The debate on the patenting of genes has resurfaced with plans to introduce a new private members’ bill banning the patenting of genetic materials. Despite one of the purposes of the recently enacted Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth) being to increase medical researchers’ access to patented genetic materials, some parliamentarians, in particular Labor back bencher Melissa Parke, consider that the Raising the Bar amendments do not go far enough. Ms Parke is lobbying for support for a private members’ bill (backed by the Cancer Council) banning the patenting of all genetic material, including human genes.
The Raising the Bar Bill (enacted in March this year) introduced a new s 119C to the Patents Act 1990 (Cth) which provides that a person may do an act that would otherwise infringe a patent for an invention if the act is done for experimental purposes relating to the subject matter of the invention. There is concern, however, that this experimental use exemption is too narrow and will not be effective and practicable for scientists and researchers because the exemption may not be operative if the experimentation has a commercial goal.
In particular, researchers and several policy makers have criticised the Bill’s failure to deal with the question of whether genes should be patentable subject matter. It is said that despite the fact that discoveries are not inventions, there has been a practice of granting patents over isolated human genes and granting patents over diagnostic tests which involve “mere comparisons of genetic sequences”. Ms Parke and others are concerned that these patents hinder medical research.
This is not the first time a bill has been introduced that aims to restrict the patenting of genetic materials. In November 2010, Senator Bill Heffernan introduced the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (Cth) which aimed to amend the Patents Act so as to expressly exclude from patentability biological materials where were identical or substantially identical to such materials as they exist in nature. See our previous post on this Bill here. This Bill was not supported because of concerns about its breadth. Its supporters hope the new Bill will be better received because it is confined to apply only to genetic material (as opposed to biological materials in general).
Further, the confidence of policy makers in Australia has been bolstered by the recent unanimous decision of the Supreme Court of the United States which set aside a ruling by the US Court of Appeals for the Federal Circuit that Myriad Genetics Inc had the right to patent two BRCA genes that account for most inherited forms of breast and ovarian cancers. On 26 March 2012 the Supreme Court remanded the matter to the Court of Appeals to be reconsidered in light of the Supreme Court’s 20 March 2012 decision in Mayo Collaborative Services v Prometheus Laboratories Inc, 566 U.S. _ (2012) which clarified the US legal position that a valid claim cannot be grounded on the laws of nature. See our previous post on these US decisions here.
We understand that support for the Bill from the Labor caucus will soon be requested. The status of the proposal will be sure to be monitored closely by the Australian biotechnology industry, medical research profession and patent lawyers alike.