Matthew Rimmer

Incentives for global public health : patent law and access to essential medicines

Introduction Access to Essential Medicines: Public Health and International Law Professor Thomas Pogge, Dr Matthew Rimmer, and Professor Kim Rubenstein Part I International Trade 1. TRIPS and Essential Medicines: Must One Size Fit All? Making the WTO Responsive to the Global Health Crisis Professor Rochelle Cooper Dreyfuss, New York University 2. The TRIPS Waiver as a Recognition of Public Health Concerns in the WTO Associate Professor Andrew Mitchell and Associate Professor Tania Voon, University of Melbourne 3. Public Law Challenges to the Regulation of Pharmaceutical Patents in the US Bilateral Free Trade Agreements Dr Hitoshi Nasu, The Australian National University 4. Global Health and Development: Patents and Public Interest Associate Professor Elizabeth Siew Kuan Ng, National University of Singapore Part II Innovation 5. The Health Impact Fund: Boosting Innovation without Obstructing Free Access Professor Thomas Pogge, Yale University and The Australian National University 6. The Health Impact Fund: A Critique Dr Kathleen Liddell, University of Cambridge 7. A Prize System as a Partial Solution to the Health Crisis in the Developing World Professor William W. Fisher and Talha Syed, Harvard Law School 8. Innovation and Insufficient Evidence: The Case for a WTO-WHO Agreement on Health Technology Safety and Cost-Effectiveness Evaluation Associate Professor Thomas Faunce, The Australian National University Part III Intellectual Property 9. Opening the Dam: Patent Pools, Innovation, and Access to Essential Medicines Professor Dianne Nicol and Dr Jane Nielsen, University of Tasmania 10. Open Source Drug Discovery: A Revolutionary Paradigm or a Utopian Model? Dr Krishna Ravi Srinivas, Research Information System for Developing Countries (RIS), India 11. Accessing and Benefit Sharing Avian Influenza Viruses through the World Health Organisation: a CBD and TRIPS Compromise thanks to Indonesia’s Sovereignty Claim? Dr Charles Lawson, Griffith University Faculty of Law and Associate Professor Barbara Hocking, Queensland University of Technology 12. The Lazarus Effect: The (RED) Campaign and Creative Capitalism Dr Matthew Rimmer, The Australian National University Part IV Health-Care 13. Beyond TRIPS: The Role of Non-state Actors and Access to Essential Medicines Professor Noah Benjamin Novogrodsky, University of Toronto 14. Securing Health Through Rights Katharine Young, Harvard University 15. The Role of National laws in Reconciling Constitutional Right to Health with TRIPS Obligations: An Examination of the Glivec Patent Case in India Dr Rajshree Chandra, Delhi University 16. Tipping Point: Thai Compulsory Licenses Redefine Essential Medicines Debate Jonathan Burton-MacLeod, The Australian National University Bibliography

The freedom to tinker: patent law and experimental use

This article considers the origins and the development of the defence of experimental use in patent law – the ‘freedom to tinker’. It explores the impact of such an exemption upon a number of important industries – such as agriculture, biotechnology and pharmaceutical drugs. This article takes a comparative approach in its analysis of patent law and experimental use. It highlights the competing norms, and lack of harmonisation between a number of jurisdictions, including the United States, the European Union and Australia. Section 2 provides a critique of the development of the common law defence of experimental use in the US. It considers a series of precedents – including Roche Products, Inc. v Bolar Pharmaceuticals, Madey v Duke University, Integra Lifesciences I Ltd v Merck KgaA, and Applera v MJ Research. Section 3 explores the operation of patent law and experimental use in Euro-pean jurisdictions. It looks at a number of significant precedents in the UK, the Netherlands, France, Italy and Germany. Section 4 considers the policy debate in a number of forums over the defence of experimental use in Australia. It examines the controversy over Genetic Technologies Limited asking research organisations to obtain a licence in respect of its patents associated with non-coding DNA and genomic mapping. It also considers the inquiries of the Australian Law Reform Commission and the Advisory Council on Intellectual Property, as well as the impact of the TRIPS Agreement and the Australia – US Free Trade Agreement. The conclusion contends that there is a need for a broad-based defence of experimental use for all the member states of the Organisation for Economic Cooperation and Development.

