The ownership question of plant gene and genome intellectual properties

The restructuring of the crop agriculture industry over the past two decades has enabled patent holders to exclude, prevent and deter others from using certain research tools and delay or block further follow-on inventions

Paspalum vaginatum Swartz, Seashore Paspalum 'SDX-1'

‘SDX-1’ originated as an open-pollinated chance seeding in an old green of ‘Adalayd’ seashore paspalum (US Plant Patent 3939) surrounded by an undefined local ecotype of the same species. ‘SDX-1’ was finer textured and had a denser, more prostrate growth habit than its putative parents which are ‘Adalayd’ (maternal) and an undefined parental genotype growing among the surrounding local ecotype. ‘SDX-1’ was compared with other promising seedlings discovered similarly at the same time, and was selected on the basis of its dwarf growth habit, tolerance of low cutting height, turf density, fine-textured growth, and apparent salt tolerance under field conditions. Breeder: Stewart T Bennett, Paul H Tillman, Michael DePew, Enviro Turf LC, Terkonsha, MI, USA. PBR Certificate Number 3660, Application Number 2006/160, granted 16 December 2008.

Franklin Barley: Patent law and plant breeders’ rights

This paper considers the relationship between patent law and plant breeders' rights in light of modern developments in biotechnology. It examines how a number of superior courts have sought to manage the tensions and conflicts between these competing schemes of intellectual property protection. Part 1 considers the High Court of Australia case of Grain Pool of Western Australia v the Commonwealth dealing with Franklin barley. Part 2 examines the significance of the Supreme Court of the United States decision in JEM Ag Supply Inc v Pioneer Hi-Bred International Inc with respect to utility patents and hybrid seed. Part 3 considers the Supreme Court of Canada case of Harvard College v the Commissioner of Patents dealing with the transgenic animal, oncomouse, and discusses its implications for the forthcoming appeal from the Federal Court case of Percy Schmeiser v Monsanto.

Gene patent practice across plant and human genomes

The uses of genetic sequences to inform, enable or create products or services for human biomedicine are substantially different from their uses in crop-based agriculture. Here, we explore what similarities and differences may emerge in patent use and strategies, and map patent-disclosed sequences onto three important plant genomes: maize (corn), rice and soybean. We focus on those referenced in the granted patent claims to compare their uses to the approach used in human gene patenting.

The placebo effect: international patent law and the protection of traditional plant medicine

Une préoccupation essentielle traverse cette thèse: l'indifférence systémique de la Loi internationale sur la propriété intellectuelle a l'égard des savoirs traditionnels autochtones. De manière générale, un écart semble d'ailleurs croissant entre l'importance des accords internationaux sur les questions d'intérêt commercial et ceux de nature sociale. Les savoirs traditionnels autochtones sur les plantes médicinales sont particulièrement désavantagés dans ce système dichotomique puisqu'ils sont non seulement à l'origine d'énormes profits commerciaux mais se trouvent aussi au cœur de multiples croyances propres à ces sociétés. L'Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (ADPIC) de l'Organisation mondiale du commerce (OMC) a cristallisé le souci de la législation internationale à l'égard d'une protection efficace des intérêts commerciaux. Deux années auparavant, la Convention sur la diversité biologique (CDB) était signée, traduisant une préoccupation à l'égard du développement durable, et elle devenait le premier accord international à tenir compte des savoirs traditionnels autochtones. On considère souvent que ces deux accords permettent l'équilibre du développement commercial et durable, requis par l'économie internationale. Après plus ample examen, on a plutôt l'impression que l'idée d'une CDB défendant, avec succès et efficacité, la nécessité du développement durable et des savoirs traditionnels autochtones contre les pressions opposées de l'ADPIC et de l'OMC est, au mieux, simpliste. La thèse explore également la fonction de la Loi sur les brevets dans la création d’industries, notamment pharmaceutique, et la manière dont ces industries influencent la législation nationale et en particulier internationale. De même, elle traite du rôle que jouent les brevets dans l'affaiblissement et la dépossession des peuples autochtones dotés de savoirs traditionnels sur les plantes médicinales, conduisant à une situation ou ces savoirs sont marginalisés ainsi que leurs détenteurs. La thèse aborde les failles institutionnelles du système juridique international qui permet une telle situation et indique l'urgente nécessité d'examiner attentivement les inégalités économiques et sociales au Nord comme au Sud, et non seulement entre eux. Finalement, la thèse suggère que la législation internationale gagnerait à s'inspirer des diverses traditions juridiques présentes à travers le monde et, dans ce cas particulier, peut être les détenteurs des connaissances traditionnelles concernant les plantes médicinales seront mieux servi par le droit des obligations.

