Patent law and biological inventions

In response to scientific breakthroughs in biotechnology, the development of new technologies, and the demands of a hungry capitalist marketplace, patent law has expanded to accommodate a range of biological inventions. There has been much academic and public debate as to whether gene patents have a positive impact upon research and development, health-care, and the protection of the environment. In a satire of prevailing patenting practices, the English poet and part-time casino waitress, Donna MacLean, sought a patent application - GB0000180.0 - in respect of herself. She explained that she had satisfied the usual patent criteria - in that she was novel, inventive, and useful: It has taken 30 years of hard labor for me to discover and invent myself, and now I wish to protect my invention from unauthorized exploitation, genetic or otherwise. I am new: I have led a private existence and I have not made the invention of myself public. I am not obvious (2000: 18). MacLean said she had many industrial applications. 'For example, my genes can be used in medical research to extremely profitable ends - I therefore wish to have sole control of my own genetic material' (2000: 18). She observed in an interview: 'There's a kind of unpleasant, grasping, greedy atmosphere at the moment around the mapping of the human genome ... I wanted to see if a human being could protect their own genes in law' (Meek, 2000). This special issue of Law in Context charts a new era in the long-standing debate over biological inventions. In the wake of the expansion of patentable subject matter, there has been great strain placed upon patent criteria - such as 'novelty', 'inventive step', and 'utility'. Furthermore, there has been a new focus upon legal doctrines which facilitate access to patented inventions - like the defence of experimental use, the 'Bolar' exception, patent pooling, and compulsory licensing. There has been a concerted effort to renew patent law with an infusion of ethical principles dealing with informed consent and benefit sharing. There has also been a backlash against the commercialisation of biological inventions, and a call by some activists for the abolition of patents on genetic inventions. This collection considers a wide range of biological inventions - ranging from micro-organisms, plants and flowers and transgenic animals to genes, express sequence tags, and research tools, as well as genetic diagnostic tests and pharmaceutical drugs. It is thus an important corrective to much policy work, which has been limited in its purview to merely gene patents and biomedical research. This collection compares and contrasts the various approaches of a number of jurisdictions to the legal problems in respect of biological inventions. In particular, it looks at the complexities of the 1998 European Union Directive on the Legal Protection of Biotechnological Inventions, as well as decisions of member states, such as the Netherlands, and peripheral states, like Iceland. The edition considers US jurisprudence on patent law and policy, as well as recent developments in Canada. It also focuses upon recent developments in Australia - especially in the wake of parallel policy inquiries into gene patents and access to genetic resources.

Information feudalism: Who owns the knowledge economy? A book review

Back in 1995, Peter Drahos wrote a futuristic article called ‘Information feudalism in the information society’. It took the form of an imagined history of the information society in the year 2015. Drahos provided a pessimistic vision of the future, in which the information age was ruled by the private owners of intellectual property. He ended with the bleak, Hobbesian image: "It is unimaginable that the information society of the 21st century could be like this. And yet if abstract objects fall out of the intellectual commons and are enclosed by private owners, private, arbitrary, unchecked global power will become a part of life in the information society. A world in which seed rights, algorithms, DNA, and chemical formulas are owned by a few, a world in which information flows can be coordinated by information-media barons, might indeed be information feudalism (p. 222)." This science fiction assumed that a small number of states would dominate the emerging international regulatory order set up under the World Trade Organization. In Information Feudalism: Who Owns the Knowledge Economy?, Peter Drahos and his collaborator John Braithwaite reprise and expand upon the themes first developed in that article. The authors contend: "Information feudalism is a regime of property rights that is not economicallyefficient, and does not get the balance right between rewarding innovation and diffusing it. Like feudalism, it rewards guilds instead of inventive individual citizens. It makes democratic citizens trespassers on knowledge that should be the common heritage of humankind, their educational birthright. Ironically, information feudalism, by dismantling the publicness of knowledge, will eventually rob the knowledge economy of much of its productivity (p. 219)." Drahos and Braithwaite emphasise that the title Information Feudalism is not intended to be taken at face value by literal-minded readers, and crudely equated with medieval feudalism. Rather, the title serves as a suggestive metaphor. It designates the transfer of knowledge from the intellectual commons to private corporation under the regime of intellectual property.

