Patent-busting: The public patent foundation, gene patents and the Seed Wars

This chapter considers the Public Patent Foundation as a novel institution in the patent framework. It contends that such a model can play a productive role in challenging the validity of high-profile patents; working as an amicus curiae in significant court cases; and also promoting patent law reform. However, there are limits to the ‘patent-busting’ of the Foundation. The not-for-profit legal services organization has only had the time and resources to challenge a number of noteworthy patents. Other jurisdictions – such as Australia – lack such public-spirited "patent-busting" entities. This chapter considers a number of key disputes involving the Public Patent Foundation. Part I examines the role of the Public Patent Foundation in the landmark dispute over Myriad Genetics’ patents in respect of breast cancer and ovarian cancer. Part II considers the role of the Public Patent Foundation in litigation between organic farmers and Monsanto. Part III examines the role of the Public Patent Foundation in larger debates about patent law reform in the United States – particularly looking at the Leahy-Smith America Invents Act 2011 (US). The conclusion contends that the patent-busting model of the Public Patent Foundation should be emulated in respect of other technological fields, and other jurisdictions – such as Australia. The initiative could also be productively applied to other forms of intellectual property – such as trade mark law, designs law, plant breeders’ rights, plant breeders’ rights, and access to genetic resources.

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 race to patent the SARS virus: The TRIPS agreement and access to essential medicines

This article considers the race to sequence the Severe Acute Respiratory Syndrome virus ('the SARS virus') in light of the debate over patent law and access to essential medicines. Part II evaluates the claims of public research institutions in Canada, the United States, and Hong Kong, and commercial companies, to patent rights in respect of the SARS virus. It highlights the dilemma of ’defensive patenting' - the tension between securing private patent rights and facilitating public disclosure of information and research. Part III considers the race to patent the SARS virus in light of wider policy debates over gene patents. It examines the application of such patent criteria as novelty, inventive step, utility, and secret use. It contends that there is a need to reform the patent system to accommodate the global nature of scientific inquiry, the unique nature of genetics, and the pace of technological change. Part IV examines the role played by the World Trade Organization and the World Health Organization in dealing with patent law and access to essential medicines. The article contends that there is a need to ensure that the patent system is sufficiently flexible and adaptable to accommodate international research efforts on infectious diseases.

Vanquishing the'Patent Trolls'

Patent law provides exclusive rights to exploit scientific inventions, which are novel, inventive, and useful. The regime is intended to promote innovation, investment in research and development, and access to scientific information. In recent times, there have been concerns that the patent system has been abused by opportunistic companies known by the phrase “patent trolls”. It has been alleged that such entities have stunted innovation and spurred unnecessary patent litigation. Adam Jaffe and Josh Lerner discuss such pathologies of patent law in their book, Innovation and Its Discontents: How our Broken Patent System is Endangering Innovation and Progress, and What To Do About It. James Bessen and Michael Meurer have addressed such concerns in their recent text, Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk. There have been particular fears about the rise of “patent trolls” in the field of information technology. Peter Dekin, an assistant general counsel at Intel, used the phrase “patent troll” to describe firms, which acquired patents only to extract settlements from companies on dubious infringement claims.

No logo: Brand bullies, trade mark law, and the Trans-Pacific Partnership

The Trans-Pacific Partnership is a sweeping trade agreement, spanning the Pacific Rim, and covering an array of topics, including intellectual property. There has been much analysis of the recently leaked intellectual property chapter of the Trans-Pacific Partnership by WikiLeaks. Julian Assange, WikiLeaks’ Editor-in-Chief, observed “The selective secrecy surrounding the TPP negotiations, which has let in a few cashed-up megacorps but excluded everyone else, reveals a telling fear of public scrutiny. By publishing this text we allow the public to engage in issues that will have such a fundamental impact on their lives.” Critical attention has focused upon the lack of transparency surrounding the agreement, copyright law and the digital economy; patent law, pharmaceutical drugs, and data protection; and the criminal procedures and penalties for trade secrets. The topic of trade mark law and related rights, such as internet domain names and geographical indications, deserves greater analysis.

