historically been acknowledged based on isolation or purification.