Under current patent law in Australia, isolated biological materials, such as isolated genes, are considered patentable. This may be about to change with dangerous ramifications for the local bio-tech industry.
In relation to the patenting of genes, the existing law establishes that the act of isolating, purifying or cloning satisfies the patentability requirement that an invention results in “an artificially created state of affairs”. This is based on the premise that an isolated, purified or recombinant nucleic acid does not exist in nature, it only exists in nature in a different form, as part of a chromosome, for example.
In 2004, the Australian Law Reform Commission (“ALRC”) recommended that “the Patents Act should not be amended to exclude genetic materials or technologies from patentability; or to provide a new medical treatment exclusion; or to expand the existing circumstances in which social and ethical considerations may be taken into account in decisions about granting patents.” The ALRC “concluded that there are significant impediments to amending the Patents Act to exclude genetic materials from patentability. These include a long history of patenting such inventions, international treaty obligations, and a biotechnology industry dependent on patents and inventions.”.
In 2008, the Advisory Council on Intellectual Property (ACIP) conducted a review of patentable subject matter, including the patenting of genetic materials. The ACIP recommended against introducing a specifc list of unpatentable subject matter and stated that “no persuasive case has been made to introduce a specific exclusion to prevent the patenting of human genes and genetic products.”
Despite the recommendations of the ALRC and ACIP, on 21 February 2011, the Patent Amendment (Human Genes and Biological Materials) Bill 2010 was introduced in the House of Representatives, with a corresponding bill already under review by a Senate committee. The proposed amendments seek to add a specifc exclusion from patentability for biological materials, including “DNA, RNA, proteins, cells and fluids” as well as components and derivatives “whether isolated or purified or not” that are “identical or substantially identical to such materials as they exist in nature”.
If passed into law, this bill would have damaging ramifications for the biotech, medical and even argricultural industries in Australia. It has the potential to drive investment and research in the affected industries offshore and deprive Australia of significant technological advances. The progress of this bill will be closely and nervously watched by many Australian and foreign stakeholders.
Please contact Cotters if you would like any further information about the changes or if you wish to request examination on any pending patent applications.
By Marcus Dalton
Cotters Patent & Trade Mark Attorneys
10 March 2011