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.

Genentech and the stolen gene: Patent law and pioneer inventions

This paper evaluates the litigation over the biotechnology patent dispute between the University of California and Genentech. First it outlines the scientific work behind the cloning of the human growth hormone, and looks at the patent office, and its treatment of biotechnological inventions. Second, it considers the court room dispute, and the legal case of the University of California and the biotechnology company in this dispute. Finally, it considers the implications of this dispute for policy reform in respect of patent law and biotechnology.

The attack of the clones: Patent law and stem cell research

This article considers the integral role played by patent law in respect of stem cell research. It highlights concerns about commercialization, access to essential medicines and bioethics. The article maintains that there is a fundamental ambiguity in the Patents Act 1990 (Cth) as to whether stem cell research is patentable subject matter. There is a need to revise the legislation in light of the establishment of the National Stem Cell Centre and the passing of the Research Involving Embryos Act 2002 (Cth). The article raises concerns about the strong patent protection secured by the Wisconsin Alumni Research Foundation and Geron Corporation in respect of stem cell research in the United States. It contends that a number of legal reforms could safeguard access to stem cell lines, and resulting drugs and therapies. Finally, this article explores how ethical concerns are addressed within the framework of the European Biotechnology Directive. It examines the decision of the European Patent Office in relation to the so-called Edinburgh patent, and the inquiry of the European Group on Ethics in Science and New Technologies into The Ethical Aspects of Patenting Involving Human Stem Cells.

The freedom to tinker: Patent law and experimental use

This article considers the origins and the development of the defence of experimental use in patent law - the ’freedom to tinker'. It explores the impact of such an exemption upon a number of important industries - such as agriculture, biotechnology, and pharmaceutical drugs. This article takes a comparative approach in its analysis of patent law and experimental use. It highlights the competing norms, and lack of harmonization between a number of jurisdictions - including the United States, the European Union, and Australia. Section 2 provides a critique of the development of the common law defence of experimental use in the United States. It considers a series of precedents - including Roche Products Inc v Bolar Pharmaceuticals, Madey v Duke University, Integra Lifesciences I Ltd v Merck KgaA, and Applera v MJ Research. Section 3 explores the operation of patent law and experimental use in European jurisdictions. It looks at a number of significant precedents in the United Kingdom, the Netherlands, France, Italy, and Germany. Section 4 considers the policy debate in a number of forums over the defence of experimental use in Australia. It examines the controversy over Genetic Technologies Limited asking research organisations to obtain a licence in respect of its patents associated with non-coding DNA and genomic mapping. It also considers the inquiries of the Australian Law Reform Commission and the Advisory Council on Intellectual Property, as well as the impact of the TRIPS Agreement and the Australia-United States Free Trade Agreement. The conclusion contends that there is a need for a broad-based defence of experimental use for all the member states of the Organisation for Economic Co-operation and Development.

The Jean Chretien Pledge to Africa act: Patent law and humanitarian aid

This article evaluates the implementation of the WTO General Council Decision in 2003, which resolved that developed nations could export patented pharmaceutical drugs to member states in order to address public health issues - such as HIV/AIDS, tuberculosis, malaria and other epidemics. The Jean Chretien Pledge to Africa Act 2004 (Canada) provides authorisation for the export of pharmaceutical drugs from Canada to developing countries to address public health epidemics. The European Union has issued draft regulations governing the export of pharmaceutical drugs. A number of European countries - including Norway, the Netherlands, France, and Switzerland - are seeking to pass domestic legislation to give force to the WTO General Council Decision. Australia has shown little initiative in seeking to implement such international agreements dealing with access to essential medicines. It is argued that Australia should implement humanitarian legislation to embody the WTO General Council Decision, emulating models in Canada, Norway, and the European Union. Ideally, there should be no right of first refusal; the list of pharmaceutical drugs should be open-ended; and the eligible importing countries should not be limited to members of the WTO.

