23 September 2011

The Senate’s Legal and Constitutional Affairs Committee has, by majority, recommended that the Senate should not pass the Patent Amendment (Human Genes and Biological Materials) Bill 2010.

The Bill is a private members’ effort and, perhaps not surprisingly, the three of its sponsor still in the Senate dissented.

(At the time of writing, it is proving difficult to get a working link to the text of the Bill itself.) According to the EM it was considered desirable to expand the ban in s 18(2) on patenting human beings and the biological processes for their generation:

The purpose of this Bill is to advance medical and scientific research and the diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature.

These biological materials even if they have been isolated, purified or synthetically made have not been transformed from products of nature into products of humankind.

Thus the Bill (a) reinforces the applicability of the proviso in section 6 of the Statute of Monopolies within the meaning of section 18(1)(a) and section 18(1A)(a), (b) reinforces the applicability of the distinction between discovery and invention and (c) applies that distinction by expressly excluding from patentability, biological materials which are identical or substantially identical to such materials as they exist in nature, however made.

Notwithstanding this, it is rather difficult to find an Australian research institute researching genes etc. which supported the idea.

The ALRC of course had previously recommended leave well enough alone.

The issue doesn’t seem likely to go away. Apart from whatever the Bill’s sponsors and their allies may get up to, the majority concluded:

5.26 Like many of those who gave evidence, the committee prefers the solutions offered in the proposed amendments of the Raising the Bar Bill. However, the committee does not consider that the amendments in the Raising the Bar Bill will resolve all of the issues in the patent system. In the opinion of the committee, serious consideration should also be given to the proposals for legislative enactment of the patentable subject matter test and the general ‘ethical’ exclusion made in the ACIP report on patentable subject matter. Other reforms may also be necessary in the future, particularly in relation to ensuring equitable access to healthcare. In this context, the committee recognises that the Senate Community Affairs References Committee has indicated it will maintain a ‘watching brief’ in relation to the impact of gene patents in Australia.[5] Despite the need for further reform to the patent system, the committee agrees that removing an area of patentable subject matter, as proposed by the Bill, is not an appropriate solution to this complex set of issues. (emphasis and hyperlink supplied)