Michael Kirby's challenge: Intellectual property, HIV/AIDS, and human rights

In July 2014, Melbourne hosted the 20th International AIDS Conference. The event opened, paying tribute to the late Dutch HIV/AIDS researcher Professor Joep Lange, with his image projected onto a screen, with the accompanying quotation: ‘If we can bring a bottle of Coke to every corner of Africa, we should be able to also deliver antiretroviral drugs.’

Intellectual property, innovation, and the environment (2014) edited by Peter Menell and Sarah Tran: A review

Peter S. Menell and Sarah M. Tran (ed.), Intellectual Property, Innovation and the Environment, Cheltenham (UK) and Northampton (MA): Edward Elgar, 2014, 756 pp Hardback 978 1 78195 160 6, http://www.e-elgar.com/bookentry_main.lasso?id=15063 There has been a longstanding deadlock over intellectual property and clean technologies in international climate talks. The United States — and other developed countries such as Japan, Denmark Germany, the United Kingdom, Australia, and New Zealand — have pushed for stronger and longer protection of intellectual property rights related to clean technologies. BASIC countries — such as Brazil, South Africa, India, and China — have pushed for greater flexibilities in respect of intellectual property for the purpose of addressing climate change and global warming. Small island states, least developed countries, and nations vulnerable to climate change have called for climate-adaptation and climate-mitigation technologies to be available in the public domain. In the lead-up to the United Nations Climate Summit in New York on the 23rd September 2014, it is timely to consider the debate over intellectual property, innovation, the environment, and climate change.

Environmental technologies, intellectual property and climate change (2013) edited by Abbe Brown

Abbe Brown from the University of Aberdeen, Scotland, is one of the leading international researchers on intellectual property and climate change. She is an intellectual dynamo. Her work brings together a mastery of intellectual property, with a strong interest in innovation theory and practice, and an engagement with public policy issues surrounding human rights, competition policy, and access to knowledge. Abbe Brown has shown a particular aptitude for tackling big ideas and wicked global problems, with intelligence, gusto, insight, and formidable wisdom.

Tesla motors’ open source revolution: Intellectual property and the carbon crisis

On the 12th June 2014, Elon Musk, the chief executive officer of the electric car manufacturer, Tesla Motors, announced in a blog that ‘all our patents belong to you.’ He explained that the company would adopt an open source philosophy in respect of its intellectual property in order to encourage the development of the industry of electric cars, and address the carbon crisis. Elon Musk made the dramatic, landmark announcement: Yesterday, there was a wall of Tesla patents in the lobby of our Palo Alto headquarters. That is no longer the case. They have been removed, in the spirit of the open source movement, for the advancement of electric vehicle technology.

