Turing and the Trans-Pacific Partnership: Intellectual Property, Public Health, and Access to Essential Medicines

A recent controversy in the United States over drug pricing by Turing Pharmaceuticals AG has raised larger issues in respect of intellectual property, access to medicines, and the Trans-Pacific Partnership (TPP). In August 2015, Turing Pharmaceuticals AG – a private biopharmaceutical company with offices in New York, the United States, and Zug, Switzerland - acquired the exclusive marketing rights to Daraprim in the United States from Impax Laboratories Incorporated. Martin Shkreli, Turing’s Founder and Chief Executive Officer, maintained: “The acquisition of Daraprim and our toxoplasmosis research program are significant steps along Turing’s path of bringing novel medications to patients with serious disorders, some of whom often go undiagnosed and untreated.” He emphasised: “We intend to invest in the development of new drug candidates that we hope will yield an even better clinical profile, and also plan to launch an educational effort to help raise awareness and improve diagnosis for patients with toxoplasmosis.” In September 2015, there was much public controversy over the decision of Martin Shkreli to raise the price of a 62 year old drug, Daraprim, from $US13.50 to $US750 a pill. The drug is particularly useful in respect to the treatment and prevention of malaria, and in the treatment of infections in individuals with HIV/AIDS. Daraprim is listed on the World Health Organization’s (WHO) List of Essential Medicines. In the face of much criticism, Martin Shkreli has said that he will reduce the price of Daraprim. He observed: “We've agreed to lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit, but a very small profit.” He maintained: “We think these changes will be welcomed.” However, he has been vague and ambiguous about the nature of the commitment. Notably, the lobby group, Pharmaceutical Research and Manufacturers of America (PhARMA), disassociated itself from the claims of Turing Pharmaceuticals. The group said: “PhRMA members have a long history of drug discovery and innovation that has led to increased longevity and improved lives for millions of patients.” The group noted: “Turing Pharmaceutical is not a member of PhRMA and we do not embrace either their recent actions or the conduct of their CEO.” The biotechnology peak body Biotechnology Industry Organization also sought to distance itself from Turing Pharmaceuticals. A hot topic: United States political debate about access to affordable medicines This controversy over Daraprim is unusual – given the age of drug concerned. Daraprim is not subject to patent protection. Nonetheless, there remains a monopoly in respect of the marketplace. Drug pricing is not an isolated problem. There have been many concerns about drug pricing – particularly in respect of essential medicines for HIV/AIDS, tuberculosis, and malaria. This recent controversy is part of a larger debate about access to affordable medicines. The dispute raises larger issues about healthcare, consumer rights, competition policy, and trade. The Daraprim controversy has provided impetus for law reform in the US. US Presidential Candidate Hillary Clinton commented: “Price gouging like this in this specialty drug market is outrageous.” In response to her comments, the Nasdaq Biotechnology Index fell sharply. Hillary Clinton has announced a prescription drug reform plan to protect consumers and promote innovation – while putting an end to profiteering. On her campaign site, she has emphasised that “affordable healthcare is a basic human right.” Her rival progressive candidate, Bernie Sanders, was also concerned about the price hike. He wrote a letter to Martin Shkreli, complaining about the price increase for the drug Daraprim. Sanders said: “The enormous, overnight price increase for Daraprim is just the latest in a long list of skyrocketing price increases for certain critical medications.” He has pushed for reforms to intellectual property to make medicines affordable. The TPP and intellectual property The Daraprim controversy and political debate raises further issues about the design of the TPP. The dispute highlights the dangers of extending the rights of pharmaceutical drug companies under intellectual property, investor-state dispute settlement, and drug administration. Recently, the civil society group Knowledge Ecology International published a leaked draft of the Intellectual Property Chapter of the TPP. Knowledge Ecology International Director, James Love, was concerned the text revealed that the US “continues to be the most aggressive supporter of expanded intellectual property rights for drug companies.” He was concerned that “the proposals contained in the TPP will harm consumers and in some cases block innovation.” James Love feared: “In countless ways, the Obama Administration has sought to expand and extend drug monopolies and raise drug prices.” He maintained: “The astonishing collection of proposals pandering to big drug companies make more difficult the task of ensuring access to drugs for the treatment of cancer and other diseases and conditions.” Love called for a different approach to intellectual property and trade: “Rather than focusing on more intellectual property rights for drug companies, and a death-inducing spiral of higher prices and access barriers, the trade agreement could seek new norms to expand the funding of medical research and development (R&D) as a public good, an area where the US has an admirable track record, such as the public funding of research at the National Institutes of Health (NIH) and other federal agencies.” In addition, there has been much concern about the Investment Chapter of the TPP. The investor-state dispute settlement regime would enable foreign investors to challenge government policy making, which affected their investments. In the context of healthcare, there is a worry that pharmaceutical drug companies will deploy their investor rights to challenge public health measures – such as, for instance, initiatives to curb drug pricing and profiteering. Such concerns are not merely theoretical. Eli Lilly has brought an investor action against the Canadian Government over the rejection of its drug patents under the investor-state dispute settlement regime of the North American Free Trade Agreement (NAFTA). The Health Annex to the TPP also raises worries that pharmaceutical drug companies will able to object to regulatory procedures in respect of healthcare. It is disappointing that the TPP – in the leaks that we have seen – has only limited recognition of the importance of access to essential medicines. There is a need to ensure that there are proper safeguards to provide access to essential medicines – particularly in respect of HIV/AIDs, malaria, and tuberculosis. Moreover, there must be protection against drug profiteering and price gouging in any trade agreement. There should be strong measures against the abuse of intellectual property rights. The dispute over Turing Pharmaceuticals AG and Daraprim is an important cautionary warning in respect of some of the dangers present in the secret negotiations in respect of the TPP. There is a need to preserve consumer rights, competition policy, and public health in trade negotiations over an agreement covering the Pacific Rim.