Race against time: The export of essential medicines to Rwanda

This article considers the significance of the first export of essential medicines under the WTO General Council Decision 2003. In July 2007, Rwanda became the first country to provide a notification under the WTO General Council Decision 2003 of its intent to import a fixed-dose, triple combination HIV/AIDS drug manufactured by the Canadian generic pharmaceuticalmanufacturer Apotex, Inc. In September 2007, Apotex was granted the first compulsory licence application under Canada's Access to Medicines Regime. This article considers the convoluted and protracted negotiations between the Government of Rwanda, Apotex and three patent holders, GlaxoSmithKline, Boehringer Ingleheim Canada and Shire BioChemical, Inc. It questions the efficiency of this process. This article considers the review of the Jean Chretien Pledge to Africa Act 2004 (Canada). It is critical of the refusal of the Conservative Government of Canada to make any amendments to the legislation to improve the cost-effective delivery of essential medicines. This article queries the proposed Hong Kong Amendment to the TRIPS Agreement 1994, given the concerns of the Africa Group. It is submitted that it is undesirable to codify the WTO General Council Decision 2003, given its failure to provide a speedy, efficient and cost-effective delivery of essential medicines.

Price and trade: World no tobacco day 2015

This special issue of Tobacco Control for World No Tobacco Day is focused on the theme of Price and Trade.

Mauve: How one man invented the colour that changed the world

In an essay, "The Books of Last Things", Delia Falconer discusses the emergence of a new genre in publishing - microhistories. She cites a number of recent titles in non-fiction and fiction - Longitude, Cod, Tulips, Pushkin's Button, Nathaniel's Nutmeg, Zarafa, The Surgeon of Crowthorne, The Potato, The Perfect Storm. Delia Falconer observes of this tradition: "One has the sense, reading these books, of a surprising weight, of pleasant shock. In part, it is because we are looking at things which are generally present around us, but modestly out of sight and mind - historical nitty gritty like cod, potatoes, longitudinal clocks - which the authors have thrust suddenly, like a Biblical visitation of frogs or locusts, in our face. Things like spice and buttons and clocks are generally seen to enable history on the large scale, but are not often viewed as its worthy subjects. And by the same grand logic of history, more unusual phenomena like cabinets of curiosities or glass-making or farm lore or sailors' knots are simply odd blips on its radar screen, interesting footnotes. These new books, microhistories, reverse the usual order of history, which argues from the general to the particular, in order to prove its inevitable progress. They start from the footnotes. But by reversing the process, and walking through the back door of history, you don't necessarily end up at the front of the same house." Delia Falconer speculates about the reasons for the popularity of microhistories. She concludes: "I would like to think that reading them is not simply an exercise in nostalgia, but a challenge to the present". In Mauve, Simon Garfield provides a new way of thinking and writing about the history of intellectual property. Instead of providing a grand historical narrative of intellectual property, he tells the story of a particular invention, and its exploitation. Simon Garfield relates how English chemist William Perkin accidentally discovered a way to mass-produce colour mauve in a factory. Working on a treatment for malaria in his London home laboratory, Perkin failed to produce artificial quinine. Instead he created a dark oily sludge that turned silk a beautiful light purple. The colour was unique and became the most desirable shade in the fashion houses of Paris and London. ... The book Mauve will have a number of contemporary resonances for intellectual property lawyers and academics. Simon Garfield emphasizes the difficulties inherent in commercialising an invention and managing intellectual property. He investigates the uneasy collaboration between industry and science. Simon Garfield suggests that complaints about the efficacy of patent offices are perennial. He also highlights the problems faced by courts and law-makers in accommodating new technologies within the logic of patent law. In his elegant microhistory of the colour mauve, Simon Garfield confirms the conclusion of Brad Sherman and Lionel Bently that many aspects of modern intellectual property law can only be understood through an understanding of the past: "The image of intellectual property law that developed during the 19th century and the narrative of identity which this engendered played and continue to play an important role in the way we think about and understand intellectual property law".

