Patentability of Gene Sequences in Australia

Introduction

The patentability of gene sequences in Australia has been significantly shaped by the distinction between discovering naturally occurring genetic information and creating a genuinely new invention. Gene patents can affect biotechnology research, genetic testing, pharmaceutical development, and access to diagnostic services. The leading authority is D’Arcy v Myriad Genetics Inc (2015), in which the High Court of Australia rejected patent claims to isolated DNA sequences that reproduced naturally occurring genetic information.

High Court of Australia

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Legal Framework

Section 18(1)(a) of the Patents Act 1990 (Cth) requires an invention to be a “manner of manufacture” within the meaning of section 6 of the Statute of Monopolies. An invention must also satisfy the relevant statutory requirements, including novelty, inventive step, and usefulness.

Following Myriad, Australia does not permit a patent over a nucleic acid sequence merely because it has been isolated, purified, or synthetically produced when it conveys the same genetic information as a sequence naturally existing in an organism. However, genuinely new synthetic sequences whose genetic information has no natural counterpart may be eligible, subject to the other requirements for patentability. Methods of using genetic information, diagnostic technologies, vectors, and engineered biological products may also qualify if the claims define a patentable invention.

IP Australia

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Important Case Laws

1. ** D’Arcy v Myriad Genetics Inc [2015] HCA 35:** The High Court unanimously held that claims to isolated nucleic acids encoding specified BRCA1 mutations or polymorphisms were not patentable. The substance of the claimed invention was genetic information that already existed in the human genome; isolating the molecule did not make that information a new invention. The judgment did not invalidate every possible patent involving genes or biotechnology.

High Court of Australia

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2. ** National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252:** The High Court of Australia developed the concept of a “manner of manufacture” for patentable subject matter. The case established an influential framework for assessing whether an invention produces an artificially created state of affairs with economic significance. However, Myriad clarified that this general approach does not automatically make naturally occurring genetic information patentable.

IPA Manuals

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3. ** Association for Molecular Pathology v Myriad Genetics, Inc., 569 U.S. 576 (2013):** The United States Supreme Court held that naturally occurring DNA is not patentable merely because it has been isolated, while synthetically created cDNA may be eligible in appropriate circumstances. This decision is a useful comparison, but it is not binding in Australia; the Australian High Court’s reasoning in D’Arcy must be applied to Australian law.

IPA Manuals

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Practical Issues and Conclusion

Gene-sequence patent disputes commonly involve whether the claimed sequence contains genuinely new genetic information, whether the invention has a demonstrated practical use, whether the specification adequately describes it, and whether the claims are novel and inventive. Australia also requires nucleotide and amino-acid sequence listings to comply with WIPO Standard ST.26 for relevant applications filed from 1 July 2022.

IP Australia

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In conclusion, Australian law distinguishes genetic information discovered in nature from inventions created through technical intervention. Under D’Arcy v Myriad, isolation or synthesis alone is insufficient when the sequence conveys information already present in a natural genome. Patent protection may remain available for genuinely new sequences, engineered products, and practical methods involving genetic material, provided all statutory requirements are met.