Relevance to impact on gene patents

Following the 2004 Australian Law Reform Commission (ALRC) report on gene patenting and human health in which it was reported that the key concept of patentable subject matter in Australia was ambiguous and obscure, the Minister for Innovation, Industry, Science and Research asked the Advisory Council on Intellectual Property (ACIP) to conduct a review into the appropriateness and adequacy of the manner of manufacture test. The terms of reference for the review asked the ACIP to inquire, report and make recommendations to the Australian Government on patentable subject matter.

The ACIP Report was released on 16 February 2011 and included a number of key recommendations including:

(a)   codification of the established principles of patentability by amendment of the Patents Act 1990 to include a statement of the law currently applied by the Courts - namely, that a patentable invention must be an "artificially created state of affairs" in the field of economic endeavour;

(b) maintenance of the current exclusion from patentability of human beings and biological processes for their generation;

(c) amendment of the Patents Act 1990 to include a general exclusion from patentability of inventions whose commercial exploitation would be wholly offensive to the Australian public; and

(d) inclusion in the Patents Act 1990 of a statement of objectives outlining the purpose of the Act so that any test for patentable subject matter must support the objectives of the patent system.

The release of the ACIP Report follows the recent publication of the Report of the Senate Community Affairs Committee Inquiry into the impact of patenting of human genes and biological materials. Significantly, neither Report makes any recommendation to specifically exclude genes and/or biological materials from patentability. Indeed, it is noteworthy that the ACIP Report specifically states: "we do not recommend the introduction [into the legislation] of a specific exclusion to prevent the patenting of human genes and genetic products".

This position is at odds with the Private Member's Bill introduced into the Australian Senate at the end of last year in support of a broad-reaching amendment to the Patents Act 1990 to prohibit patenting of genes and biological materials. Currently, the Bill is before the Legal and Constitutional Affairs Legislation Committee for consideration. The deadline for making submissions to the Committee is 25 February 2011. The Committee is due to report on 16 June 2011.

The text of the ACIP Report may be viewed at:

If you would like further information regarding the Reports discussed above, or any of the issues raised, our experienced attorneys at Shelston IP would be pleased to assist.

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