A Submission to the Inquiry into the Resale Royalty Right for Visual Artists Bill 2008 (Cth)

A right of resale, or droit de suite (a right to follow), is a legislative instrument under intellectual property law, which enables artists to receive a percentage of the sale price whenever artistic works are resold. A French legal scholar, Albert Vaunois, first articulated the need for a 'droit de suite' in connection with fine art back in 1893. The French Government introduced a scheme to protect the right of resale in 1920, after controversy over artists living in poverty, while public auction houses were profiting from the resale of their artistic creations. In the United States, there has been less support for a right of resale amongst legislatures. After lobbying from artists such as the king of pop art, Robert Rauschenberg, the state of California passed the Resale Royalties Act in 1977. At a Federal level, the United States Congress has shown some reluctance in providing national recognition for a right of resale in the United States. A number of other European countries have established a right of resale. In 2001, the European Council adopted the Artists' Resale directive and recognised that the 'artist's resale right forms an integral part of copyright and is an essential prerogative for authors.' In 2006, the United Kingdom promulgated regulations, giving effect to a right of resale in that jurisdiction. However, a number of Latin American and African countries have established a right of resale. The New Zealand Parliament has debated a bill on a right of resale.

Inventing life: Patent law and synthetic biology

With promises of improved medical treatments, greener energy and even artificial life, the field of synthetic biology has captured the public imagination and attracted significant government and commercial investment. This excitement reached a crescendo on 21 May 2010, when scientists at the J Craig Venter Institute in the United States announced that they had made a “self-replicating synthetic bacterial cell”. This was the first living cell to have an entirely human-made genome, which means that all of the cell’s characteristics were controlled by a DNA sequence designed by scientists. This achievement in biological engineering was made possible by combining molecular biotechnology, gene synthesis technology and information technology.

Pacific Rim treaty threatens public health: Patent law and medical procedures

Doctors, surgeons, and physicians around the Pacific Rim should be concerned by the proposals revealed by WikiLeaks in the Trans-Pacific Partnership (TPP). One of the most controversial features of the TPP is the proposal to provide for patent protection in respect of medical procedures. As Public Citizen observed, ‘Health providers, including surgeons, could be liable for the methods they use to treat patients.’ The civil society group noted: ‘Essentially, except for when a surgeon uses her bare hands, surgical methods would be patentable under the U.S. proposal.’ The TPP takes a broad approach to patents and medicine; lacks appropriate safeguards; and fails to address larger questions about equity, development, and human rights. Such a measure could result in greater litigation against medical professionals; barriers to access to medical procedures for patients; and skyrocketing health costs.

TPP draft reveals surgical strike on public health

On 13 November, WikiLeaks released a secret draft text of the Intellectual Property Chapter of the Trans-Pacific Partnership (TPP). The text reveals substantive proposals for expanded protection in respect of copyright, patent, trade mark and trade secrets law, and intellectual property enforcement.

IPCC Makes Climate A Human Rights Issue

The Intergovernmental Panel on Climate Change (IPCC) has published its latest report upon the impacts of global warming, highlighting the pernicious impact of climate change upon public health, well-being, and even the survival of the human race.

