Recently, Vaughan Barlow details the ramifications of the Patent Amendment (Human Genes and Biological Materials) Bill (2010), currently being debated before the Australian parliament.
The Bill seeks to ban the patenting of all biological material that is “identical or substantially identical to such materials as they exist in nature”. If passed, this legislation may significantly jeopardize the biotechnology, pharmaceutical, medical and agricultural industries in Australia.
Among other proposed changes, the Bill seeks to amend section 18 of the Patents Act (1990) as follows:
(1) Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and
(b) when compared with the prior art base as it existed before the priority date of that claim:
(i) is novel; and
(ii) involves an inventive step; and
(c) is useful;
(2) Human beings, and the biological processes for their generation, are not patentable inventions.
(2) The following are not patentable inventions:
(a) human beings, and the biological processes for their generation; and
(b) 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.
(5) In this section:
biological materials, in section 18, includes DNA, RNA, proteins, cells and fluids.
The proposed ban on patenting of biological materials under section 18(2) is therefore far broader than the current ban, which is limited to “human beings and the biological processes for their generation”. Proposed section 18(2)(b) bans from patentability all biological materials that are “identical or substantially identical” to those existing in nature.
According to Barlow:
In addition to Australia’s potential contravention of its obligations under TRIPS, the commercial reality of banning from patentability all biological material that exists in nature could result in the biotechnology, pharmaceutical, medical and agricultural industries withdrawing investment in Australia. As a consequence, there is the potential for future difficulty in accessing medicines and associated problems in the provision of healthcare. This possible lack of investment could arise not only because of diminished returns on investments through a lack of patent rights, but also because of the remaining significant costs in obtaining regulatory approval.
Patent applicants seeking to claim biological materials in Australia should watch the progress of the Patent Amendment (Human Genes and Biological Materials) Bill (2010).
Vaughan Barlow is a patent and trademark attorney with Pizzeys Patent and Trade Mark Attorneys in Australia.