Recent developments in the US regarding gene patentability have sparked a similar review in Australia patentability laws. Isolated biological materials, including genes, may be excluded from patent protection in Australia if proposed amendments to Section 18 of the Australian Patents Act are passed into legislation.
This could cut out a significant level of patent protection available to both Australian and overseas biotech companies who already commercialize and/or plan to commercialize in Australia.
On 24 November 2010, Senator Bill Heffernan introduced a private members bill proposing the exclusion from patentability of biological materials to the Australian Senate. The proposed bill includes "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".
The proposed amendments also include the requirement for an invention to be "a manner of manufacture within the full meaning, including the proviso, of Section 6 of the Statute of Monopolies". The proviso referred to being the original (1623) exclusion for subject matter that is "contrary to law", "mischievous to the State, by raising Prices of Commodities at home", "Hurt of trade" or "generally inconvenient".
Biological materials considered not to be patentable
The definition of biological materials considered not to be patentable in the amendments includes "DNA, RNA, proteins, cells and fluids". This would encompass genes, antibodies and cell cultures such as stem cells. If the bill is passed, it will impact on biotechnology and pharmaceutical organizations who develop novel therapies, vaccines, biological tests, drug delivery platforms and organic chemicals of biological origin such as secondary metabolites.
Discourage research and development
Without patent protection for the isolated biological material of interest (which can often be the primary tools used), the ability to protect your commercial advantage is severely diminished, which translates to a lesser incentive to innovate and will deter future research and development.
The case for the proposed amendments
The argument behind these proposed amendments as outlined in the Bills accompanying Explanatory Memorandum is that biological materials isolated from the natural environment are not an invention even if they have been isolated, purified or synthetically. This is accompanied by the argument that isolated biological material is not a man-made product.
However, Heffernan has failed to comprehend that, similar to many inventions that are patentable, it is often not the difficulty in making a given device, it is the idea or discovery behind it that makes something inventive. Thus, for an isolated gene, we argue it is not the ability to isolate it that makes it patentable – it is the research behind, and the identification of, the commercial uses of that particular isolated matter over all other genes that makes the isolate gene an inventive feature. The same argument also applies to other types of isolated biological material.
What comprises a biological material?
The Bill is unclear as to what will constitute a derivative of a biological material-the wording "identical or substantially identical to such materials as they exist in nature" appears to extend the exclusion beyond natural molecules. For example small changes in nucleic acid sequences (such as point mutations) can lead to a large change in biological function.
Although unlikely, there is no indication of whether the bill will operate retrospectively to deprive existing owners of patents for biological materials to lose their patent rights.
The Bill has been referred to the Senate Legal and Constitutional Affairs Legislation Committee to report on in June 2011. In the interim, the Committee has requested submissions on the proposed bill to be provided by 25 February 2011.
For reasons outlined above, James & Wells Intellectual Property have filed submissions on behalf of their Australasian biotech clients to the Senate Inquiry, to support that isolated biological material should remain patentable subject matter.
You will need to consider how such legislation, if passed, may affect your ability to protect your innovation relating to isolated genetic material and its method(s) of use. By discussing your portfolio with your IP professional, you can form a strategy to best secure ownership of your R&D in the event the proposed bill is passed.
As per our standard practice, James & Wells Intellectual Property recommend that patents relating to isolated biological material and their methods of use are drafted with many fall-back positions available in the event isolated biological material, in their broadest sense, will not be patentable in the future.
This article was written by Dr Justin Sweetman an Associate in the James & Wellsr Auckland office. To contact Justin please email him on firstname.lastname@example.org or phone 09 914 6740.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
James and Wells is the 2010 New Zealand Law Awards winner of the Intellectual Property Law Award for excellence in client service.