Gene patent opponents take the fight back to Parliament

Less than eight months ago the most recent attempt to legislate against so-called "gene patents" – the Patent Amendment (Human Genes and Biological Materials) Bill 2010 – was effectively killed by a Senate committee report containing just one recommendation: "the Committee recommends that the Senate should not pass the Bill." (For further details please see "Protecting biologicals down under".)

Since then, the Intellectual Property Amendment (Raising the Bar) Act 2012 has been passed into law, providing (among many other things):

• A new defence to infringement for research uses of a patented invention. 
• Elevated standards for utility and inventive step which should go some way towards preventing the grant of patents that cover isolated genes obtained by non-inventive techniques, or that are not limited by some specific practical application.

However, opponents of gene patents remain unsatisfied. On 14th May 2012 the ABC television programme Lateline ran a report on a new push to ban the patenting of genes, this time through a private member's bill to be introduced by Labour Member of Parliament Melissa Parke (the member for Fremantle, Western Australia). The report was followed by an interview with Parke and Liberal Senator Bill Heffernan (who was the driving force behind the previous gene patents bill).

The Lateline report was rather one-sided, providing much inaccurate – or at least incomplete – information with no balancing input from any of the organisations (including many research institutions, such as the Walter and Eliza Hall Institute) which opposed the previous attempt to bar patents on genes. It appears that the opposition camp has once again caught patent supporters off guard, with Lateline reporting that it had contacted AusBiotech, but that the organisation was unable to comment in time to contribute to the report.

Scope of proposed exclusion
As yet, the proposed legislation has not been introduced into Parliament. However, Parke says that she will soon be seeking the support of the Labour Party caucus.

In the meantime, the following text – which may or may not be the actual final text of the proposed bill – was clearly visible in a few frames of the Lateline report. It appears to be a proposed replacement for the existing Section 18(2) of the Patents Act 1990, which contains the single express exclusion that "Human beings, and the biological processes for their generation, are not patentable inventions".

"18(2) The following are not patentable inventions:

(a) human beings, and the biological processes for their generation;

(b) genetic materials that exist in nature, or are the same as or not markedly different from those existing in nature, whether such materials are in situ, isolated or purified;

(c) any method that involves the mere comparison of genetic materials or genetic sequences in the provision of a diagnosis for a human being.

(2A) A reference in subsection (2) to genetic materials includes, but is not limited to, DNA or RNA whether in whole or in part or in fragments, however made."

If this is indeed the amendment which will be proposed to Parliament, it is significantly more focused than the Patent Amendment (Human Genes and Biological Materials) Bill. The previous bill failed in part because of concerns that it was overly broad in its language, and would therefore have had the unintended effect of excluding a wide range of inventions in the biological, medical and agricultural fields from patentability.

The above language is directed specifically to genetic materials (and not other "biological materials", as covered in the earlier bill). However, it goes further than simply barring patents on genes themselves (which seems to be how Parke and Heffernan are promoting it) to encompass genetic tests that are based on a "mere comparison" of genetic materials. This is a surprising development considering that one of the arguments that has been consistently presented by supporters of a ban is that there is no intention to bar patents on specific applications of genetic technologies, including diagnostic methods.

As yet, there has been no response from the Australian biotechnology industry. It is likely that supporters of gene patents are waiting for the proposed legislation to be introduced into Parliament, at which time it is expected that a public review process will be initiated. There is a long road ahead before any proposal can become law.