The empire of cancer: Gene patents and cancer voices

In his book, The Emperor of All Maladies, Siddhartha Mukherjee writes a history of cancer — "It is a chronicle of an ancient disease — once a clandestine, 'whispered-about' illness — that has metamorphosed into a lethal shape-shifting entity imbued with such penetrating metaphorical, medical, scientific, and political potency that cancer is often described as the defining plague of our generation." Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned cancer research, diagnosis, and treatment. In the area of access to essential medicines, there has been much debate over Novartis’ patent application in respect of Glivec, a treatment for leukaemia. India’s Supreme Court held that the Swiss company’s patent application violated a safeguard provision in India’s patent law designed to stop evergreening. In the field of tobacco control, the Australian Government introduced plain packaging for tobacco products in order to address the health burdens associated with the tobacco epidemic. This regime was successfully defended in the High Court of Australia. In the area of intellectual property and biotechnology, there have been significant disputes over the Utah biotechnology company Myriad Genetics and its patents in respect of genetic testing for BRCA1 and BRCA2, which are related to breast cancer and ovarian cancer. The Federal Court of Australia handed down a decision on the validity of Myriad Genetics’ patent in respect of genetic testing for BRCA1 in February 2013. The Supreme Court of the United States heard a challenge to the validity of Myriad Genetics’ patents in this area in April 2013, and handed down a judgment in July 2013. Such disputes have involved tensions between intellectual property rights, and public health. This article focuses upon one of these important test cases involving intellectual property, public health, and cancer research. In June 2010, Cancer Voices Australia and Yvonne D’Arcy brought an action in the Federal Court of Australia against the validity of a BRCA1 patent — held by Myriad Genetics Inc, the Centre de Recherche du Chul, the Cancer Institute of Japan and Genetic Technologies Limited. Yvonne D’Arcy — a Brisbane woman who has had treatment for breast cancer — maintained: "I believe that what they are doing is morally and ethically corrupt and that big companies should not control any parts of the human body." She observed: "For my daughter, I've had her have [sic] mammograms, etc, because of me but I would still like her to be able to have the test to see if the mutation gene is in there from me." The applicants made the following arguments: "Genes and the information represented by human gene sequences are products of nature universally present in each individual, and the information content of a human gene sequence is fixed. Genetic variations or mutations are products of nature. The isolation of the BRCA1 gene mutation from the human body constitutes no more than a medical or scientific discovery of a naturally occurring phenomenon and does not give rise to a patentable invention." The applicants also argued that "the alleged invention is not a patentable invention in that, so far as claimed in claims 1–3, it is not a manner of manufacture within the meaning of s 6 of the Statute of Monopolies". The applicants suggested that "the alleged invention is a mere discovery". Moreover, the applicants contended that "the alleged invention of each of claims 1-3 is not a patentable invention because they are claims for biological processes for the generation of human beings". The applicants, though, later dropped the argument that the patent claims related to biological processes for the generation of human beings. In February 2013, Nicholas J of the Federal Court of Australia considered the case brought by Cancer Voices Australia and Yvonne D’Arcy against Myriad Genetics. The judge presented the issues in the case, as follows: "The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of 'gene patenting'. Briefly stated, the issue to be decided is whether under the Patents Act 1990 (Cth) a valid patent may be granted for a claim that covers naturally occurring nucleic acid — either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) — that has been 'isolated'". In this context, the word "isolated" implies that naturally occurring nucleic acid found in the cells of the human body, whether it be DNA or RNA, has been removed from the cellular environment in which it naturally exists and separated from other cellular components also found there. The genes found in the human body are made of nucleic acid. The particular gene with which the patent in suit is concerned (BRCA1) is a human breast and ovarian cancer disposing gene. Various mutations that may be present in this gene have been linked to various forms of cancer including breast cancer and ovarian cancer.' The judge held in this particular case that Myriad Genetics’ patent claims were a "manner of manufacture" under s 6 of the Statute of Monopolies and s 18(1)(a) of the Patents Act 1990 (Cth). The matter is currently under appeal in the Full Court of the Federal Court of Australia. This article interprets the dispute over Myriad Genetics in light of the scholarly work of Nobel Laureate Professor Joseph Stiglitz on inequality. Such work has significant explanatory power in the context of intellectual property and biotechnology. First, Stiglitz has contended that "societal inequality was a result not just of the laws of economics, but also of how we shape the economy — through politics, including through almost every aspect of our legal system". Stiglitz is concerned that "our intellectual property regime … contributes needlessly to the gravest form of inequality." He maintains: "The right to life should not be contingent on the ability to pay." Second, Stiglitz worries that "some of the most iniquitous aspects of inequality creation within our economic system are a result of 'rent-seeking': profits, and inequality, generated by manipulating social or political conditions to get a larger share of the economic pie, rather than increasing the size of that pie". He observes that "the most iniquitous aspect of this wealth appropriation arises when the wealth that goes to the top comes at the expense of the bottom." Third, Stiglitz comments: "When the legal regime governing intellectual property rights is designed poorly, it facilitates rent-seeking" and "the result is that there is actually less innovation and more inequality." He is concerned that intellectual property regimes "create monopoly rents that impede access to health both create inequality and hamper growth more generally." Finally, Stiglitz has recommended: "Government-financed research, foundations, and the prize system … are alternatives, with major advantages, and without the inequality-increasing disadvantages of the current intellectual property rights system.’" This article provides a critical analysis of the Australian litigation and debate surrounding Myriad Genetics’ patents in respect of genetic testing for BRCA1. First, it considers the ruling of Nicholas J in the Federal Court of Australia that Myriad Genetics’ patent was a manner of manufacture as it related to an artificially created state of affairs, and not mere products of nature. Second, it examines the policy debate over gene patents in Australia, and its relevance to the litigation involving Myriad Genetics. Third, it examines comparative law, and contrasts the ruling by Nicholas J in the Federal Court of Australia with developments in the United States, Canada, and the European Union. Fourth, this piece considers the reaction to the decision of Nicholas at first instance in Australia. Fifth, the article assesses the prospects of an appeal to the Full Federal Court of Australia over the Myriad Genetics’ patents. Finally, this article observes that, whatever happens in respect of litigation against Myriad Genetics, there remains controversy over Genetic Technologies Limited. The Melbourne firm has been aggressively licensing and enforcing its related patents on non-coding DNA and genomic mapping.

From Kafka to KAFTA: Intellectual property, and the Korea-Australia free trade agreement

