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.

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.

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.

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.]

Myriad genetics: Patent law and genetic testing

This paper considers the legal challenges to the legal validity of the patents held by Myriad Genetics in respect of genetic testing for breast cancer and ovarian cancer. It argues that broad-based patents on gene sequences and medical diagnostics will have a harmful effect upon access to patient care, genetic research, and the administration of public health care.

Precious images: Copyright law and television broadcasts

Over the last several years, Australian media magnate Kerry Packer has sought to maximise the value of the intellectual property assets of the television station Channel Nine. He has made a concerted effort to expand the scope of copyright protection over television broadcasts screened. The television station Channel Nine has taken a number of legal actions against its rivals and competitors - including the Australian Broadcasting Corporation and Network Ten. It has alleged that the broadcasters have used substantial parts of copyrighted television broadcasts without their permission.

The new conquistadors: Patent law and expressed sequence tags

It's akin to the old Spanish, English and Portuguese explorers. They would take their boats until they found some edge of land, then they would go up and plant the flag of their king or queen. They didn't know what they'd discovered; how big it is, where it goes to - but they would claim it anyway. David Korn of the Association of American Medical Colleges This article analyses recent litigation over patent law and expressed sequence tags (ESTs). In the case of In re Fisher, the United States Court of Appeals for the Federal Circuit engaged in judicial consideration of the revised utility guidelines of the United States Patent and Trademark Office (USPTO). In this matter, the agricultural biotechnology company Monsanto sought to patent ESTs in maize plants. A patent examiner and the Board of Patent Appeals and Interferences had doubted whether the patent application was useful. Monsanto appealed against the rulings of the USPTO. A number of amicus curiae intervened in the matter in support of the USPTO - including Genentech, Affymetrix, Dow AgroSciences, Eli Lilly, the National Academy of Sciences, and the Association of American Medical Colleges. The majority of the Court of Appeals for the Federal Circuit supported the position of the USPTO, and rejected the patent application on the grounds of utility. The split decision highlighted institutional tensions over the appropriate thresholds for patent criteria - such as novelty, non-obviousness, and utility. The litigation raised larger questions about the definition of research tools, the incremental nature of scientific progress, and the role of patent law in innovation policy. The decision of In re Fisher will have significant ramifications for gene patents, in the wake of the human genome project. Arguably, the USPTO utility guidelines need to be reinforced by a tougher application of the standards of novelty and non-obviousness in respect of gene patents.

Miami heat: Patent law, informed consent and benefit-sharing

This article considers whether the granting of patents in respect of biomedical genetic research should be conditional upon the informed consent of research participants. It focuses upon several case studies. In Moore v the Regents of the University Of California, a patient sued his physician for breach of fiduciary duty and lack of informed consent, because the doctor had obtained a patent on the patient's cell line, without the patient's authorisation. In Greenberg v Miami Children's Hospital, the research participants, the Greenbergs, the National Tay Sachs and Allied Diseases Association, and Dor Yeshorim brought a legal action against the geneticist Reubon Matalon and the Miami Children's Hospital over a patent obtained on a gene related to the Canavan disease and accompany genetic diagnostic test. PXE International entered into a joint venture with Charles Boyd and the University of Hawaii, and obtained a patent together for ‘methods for diagnosing Pseudoxanthoma elasticum’. In light of such case studies, it is contended that there is a need to reform patent law, so as to recognise the bioethical principles of informed consent and benefit-sharing. The 2005 UNESCO Declaration on Bioethics and Human Rights provides a model for future case law and policy-making.

How to be alone: New Dimensions in Privacy Law

The book, New Dimensions in Privacy Law, has an arresting cover — a pack of paparazzi take photographs, with their flash-bulbs popping and exploding,like starbursts in the sky. The collection explores the valiant efforts of courts and parliaments to defend the privacy of individuals against such unwanted intrusions.

Remixing Canadian copyright law: A review essay on'An Emerging Intellectual Property Paradigm','Canadian Copyright: A Citizen's Guide'; and'RiP!: A Remix Manifesto', Prometheus, Vol. 27 (3), p. 297-305

In her album, Hymns of the 49th Parallel, the chanteuse K.D. Lang pays tribute to a series of great Canadian songwriters—such as Neil Young, Leonard Cohen, Joni Mitchell and Jane Siberry. In a similar spirit of celebration, this review essay pays homage to a number of recent texts and films dealing with Canadian intellectual property. First, it considers Ysolde Gendreau’s collection, An Emerging Intellectual Property Paradigm: Perspectives from Canada. Second, this essay looks at Laura Murray and Samuel Trosow’s manual, Canadian Copyright: A Citizen’s Guide. Finally, this review evaluates Brett Gaylor’s documentary, RiP! A Remix Manifesto. The three works share certain affinities—a spirit of scepticism about the legitimacy and the efficacy of existing networks of law, policy and bureaucracy; a populist interest in the impact of intellectual property on the everyday lives of citizens, creators and consumers; a passion for human rights; and a melioristic desire for sensible law reform of copyright law and related regimes of intellectual property.

Creation and copyright law: The case of 3D printing

The Australian Law Reform Commission is conducting an inquiry into copyright law and the digital economy in 2012 and 2013.The President, Rosalind Croucher, stated: “While the Copyright Act has been amended on occasion over the past 12 years to account for digital developments, these changes occurred before the digital economy took off. The Australian Law Reform Commission will need to find reforms that are responsive to this new environment, and to future scenarios that are still in the realm of the imagination. It is a complex and important area of law and we are looking forward to some robust debate and discussion during the course of this very important Inquiry.”

IT pricing: Copyright law, consumer rights, and competition policy. A submission to the House of Representatives Standing Committee on Infrastructure and Communications Inquiry into IT Pricing

For a hundred years, since Federation, Australian consumers have suffered the indignity and the tragedy of price discrimination. From the time of imperial publishing networks, Australia has been suffered from cultural colonialism. In respect of pricing of copyright works, Australian consumers have been gouged; ripped-off; and exploited. Digital technologies have not necessarily brought an end to such price discrimination. Australian consumers have been locked out by technological protection measures; subject to surveillance, privacy intrusions and security breaches; locked into walled gardens by digital rights management systems; and geo-blocked.