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Today, the U.S. Supreme Court ruled that naturally occurring DNA is a product of nature and, as such, is not patentable. Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (U.S. June 13, 2013). However, according to the Court, complementary DNA (cDNA)—which is a synthetic gene construct that contains the same protein-coding nucleic acid base pairs found in naturally occurring DNA but omits the non-coding regions of a gene—is patent eligible because it is not naturally occurring. The Court delivered its ruling in the context of a challenge to patents that Myriad Genetics obtained after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer in humans.

The Supreme Court has previously held that “anything under the sun made by man” can be patented if it meets the Patent Act’s criteria of novelty, usefulness, and non-obviousness. However, the Court has long recognized that a product of nature–in simplified terms, a naturally existing composition of elements and materials–is not patentable. Determining whether a claimed invention is really a product of nature has often proved difficult for lawyers, patent examiners, and judges.

In the present case, Justice Clarence Thomas, who wrote the Court’s majority opinion, held that merely isolating the specific BRCA1 and BRCA2 genes did not constitute a patentable invention: “Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes . . . patent eligible.” According to the Court, “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

The Court determined that cDNA is not inherently unpatentable because it is not a product of nature:

cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments…. [C]reation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring…. [T]he technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101 [of the Patent Act], except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

Justice Thomas’s opinion notes three important limitations on the Court’s holding. First, there were “no method claims before this Court.” Thus, if Myriad had “created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. Second, the Court observed that the case did “not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes.” Third, the Court did not consider “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.” Instead, the Court’s primary holding was limited to the proposition “that genes and the information they encode are not patent eligible under §101 [of the Patent Act] simply because they have been isolated from the surrounding genetic material.”

by Shawn N. Sullivan, June 13, 2013.

A judge of the Federal Court of Australia held that naturally-occurring DNA and RNA sequences isolated from the human body may be patented under Australian law. Cancer Voices Australia v. Myriad Genetics Inc. [2013] FCA 65 (Austr. Fed. Ct. Feb. 15, 2013). The case involved a challenge to Myriad Genetics’s Australian Patent No. 686004 on the isolated BRCA1 gene and corresponding RNA, whose presence in humans indicates a predisposition to breast and ovarian cancer. Notably, Myriad’s US patent on the BRCA1 gene is currently the subject of a patent validity challenge in the U.S. Supreme Court.

BASIS OF THE PATENT CHALLENGE. As explained by the court, Myriad’s patent claims related to “isolated” nucleic acids, which the court defined as “naturally occurring nucleic acid found in the cells of the human body, whether it be DNA or RNA, [that] has been removed from the cellular environment in which it naturally exists and separated from other cellular components also found there.” The challengers contended that Myriad had claimed an unpatentable “product of nature” because the patent did not indicate a substantial difference between the sequences of the claimed isolated nucleotides and the sequences of the same molecules as they exist in human cells. Their argument was that naturally occurring DNA and RNA, even in isolated form, cannot form the basis of a valid patent. The court disagreed.

“PRODUCT OF NATURE” INQUIRY FOUND “UNHELPFUL.” The court acknowledged that some patent authorities, including the U.S. Supreme Court, hold that “products of nature” are not capable of being patented. However, the court opined that, “in the field of biotechnology in which micro-organisms play a critical role in the development, manufacture and use of diagnostic and therapeutic products and techniques,” it is especially “unhelpful” to view the question of patentability in terms of whether the claimed invention is a “product of nature.” Indeed, Australian jurisprudence recognizes “a clear distinction … between the discovery of one of nature’s laws” –which is not patentable– “and of its application to some new and useful purpose”–which may constitute patentable subject matter.

“MANNER OF MANUFACTURE.” According to the court, the relevant inquiry for determining the patentability of Myriad’s claimed invention was whether the claims were directed to a “manner of manufacture” within the meaning of the applicable statute. Citing Re GEC’s Application (1943) 60 RPC 1, and National Research Development Corporation v Commissioner of Patents [1959] HCA 67 (1959), the court explained that “a product that consists of an artificially created state of affairs which has economic significance will constitute a ‘manner of manufacture.’” In the court’s view, this judicially-created definition “does not require the court to ask whether a micro-organism is ‘markedly different’ to something that already exists in nature for the purpose of deciding whether it constitutes patentable subject matter.” The court determined that the prerequisite of patentability–an “altered state of affairs” –may exist even if the isolated nucleotide sequences are identical to those that exist in nature. The court explained that,

In the context of biological material, an artificial state of affairs may manifest itself in different ways. The physical properties of the naturally occurring material may have changed as a result of it having been isolated. But even if the physical properties of the material have not changed, the removal of the material from its natural environment and its separation from other cellular components may still give rise to what might reasonably be described as an artificial state of affairs.

In my opinion the patentability of the isolated nucleic acids referred to in the disputed claims does not turn upon what changes have been made to the chemical composition of such substances as a result of them having been isolated. In particular, the question of whether these substances constitute patentable subject matter does not depend upon the type of chemical bond that may have been broken in the process of isolating them. It is inevitable that some bonds will be broken in the course of isolating nucleic acids, but it is not apparent from the evidence that these will necessarily include covalent bonds.

The court elaborated on the notion that isolation of a naturally-occurring gene by itself is sufficient to constitute a manner of manufacture:

[I]n the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and “isolated” nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell. Extraction of nucleic acid requires human intervention that necessarily results in the rupture of the cell membrane and the physical destruction of the cell itself. And purification of the extracted nucleic acid requires human intervention that results in the removal of other materials which were also originally present in the cell. It is only after both these steps are performed that the extracted and purified product may be properly described as “isolated” in the sense that word is used in the disputed claims.

CONCLUSION. The court found that its interpretation of the applicable law was supported by recent legislative history, the practice of the Australian Patent Office, and by a 2004 report of the Australian Law Reform Commission regarding gene patents. Accordingly, the court overruled the objections to Myriad’s patent and concluded:

There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent. However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells. The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated.

by Shawn N. Sullivan, February 28, 2013.