On 29 March 2010, the US District Court for the Southern District of New York found several of the patent claims on the BRCA1 and BRCA2 breast cancer genes held by Myriad Genetics to be invalid. The patents were initially issued on the basis that the genes were isolated and purified to a non-naturally occurring state, however the court found, amongst other things, that the purification was not markedly different from a product of nature and thus was not patentable. The ruling may have implications for holders of other gene patents and the patentability of other naturally occurring substances. It has the potential to directly affect the operation of the healthcare and medical research industries, particularly with regards to cancer treatment and prevention, and may alter the accessibility of such therapies to patients.
Myriad Genetics' patents for the testing of the breast cancer genes are currently licensed for use in Australia to Genetic Technologies Limited. Genetic Technologies attempted to enforce its rights and stop other laboratories from performing the tests as recently as 2008, but was forced to back down following public protest. The US court decision has prompted further debate about the legitimacy of gene patents in Australia. A Federal Government inquiry into the issue is currently underway and is expected to report in September 2013.
Operation of gene patents prior to invalidation Awarding of BRCA1 and BRCA2 patents in US Patentable subject matter There are no special proscriptions for specific subject matter in US patent law, and Congress and the courts have consistently declined to enact limitations on patentable subject matter for specific industries.Holman, C.M., "The impact of human gene patents on innovation and access: a survey of human gene patent litigation", UMKC Law Review, Vol. 76, No. 2, 2007, p296 Accordingly, a DNA sequence, like other molecules, is eligible to be considered for patenting by the United States Patent and Trademark Office, provided that the patentee alters its environment or structure.Gold, E.R., "Gene patents and medical access", Intellectual Property Forum, No. 49, 2002, p20 Myriad Genetics' patent applications were eligible as the BRCA genes were isolated from their natural environment.
Tests Under international standards, patentable matter must satisfy tests of novelty, inventive step and industrial application, to protect subject matter in the public domain.Gold, E.R., "Gene patents and medical access", Intellectual Property Forum, No. 49, 2002, p21 The industrial application step is the most difficult to meet under US patent law. A DNA sequence is only able to meet this criterion if a direct industrial use for the sequence can be identified. This would not have been difficult for Myriad Genetics to demonstrate in its BRCA patent applications, as its inventions were designed for the purposes of testing subjects for their susceptibility to breast and ovarian cancers.
International trade law dictates that a country can apply no additional tests in evaluating patentability, and must apply these tests without discriminating against biological inventions. Therefore, ethics-based criteria would not have factored into the USPTO's decision to allow Myriad Genetics to patent the BRCA1 and BRCA2 genes.
Scope of awarded patents Myriad Genetics' BRCA patents have broad scope in the US. The company's claims consist of harmful mutations in the BRCA1 and BRCA2 genes, the use of the mutations to diagnose and screen for breast and ovarian cancers, and the development of treatments for these cancers.
Application of BRCA1 and BRCA2 patents in US market
Monopolistic behaviour Although Myriad Genetics is one of few gene patent holders to seek infringement litigation against its patents and has only done so twice,Holman, C.M., "The impact of human gene patents on innovation and access: a survey of human gene patent litigation", UMKC Law Review, Vol. 76, No. 2, 2007, p355 the existing threat of litigation, according to anecdotal evidence from some laboratories, has been sufficient to keep competitors in the US from challenging Myriad Genetics' monopoly on BRCA gene testing.Holman, C.M., "The impact of human gene patents on innovation and access: a survey of human gene patent litigation", UMKC Law Review, Vol. 76, No. 2, 2007, p299 As a result, the company's monopoly may inhibit research and prevent the development of improvements in breast cancer testing technology. A counter-argument is that gene patents encourage innovation because patents can provide financial rewards.Sharon, B., "Who owns your DNA", Newsweek, Vol. 155, No. 7, p. 22
Accessibility of BRCA testing Myriad Genetics has used sequencing of the BRCA genes to develop a test for hereditary breast and ovarian cancers, which it markets to laboratories as BRACAnalysis. As at 2010, the test costs US$3,400,Sharon, B., "Who owns your DNA", Newsweek, Vol. 155, No. 7, 2010, p. 22 which is three times the cost of pre-patented testing. (2004) 26(3) Sydney Law Review 447 p 452. The company currently has agreements with major health organisations in the US and international licensing agreements for exclusive provisions. Consequently, individuals wishing to be tested for breast or ovarian cancer predisposition would be unable to circumnavigate Myriad Genetics' prices either within the US or by seeking testing abroad. Accessibility therefore remains an issue, despite the widespread availability of testing.