Is there a case to be made for a global patent system? The example of plant biotechnology

The assessment of patterns of patentability in plant biotechnology on the basis of existing statistics shows a considerable concentration of patents to a few countries, in particular the United States, Australia, Japan, China, Mexico, Brazil, Germany, Canada, New Zealand, South Korea, India, Spain and Hungary. These patterns suggest that there is a clear relationship between the choice of patent jurisdictions and the biotechnology regulatory framework. This observation of the geographic distribution of biotechnology patents lends credence to maintaining a system of territorial rights that allow for regulatory competition, but continuing the process of substantive patent law harmonization which potentially minimize trade barriers.

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.

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.

Plant Breeder's Rights: An Australian commentary December 2004

The aim of this manual is to provide a practical guide to the Plant Breeder's Rights Act 1994 (Cth). It is a resource of information about the legislation, its administration, and its operation. This commentary is intended to assist plant breeders, scientific researchers, and business managers who want to make a more effective use of the Plant Breeder's Rights Act 1994 (Cth) in the management and commercialisation of their intellectual property rights. It is also designed to enhance the understanding of the legislation among lawyers, patent attorneys, qualified persons, and policy-makers.

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.

Transferring Results of Behavioral Research to Industry to Improve Animal Welfare on the Farm, Ranch and the Slaughter Plant

The article focuses on three results of the study: "(1)Communicate your results outside the research. Write articles in popular and industry magazines. Speak at producer meetings and develop websites that can be used to transfer research results into practice. (2) Choose places (e.g. farms or plants) that have managers who believe in your research, and be prepared to spend a lot of time with the first place that uses your findings. (3) to fail. (4) Do not allow your technology to get tied up in patent disputes."

Recent advances in the application of in vitro systems to plant improvement

The horticultural industry was instrumental in the early development and exploitation of genetic techniques over a century ago. This review will describe recent advances in a range of in vitro methods and their application to plant breeding, with especial emphasis on horticultural crops. These methods include improvements in the efficiency of haploid breeding techniques in many fruit and vegetable species using either microspore-derived or ovule-derived plants. Significant molecular information is now available to supplement these essentially empirical approaches and this may enable the more predictable application of these technologies in previously intransigent crops. Similarly there are now improved techniques for isolation of somatic hybrids, by application of either in vitro fertilisation or the culture of excised ovules from interspecific crosses. In addition to examples taken from the traditional scientific literature, emphasis will also be given to the use of patent databases as a valuable source of information on recent novel technologies developed in the commercial world.

Review: intellectual property aspects of plant transformation

One of the recurring themes of the debates concerning the application of genetic transformation technology has been the role of Intellectual Property Rights (IPR). This term covers both the content of patents and the confidential expertise usually related to methodology and referred to as 'Trade Secrets'. This review explains the concepts behind patent protection, and discusses the wide-ranging scope of existing patents that cover all aspects of transgenic technology, from selectable markers and novel promoters to methods of gene introduction. Although few of the patents in this area have any real commercial value, there are a small number of key patents that restrict the 'freedom to operate' of new companies seeking to exploit the methods. Over the last 20 years, these restrictions have forced extensive cross-licensing between ag-biotech companies and have been one of the driving forces behind the consolidation of these companies. Although such issues are often considered of little interest to the academic scientist working in the public sector, they are of great importance in any discussion of the role of 'public-good breeding' and of the relationship between the public and private sectors.

Method for the production of cotton somatic embryos. United States Patent Application

The present invention provides Inter alia, a method for the production of cotton somatic embryos comprising (a) isolating a totipotent stomatal cell-containing epidermal explant from leaf material excised from a cotton plant; and (b) culturing said explant in a basal medium which comprises an embryogenic callus-inducing quantity of an auxin and a cytokinin under an embryogenic callus inducing intensity of light until embryogenic callus is formed; and (c) sub-culturing said embryogenic callus onto a somatic embryo differentiation media to produce said somatic embryos. Plants may be regenerated from the somatic embryos and in a particular embodiment of the invention said totipotent stomatal cell is transformed, prior to the inducement of embryogenic callus, with a polynucleotide that provides for a desired agronomic trait.

Method of plant tissue culture and regeneration

Plants may be regenerated from stomatal cells or protoplasts of such cells. Prior to regeneration the cells or protoplasts may be genetically transformed by the introduction of hereditary material most preferably by a DNA construct which is free of genes which specify resistance to antibiotics. The regeneration step may include callus formation on a hormone-free medium. The method is particularly suitable for sugar beet.