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 1980’s, 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, Françoise Barré-Sinoussi, and other French scientists from the Pasteur Institute 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 identify the AIDS virus and to invent the antibody test, and that the American test was dependent upon the French research. In March 1987, an agreement was brokered by President Ronald Reagan and French Prime Minister Jacques Chirac, which resulted in the Department of Health and Human Services and the Institut Pasteur sharing the patent rights to the blood test for AIDS. In 1992, the Federal Office of Research Integrity found that Gallo had committed scientific misconduct, by falsely reporting facts in his 1984 scientific paper. A subsequent investigation by the National Institutes of Health, the United States Congress, and the US attorney-general cleared Gallo of any wrongdoing. In 1994, the United States government and French government renegotiated their agreement regarding the AIDS blood test patent, in order to make the distribution of royalties more equitable... The dispute between Luc Montagnier and Robert Gallo was not an isolated case of scientific rivalry and patent races. It foreshadowed further patent conflicts over research in respect of HIV/AIDS. Michael Kirby, former Justice of the High Court of Australia diagnosed a clash between two distinct schools of philosophy - ‘scientists of the old school... working by serendipity with free sharing of knowledge and research’, and ‘those of the new school who saw the hope of progress as lying in huge investments in scientific experimentation.’ Indeed, the patent race between Robert Gallo and Luc Montagnier has been a precursor to broader trade disputes over access to essential medicines in the 1990s and 2000s. The dispute between Robert Gallo and Luc Montagnier captures in microcosm a number of themes of this book: the fierce competition for intellectual property rights; the clash between sovereign states over access to medicines; the pressing need to defend human rights, particularly the right to health; and the need for new incentives for research and development to combat infectious diseases as both an international and domestic issue.

The artist is a thief: A book review

Stephen Gray is a writer and law lecturer who has been living in Darwin since 1989. He started out writing formal legal pieces about how copyright law had unsuccessfully sought to accommodate Aboriginal art. Such work led him to further investigate the philosophical questions underlying the legal issues affecting both traditional and urban Indigenous people. Gray has also explored matters of bioprospecting in relation to Indigenous biological resources. He has investigated the introduction of a label of authenticity into Australia. Gray has also published a number of articles about other legal issues affecting Indigenous people. He has explored such topics as native title, customary law, alternative dispute resolution, and criminal law. Gray has recently been awarded The Australian/ Vogel Literary Award for his novel The Artist is a Thief. He was inspired to write a book after being sent out to a community on a possible copyright claim as part of his job in the law faculty of Northern Territory University: "I wrote an academic article and then a more philosophical piece talking about the copyright act and the way it doesn't really protect traditional artists who have a very different view of the place of their art. The pieces were interesting, but I felt there was something more there that needed a fictional expression as well." It is ironic that such a self-conscious and sophisticated meditation upon appropriation and authenticity should win The Australian/ Vogel Literary Award. The inaugural award in 1980 was won by Paul Radley, who later revealed his books were mostly written by his uncle, and in 1993 it was won by Helen Demidenko, aka Darville, who had lied about her Ukrainian background and family history.

International copyright law: A book review

n his 1994 book, Copyright's Highway, Paul Goldstein made the telling prophecy: The celestial jukebox may also portend more revolutional changes in international copyright markets. As the celestial jukebox disseminates information and entertainment over the air and without regard for national boundaries, the importance of the nation-state as a traditional guarantor of copyright may be replaced by international institutions such as the newly established World Trade Organization. In retrospect, it was an accurate prediction. The celestial jukebox has shown little respect for national boundaries. In particular, ephemeral file-sharing programs such as Napster, Freenet and Filetopia have posed difficulties for copyright law. International treaties have taken on larger significance and international institutions such as the World Intellectual Property Organization and World Trade Organization have assumed a greater role in regulating international copyright markets.

Shine: Copyright law and film

This article looks at the various experiences of the film-makers involved in Shine in relation to copyright policy and litigation. Part 1 considers the involvement of Jan Sardi in the campaign to get screenwriters included in the moral rights regime in the film industry. Part 2 recounts the efforts of Scott Hicks to push for directors to acquire royalties under the retransmission scheme in the Copyright Amendment (Digital Agenda) Act 2000 (Cth). Part 3 discusses the contractual dispute between independent producer Jane Scott and the distributor over the gross receipts to the film Shine. Part 4 explores the disputes over the use of Sergei Rachmaninov's music in the film Shine.