Skip to content.

Home

Allens

Restrictions on patenting human genes in Australia – Patents Amendment Act 2001 (Cth) raises the bar

In brief: Lawyer Erica Davis discusses the introduction of tougher requirements for patentability by the new Patents Amendment Act.

Can our genes be patented in Australia?

Human genetic material is not excluded from being patented in Australia: the Patents Act 1990 (Cth) excludes human beings and the processes for their generation from patentability, but does not exclude human genes. As a member of the World Trade Organisation, Australia is not permitted to specifically exclude human genes from patentability, as it would be contrary to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) – the permissible exclusions from patentability are set out in Article 27 of TRIPS.

Members of the WTO can, however, restrict (not exclude) the patentability of human genes through the interpretation of the requirements of novelty, inventiveness and utility. In Australia, this can be done by amending the Patents Act, and further by patent practitioners and the courts in their interpretation of the Patents Act. Although any such restriction will apply across the board to all patents, in practice the restriction may have a specific application to human gene patents.

Return to top

Current criteria for human gene patenting in Australia

Human gene patents are subject to the normal criteria of novelty, inventiveness and utility. The technical requirements of these criteria are set in the Patents Act. 

The most recent information released by the Australian Patent Office in 1998 indicates that genes 'existing in, and reproducible from, microorganisms or like biological material' are patentable, including human genes 'which have for the first time been identified and copied from their natural source and manufactured synthetically as unique materials with a definite industrial use' (emphasis added). 

Applications for human genes and gene sequence patents have been accepted in Australia. There has not yet, however, been any judicial consideration of the interpretation of the criteria in relation to human gene patents and it is probable that not all gene patents granted would survive judicial scrutiny. The majority of applicants for human gene patents in Australia are foreign.

Introducing tougher requirements for patentability - Patents Amendment Act 2001 (Cth)

The Patents Amendment Act 2001, commencing 1 April 2002 (unless proclaimed earlier), introduces a raft of tougher requirements for patent applications generally, bringing the Australian patent system into line with that of other countries7n details of the changes are reported in AAR January 2002 Intellectual Property Bulletin. The Patents Amendment Act stems from recommendations of the Intellectual Property and Competition Review Committee and the Advisory Council on Industrial Property and applies to all patents.

The current concern that the threshold for human genetic material to satisfy the requirements of novelty and inventiveness is too low is addressed to some extent by the changes to be introduced by the Patents Amendment Act. The amendments raise the threshold in relation to the novelty and inventive step criteria by expanding the prior art base (generally what is known in the field) against which these criteria are tested to include documents published and acts done anywhere in the world. In addition, it will be possible to assess novelty on the basis of a combination of common general knowledge with two or more pieces of prior art where a skilled person could reasonably be expected to do so. 

In practice, this means that an international expert could be used to collect additional information from any public source anywhere in the world if it can be shown that the international expert could have been reasonably expected to combine those additional pieces of information. The introduction of these more stringent requirements brings Australia into line with international standards and makes it more likely that inventions, including human genes, patentable in Australia will also be patentable in other countries. 

The applicant is required to disclose all prior art searches in relation to the invention. In practical terms, this means that the examiner is able to assess the requirements of novelty and inventiveness against a more complete art base consisting of all of the relevant prior art of which the applicant is aware.

A further restriction on the patenting of human genetic material with little inventive merit is imposed by replacing the current presumption of patentability. A patent application must prove to the Commissioner of Patents on the balance of probabilities that the genetic material is novel and inventive. 

The Patents Amendment Act does not restrict or clarify the test of industrial applicability.  To satisfy the test in Australia, a human gene patent must have commercial applicability and usefulness. The Patents Act currently provides little guidance as to how to satisfy the test of commercial applicability and does not require the Patents Office to examine the usefulness requirement. The IPCRC has recommended that the usefulness test should require the applicant to provide evidence of specific, substantial and credible utility to the Patents Office as part of the examination process. 

Return to top

What next?

Hopefully, the threshold for patentability of the human genome in Australia will soon be clarified by judicial interpretation of:

  • the application of the Patents Act to the grant of patents for human genetic material generally; and 
  • the effect of the changes made by the Patents Amendment Act on the tests of novelty and inventiveness in relation to human genetic material specifically.

Investigation will no doubt continue into ways of reducing the problems brought about by applications for broad human gene patents with little industrial applicability or usefulness. 

In addition, Australia may decide to regulate the way in which human gene patents are used.

For further information, please contact:

Return to top

Share with

What are these?