The Alchemy of Junk: Patent Law and Non-Coding DNA

This article considers the recent international controversy over the patents held by a Melbourne firm, Genetic Technologies Limited (GTG), in respect of non-coding DNA and genomic mapping. It explores the ramifications of the GTG dispute in terms of licensing, litigation and policy reform, and - as a result of this dispute - the perceived conflict between law and science. GTG has embarked upon an ambitious licensing program with twenty seven commercial licensees and five research licensees. Most significantly, GTG has obtained an exclusive licence from Myriad Genetics to use and exploit its medical diagnostics in Australia, New Zealand, and the Asia-Pacific region. In the US, GTG brought a legal action for patent infringement against the Applera Corporation and its subsidiaries. In response, Applera counterclaimed that the patents of GTG were invalid because they failed to comply with the requirements of US patent law, such as novelty, inventive step, and written specifications. In New Zealand, the Auckland District Health Board brought legal action in the High Court, seeking a declaration that the patents of GTG were invalid, and that, in any case, the Board has not infringed them. The New Zealand Ministry of Health and the Ministry of Economic Development have reported to Cabinet on the issues relating to the patenting of genetic material. Similarly, the Australian Law Reform Commission (ALRC) has also engaged in an inquiry into gene patents and human health; and the Advisory Council on Intellectual Property (ACIP) has considered whether there should be a new defence in respect of experimental use and research.

Japonica Rice: Intellectual Property, Scientific Publishing and Data-sharing

Abstract This article examines a series of controversies within the life sciences over data sharing. Part 1 focuses upon the agricultural biotechnology firm Syngenta publishing data on the rice genome in the journal Science, and considers proposals to reform scientific publishing and funding to encourage data sharing. Part 2 examines the relationship between intellectual property rights and scientific publishing, in particular copyright protection of databases, and evaluates the declaration of the Human Genome Organisation that genomic databases should be global public goods. Part 3 looks at varying opinions on the information function of patent law, and then considers the proposals of Patrinos and Drell to provide incentives for private corporations to release data into the public domain.

The Jean Chrétien Pledge to Africa Act: patent law and humanitarian aid

This article evaluates the implementation of the World Trade Organization (WTO) General Council Decision in 2003, which resolved that developed nations could export patented pharmaceutical drugs to member states in order to address public health issues, such as HIV/AIDS, tuberculosis, malaria and other epidemics. The Jean Chrétien Pledge to Africa Act 2004 (Canada) provides authorisation for the export of pharmaceutical drugs from Canada to developing countries to address public health epidemics. The EU has issued draft regulations governing the export of pharmaceutical drugs. A number of European countries, including Norway, the Netherlands, France and Switzerland, are seeking to pass domestic legislation to give force to the WTO General Council Decision. Australia has shown little initiative in seeking to implement such international agreements dealing with access to essential medicines. It is argued that Australia should implement humanitarian legislation to embody the WTO General Council Decision, emulating models in Canada, Norway and the EU. Ideally, there should be no ‘right of first refusal’, the list of pharmaceutical drugs should be open-ended, and the eligible importing countries should not be limited to members of the WTO.

Trade wars in the TRIPS Council: Intellectual property, technology transfer, and climate change

This Chapter considers the geopolitical conflicts in respect of intellectual property, trade, and climate change in the TRIPS Agreement 1994 under the World Trade Organization (WTO). In particular, it focuses upon debates in the TRIPS Council on the topic of patent law and clean energy in 2013 and 2014. The chapter highlights the development agenda of a number of developing countries who are keen for access to clean energy to combat climate change and global warming. It also considers the mixed contributions of members of the BRICS/ BASIC group – including Brazil, India, China, and South Africa. This chapter highlights the intellectual property maximalist position of a number of developed countries on intellectual property, climate change, and trade. Seeking to overcome this conflict and stalemate, this Chapter puts forward both procedural and substantial reform options in respect of intellectual property, trade, and climate change in the TRIPS Council and the WTO. It also flags that the TRIPS Agreement 1994 could well be displaced by the rise of mega-regional trade agreements – such as the Trans-Pacific Partnership (TPP), and the Trans-Atlantic Trade and Investment Partnership (TTIP).