This paper provides a critical examination of the intellectual property sections of the Korea-Australia Free Trade Agreement 2014. Chapter 13 of the Korea-Australia Free Trade Agreement 2014 deals with the subject of intellectual property law. The Chapter covers such topics as the purposes and objectives of intellectual property law; copyright law; trade mark law; patent law; and intellectual property enforcement. The Joint Standing Committee on Treaties in the Australian Parliament highlighted the controversy surrounding this chapter of the agreement: The intellectual property rights chapter of KAFTA has drawn considerable attention from academics and stakeholders regarding the proposed need for changes to Australian intellectual property law and the inclusion of intellectual property in the definition of investment with regard to the investor-state dispute mechanism. Other concerns raised with the Committee include the prescriptive nature of the chapter, the lack of recognition of the broader public interests of intellectual property rights, and possible changes to fair use provisions. Article 13.1.1 of the Korea-Australia Free Trade Agreement 2014 provides that: ‘Each Party recognises the importance of adequate and effective protection of intellectual property rights, while ensuring that measures to enforce those rights do not themselves become barriers to legitimate trade.’ This is an unsatisfactory description of the objectives and purposes of intellectual property law in both Australia and Korea. There is a failure to properly consider the range of public purposes served by intellectual property law – such as providing for access to knowledge, promoting competition and innovation, protecting consumer rights, and allowing for the protection of public health, food security, and the environment. Such a statement of principles and objectives detracts from the declaration in the TRIPS Agreement 1994 of the public interest objectives to be served by intellectual property. Chapter 11 of the Korea-Australia Free Trade Agreement 2014 is an investment chapter, with an investor-state dispute settlement regime. This chapter is highly controversial – given the international debate over investor-state dispute settlement; the Australian context for the debate; and the text of the Korea-Australia Free Trade Agreement 2014. In April 2014, the United Nations Conference on Trade and Development (UNCTAD) released a report on Recent Developments in Investor-State Dispute Settlement. The overall figures are staggering. UNCTAD reports a significant growth in investment-state dispute settlement, across a wide array of different fields of public regulation. Given the broad definition of investment, intellectual property owners will be able to use the investor-state dispute settlement regime in the Korea-Australia Free Trade Agreement 2014. This will have significant implications for all the various disciplines of intellectual property – including copyright law, trade mark law, and patent law.

Beyond blue gene: Intellectual property and bioinformatics

This article considers the challenges posed to intellectual property law by the emerging field of bioinformatics. It examines the intellectual property strategies of established biotechnology companies, such as Celera Genomics, and information technology firms entering into the marketplace, such as IBM. First this paper argues that copyright law is not irrelevant to biotechnology, as some commentators would suggest. It claims that the use of copyright law and contract law is fundamental to the protection of biomedical and genomic databases. Second this article questions whether biotechnology companies are exclusively interested in patenting genes and genetics sequences. Recent evidence suggests that biotechnology companies and IT firms are patenting bioinformatics software and Internet business methods, as well as underlying instrumentation such as microarrays and genechips. Finally, this paper evaluates what impact the privatisation of bioinformatics will have on public research and scientific communication. It raises important questions about integration, interoperability, and the risks of monopoly. It finally considers whether open source software such as the Ensembl Project and peer to peer technology like DSAS will be able to counter this trend of privatisation.

Intellectual property and biofuels: The energy crisis, food security, and climate change

In light of larger public policy debates over intellectual property and climate change, this article considers patent practice, law, and policy in respect of biofuels. This debate has significant implications for public policy discussions in respect of energy independence, food security, and climate change. The first section of the paper provides a network analysis of patents in respect of biofuels across the three generations. It provides empirical research in respect of patent subject matter, ownership, and strategy in respect of biofuels. The second section provides a case study of significant patent litigation over biofuels. There is an examination of the biofuels patent litigation between the Danish company Novozymes, and Danisco and DuPont. The third section examines flexibilities in respect of patent law and clean technologies in the context of the case study of biofuels. In particular, it explores the debate over substantive doctrinal matters in respect of biofuels – such as patentable subject matter, technology transfer, patent pools, compulsory licensing, and disclosure requirements. The conclusion explores the relevance of the debate over patent law and biofuels to the larger public policy discussions over energy independence, food security, and climate change.

Japonica rice: Intellectual property, scientific publishing and data-sharing

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 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.

Stabilization of stormwater biofilters: Impacts of wetting and drying phases and the addition of organic matter to filter media

Ripening period refers to a phase of stabilization in sand filters in water treatment systems that follows a new installation or cleaning of the filter. Intermittent wetting and drying, a unique property of stormwater biofilters, would similarly be subjected to a phase of stabilization. Suspended solids, is an important parameter that is often used to monitor the stabilization of sand filters in water treatment systems. Stormwater biofilters however, contain organic material that is added to the filter layer to enhance nitrate removal, the dynamics of which is seldom analysed in stabilization of stormwater biofilters. Therefore, in this study of stormwater biofiltration in addition to suspended solids (Turbidity), organic matter (TOC, DOC, TN and TKN) was also monitored as a parameter for stabilization of the stormwater biofilter. One Perspex bioretention column (94 mm internal diameter) was fabricated with filter layer that contained 8% organic material and fed with tapwater with different antecedent dry days (0 – 40 day) at 100 mL/min. Samples were collected from the outflow at different time intervals between 2 – 150 minutes and were tested for Total Organic Carbon, Dissolved Organic Carbon, Total Nitrogen, Total Kjeldhal Nitrogen and Turbidity. The column was observed to experience two phases of stabilization, one at the beginning of each event that lasted for 30 minutes while the other phase was observed across subsequent events that related to the age of filter.