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A crowning glory: patent law and public health

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…

The legislation currently before parliament aims to safeguard access to scientific inventions protected by patents. Image from shutterstock.com

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.

Democracy Now! provided an overview of the Supreme Court of the United States conflict

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.

Ellen t'Hoen on Making Essential Medicines Available to the World

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.

Join the conversation

31 Comments sorted by

  1. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    The Hon. Yvette D’Ath, Member for Petrie, and Parliamentary Secretary for Climate Change, Industry and Innovation, said this about the Intellectual Property Laws Amendment Bill 2013 (Cth) in her second reading speech: http://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;query=Id%3A%22chamber%2Fhansardr%2F30431c55-8b12-46e8-9c61-f8cee4edee63%2F0025%22

    "The key to our intellectual property system is striking the right balance between encouraging innovation and providing equitable access…

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  2. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    The reforms to Crown Use will also be of assistance in dealing with vexatious and frivolous litigation - particularly by non-practising patent entities - so-called "patent trolls".

    There has been much concern in the United States about patent trolls holding companies and small-businesses to ransom with the threat of patent litigation. This American Life has engaged in investigative journalism on "When Patents Attack": http://www.thisamericanlife.org/radio-archives/episode/441/when-patents-attack

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  3. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    Cancer Council Australia have put a press release on the bill:

    Patent system changes a step in the right direction

    New safeguards announced by the Federal Government will help to protect consumers from commercial monopolies over vital services such as genetic testing for cancer risk, Cancer Council Australia said today.

    Cancer Council Australia CEO, Professor Ian Olver, said he welcomed a bill that would clarify the application of Crown use provisions to help ensure that patent enforcement…

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  4. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    Medicines Australia - which represents brand-name pharmaceutical companies - has published this press release on the bill: http://medicinesaustralia.com.au/2013/06/20/ip-bill-good-australian-response-to-global-health/

    IP bill good Australian response to global health - 20 June 2013

    New legislation implementing the ‘TRIPS Protocol’ will give Australian companies the ability to help respond to future health crises in less developed countries Medicines Australia Chief Executive Dr Brendan Shaw…

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  5. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    The Coalition's Judi Moylan on the Intellectual Property Laws Amendment Bill 2013 (Cth): http://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;query=Id%3A%22chamber%2Fhansardr%2F63afe481-6097-4111-97a1-ade20535e053%2F0040%22

    "I thank my colleague the member for Moreton for his kind words. It has been a great pleasure to work with him. I have spoken in this House and written to the Speaker previously about the incredibly short time frames in which committees are expected to scrutinise…

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    1. Matthew Rimmer

      ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

      In reply to Matthew Rimmer

      Unfortunately, Judi Moylan's discussion of the position of non-WTO members ignores existing practice in relation to national export regimes for access to essential medicines, and the universality of human rights.

      The Judi Moylan asserts that 'Black letter compliance with TRIPS would prevent Australia from assisting [non-WTO members]'. However, she provides no legal authority for her assertion that export of medicines to non-WTO members could be non-compliant with TRIPS. This position seems to…

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  6. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    As the Democracy Now! video notes, the film actress Angelina Jolie has made an important contribution to the debate over gene patents. She wrote about the issue of affordability of genetic testing in an op-ed for the New York Times: http://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html?_r=0

    "Breast cancer alone kills some 458,000 people each year, according to the World Health Organization, mainly in low- and middle-income countries. It has got to be a priority to ensure that more women…

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  7. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    The great geneticist and public researcher, Mary-Claire King, was interviewed on the Supreme Court of the United States ruling in the Myriad case on gene patents. She commented: "I am delighted. This is a fabulous result for patients, physicians, scientists and common sense. When I was working on it from 1974 to 1994, it did not cross my mind that a legal case that would end up in the Supreme Court would be the consequence of my work. But it did and sometimes that's what happens when you start in a new area of science. It is a relief to have a decision after so many years, and I'm so gratified that it was a unanimous decision."