Awarding of BRCA1 and BRCA2 patent licenses in Australia
Patentable subject matter Although Australia's Patents Act 1990,. prohibits patenting 'human beings and the biological processes for their generation', in recent times virtually no class of patent matter has been held unpatentable by the courts. Like the USPTO, the Australian Patent Office accepts applications for human gene and gene sequences, provided that they have been separated from the human body. In Bristol-Myers Squibb, Finkelstein J declared that it was up to the Australian Parliament to amend the Patents Act 1990 if it did not consider medical treatment patentable. (2002) 30 Federal Law Review 97. In 2015, the High Court of Australia unanimously ruled that isolated nucleic acid does not qualify as proper subject matter for patent protection.. This decision moves Australia's laws regarding patentable subject matter closer towards those of the US.
Tests Under section 18 of the Patents Act 1990, a patent can only be granted if the subject matter is a manner of manufacture (invention) within section 6 of the Statute of Monopolies 1623, which is novel and involves an inventive step when compared to the prior art base, and is useful. In light of the absence of special treatment for biotechnology-related processes, and the innovativeness and usefulness of its patents, it is unlikely that Genetic Technologies' BRCA licenses could be successfully contested under Australian patent law.
Challenges to license validity Under section 46 of the Trade Practices Act 1974, a corporation with a substantial degree of market power is prohibited from taking advantage of its power to substantially damage competition. However, recent court decisions have been reluctant to apply this section to invalidate patents. For example, in Warman International v Envirotech Australia Pty Ltd, Wilcox J held that "to exercise in good faith an extraneous legal right, though the effect may be to lessen, or even eliminate competition, is to take advantage of that right, not of market power.". Given the broad claims of gene sequence patents, such as the BRCA patents licensed to Genetic Technologies, and the courts' limited regard for anti-competition provisions, it is unlikely that Genetic Technologies' monopoly could be contested under the Trade Practices Act 1974. This could potentially limit the availability of products and processes related to the BRCA genes.
Application of BRCA1 and BRCA2 patent licenses in Australian market Monopolistic behaviour Genetic Technologies has had less success than Myriad Genetics in enforcing its exclusive rights to BRCA gene testing in its home country. Genetic Technologies has made multiple attempts to force other laboratories to stop performing BRCA tests, but yielded to public pressure to cease its attempts.
Accessibility of BRCA Testing The Australian Law Reform Commission has declined to recommend amendments to gene patent and licensing laws on the basis that there is a lack of evidence that gene patenting and licensing has significantly affected Australian health care costs. The BRCA test would have cost A$2,100 through Genetic Technologies, but public laboratory BRCA tests are subsidised by the federal government.
Genetic Technologies' failure to enforce its patent rights may embolden other players in the biomedical industry to pursue research and development related to patented gene sequences. Conversely, it could serve as a demotivator for Genetic Technologies. The effects of gene patents on development in the medical industry will become clearer when an Australian Senate inquiry report is released in June 2010.
US court decision on gene patents On 29 March 2010, Judge Robert Sweet of the US District Court for the Southern District of New York found that there was no evidence Myriad Genetics went to any great length in inventing a process to isolate the genes in question. As such he dismissed the case on a summary hearing in favour of the plaintiff, the American Civil Liberties Union, as being the 'longest of long shots'. Justice Sweet found no evidence which could be considered by a jury in favour of the defendant, and dismissed the argument that the gene should be patented on the basis that it was isolated from the human body, referring to the practice as a 'lawyers trick'. Myriad Genetics has claimed it will appeal the decision up to the US Supreme Court to obtain an authoritative and binding decision, which they have lost as of 15 June 2013.
Myriad Genetics has a number of possible arguments that it could put forward in any forthcoming appeals, and will likely be focussing on the law surrounding validation of gene patents based on their isolation. The company argues that the fact that it has been able to isolate the genes should be considered. This is a direct derivative of the black letter law which states that if the gene was newly isolated and characterised, then it was not a mere discovery; it was an industrially applicable technical solution to a technical problem.
Conversely, the notion that the patenting of human genes is invalid may have support in the decision reached in the Howard Florey/Relaxin case,EPOR 541 1995 where an attempt was made to take out a patent on a naturally occurring human hormone. The verdict from this case stated that 'to find a substance freely occurring in nature is a mere discovery and therefore not patentable. However, if the substance found in nature has first to be isolated from its surroundings and a process for obtaining it is developed, that process is patentable.'
Implications of the court's decision on the US industry The President and CEO of Myriad Genetics, Peter Meldrum, claims that the existence of gene patents and their granting to young start-up biotechnology companies is crucial for the development of the industry. He said that the decision to invalidate the patents would stifle the industry by not giving the needed support and incentives for biotechnology start-ups. The American Civil Liberties Union counters that with the patents now invalidated, the industry will prosper due to the gene or DNA in question now not being reserved exclusively for a particular group of industry participants.
Relevance of the US court decision to Australia