Opinion: On gene patents, divided we stand, united we fall

By Mark Egerton

The Senate Legal and Constitutional Affairs Committee is reviewing a private member’s Bill (Human Genes and Biological Materials Bill 2010) introduced by Senators Coonan, Heffernan, Siewert and Xenophon which seeks to amend section 18 of the Australian Patents Act (1990) to exclude from patentable subject matter “biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature”.

While one opponent of gene patents has likened patent attorneys to “a bunch of tax evaders” for their ability to circumvent patentability exclusions, one does not have to be a patent attorney, IP lawyer or tax evader to cringe at the difficulty that will arise in interpreting and applying the full scope of this proposed exclusion.

All that is clear is that it is not just genes, nor just human biological materials, that are the subject of this technology-based exclusion. A Gene Patents Report from the Senate Community Affairs Reference Committee released in November 2010 recommended that rather than use a technology-based exclusion to prevent gene patents, the Patents Act be amended to “toughen up” the inventive step, and disclosure requirements of the Australian Patents Act to make it harder to obtain patents and restrict patent scope in all areas of technology.

The more recent ACIP Report into the Australian patent system released last week has also reviewed patentable subject matter in the context of several contentious technology areas (genes and other biological materials, software and business methods) and recommended against a specific exclusion of genes and other biological materials.

This private member’s Bill exists within a milieu of debate about the legality of patenting biological materials, such as genes, which at times enters the realms of ethics (“they’re patenting life!”), philosophy (isolating genes is merely a discovery, not an invention) and economics (gene patents increase the cost of healthcare) that has never been settled.

Opponents of the private member’s Bill, such as myself, have argued that this is a debate that should have been settled many years ago in the heyday of gene patents, in the early 1990s to early 2000s).

New patent applications with broad claims to newly isolated genes, proteins or other biological materials are far less common than, say, ten years ago. The only effect of the private member’s Bill, if successful, would be to destabilise an Australian biotechnology industry built under a patent regime where genes and other biological materials have not been excluded from patentability.

Probably one reason for the recent revival of the gene patentability debate has been the controversy over the existence and enforcement of Myriad’s BRCA1/BRCA2 patents in Australia and the USA.

In Australia, Cancer Voices Australia and Yvonne D'Arcy have challenged the validity of the Australian BRCA patents. One outcome of this challenge has been an offer by Myriad to surrender its Australian BRCA1 patent, but at the time of writing this battle is still being waged.

Meanwhile, in the USA the District Court of the Southern District of New York invalidated the US BRCA patents partly for lack of patentable subject matter in relation to the claims to the genes and also claims to diagnostic methods that utilise these genes.

Myriad appealed this decision to the Federal Circuit in June 2010. The Federal Circuit’s decision is expected to be released mid-2011. My initial gut feeling was that Myriad would win on appeal, certainly for the diagnostic method claims and probably for the gene claims.

However, the US Department of Justice has weighed in supporting the decision of the District Court of the Southern District of New York, which combined with the recent “anti-gene patent” comments of Federal Circuit Judge Dyk in an unrelated case, make me less certain of the outcome.

While the decision of the Federal Circuit in the US will not determine the position of gene patents in Australia, it may influence the outcome of the debate in this country.

What has become evident from the submissions to the various Committees and Courts has been the divided opinion within and between the research, legal and biotechnology communities on the question of gene patenting.

My personal view is that the private member’s Bill will fail, but whatever the outcome, if any of the various, proposed changes to the Australian patent system undermine the viability of the Australian biotechnology industry, we will all fall together.

Mark Egerton is Partner and Head of Life Sciences at Fisher Adams Kelly, Patent and Trade Marks Attorneys.