[author: Kevin E. Noonan]
Last year, the Australian Senate rejected a call for banning patents on human genes in Australia. This result came after almost a decade of debate, resulting in several Reports (including the 2011 ACIP Report on Patentable Subject Matter, the Senate Gene Patents Report, issued November 24, 2010, and the 2004 Australian Law Reform Commission's Report on Genes and Ingenuity: Gene Patenting and Human Health (ALRC 99 Report) (see "News from Abroad: The Gene Patents Debate in Australia -- An Update"). On November 23, 2011, the Australian government released a combined report (that can be accessed here). And the Australian Senate determined that the Australian Patent Act of 1990 should not be amended to exclude human genes as patent-eligible subject matter, pursuant to a 124-page report that recommended against passage of the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which was introduced by Senators Helen Coonan, Bill Heffernan, Rachel Siewert, and Nick Xenophon (see "Australian Senate Committee Issues Recommendation on Gene Patenting Bill").
Undaunted, another Member of Parliament (Melissa Parke, the Labor representative from Fremantle, Western Australia), is reported (by Intellectual Asset Management, "Gene patent opponents take the fight back to Parliament") to be ready to introduce a bill to amend Section 18(2) of the Patents Act, as follows:
18(2) The following are not patentable inventions:
(a) human being, and the biological processes for their generation;
(b) genetic materials that exist in nature, or are the same as or not markedly different from those existing in nature whether such materials are in situ, isolated or purified;
(c) any method that involve the mere comparison of genetic materials or genetic sequences in the provision of a diagnosis for a human being.
18(2)(A) A reference in subsection (2) to genetic materials includes, but is not limited to, DNA or RNA whether in whole or part or in fragments, however made.
While wrongheaded, this proposal has a few advantages over judicial solutions that may arise in the U.S., for example. First, it is expressly limited to genetic material, and so avoids the risk of determining that "products of nature" are somehow patent ineligible. While this bill shares the infirmity with Congressman Becerra's thrice-rejected (or maybe more correctly, ignored) bill to ban "gene patenting" in that it encompasses more than human DNA (thus threatening cucumber or tomato gene patents as well as human ones), it does avoid the risk of finding the antibiotics, anticancer drugs, improved lubricants or silicon formulations, or antibodies (the most common form of biologic drug) would become unpatentable. It also permits any such ban to be considered by Australia's elected representatives, rather than judges without any particular expertise in technology (some of whom are comfortable overturning the opinions of judges that do have such "special expertise").
But unlike earlier proposals (including last year's), this bill would also ban "applications" of genetic technology, albeit only those that "mere[ly] compar[e]" genetic sequences. Such claims have already been held unpatentable in the U.S. under the Bilski and AMP v. USPTO precedent. It is unclear whether claims further reciting other affirmative steps in identifying a sequence would fall within the scope of the proposed ban. Also precluded from patent protection would be synthetic DNA including oligonucleotide fragments (while blessedly being devoid of a reference to a "magic microscope" as justification for the ban). It is unclear whether cDNA would be considered "markedly different" under the bill, although this would depend on whether the chemical or informational properties of DNA are considered.
The prospect of the bill being introduced is another testament to the persistence of the anti-gene patenting proponents on the issue, reminiscent of other motivated political factions. Whether this bill gains sufficient traction to have a chance of passage, or whether political fatigue or indifference prevent its passage will be closely monitored, here and anywhere the issue is seriously considered.