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.

Gone with the wind: copyright law and fair use

The copyright defence of fair use has been tested in a recent United States case involving the classic Gone with the wind. [Suntrust Bank, as Trustee of the Stephens Mitchell trusts v Houghton Mifflin Company (2001) 136 F. Supp. 2d 1357; and Suntrust Bank, as Trustee of the Stephens Mitchell trusts v Houghton Mifflin Company (2001) US Appeal Lexis 21690.]

UK Design as a global industry : international trade and intellectual property Executive Summary

This is an independent report comissioned by the Intellectual Property Office (IPO) and supported by the Design Council.

Intellectual property, TRIPS and development

Intellectual property is crucial to the promotion of innovation. It provides an incentive to innovate as well as security for investment in innovation. The industries of the 21st century-information technology, biotechnology, pharmaceuticals, communications, education and entertainment – are all knowledge-based. The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement), adopted in 1994 at the conclusion of the Uruguay Round of trade negotiations, requires all WTO member countries to provide for the protection and enforcement of intellectual property rights. Having forged a link for the first time between intellectual property rights and the international trading system, the adoption of TRIPS means that any country that aims to participate fully in the global economy needs to understand the role of intellectual property and align its intellectual property laws and practices with the international minimum standards prescribed by TRIPS. However, for developing and least-developed countries, the implementation of intellectual property systems and enforcement mechanisms raises questions and challenges. Does recognition and enforcement of intellectual property serve their development needs and objectives? Does TRIPS encourage or hinder the transfer of technologies to developing and least-developed countries, particularly those that meet urgent needs in areas such as public health, food security, water and energy? What is the effect of TRIPS on developing countries’ access to knowledge and information? Is there scope for flexibility in implementation of TRIPS in pursuit of development strategies?

