Our News Alert of 25 November 2010 reported on the introduction of the Patent Amendment (Human Genes and Biological Materials) Bill 2010 to the Australian Parliament. The Bill proposes significant amendments to the Patents Act (1990), specifically to exclude gene sequences and other biological materials from patentability in Australia. The Bill was immediately referred to the Senate Legal and Constitutional Affairs Legislation Committee for further inquiry and report.
The Report of the Senate Committee was released on 21 September 2011, concluding that “the Committee recommends that the Senate should not pass the Bill.”
The Report provides the Committee’s views on several key issues raised by the Bill, some of which are as follows. The Committee considered that “difficult policy questions” concerning the distinction between discoveries and inventions were preferably addressed by a “technology neutral approach” rather than the approach of the Bill which would “focus on one category of inventions only.” The Report makes reference to the Raising the Bar Bill as providing “technology neutral changes” which “should contribute to improving the quality of inventions which are granted patents.”
The Report noted that the “imprecise language” of the Bill could discourage investment in R&D and “encourage litigation by those seeking to clarify patent rights”. The Committee received “no evidence that patents on human genes or biological materials are systematically leading to adverse impacts in the provision of healthcare in Australia” and indeed that there was evidence that passage of the Bill would “have significant adverse consequences for healthcare in Australia.”
The Committee acknowledged that “legal uncertainty in relation to patents can cause anxiety for researchers and delays for research” but at the same time concluded that the evidence “indicates that patents over human genes and biological materials have not hindered research, particularly medical research, in Australia.” In fact, there was “clear evidence” that patents have encouraged and contributed to R&D activities, which R&D may be driven overseas by enactment of the Bill. The “preferable approach” was instead to provide a clear research exemption from infringement for certain activities, as proposed in the Raising the Bar Bill.
In a dissenting Report, the three principal sponsors of the Bill (Senators Heffernan, Siewert and Xenophon) recommended that the Senate pass the Bill in an amended form. That amended form would have the effect that biological materials, whether isolated or not and however made, which are structurally and functionally identical to such materials as they exist in nature would be excluded from patentable subject matter.
The Bill remains at the Second Reading stage and will at some time come up for debate and decision by the full Senate which will no doubt take into consideration the recommendation of the Committee.