Protecting biologicals down under

The gene patenting debate ends (for now)
It has been almost a year since we reported on the possibility that the Australian government might legislate to outlaw patents on genetic materials (for further details please see "Outlawing of gene patents remains on political agenda"). Through a controversial private member's bill introduced into Parliament – the Patent Amendment (Human Genes and Biological Materials) Bill 2010 – conservative interests in Parliament sought to exclude from patentability in Australia:

biological materials including their components and derivatives, whether isolated or not and however made, which are identical to such materials as they exist in nature.

"Biological materials" were defined to include DNA, RNA, proteins, cells and fluids. Although the purpose of the bill as set out in the explanatory memorandum was to enable doctors, clinicians and medical and scientific researchers to have “free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature”, there was widespread concern by personnel in these sectors, as well as in the legal and commercial sectors, regarding the potential impact of such legislation. It was widely thought that the proposed scope of the bill would extend to materials far beyond its original intent and that the Australian medical research sector, the access of the public to modern medicines and the reputation of the nation would all be hard hit by the passage of such short-sighted legislation.

The bill was sent for public consultation through the Senate Legal and Constitutional Affairs Committee. After receipt of over 120 written submissions, the collection of a large number of oral submissions through public hearings in several states and a number of delays, the committee concluded in a report of 21st September 2011 that the current patent system is adequate to allow access to genes and biological materials, making proposed amendments to the Patents Act unnecessary. The committee recommended that although the bill was well intentioned, Parliament should not pass the bill.

Exemptions for experimental use and regulatory approval (for devices and agrochemicals)
Much of the lobbying against the bill focused on pending legislation before Parliament: the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011. This bill provides for two new exemptions to the Patents Act which, if properly utilised, will provide clinicians, researchers and the wider community with appropriate access to patents for biological materials. Although it was expected that this legislation might pass both houses in the Spring session, there has been much political focus on carbon emissions legislation, the management of illegal immigrants and formal commitments, and at the time of writing only a maximum of seven sitting days remain this year. It seems possible that we may have to wait until 2012 for new provisions to give researchers the kind of experimental use and regulatory freedom statutorily enjoyed by innovators in other countries.

Impact of Brustle decision concerning human stem cells
The proponents of the Patent Amendment (Human Genes and Biological Materials) Bill 2010 were mostly conservative members of Parliament encouraged by a well-known academic with a longstanding grudge against the biotechnology industry. One solution proffered by antagonists to the bill was the inclusion of a “morality clause” as a qualification to the patentability sections of the Patents Act. In contrast to European patent legislation, such an exclusion is not currently found in Section 18 of the Australian Patents Act, in which the only exception is to “human beings and the biological processes for their generation”. This suggestion received little discussion in the final Senate report. With the handing down in Europe of the Brustle decision on 18th October 2011, it seems probable that Australian lobbyists against the patentability of biologicals, now including innovations derived from human stem cells, may find new sources of support for their view:

That IP Australia has, through an errant policy, permitted the patenting of natural phenomena in violation of [a] basic principle of patent law [and correction] requires legislative intervention.” (Dissenting Report: Executive Summary.)

In the interim, the only obstacle in Australia to the patenting of human stem cells is the aforementioned exception which, for practical purposes, means that if a claim directed to stem cell-derived subject matter might include human beings within its scope, an appropriate disclaimer is required as part of the claim definition.

At present, the Australian environment for research into and the IP protection of biologicals remains a liberal one. The government remains committed to medical innovation and its protection as demonstrated by its regular upgrading of IP legislation to ensure global best practice and by its rigorous review of all proposed changes that might undermine a well developed reputation for excellent pure and applied medical research outcomes.


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