Changes in disability, physical/mental health states and quality of life during an 8-Week multimodal physiotherapy programme in patients with chronic non-specific neck pain: A prospective cohort study

Aim The aim of this study was to analyse the effect of an 8-week multimodal physiotherapy programme (MPP), integrating physical land-based therapeutic exercise (TE), adapted swimming and health education, as a treatment for patients with chronic non-specific neck pain (CNSNP), on disability, general health/mental states and quality of life. Methods 175 CNSNP patients from a community-based centre were recruited to participate in this prospective study. Intervention: 60-minute session (30 minutes of land-based exercise dedicated to improving mobility, motor control, resistance and strengthening of the neck muscles, and 30 minutes of adapted swimming with aerobic exercise keeping a neutral neck position using a snorkel). Health education was provided using a decalogue on CNSNP and constant repetition of brief advice by the physiotherapist during the supervision of the exercises in each session. Study outcomes: primary: disability (Neck Disability Index); secondary: physical and mental health states and quality of life of patients (SF-12 and EuroQoL-5D respectively). Differences between baseline data and that at the 8-week follow-up were calculated for all outcome variables. Results Disability showed a significant improvement of 24.6% from a mean (SD) of 28.2 (13.08) at baseline to 16.88 (11.62) at the end of the 8-week intervention. All secondary outcome variables were observed to show significant, clinically relevant improvements with increase ranges between 13.0% and 16.3% from a mean of 0.70 (0.2) at baseline to 0.83 (0.2), for EuroQoL-5D, and from a mean of 40.6 (12.7) at baseline to 56.9 (9.5), for mental health state, at the end of the 8-week intervention. Conclusion After 8 weeks of a MPP that integrated land-based physical TE, health education and adapted swimming, clinically-relevant and statistically-significant improvements were observed for disability, physical and mental health states and quality of life in patients who suffer CNSNP. The clinical efficacy requires verification using a randomised controlled study design.

One-step synthesis of high quality kesterite Cu2ZnSnS4nanocrystals: A hydrothermal approach

The present work demonstrates a systematic approach for the synthesis of pure kesterite-phase Cu2ZnSnS4 (CZTS) nanocrystals with a uniform size distribution by a one-step, thioglycolic acid (TGA)-assisted hydrothermal route. The formation mechanism and the role of TGA in the formation of CZTS compound were thoroughly studied. It has been found that TGA interacted with Cu2+ to form Cu+ at the initial reaction stage and controlled the crystal-growth of CZTS nanocrystals during the hydrothermal reaction. The consequence of the reduction of Cu2+ to Cu+ led to the formation Cu2−xS nuclei, which acted as the crystal framework for the formation of CZTS compound. CZTS was formed by the diffusion of Zn2+ and Sn4+ cations to the lattice of Cu2−xS during the hydrothermal reaction. The as-synthesized CZTS nanocrystals exhibited strong light absorption over the range of wavelength beyond 1000 nm. The band gap of the material was determined to be 1.51 eV, which is optimal for application in photoelectric energy conversion device.

The alchemy of junk: patent law and non-coding DNA

This article considers the recent international controversy over the patents held by a Melbourne firm, Genetic Technologies Limited (GTG), in respect of non-coding DNA and genomic mapping. It explores the ramifications of the GTG dispute in terms of licensing, litigation, and policy reform, and—as a result of this dispute—the perceived conflict between law and science. GTG has embarked upon an ambitious licensing program with twenty seven commercial licensees and five research licensees. Most significantly, GTG has obtained an exclusive licence from Myriad Genetics to use and exploit its medical diagnostics in Australia, New Zealand, and the Asia-Pacific region. In the US, GTG brought a legal action for patent infringement against the Applera Corporation and its subsidiaries. In response, Applera counterclaimed that the patents of GTG were invalid because they failed to comply with the requirements of US patent law, such as novelty, inventive step, and written specifications. In New Zealand, the Auckland District Health Board brought legal action in the High Court, seeking a declaration that the patents of GTG were invalid, and that, in any case, the Board has not infringed them. The New Zealand Ministry of Health and the Ministry of Economic Development have reported to Cabinet on the issues relating to the patenting of genetic material. Similarly, the Australian Law Reform Commission (ALRC) has also engaged in an inquiry into gene patents and human health; and the Advisory Council on Intellectual Property (ACIP) has considered whether there should be a new defence in respect of experimental use and research.