    http://www.newscientist.com/article/dn23708-court-ruling-on-genes-is-a-victory-for-common-sense.html

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  8. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    On the topic of access to essential medicines, UN Secretary-General Ban Ki-moon discussed access to medicines to treat HIV/AIDS the other week: "We have to expand antiretroviral therapy. This is a human rights imperative & a public health necessity". http://www.un.org/apps/news/infocus/sgspeeches/statments_full.asp?statID=1893#.UcL4SfnI1yJ

    Remarks to General Assembly on Implementation of the Declaration of Commitment on HIV/AIDS and the Political Declarations on HIV/AIDS
    Secretary-General Ban…

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  9. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    Coalition member Senator Richard Colbeck raises rather weak and nugatory objections to the Intellectual Property Laws Amendment Bill 2013 (Cth):

    Economics Legislation Committee

    Report

    Senator Richard COLBECK (Tasmania):

    I want to make some very quick comments around the Economics Legislation Committee report on consideration of time critical bills—the Intellectual Property Laws Amendment Bill and the statement in there that there are 'no substantive matters which require examination…

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    1. Matthew Rimmer

      ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

      In reply to Matthew Rimmer

      The House of Representatives Standing Committee on Social Policy and Legal Affairs very succinctly deals with such cavils: "The consultative processes for each of the schedules in the bill were extensive and have provided opportunities for many issues to be considered in some depth." There has been a decade long debate on crown use, and access to essential medicines. The matters have considered in policy processes by the Australian Law Reform Commission, the Advisory Council on Intellectual Property, the Joint Standing Committee on Treaties, the Productivity Commission, and IP Australia. There has been ample opportunity for policy consultation in all these forums across a decade.

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    2. Matthew Rimmer

      ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

      In reply to Matthew Rimmer

      In addition to cavilling about access to essential medicines, the same professional body (IPTA) objected to the plain packaging of tobacco products.

      The High Court of Australia upheld Australia's plain packaging regime. In the 2012 case on plain packaging, the Chief Justice of the High Court of Australia, Robert French, emphasized that the role of intellectual property law is to promote public objectives. His Honour observed: ‘There are and always have been purposive elements reflecting public…

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  10. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    UNICEF has handed down an important report, highlighting the need for access to life-saving essential medicines for children and women: http://www.unicef.org/supply/files/UNICEF_Supply_Annual_Report_2012_web.pdf

    Brittany Ngo for IP Watch summarizes the report: http://www.ip-watch.org/2013/06/21/unicef-supply-annual-report-highlights-medical-products-access-innovation/

    "In its recently released Supply Annual Report for 2012, the United Nations agency UNICEF assessed its programme work in developing…

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  11. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    It should be noted that Coalition has long supported action on access to essential medicines.

    In August 2002, the Conservative Trade Minister Mark Vaile endorsed the Doha Declaration on the TRIPS Agreement and Public Health 2001, saying:

    "As the WTO Director General Supachai Panitchpakdi has noted, this is an historic agreement. It is a further demonstration that the WTO is able to respond to the public-health problems faced by developing countries, and to make its contribution to broader domestic…

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  12. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    The World Trade Organization has reported that the following countries and groups have implemented the WTO General Council Decision 2003 on the export of essential medicines - http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm

    • Norway: Amendments to Sections 49 and 50 of the Patent Act of 15 December 1967 No.9 and to Patent Regulations of 20 December 1996 No.1162 provide the legal basis to act as an exporting Member — document IP/C/W/427

    • Canada: Amendments to the Patent Act and Food…

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  13. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    The House of Representatives passed the access to medicines bill 72-68 on the 24th June 2013.

    The ALP supported the bill - with speeches by Yvette D'Ath and Melissa Parke. While supporting the reforms, Parke called for a reconsideration of patentability of genes, in light of the Supreme Court of the United States decisions in the Myriad case and the Prometheus case.