‘Storyline patents’: are plots patentable?

The most interesting questions that arise in patent law are the ones that test the boundaries of patentable subject matter. One of those questions has been put forward recently in the United States in an argument in favour of patenting the plots of fictional stories. United States attorney Andrew F Knight has claimed that storylines are patentable subject matter and should be recognised as such. What he claims is patentable is not the copyrightable expression of a written story or even a written outline of a plot but the underlying plot of a story itself. The commercial application of ‘storyline patents’, as he describes them, is said to be their exclusive use in books and movies. This article analyses the claims made and argues that storylines are not patentable subject matter under Australian law. It also contends that policy considerations, as well as the very nature of creative works, weigh against recognition of ‘storyline patents’.

Prosecution history estoppel in the UK?

The doctrine of 'prosecution history estoppel' (PH estoppel) as developed in the United States has strong intuitive appeal, especially when applied to counterbalance a related patent law principle, the doctrine of equivalents. The doctrines are receiving increasing attention in US patent decisions, to the point where one patent litigator recently compared them to "two cars that keep bumping fenders. They are frequently returned to the shop for repairs". Could PH estoppel find its way into UK patent law? This article briefly examines the doctrine, its evolution in the US and the problems associated with importing the doctrine into the UK. As the EU legislation stands, Article 69 and the Protocol to the European Patent Convention (EPC) pose serious obstacles to using the doctrine directly in claim construction. However there appears to be some scope to apply the doctrine as a limited form of defence in infringement actions.

Artful determination : "state of the art" and PCME Ltd v. Goyen COntrols Co. UK Ltd

In a recent decision by Mr Justice Laddie, a patent was held anticipated by, inter alia, prior use of a device which fell within the claims of the patent in suit, even though its circuitry was enclosed in resin. The anticipating invention had been "made available to the public" within the terms of section 2 (2) of the Patents Act 1977 because its essential integers would have been revealed by an interesting character, the "skilled forensic engineer".

Locking away the mysteries of fair basis : Lockwood v Doric in the High Court

This article updates a previous article on the Lockwood v Doric fair basing case in the Full Court of the Federal Court which was recently appealed to the High Court. The High Court's decision provides a new and welcome level of clarity in this difficult area of patent law. With this new clarity we can finally lock away some of the mysteries that have plagued the area for some time. Already, indications are that Lockwood's guidelines are being usefully applied in the Patent Office and Federal Court.

Does the fair basing "problem child" escape Lockwood?

In an earlier article the concept of fair basing in Australian patent law was described as a "problem child", often unruly and unpredictable in practice, but nevertheless understandable and useful in policy terms. The article traced the development of several different branches of patent law that were swept under the nomenclature of "fair basing" in Britain in 1949. It then went on to examine the adoption of fair basis into Australian law, the modern interpretation of the requirement, and its problems. This article provides an update. After briefly recapping on the relevant historical issues, it examines the recent Lockwood "internal" fair basing case in the Federal and High Courts.

Australia experiments with 'experimental use' exemption

Lawmakers are asking whether Australian researchers need an express 'experimental use' defense against patent infringement. The overriding policy for establishing a patent system is indisputably the promotion of innovation. According to traditional intellectual property pedagogy, the incentive to innovate flows from the reward afforded to the inventor. A balancing policy is that the patentee must fully disclose the invention to help minimize the risks of duplication and provides a basis for improvements by further research.Where there is uncertainty as to how these competing policy limbs are balanced and whether a patentee can exclude others from experimenting on a patented invention, the uncertain legal environment disadvantages both the patentee and researcher. Different jurisdictions have treated the experimental use question quite differently with varied results for the researcher. The biotechnology industry is evolving at an unprecedented pace and the law will as is always the case, lag behind in its usual cautious fashion. The Australian law may finally catch up to researchers' concerns.

Licensing technology : negotiating and drafting technology transfer agreements [3rd ed.]