Incorporating process variability into stormwater quality modelling

Process variability in pollutant build-up and wash-off generates inherent uncertainty that affects the outcomes of stormwater quality models. Poor characterisation of process variability constrains the accurate accounting of the uncertainty associated with pollutant processes. This acts as a significant limitation to effective decision making in relation to stormwater pollution mitigation. The study undertaken developed three theoretical scenarios based on research findings that variations in particle size fractions <150µm and >150µm during pollutant build-up and wash-off primarily determine the variability associated with these processes. These scenarios, which combine pollutant build-up and wash-off processes that takes place on a continuous timeline, are able to explain process variability under different field conditions. Given the variability characteristics of a specific build-up or wash-off event, the theoretical scenarios help to infer the variability characteristics of the associated pollutant process that follows. Mathematical formulation of the theoretical scenarios enables the incorporation of variability characteristics of pollutant build-up and wash-off processes in stormwater quality models. The research study outcomes will contribute to the quantitative assessment of uncertainty as an integral part of the interpretation of stormwater quality modelling outcomes.

Perceived quality of e‐health services: A conceptual scale development of e‐health service quality based on the C‐OAR‐SE approach

Purpose Health service quality is an important determinant for health service satisfaction and behavioral intentions. The purpose of this paper is to investigate requirements of e‐health services and to develop a measurement model to analyze the construct of “perceived e‐health service quality.” Design/methodology/approach The paper adapts the C‐OAR‐SE procedure for scale development by Rossiter. The focal aspect is the “physician‐patient relationship” which forms the core dyad in the healthcare service provision. Several in‐depth interviews were conducted in Switzerland; first with six patients (as raters), followed by two experts of the healthcare system (as judges). Based on the results and an extensive literature research, the classification of object and attributes is developed for this model. Findings The construct e‐health service quality can be described as an abstract formative object and is operationalized with 13 items: accessibility, competence, information, usability/user friendliness, security, system integration, trust, individualization, empathy, ethical conduct, degree of performance, reliability, and ability to respond. Research limitations/implications Limitations include the number of interviews with patients and experts as well as critical issues associated with C‐OAR‐SE. More empirical research is needed to confirm the quality indicators of e‐health services. Practical implications Health care providers can utilize the results for the evaluation of their service quality. Practitioners can use the hierarchical structure to measure service quality at different levels. The model provides a diagnostic tool to identify poor and/or excellent performance with regard to the e‐service delivery. Originality/value The paper contributes to knowledge with regard to the measurement of e‐health quality and improves the understanding of how customers evaluate the quality of e‐health services.

Quality in group service encounters: A theoretical exploration of the concept of a simultaneous multi‐customer co‐creation process

Purpose The purpose of this paper is to explore the concept of service quality for settings where several customers are involved in the joint creation and consumption of a service. The approach is to provide first insights into the implications of a simultaneous multi‐customer integration on service quality. Design/methodology/approach This conceptual paper undertakes a thorough review of the relevant literature before developing a conceptual model regarding service co‐creation and service quality in customer groups. Findings Group service encounters must be set up carefully to account for the dynamics (social activity) in a customer group and skill set and capabilities (task activity) of each of the individual participants involved in a group service experience. Research limitations/implications Future research should undertake empirical studies to validate and/or modify the suggested model presented in this contribution. Practical implications Managers of service firms should be made aware of the implications and the underlying factors of group services in order to create and manage a group experience successfully. Particular attention should be given to those factors that can be influenced by service providers in managing encounters with multiple customers. Originality/value This article introduces a new conceptual approach for service encounters with groups of customers in a proposed service quality model. In particular, the paper focuses on integrating the impact of customers' co‐creation activities on service quality in a multiple‐actor model.