    Surprisingly, the Coalition opposed the access to medicines bill - with Sophie Mirabella and Dennis Jensen leading the attack…

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  14. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    Melissa Parke (ALP, Fremantle—Parliamentary Secretary For Homelessness and Social Housing and Parliamentary Secretary for Mental Health) gave a thoughtful speech on gene patents and access to medicines on the 24th June 2013:

    "I welcome the Intellectual Property Laws Amendment Bill 2013 and thank the Minister for Industry and Innovation, Greg Combet, and Parliamentary Secretary Yvette D'Ath for bringing forward these reforms which represent an important step towards improving the current patent…

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  15. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    Sophie Mirabella (Coalition) opposed the bill on access to medicines and crown use on the 24 June 2013 in the House of Representatives:

    "In a number of respects I am disappointed that it is necessary to rise to speak on the Intellectual Property Laws Amendment Bill 2013. It should have been quite clear by now to the people in the Labor Party who are responsible for this bill that it is simply not ready for introduction into the parliament. I am sure this is of no concern to some on the other side…

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  16. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    Dennis Jensen (Tangney, Coalition) gave this speech, opposing access to essential medicines and other measures in the Intellectual Property Laws Amendment Bill 2013 (Cth) in the House of Representatives on the 24th June 2013:

    "The coalition does not support this bill, the Intellectual Property Laws Amendment Bill 2013, and I say so clearly and deliberately so that there is no misunderstanding. The community of IP lawyers and judicious practitioners take issue with the contents of this bill. I…

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  17. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    Yvette D'Ath (ALP member for Petrie—Parliamentary Secretary for Climate Change, Industry and Innovation) gave this speech on the Intellectual Property Laws Amendment Bill 2013 (Cth) in the House of Representatives on the 24th June 2013:

    "I thank my fellow members for their contributions to the debate. It is disappointing to hear those on the other side will be opposing this legislation but unfortunately we hear that all too often in this chamber. I would like to take a moment to thank all of the…

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  18. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    The Director-General of IP Australia, Philip Noonan, provided this overview of the legislation at the public hearing:
    http://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;query=Id%3A%22committees%2Fcommrep%2F33257c25-06f2-471d-9344-e6efc20217eb%2F0001%22

    Mr Noonan: There are a total of six schedules in the bill. The first three are about adjusting the balance in the patent system. Crown use is dealt with in the first schedule. That is an important safeguard but an exceptional use where…

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  19. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    Dianne Nicol and Olasupo Owoeye, 'Using TRIPS flexibilities to facilitate access to medicines' (2013) 91 Bulletin of the World Health Organization 533-539, http://www.who.int/bulletin/volumes/91/7/12-115865/en/index.html

    "Australia’s move towards putting into practice the Implementing Decision and the Protocol is a positive step in redressing the imbalance in the ability to access medicines between lower-income countries and rich countries. Other rich countries that have not yet implemented compliant…

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  20. Matthew Rimmer

    ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

    President Barack Obama discusses HIV/AIDS with Archbishop Desmond Tutu in South Africa: http://www.whitehouse.gov/the-press-office/2013/06/30/remarks-president-obama-and-archbishop-tutu-after-roundtable-discussion

    President Barack Obama: "Together, we’re investing in building South Africa’s capacity to manage a national response to HIV/AIDS. The South African government is showing leadership up and down the line, and the health minister here has talked about all the initiatives that are taking…

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  21. alexander j watt

    logged in via Twitter

    Thanks Matthew for your sort of 'live blog' here, on the passage of this bill through parliament. It is an illuminating account which might was well stand next to hansard as a record of govt activity. I long for the day when these matters can be debated live in the free air of the internet instead of in the broom cupboard of parliament house.

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    1. Matthew Rimmer

      ARC Future Fellow and Associate Professor in Intellectual Property at Australian National University

      In reply to alexander j watt

      Its still uncertain what will be the fate of the bill. If Kevin Rudd recalls Parliament, there could be time for the bill to pass through Senate. If not, the bill could lapse with the Federal Election.

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