The global tobacco epidemic, the plain packaging of tobacco products, and the World Trade Organization

In response to complaints by Ukraine, Honduras, the Dominican Republic, Cuba, and Indonesia, the Government of Australia has defended the introduction of plain packaging of tobacco products in the World Trade Organization. This article focuses upon the legal defence of Australia before the WTO Panel. A key part of its defence has been the strong empirical evidence for the efficacy of plain packaging of tobacco products as a legitimate health measure designed to combat the global tobacco epidemic. Australia has provided a convincing case that plain packaging of tobacco products is compatible with the TRIPS Agreement 1994 – particularly the clauses relating to the aims and objectives of the agreement; the requirements in respect of trade mark law; and the parallel measures in relation to access to essential medicines. Australia has also defended the consistency of plain packaging of tobacco products with the TBT Agreement 1994. Moreover, Australia has provided clear reasons for why the plain packaging of tobacco products is compatible with GATT. The position of Australia has been reinforced by a number of third parties – such as New Zealand, the United Kingdom, Ireland, Norway, Canada, and others - which have also been pioneers in tobacco control and public health. Australia’s leadership in respect of tobacco control and plain packaging of tobacco products is further supported by larger considerations in respect of international public health law, human rights, and sustainable development.

The High Court of Australia and the Marlboro Man: The Battle over the Plain Packaging of Tobacco Products

Part I: Challenges of Non-Communicable Diseases 1. Introduction, Tania Voon 2. Making Effective Use of Law in the Global Governance of NCD Prevention, Jonathan Liberman 3. Researchers and Research Knowledge in Evidence-Informed Policy Innovation, Evan Anderson and Scott Burris Part II: NCD Risk Regulation under International and Comparative Law 4. International Human Rights Law, Tanya E Baytor and Oscar A Cabrera 5. International Trade Law, Tania Voon and Andrew D Mitchell 6. International Investment Law, Benn McGrady 7. International Intellectual Property Law, Mark Davison 8. Interaction with Domestic Intellectual Property Law, Enrico Bonadio 9. Constitutional Perspectives: United Kingdom and South Africa, Stephanie Palmer Part III: National and Regional Perspectives of NCD Risk Regulation 10. United States, Stephen D Sugarman 11. Canada, Barbara von Tigerstrom 12. Latin America, Fernanda Alonso and Alejandro Madrazo 13. European Union, Alberto Alemanno and Amandine Garde 14. Africa, Rachel Kitonyo-Devotsu 15. New Zealand, Susy Frankel 16. Australia, Sondra Davoren, Caroline Mills and Alexandra Jones Part IV: Case Study of a Legal Dispute 17. The High Court of Australia and the Marlboro Man, Matthew Rimmer

Introduction: Access to essential medicines: public health and international law

Historically, there have been intense conflicts over the ownership and exploitation of pharmaceutical drugs and diagnostic tests dealing with infectious diseases. Throughout the 1980s, there was much scientific, legal and ethical debate about which scientific group should be credited with the discovery of the human immunodeficiency virus and the invention of the blood test devised to detect antibodies to the virus. In May 1983, Luc Montagnier, Francoise Barre-Sinoussi and other French scientists from the Institut Pasteur in Paris published a paper in Science, detailing the discovery of a virus called lymphadenopathy (‘LAV’). A scientific rival, Robert Gallo of the National Cancer Institute, identified the AIDS virus and published his findings in the May 1984 issue of Science. In May 1985, the United States Patent and Trademark Office awarded the American patent for the AIDS blood test to Gallo and the Department of Health and Human Services. In December 1985, the Institut Pasteur sued the Department of Health and Human Services, contending that the French were the first to

The last taboo: patenting human beings

This article considers the efforts of the Australian Law Reform Commission to clarify the meaning of section 18(2) of the Australian Patents Act 1990 (Cth): ‘Human beings and the biological processes for their generation are not patentable inventions.’ It provides a critique of the proposals of the Commission with respect to patent law and stem cell research. The Commission has recommended that IP Australia should develop examination guidelines to explain how the criteria for patentability apply to inventions involving stem cell technologies. It has advised the Australian Government that the practice code of the United Kingdom Patent Office (UKPO) would be a good model for such guidelines, with its distinction between totipotent and pluripotent stem cells. Arguably, though, there is a need to codify this proposal in a legislative directive, and not merely in examination guidelines. The Commission has been reluctant to take account of the ethical considerations with respect to patent law and stem cell research. There could be greater scope for such considerations, by the use of expert advisory boards, opposition proceedings and the requirement of informed consent. The Commission has put forward a number of general and specific recommendations to enhance access to patented stem cell technologies. It recommends the development of a research exemption, and the modernisation of compulsory licensing and crown use provisions. It also explores the establishment of a stem cell bank and the promulgation of guidelines by funding agencies. Such proposals to promote greater public access to stem cell research are to be welcomed.