The Myriad decision: Judicial criticism of the Bayh-Dole Act and its progeny?
By Kathryn R. James, Chapman University School of Law, Orange, CA
Recently, a federal court in New York ruled against the Utah-based biopharmaceutical research and development company, Myriad Inc .The issue in the case was whether or not patents held by Myriad over specific genes related to susceptibility to breast and ovarian cancer were valid under the Patent Act and the Constitution. The court’s rejection of the patents’ validity was unexpected by many, as the courts have typically upheld genetic patents as valid since 1980. Hence, while Myriad will almost certainly appeal, the decision potentially represents the beginning of a judiciary rejection – or, at the least, criticism - of the last 30 years of judicial and legislative encouragement of the commercialization of medicinal research and development .
Background and Decision
Myriad Inc. was formed in 1991 by Marc Skolnick (and a team of scientists) at the University of Utah’s Center for Genetic Epidemiology, who were one of many groups attempting to identify the BRCA 1 gene, which had recently been located by another group of scientists and was believed to be the first gene that could indicate hereditary susceptibility to breast and ovarian cancer. Myriad ostensibly was formed in order to procure significant funding so as to enable it to be the first to identify and thereafter patent all research and commercial uses for the BRCA 1 gene. Between 1994 and 1995, Myriad successfully obtained multiple patents over the exclusive use of the BRCA 1 gene , which led to Myriad’s discovery of and acquisition of patents over BRCA 2 between 1996 and 1998 .
The litigation against Myriad and the US Patent and Trademark Office was first brought in the Federal Court in 2009 by multiple plaintiffs assembled by the American Civil Liberties Union, including individual patients, companies, and broad-reaching organizations . The action sought to challenge the fifteen claims of seven patents held by Myriad that related to BRCA 1 and BRCA 2 , two genes whose mutations and the sequencing thereof are associated with breast and ovarian cancer susceptibility . The plaintiffs claimed that the isolation of the genes, the sequencing process to identify and classify mutations, and the diagnostic method employed for testing did not constitute patentable material even under the “broad scope” of the Constitution and the Patent Act .
On March 29, 2010, the Court struck down all seven patents as invalid, asserting that each failed to meet the requirements of 35 U.S.C.S. § 101 and 102 . Judge Robert W. Sweet delivered the opinion, stating “purification of a product of nature, without more, cannot transform it into patentable subject matter”, but instead the “purified product must possess markedly different characteristics in order to satisfy the requirements of 35 U.S.C.S. § 101.” The Court did not address the question of Constitutionality , as it asserted that the issue could be wholly adjudicated on the basis of patent law .
Much attention has been given to the possibility that this decision will reach the average patient by heightening access to and quality of genetic testing. However, the greater significance of the decision – even if partially reversed on appeal – is that it may represent the courts’ beginning to challenge the industry norm of rigorous medicinal patenting that began with the passage of the Bayh-Dole Act in 1980 . That same year, the U.S. Supreme Court upheld as valid patents covering living organisms for research and commercial purposes . These two events enabled legislative and judicial predication for the acquisition of medicinal (including genetic) patents, the frequency of which has increased significantly since then . While there has been fervent opposition to the commercialization of medical research and development by all tiers of stakeholders , the Myriad case is the most significant and visible judiciary expression of that opposition.
Why the court ruled against Myriad
The nature of the genetic patents in the Myriad case differed from previous genetic patent litigation, as Myriad’s patents pertain to the isolation and sequencing of genes for diagnostic purposes, as opposed to being used for the development of medicinal therapies. Even so, the decision is likely to be appealed, and given precedent it is likely that Myriad’s patents covering the BRCA 1 and BRCA 2 genes themselves will be upheld. However, whether or not Myriad’s patents over the diagnostic tests will be held as valid is not as certain, and this has fueled the public discussion regarding better access, availability, and reliability of the test over which Myriad currently holds a monopoly.
However, the efficacy of the test – and therefore the significance of broader access to it - has been largely misconstrued in the public discourse. The test that Myriad controlled strictly examines the presence of particular mutations in persons with a hereditary risk of breast or ovarian cancer. Of all cases of breast cancer, between 5 and 10 percent are hereditary . While a significant percentage, the test is not conclusive for those who receive either a negative or positive result – that is, if a patient discovers that she possesses the particular mutations of BRCA 1 or 2 that lend to the development of breast cancer, it does not suggest any probability of cancer – only the possibility . Conversely, a patient that does not possess the particular mutations is not guaranteed that she will not develop breast or ovarian cancer . While the test enables a patient with a positive test result to take preemptive action , it bears little utility on the actual decision to take such action . This is a large part of the criticism of Myriad’s practices – i.e., the test is one of such complexity, and relevant to so limited a class, that it should by administered under the care and control of medical “gatekeepers” who might fully inform patients of the test’s implications, both before and after testing.
