High Court Invalidates BRCA1 “Gene Patent” and Casts Doubt on Patentability of Isolated Genes

Global Publication October 2015

Background and Decision

The High Court of Australia has unanimously invalidated a patent, owned by Myriad Genetics, which related to the BRCA1 gene. The BRCA1 gene, and associated protein, are involved in repair of DNA in some human cells. In the 1990s, Myriad Genetics identified the location of the BRCA1 gene within the human genome, and mutations (variations in the gene’s sequence) which increased the susceptibility of the patient to breast and ovarian cancer. Myriad Genetics’ patent, broadly, included claims to isolated DNA (i.e. removed from the cell, and dissociated from the cellular proteins which bind to DNA) with these mutations. The patent granted Myriad Genetics the sole right to isolate the BRCA1 gene for the purposes of genetic testing.

The case only considered whether the claims related to a “manner of manufacture” and were therefore patentable subject matter. The High Court has overturned previous Federal Court, and Full Federal Court, decisions that found that they did. The High Court’s decision has cast significant doubt on the validity of gene patents in general, although the work of the Human Genome Project has largely rendered such patents obsolete.

The High Court issued three separate judgments on the patent in issue, each of which provides substantially different reasoning for the invalidity of the patent. The judgment of the Chief Justice and Justices Kiefel, Bell and Keane (majority judgment) provides a substantial revision of the formulation of the test to determine whether an invention relates to a manner of manufacture, for the first time since the decision in National Research Development Corporation v Commissioner of Patents (NRDC) was handed down in 1959. As recently as December 2013, the High Court had specifically upheld the NRDC test in relation to methods of treatment of humans in the Apotex v Sanofi Aventis case.

What it means:

  • The patent in issue expired in 2014. Therefore there is unlikely to be substantive change in the cost of genetic testing for BRCA1. Since around 2010, Myriad Genetics’ local licensee had stopped enforcing its exclusive rights, and indeed Myriad Genetics made an offer to voluntarily surrender the patent.
  • This decision may be seen as invalidating many patents which cover isolated genetic material. Products produced from the isolated genetic materials may still be patentable. For example, claim 4 of the patent related to a probe comprising isolated DNA. The validity of the claim was not in dispute, and at least one judge referred to it positively.
  • The NRDC test, for what constitutes a manner of manufacture, of an “artificially created state of affairs of economic significance” is not sufficient to determine patentability for products which fall outside the established boundaries of patentable subject matter. In new fields of invention, the test has been substantially changed into a form which provides, arguably, less clarity as to what represents patentable subject matter. The majority of the Court articulated a test which requires heavy emphasis on policy considerations when determining the patentability of novel categories of inventions.
  • The Court passed the onus of determining patentability of isolated genes to the legislature. Accordingly the Commonwealth Parliament will need to consider whether to legislate to enable the protection of isolated genes or nucleotides. The Parliament has previously declined opportunities to expressly exclude these products as patentable subject matter against the backdrop of the continued granting of patents by the Patent Office. However, given the strong commentary against gene patents by now Prime Minister Malcolm Turnbull in 2010,1 and the public outcry regarding the claims in dispute, it seems unlikely that the Commonwealth will legislate specifically in favour of gene patenting. The Court’s approach on this issue is in marked contrast with the Court’s usual position of adopting a broad definition of manner of manufacture and attributing to Parliament the role of constraining it. In this case, the High Court has reversed the roles, and in doing so adopted what appears on its face to be a quasi-legislative approach to questions of patentable subject matter.
  • It is unclear the extent to which this decision will impact upon inventions other than isolated DNA. Given the majority of the Court focused heavily on policy considerations, it is possible that the scope of the decision may prove not to be confined to isolated DNA. The comments of Justice Gordon regarding the delineation of the class of chemical compounds may cause concerns for patent holders in areas such as chemicals which routinely use “Markush formulas” in patent specifications.
  • The reasoning of Gageler and Nettle JJ which introduced a concept of inventiveness into the test for manner of manufacture potentially undercuts the existing, distinct statutory requirements of inventive step and novelty which were not included in the subject matter of this case.
  • Several Judges in the High Court decided that the act of isolating DNA from the human cell did not change its substantive nature as it existed within the cell. They considered that it was the information carried by the DNA that was of critical importance rather than the product which carried it. This assessment led to a conclusion in direct conflict with the decision of all 6 Justices in the Federal Court, who concluded that since the act of isolation fundamentally changed the very nature of the nucleic acid an artificially created state of affairs resulted. The conclusion on the nature of isolated DNA reached by the High Court suggests that the Court could have maintained and applied the standing NRDC test and concluded that the isolated genetic material was not a manner of manufacture as it was not an “artificially created state of affairs”.
  • The Court made several comments regarding the chilling effect a gene patent might have on innovation and research in Australia but largely failed to consider the opposite position. Without appropriate patent protection in Australia, there is a very real possibility of a loss of commercial research in these areas. It should be noted that the decision places Australia’s patent protection of genes in direct conflict with many major overseas trading partners, such as the European Union, which expressly permits gene patents. The United States is the major exception to this; the US Supreme Court decision on related patents also held that gene sequences were not patentable.

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