Australian patent law reforms are critical to ensuring Australians have access to vital health-care services and technologies and that people in developing countries have access to affordable, life-saving medicines.
This week, the Australian Parliament is debating a bill on patent law and public health entitled the Intellectual Property Laws Amendment Bill 2013 (Cth).
The legislation gives Australian governments greater powers to exploit patents without authorisation from the patent owner via stronger provisions for Crown use and compulsory licensing.
Crown use allows federal and state governments to access patents without the patent owners' permission. Compulsory licensing compels patent owners to provide access to patented inventions. Both require adequate compensation to be paid to the patent holder.
The reforms will improve access to cancer testing and treatment and essential medicines for diseases such as HIV/AIDS, tuberculosis, and malaria.
The House of Representatives Standing Committee on Social Policy and Legal Affairs handed down its report yesterday recommending the bill be passed. The House of Representatives is debating the bill today.
The reforms implement the recommendations of the Australian Law Reform Commission, the Advisory Council on Intellectual Property, the Joint Standing Committee on Treaties, and the Productivity Commission.
Crown use and gene patents
The Crown use reforms will clarify the power of governments to provide access to patents for public services.
The proposed legislation will improve access to technology to test for breast cancer BRCA1 and BRCA genes which increase the risk of breast and ovarian cancer. This is significant because of two international challenges to the validity of patents on gene testing.
Last week, the Supreme Court of the United States delivered its decision on patenting genetic testing for breast cancer and ovarian cancer in Association for Molecular Pathology v. Myriad Genetics.
In the lead judgment, Justice Thomas commented:
Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.
There has been a parallel long-running controversy in Australia over patents covering genetic testing for breast cancer and ovarian cancer.
Back in 2008, Melbourne-based Genetic Technologies Limited, the commercial licensee for patents on the BRCA1 and BRCA2 breast and ovarian cancer genes, sought to enforce its patent claims over the state and territory laboratories, which were providing genetic testing services.
Although the company withdrew its claim, there was uncertainty at the time as to whether Crown use provisions could be invoked to provide Australian women with access to genetic testing services.
In 2013, the Federal Court of Australia held that patents can be granted for genes, in a dispute between Cancer Voices Australia v. Myriad Genetics Inc.. The Full Court of the Federal Court of Australia will hear an appeal against that decision in August.
In its report, the House of Representatives Standing Committee on Social Policy and Legal Affairs supported reforms to Crown use:
The Committee is aware there have been difficulties with the existing Crown use provisions and believes that maintaining the status-quo could result in continued uncertainty about when Crown use could be invoked.
The committee “welcomes the idea that its use is clarified so that in future, where necessary, the provision can be used with more certainty.”
Compulsory licensing and access to essential medicines
There has been much debate about compulsory licensing and access to essential medicines - particularly to deal with public health epidemics, such as HIV/AIDS, tuberculosis and malaria. Countries such as Brazil, India, Thailand, Indonesia and Ecuador have used compulsory licensing to reduce the prices of pharmaceutical drugs for their citizens.
There has also been controversy over patenting the genetic sequences of viruses - such as the SARS virus, avian influenza, and the MERS-Coronavirus. Countries have been concerned that such patents may slow or delay responses to pandemics.
The Australian bill also introduces a compulsory licensing regime to allow for the export of essential medicines to developing countries and least-developed countries. The bill will:
advance the human right to health for everyone, including children, in developing countries by assisting with the treatment of serious health problems such as HIV/AIDS, malaria and tuberculosis.
The bill will fulfil Australia’s obligations under the World Trade Organization (WTO) General Council Decision 2003. A number of developed countries, members of the BASIC group (Brazil, South Africa, India and China), and regional groups have established domestic regimes to implement the WTO General Council Decision 2003.
In 2013, three major international institutions – the WTO, the World Intellectual Property Organization, and the World Health Organization – released a joint report, Promoting Access to Medical Technologies and Innovation. The report emphasised that the export mechanism provided “an additional legal pathway for access to medicines” and “has special significance as the sole amendment proposed to any of the WTO multilateral trade agreements since their adoption in 1994.”
There is bipartisan support for Australia adopting a mechanism for the export of essential medicines. In 2013, the House of Representatives Standing Committee on Social Policy and Legal Affairs welcomed “the actions of the Government to ensure that developing countries experiencing a health crisis can access vital medicines quickly and reasonably.”
The committee commented:
Introducing regulation to implement the TRIPS protocol in Australia to provide for another avenue for developing countries to obtain vital medicines is a worthy and entirely necessary step in the view of the committee.
It is a matter of urgency that Australia fulfil its international obligations, and establish a fast, effective, and flexible mechanism for access to essential medicines.
It is critical that the House of Representatives and the Senate pass the vital bill on patent law and public health, before Parliament winds up next week, and the election.
Ideally, in the future, the Australian Parliament should consider further issues raised by the Productivity Commission in respect of patent law and compulsory licensing relating to competition and the public interest. There is also a need to develop a flexible mechanism to allow for compulsory licensing to deal with a wide range of issues of humanitarian aid and development.