It is likely that the Court took this issue into account in denying Myriad sole control over the use of the genes. That is, Myriad developed and administered the test, but did very little in terms of making the test results useful to patients. Previously, genetic tests analogous to that which is under discussion herein were only administered in a controlled, university, research environment. Myriad commercialized genetic testing without facilitating sister services – i.e. counseling, physician training, etc. – which seems to indicate that Myriad was motivated by profiting from the test as a market commodity, as opposed to responsibly providing it for the purposes of medical advancement in detection and treatment of breast and ovarian cancer . That is to say, Myriad provided the test (for a cost); but, without further medical services, the test is not only of little practical use but also possibly harmful to the patient who chose to take it . Further, the decision to take the test might have been spurred by direct-to-customer advertising employed by Myriad. Myriad’s business model was seemingly designed with profits as opposed to patients in mind . While this was not the central legal grounds upon which the Court ruled against Myriad (as the Court’s interpretation of the “broad scope” afforded by Patent Act and the Constitution was the grounds for invalidating the patents), it is likely that Myriad’s unpalatable practices factored into the Court’s rationale as a policy consideration .
The Myriad decision as a criticism of Bayh-Dole
There is a very real possibility that the case represents a shift in the judiciary away from encouraging extensive patent protection in the medical industry. This may be a response to multiple factors, one of which being the lack of legislative guidance as to medicinal patents. The only standing legislation regarding the intersection of patents and medicine is the Bayh-Dole Act, which is largely criticized as anachronistic . The purpose of the act was to encourage greater commercialization of medicinal research and development on the part of publicly funded institutions at a time when the Unite States feared that it was sliding into global economic and technological obscurity.
The effect of the Act was to heighten the commercial relationship between research universities and private corporations. That is, publicly funded institutions (universities) became more likely to procure federal grants should they retain a private business partner that promised to market the potential medicinal development from university technology in exchange for licensing upon the acquisition of a patent . Criticism of the Act cited the fear that both public and private institutions would begin directing their research and development endeavors according to profit motive as opposed to meeting medicinal needs. Myriad represents an almost caricature-like example of the pitfalls of this technology transfer; Myriad seemingly came into existence under the sole premise of obtaining exclusive control over all uses of the BRCA 1 gene (as it enjoyed access to the extensive University of Utah-based database and the research into the gene incited therein) so as to gain a valuable market commodity – not to contribute to broader medical research .
While there are both critics and proponents of Bayh-Dole, there is an “evidence gap” regarding the effect that patents bear on research – i.e. whether the current patent and licensing scheme encourages or discourages research and the accessibility to the findings thereof. However, in regard to genetic patents in particular, there is evidence to suggest that, either in spite of patents or due to them, “[…] current licensing practices […] seem to facilitate both academic research and commercial testing.” , Even so, the climate under which Bayh-Dole was enacted – i.e. a lack of medicinal commercialization – has obviously changed (due to the Act), and there is little substantive evidence to support the claim that the Bayh-Dole Act incentivized further and greater research or in the generation of revenue.
It is possible that the Bayh-Dole Act has survived beyond its utility due to an affable climate – i.e. the primarily private, commercial nature of US health care. Conversely, in single payer systems, the market and medicine are almost completely mutually exclusive. Myriad encountered limitations to its patents and strong overall resistance against its entry into the European and Canadian public health care systems, largely because the state – as opposed to the private sector - was left to assume the cost of Myriad’s services, patents, and business model . This decision affirms concerns that these systems articulated, and thus may represent a judiciary that is critical of a legislative and judicial rationale that supports medicine for profit instead of health.
While the Bayh-Dole Act is not specifically mentioned in the opinion , the Myriad case potentially represents a substantial judiciary criticism of the present commercialization of medicinal research and development as incurred by the Act. Irrespective of whether the patents are upheld as valid upon appeal – which, it is likely that at least a portion of them will be - the decision of the Federal Court sends a clear message to Myriad and like entities with like practices regarding the willingness of the judiciary to reject its previous compliance with extensive medicinal patenting in favor of a more scrupulous approach that satisfies policy concerns in regard to medical research and development being motivated by an interest in profits as opposed to the needs of patients.
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