Part I of this book covers the commercial and contractual background to technology licensing agreements. Part II discusses the European Community's new regime on the application and enforcement of Article 81 to technology licensing agreements. EC Council Regulation 1/2003 replaced the Council Regulation 17/1962 and repealed the system under which restrictive agreements and practices could be notified to the EC Commission. A new Commission regulation on technology transfer agreements, Regulation 772/2004. These two enactments required consequential amendments to the chapters in Part III where the usual terms of technology licensing agreements are analysed and exemplified by reference to decided cases.

Bilski v Kappos : The United States Supreme Court delivers mixed views on patenting non-physical inventions and business methods

The United States Supreme Court has handed down a once in a generation patent law decision that will have important ramifications for the patentability of non-physical methods, both internationally and in Australia. In Bilski v Kappos, the Supreme Court considered whether an invention must either be tied to a machine or apparatus, or transform an article into a different state or thing to be patentable. It also considered for the first time whether business methods are patentable subject matter. The decision will be of particular interest to practitioners who followed the litigation in Grant v Commissioner of Patents, a Federal Court decision in which a Brisbane-based inventor was denied a patent over a method of protecting an asset from the claims of creditors.

Enabling open access to and re-use of publicly funded research data in Malaysian public universities : a legal and policy analysis

Numerous statements and declarations have been made over recent decades in support of open access to research data. The growing recognition of the importance of open access to research data has been accompanied by calls on public research funding agencies and universities to facilitate better access to publicly funded research data so that it can be re-used and redistributed as public goods. International and inter-governmental bodies such as the ICSU/CODATA, the OECD and the European Union are strong supporters of open access to and re-use of publicly funded research data. This thesis focuses on the research data created by university researchers in Malaysian public universities whose research activities are funded by the Federal Government of Malaysia. Malaysia, like many countries, has not yet formulated a policy on open access to and re-use of publicly funded research data. Therefore, the aim of this thesis is to develop a policy to support the objective of enabling open access to and re-use of publicly funded research data in Malaysian public universities. Policy development is very important if the objective of enabling open access to and re-use of publicly funded research data is to be successfully achieved. In developing the policy, this thesis identifies a myriad of legal impediments arising from intellectual property rights, confidentiality, privacy and national security laws, novelty requirements in patent law and lack of a legal duty to ensure data quality. Legal impediments such as these have the effect of restricting, obstructing, hindering or slowing down the objective of enabling open access to and re-use of publicly funded research data. A key focus in the formulation of the policy was the need to resolve the various legal impediments that have been identified. This thesis analyses the existing policies and guidelines of Malaysian public universities to ascertain to what extent the legal impediments have been resolved. An international perspective is adopted by making a comparative analysis of the policies of public research funding agencies and universities in the United Kingdom, the United States and Australia to understand how they have dealt with the identified legal impediments. These countries have led the way in introducing policies which support open access to and re-use of publicly funded research data. As well as proposing a policy supporting open access to and re-use of publicly funded research data in Malaysian public universities, this thesis provides procedures for the implementation of the policy and guidelines for addressing the legal impediments to open access and re-use.

Submission: Towards a Stronger and More Efficient IP Rights System : Getting the Balance Right

1. In March 2009, the Australian Government, through IP Australia its administrator of Intellectual Property Rights (IPR) acquired by registration or grant, issued two consultation papers for comment by interested stakeholders. 2. The Consultation Papers have invited written submissions directed towards the object of the paper, namely encouraging discussion on certain proposed changes and their impact on business and innovation. 3. I understand the invitation to make written submissions is predominantly in the areas raised by the Consultation Papers and the questions posed. However, I have made a brief reference to several other areas of concern with the current Australian patent law, which in my opinion inhibit innovation and therefore come under the wider agenda of the government to work toward a stronger and more efficient IP rights system. 4. In this regard, the Consultation Papers indicate that if the IPR are less likely to be invalidated and more likely to be enforced, this confidence will reflect in a greater investment in research leading to innovation. 5. This submission relates to the Balance Paper.