Key determinants of real estate service quality among renters and buyers

Purpose The purpose of this study is to compare quality perceptions of virtual servicescapes and physical service encounters among buyers and renters of real estate. Design/methodology/approach Qualitative data from a sample of 27 professionals engaged in higher education in the USA are gathered by recorded interview before being transcribed and imported into MAXQDA 2007 software for analytical coding. Findings Particular differences are found to exist between renters and buyers with regard to specific service attributes – for example, description of properties and type of visuals during the pre‐purchase stage, knowledge/experience and honest behavior of realtors during the service encounter stage and a continuous relationship with the realtor in the post‐encounter stage. Research limitations/implications Generalization of the results is limited because the study utilizes data from only one industry (real estate) and from only one demographic segment (professionals in higher education). Practical implications Real‐estate firms need to pay attention to both the training of agents and the design and content of their websites. Originality/value This paper contributes to knowledge regarding virtual servicescapes in professional services.

Investigating the concept of potential quality: An exploratory study in the real estate industry

Purpose The purpose of this research is to examine the concept of “potential quality” – that is, a company's tangible search qualities (such as the physical servicescape and virtual servicescape) – within the context of the real‐estate industry in the USA. Design/methodology/approach This qualitative study collects data by conducting personal in‐depth interviews with 34 respondents who had been recent buyers or renters of property. The data are then coded and themed to identify quality dimensions relevant to this industry. Findings The results indicate that a buyer's perception of the overall service quality of real‐estate service consists of two components: the interaction with a realtor (process quality); and the virtual servicescape, especially the firm's website design and content (potential quality). The study concludes that existing scales (such as SERVQUAL and RESERV) fail to capture the tangible component of service quality sufficiently in the real‐estate industry. Research limitations/implications The study uses data from only one industry (real estate) and from only one demographic segment (professionals in higher education). Practical implications Service providers of intangible, high‐contact services must appreciate the importance of the virtual servicescape as a surrogate quality indicator that can help to reduce information asymmetries and consumers' uncertainty with regard to initiating a business relationship. Real estate firms need to pay attention to the training of agents and the design and content of their e‐service systems. Originality/value This study integrates potential quality, process quality, and outcome quality in a comprehensive proposed model. In particular, the study identifies “potential quality” as a combination of the attributes of the virtual service environment and the physical service environment.

Conceptualizing and measuring brand relationship quality

Many consumer markets are now characterized by a high degree of market saturation and an increasing level of competition, in particular from retailer brands. Furthermore, consumers face an ever increasing level of product variety. For instance, about 30,000 new products in the fast moving consumer goods (FMCG) market have been launched in Germany in a single year representing about 600 products per week. The increasing number of consumer brands thus has led to a form of “brand inflation” in FMCG markets. In addition, the role of consumers in the marketplace has changed as well. Consumers are more price sensitive, they have higher expectations with regard to product quality and customer service, and they rely rather on word-of-mouth communication than on traditional advertising. In addition, it appears that consumers have become more critical with regard to the perception of brands. High levels of price competition have led to a decreasing level of brand awareness and increased switching intentions of brands. As a consequence, the role of customer loyalty has become an increasingly important topic for businesses in consumer markets.

Incentives for global public health: Patent law and access to essential medicines

This portrait of the global debate over patent law and access to essential medicines focuses on public health concerns about HIV/AIDS, malaria, tuberculosis, the SARS virus, influenza, and diseases of poverty. The essays explore the diplomatic negotiations and disputes in key international fora, such as the World Trade Organization, the World Health Organization and the World Intellectual Property Organization. Drawing upon international trade law, innovation policy, intellectual property law, health law, human rights and philosophy, the authors seek to canvass policy solutions which encourage and reward worthwhile pharmaceutical innovation while ensuring affordable access to advanced medicines. A number of creative policy options are critically assessed, including the development of a Health Impact Fund, prizes for medical innovation, the use of patent pools, open-source drug development and forms of 'creative capitalism'.