Climate-ready crops: Intellectual property, agriculture, and climate change

In The Climate Change Review, Ross Garnaut emphasised that ‘Climate change and climate change mitigation will bring about major structural change in the agriculture, forestry and other land use sectors’. He provides this overview of the effects of climate change on food demand and supply: ‘Domestic food production in many developing countries will be at immediate risk of reductions in agricultural productivity due to crop failure, livestock loss, severe weather events and new patterns of pests and diseases.’ He observes that ‘Changes to local climate and water availability will be key determinants of where agricultural production occurs and what is produced.’ Gert Würtenberger has commented that modern plant breeding is particularly concerned with addressing larger issues about nutrition, food security and climate change: ‘Modern plant breeding has an increasing importance with regard to the continuously growing demand for plants for nutritional and feeding purposes as well as with regard to renewal energy sources and the challenges caused by climate changes.’ Moreover, he notes that there is a wide array of scientific and technological means of breeding new plant varieties: ‘Apart from classical breeding, technologies have an important role in the development of plants that satisfy the various requirements that industrial and agricultural challenges expect to be fulfilled.’ He comments: ‘Plant variety rights, as well as patents which protect such results, are of increasingly high importance to the breeders and enterprises involved in plant development programmes.’ There has been larger interest in the intersections between sustainable agriculture, environmental protection and food security. The debate over agricultural intellectual property is a polarised one, particularly between plant breeders, agricultural biotechnology companies and a range of environmentalist groups. Susan Sell comments that there are complex intellectual property battles surrounding agriculture: 'Seeds are at the centre of a complex political dynamic between stakeholders. Access to seeds concerns the balance between private rights and public obligations, private ownership and the public domain, and commercial versus humanitarian objectives.' Part I of this chapter considers debates in respect of plant breeders’ rights, food security and climate change in relation to the UPOV Convention 1991. Part II explores efforts by agricultural biotechnology companies to patent climate-ready crops. Part III considers the report of the Special Rapporteur for Food, Olivier De Schutter. It looks at a variety of options to encourage access to plant varieties with climate adaptive or mitigating properties.

The Black Label: trade mark dilution, culture jamming, and the no logo movement

This article considers the ongoing debate over the appropriation of well-known and famous trade marks by the No Logo Movement for the purposes of political and social critique. It focuses upon one sensational piece of litigation in South Africa, Laugh It Off Promotions v. South African Breweries International (Finance) B.V. t/a Sabmark International. In this case, a group called Laugh It Off Promotions subjected the trade marks of the manufacturers of Carling Beer were subjected to parody, social satire, and culture jamming. The beer slogan “Black Label” was turned into a T-Shirt entitled “Black Labour/ White Guilt”. In the ensuing litigation, the High Court of South Africa and the Supreme Court of Appeal were of the opinion that the appropriation of the mark was a case of hate speech. However, the Constitutional Court of South Africa disagreed, finding that the parodies of a well-known, famous trade mark did not constitute trade mark dilution. Moseneke J observed that there was a lack of evidence of economic or material harm; and Sachs J held that there is a need to provide latitude for parody, laughter, and freedom of expression. The decision of the Constitutional Court of South Africa provides some important insights into the nature of trade mark dilution, the role of parody and satire, and the relevance of constitutional protections of freedom of speech and freedom of expression. Arguably, the ruling will be of help in the reformation of trade mark dilution law in other jurisdictions – such as the United States. The decision in Laugh It Off Promotions v. South African Breweries International demonstrates that trade mark law should not be immune from careful constitutional scrutiny.

Moving towards open standards

Standards are designed to promote the interoperability of products and systems by enabling different parties to develop technologies that can be used together. There is an increasing expectation in many technical communities, including open source communities, that standards will be ‘open’. However, standards are subject to legal rights which impact upon, not only their development, but also their implementation. Of central importance are intellectual property rights: technical standards may incorporate patented technologies, while the specification documents of standards are protected by copyright. This article provides an overview of the processes by which standards are developed and considers the concept of ‘interoperability’, the meaning of the term ‘open standard’ and how open standards contribute to interoperability. It explains how intellectual property rights operate in relation to standards and how they can be managed to create standards that are open, not only during their development, but also in implementation.

Creative Commons : the next generation : Creative Commons licence use five years on

Since its launch in 2001, the Creative Commons open content licensing initiative has received both praise and censure. While some have touted it as a major step towards removing the burdens copyright law imposes on creativity and innovation in the digital age, others have argued that it robs artists of their rightful income. This paper aims to provide a brief overview and analysis of the practical application of the Creative Commons licences five years after their launch. It looks at how the Creative Commons licences are being used and who is using them, and attempts to identify likely motivations for doing so. By identifying trends in how this licence use has changed over time, it also attempts to rebut arguments that Creative Commons is a movement of academics and hobbyists, and has no value for traditional organisations or working artists.

