Gene Genie: The Judicial Revolution in Biotech IP

Australasian Biotechnology

Prof Matthew Rimmer, Intellectual Property and Innovation Law, Faculty of Law in the Queensland University of Technology (QUT)

Over the past few years, there have been some dramatic developments in intellectual property (IP) and biotechnology. In landmark rulings in gene patents in superior courts in the United States and Australia, as well as a significant settlement in Canada, the judiciary has sought to draw tighter boundaries around what can be protected as an invention under patent law. The superior courts have been keen to emphasise that mere products of nature, abstract ideas, and intellectual information cannot be protected under patent law. This has caused some consternation among the commercial providers of medical diagnostics, the pharmaceutical industry and the biotechnology sector. The judicial revolution in IP and biotechnology will have an impact in agriculture, medicine, health care and clean technologies.

United States

In 2013, the Supreme Court of the United States rejected Myriad Genetics’ patent claims to isolate genes related to breast and ovarian cancer on the grounds that they were products of nature. This ruling sought to demarcate the scope of patentable subject matter in new technologies.

The precedent has been applied in a number of cases by lower courts. In 2016, the United States Court of Appeals for the Federal Circuit ruled against Australian company Genetic Technologies, finding that its patent for methods of detecting genetic variations was invalid. This ruling is significant given that Genetic Technologies has been Myriad Genetics’ exclusive licensee of genetic testing in Australia and New Zealand, and has faced controversy over patent claims in non-coding and genomic mapping.

Australia

In October 2015, the High Court of Australia handed down a landmark decision, ruling 7–0 in favour of Yvonne D’Arcy in her challenge against Myriad Genetics’ patents on genetic testing for breast and ovarian cancer.

Reading the Myriad Genetics’ patent claims, French CJ, Kiefel, Bell and Keane JJ were concerned about the chilling effect of broad, over-reaching claims:

‘Claims 1 to 3 include the products of applying any process, known or unknown, to the cells of a human being which extracts or replicates from them nucleotides which code for mutant or polymorphic BRCA1 in the sequences specified in the Patent, whether or not the isolate contains other components and sequences.’

French CJ and his colleagues concluded that its patentability would not serve the purposes of the concept of ‘manner of manufacture in s 18(1)(a) of the Act or of the Act itself’. IP Australia has sought to develop new patent examination guidelines in the wake of this decision.

Canada

In Canada, the Children’s Hospital of Eastern Ontario (CHEO) has launched a legal challenge against gene patents in order to protect patient care. It stated, ‘Our clinicians and scientists believe that no one should be able to patent human DNA…. [because] it would be like patenting water or air.’ CHEO hoped that Canada would follow Australia’s lead after the ruling of the High Court of Australia: ‘The ruling sets a significant international trend and CHEO is optimistic about its own legal challenge to gene patents in Canada, which was launched in November 2014.’

In the end, CHEO and patent holders reached settlement; Transgenomic agreed to provide CHEO and other Canadian public-sector laboratories and hospitals with the right to test Canadians for the long QT syndrome on a not-for-profit basis. Debate continues about whether this settlement is a positive solution to the conflict over gene patents.

Conclusion

Superior courts in the United States, Australia, and Canada are now taking a stricter approach to IP and biotechnology, and the judiciary seeks to delineate unpatentable biotechnology subject matter. While the Supreme Court of the United States has explored the notion of ‘products of nature’, the High Court of Australia has emphasised that purely intellectual information is not patentable. IP disputes will have significant impact on patient care, research freedom, access to health care, innovation and commercialisation. There are also major implications for the biotechnology industry in medicine, diagnostics, agriculture and the environment. Rather than focusing on gene patents, the industry will have to instead focus upon downstream inventions.

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Dr Matthew Rimmer is a Professor in Intellectual Property and Innovation Law at the Faculty of Law in the Queensland University of Technology (QUT). He is a leader of the QUT Intellectual Property and Innovation Law research program, and a member of the QUT Digital Media Research Centre (QUT DMRC), the QUT Australian Centre for Health Law Research (QUT ACHLR), and the QUT International Law and Global Governance Research Program (QUT IL GG). Rimmer has published widely on copyright law and information technology, patent law and biotechnology, access to medicines, plain packaging of tobacco products, intellectual property and climate change, and Indigenous Intellectual Property. He is currently working on research on intellectual property, the creative industries, and 3D printing; intellectual property and public health; and intellectual property and trade, looking at the Trans-Pacific Partnership, the Trans-Atlantic Trade and Investment Partnership, and the Trade in Services Agreement. His work is archived at SSRN Abstracts and Bepress Selected Works.

Matthew Rimmer, ‘Gene Genie: The Judicial Revolution in Biotech IP’ (2016) 26 (2) Australasian Biotechnology 60.

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