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Plaintiffs Challenging Myriad's Aussie BRCA Patent Will Appeal Federal Court's Dismissal of Case

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Originally published Feb. 19.

Cancer Voices Australia, a patient group legally challenging Myriad Genetics' patent covering mutations in the BRCA1 gene linked to increased risk of hereditary breast and ovarian cancer, will likely appeal a federal court's recent decision to dismiss the case.

The Federal Court of Australia last week deemed that Myriad's patent on isolated gene sequences is valid under the country's laws outlining patentable subject matter.

Under Australian patent law, human beings and the biological processes involved in the creation of human beings are not patentable, but any "manner of manufacture," as well as claims that are novel, inventive, and useful, are patentable. "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," Federal Court Justice John Nicholas wrote in dismissing the case, Cancer Voices Australia v Myriad. "However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells."

In this case, the plaintiffs, Cancer Voices Australia and Yvonne D'Arcy, represented by law firm Maurice Blackburn, are challenging the validity of Myriad's Australian patent, entitled "In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene." The plaintiffs brought their lawsuit against Myriad in 2010, after a US federal district court ruled that several of Myriad's BRCA patents underlying its BRACAnalysis test were not patentable (PGx Reporter 3/31/2010).

The Australian patent at issue (No 686004) covers "an isolated polynucleotide comprising all, or a portion of the BRCA1 locus or of a mutated BRCA1 locus, preferably at least eight bases and not more than about 100 kb in length." The patent, held by Myriad, Centre de Recherche de Chul in Canada, and the Cancer Institute in Japan, was licensed to Australian testing services firm Genetic Technologies.

The plaintiffs have argued that the challenged patent is invalid because DNA and RNA isolated from the body are not materially different from DNA or RNA occurring inside the body, and as such, the isolated gene fragments are products of nature that cannot form the basis of a valid patent. The defendants, meanwhile, have maintained that the claims in the disputed patent are valid because they cover "an artificial state of affairs, providing a new and useful effect that is of economic significance," Justice Nicholas wrote. "The respondents rely on evidence said to show that nucleic acid found in a human cell differs chemically, structurally and functionally from the isolated nucleic acid of the disputed claims."

Despite the Federal Court's ruling to dismiss, the plaintiffs remain steadfast in their efforts to end the practice of patenting isolated gene sequences. "The process for seeking to overturn the decision in Australia is to lodge an appeal to the full Federal Court," Rebecca Gilsenan, a lawyer at Maurice Blackburn representing the plaintiffs, told PGx Reporter. "At this stage I can say an appeal is likely and we will make an announcement" in the next two weeks.

In deciding the case, Justice Nicholas relied heavily on the Australia High Court's decision in National Research Development Corporation v Commissioner of Patents, which was a key case that clarified the term "manner of manufacture" in terms of patentable subject matter. This case arose when the NRDC applied for patents to apply known chemicals as a substance to kill weeds but not crops. The chemical, although known in terms of its composition, had not been used for this specific purpose. The Commissioner of Patents rejected NRDC's patent, saying that the claimed invention was an agricultural process and not a "manner of manufacture," and that it involved only a new use of an already known substance.

The NRDC appealed to the High Court, which upheld its patent, reasoning that the NRDC discovered new, weed-killing properties of a known chemical through scientific ingenuity and therefore made the substance patentable. As such, the High Court held that it was the process or the manner of manufacture that made the substance useful for this purpose, not solely the chemical itself. Furthermore, the High Court said that the patent claimed a product developed out of an "artificially created state of affairs," in that the inventors had to observe the chemicals' effect on weeds versus crops

Using the NRDC decision as a springboard, Justice Nicholas reasoned in the BRCA case that isolated gene sequences claimed in Myriad's patents are a manner of manufacture in that they constitute an artificially created state of affairs. "In 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," he wrote in his decision.

"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," Justice Nicholas continued. "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."

Although Australian and US law differ substantially in terms of what is considered patentable, the arguments used by the plaintiffs and defendants in the Aussie and US gene patent challenges are alike. For example, the plaintiffs' focus on the similarities between naturally occurring DNA and isolated DNA in the information they contain about the association with disease to assert that the isolated gene fragments aren't a manner of manufacture mirrors the reasoning used by the US Federal District Court Judge Robert Sweet three years ago in invalidating several of Myriad's patents on isolated BRCA1/2 gene sequences.

In his March 2010 decision, Sweet ruled that isolated DNA containing BRCA1/2 gene sequences, as described in Myriad's patents, is not markedly different from gene sequences naturally occurring in the body in function or in the information they contain. Naturally occurring substances are not patentable under US patent law 35 USC Section 101. Sweet's decision has since been partly overturned by the US Court of Appeals for the Federal Circuit with regard to the patent eligibility of isolated gene sequences (PGx Reporter 8/22/2012).

However, plaintiffs in the US have pursued the case, entitled Association for Molecular Pathology et al. v. USPTO, up to the US Supreme Court, which is slated to hear the case on April 15. In that lawsuit, researchers and patients represented by the American Civil Liberties Union and the Public Patent Foundation are challenging a number of claims in several BRCA patents held by the University of Utah and exclusively licensed to Myriad.

In the US, 35 USC Section 101 states that inventors can patent a "new and useful process, machine, manufacture, or composition of matter," or an improvement upon such things. However, patentable subject matter is then held up against three judicial exceptions to Section 101, in order to ensure that the claimed invention isn't an abstract idea, a natural phenomenon, or a law of nature. The plaintiffs in AMP v USPTO assert that Myriad's patents on isolated gene fragments claim naturally occurring substances.

As AMP v USPTO has made its way up the hierarchy of the US court system, the Supreme Court has decided a number of cases, mainly Mayo v Prometheus and Bilski v Kappos, which will likely have significant bearing on how it resolves the questions surrounding the patentability of genes.

In Mayo v Prometheus, a case that invalidated method patents held by Prometheus Labs, the Supreme Court emphasized that "an application of a law of nature … to a known structure or process may [deserve] patent protection," but in order to transform a law of nature into something worthy of a patent, the applicant "must do more than simply state the law of nature while adding the words 'apply it.'"

Moreover, in Bilski v Kappos, a case challenging the patentability of a business method, the Supreme Court invalidated the patent as an abstract idea, but held that the so-called machine-or-transformation test is not the sole test of patent eligibility under the criteria laid out under Patent Act 35 USC Section 101.

Plaintiffs in the Australia case are closely watching the outcome of the US lawsuit. "The relevant law in Australia and the US is not identical and a decision of the US Supreme Court in the gene patenting case will not bind an Australian court," Maurice Blackburn's Gilsenan said. "Having said that, I think that if the litigation is still on foot in Australia when the US Supreme Court decides AMP v UPSTO, the Australian court will likely take note of the reasons and conclusion of the US Supreme Court. At a less formal level, I think if the US Supreme Court decides in favor of the plaintiffs in AMP v UPSTO that that will boost the efforts of people and groups who advocate against gene patents in Australia."

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