More legislative traffic on the 'Doi Moi' superhighway : technology transfer, IP and competition law in Vietnam

Since 1986 Vietnam has been engaged in the transition from a centrally-controlled economy to a socialist-oriented market economy (the 'doi moi' renovation). The process for global economic integration has been slow given the magnitude of necessary reforms. Consequently technology entrepreneurs often discount Vietnam as a possible commercialization base which means that it is not realising its economic potential as a hub of technology transfer in the Asia-Pacific region. Three significant factors in the current uncertainty are Vietnam's laws on competition, intellectual property and technology transfer. Another problem is the lack of literature on these laws. This article first discusses the conceptual relationship between competition, intellectual property and technology transfer. Hopefully the article will provide some guidance for the technology entrepreneur considering foreign direct investment (FDI) in Vietnam. The bottom line is that these laws still need further reform to bolster entrepreneurial confidence.

The human Fertilisation and Embryology Act 2008 : a multidisciplinary workshop

Event report following a multidisciplinary workshop at the Economic and Social Research Council's Genomics Policy and Research Forum, which took place at the University of Edinburgh on 20 January 2011.

Bloomsday: Copyright estates and cultural festivals

Copyright estates have been unduly empowered by the extension of the term of copyright protection in Europe, the United States, Australia and elsewhere. The Estate of the Irish novelist, James Joyce, has been particularly aggressive in policing his revived copyrights. The "keepers of the flame" have relied upon threats of legal action to discourage the production of derivative works based upon the canonical texts of the novelist. The Estate has also jealously guarded the reputation of the author by vetoing the use of his work in various scholarly productions. Most radically of all, the grandson Stephen Joyce threatened to take legal action to prevent the staging of "Rejoyce Dublin 2004", a festival celebrating the centenary of Bloomsday. In response, the Irish Parliament rushed through emergency legislation, entitled the Copyright and Related Rights (Amendment) Act 2004 (Ireland) to safeguard the celebrations. The legislation clarified that a person could place literary and artistic works on public exhibition, without breaching the copyright vested in such cultural texts. Arguably, though, the ad hoc legislation passed by the Irish Parliament is inadequate. The Estate of James Joyce remains free to exercise its suite of economic and moral rights to control the use and adaptation of works of the Irish novelist. It is contended that copyright law needs to be revised to promote the interests of libraries and other cultural institutions. Most notably, the defence of fair dealing should be expanded to allow for the transformative use of copyright works, particularly in respect of adaptations and derived works. There should be greater scope for compulsory licensing and crown acquisition of revived copyrights.

Amateur Media : Social, Cultural and Legal Perspectives

The rise of Web 2.0 has pushed the amateur to the forefront of public discourse, public policy and media scholarship. Typically non-salaried, non-specialist and untrained in media production, amateur producers are now seen as key drivers of the creative economy. But how do the activities of citizen journalists, fan fiction writers and bedroom musicians connect with longer traditions of extra-institutional media production? This edited collection provides a much-needed interdisciplinary contextualisation of amateur media before and after Web 2.0. Surveying the institutional, economic and legal construction of the amateur media producer via a series of case studies, it features contributions from experts in the fields of law, economics and media studies based in the UK, Europe and Singapore. Each section of the book contains a detailed case study on a selected topic, followed by two further pieces providing additional analysis and commentary. Using an extraordinary array of case studies and examples, from YouTube to online games, from subtitling communities to reality TV, the book is neither a celebration of amateur production nor a denunciation of the demise of professional media industries. Rather, this book presents a critical dialogue across law and the humanities, exploring the dynamic tensions and interdependencies between amateur and professional creative production. This book will appeal to both academics and students of intellectual property and media law, as well as to scholars and students of economics, media, cultural and internet studies.

Submission to Communications Alliance Industry Code: Copyright Notice Scheme

In making this submission, we suggest that Australia learn from the experiences of other jurisdictions, and avoid some of the mistakes that have been made. In particular, this involves: * Ensuring that adequate information is available to evaluate the success of the scheme * Ensuring that notices sent to consumers provide full and accurate information that helps them understand their rights and options * Limiting the potential abuse of the system, and particularly attempts to intimidate consumers into paying unfair penalties through ‘speculative invoicing’ * Avoiding the potential for actual or perceived bias in the scheme’s oversight body