Kava and St. John's wort : current evidence for use in mood and anxiety disorders

Background: Mood and anxiety disorders pose significant health burdens on the community. Kava and St John’s wort (SJW) are the most commonly used herbal medicines in the treatment of anxiety and depressive disorders, respectively. Objectives: To conduct a comprehensive review of kava and SJW, to review any evidence of efficacy, mode of action, pharmacokinetics, safety and use in Major Depressive Disorder (MDD), Bipolar Disorder (BP), Seasonal Affective Disorder (SAD), Generalized Anxiety Disorder (GAD), Social Phobia (SP), Panic Disorder (PD), Obsessive-Compulsive Disorder (OCD), and Post Traumatic Stress Disorder (PTSD). Methods: A systematic review was conducted using the electronic databases MEDLINE, CINAHL, and The Cochrane Library during late 2008. The search criteria involved mood and anxiety disorder search terms in combination with kava, Piper methysticum, kavalactones, St John’s wort, Hypericum perforatum, hypericin and hyperforin. Additional search criteria for safety, pharmacodynamics , and pharmacokinetics was employed. A subsequent forward search was conducted of the papers using Web of Science cited reference search. Results: Current evidence supports the use of SJW in treating mild-moderate depression, and for kava in treatment of generalized anxiety. In respect to the other disorders, only weak preliminary evidence exists for use of SJW in SAD. Currently there is no published human trial on use of kava in affective disorders, or in OCD, PTSD, PD or SP. These disorders constitute potential applications that warrant exploration. Conclusions: Current evidence for herbal medicines in the treatment of depression and anxiety only supports the use of Hypericum perforatum for depression, and Piper methysticum for generalized anxiety.

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.

Building Indigenous research capacity : a personal perspective

The International Network of Indigenous Health Knowledge and Development (INIHKD) Conference was held from Monday 24 May to Friday 28 May 2010 at Kiana Lodge, Port Madison Indian Reservation, Suquamish Nation, Washington State, United States of America. The overall theme for the 4th Biennial Conference was ‘Knowing Our Roots: Indigenous Medicines, Health Knowledges and Best Practices’.

The 4th International Network of Indigenous Health Knowledge and Development Conference

The International Network of Indigenous Health Knowledge and Development (INIHKD) Conference was held from Monday 24 May to Friday 28 May 2010 at Kiana Lodge, Port Madison Indian Reservation, Suquamish Nation, Washington State, United States of America. The overall theme for the 4th Biennial Conference was ‘Knowing Our Roots: Indigenous Medicines, Health Knowledges and Best Practices’. This article details the experience of participants who were at the INIHKD Conference. It concludes with an encouragement to people to attend the 5th INIHKD Conference in Australia in 2012.

The patentability of non-physical inventions : lessons from the United States

Patent systems around the world are being pressed to recognise and protect challengingly new and exciting subject matter in order to keep pace with the rapid technological advancement of our age and the fact we are moving into the era of the ‘knowledge economy’. This rapid development and pressure to expand the bounds of what has traditionally been recognised as patentable subject matter has created uncertainty regarding what it is that the patent system is actually supposed to protect. Among other things, the patent system has had to contend with uncertainty surrounding claims to horticultural and agricultural methods, artificial living micro-organisms, methods of treating the human body, computer software and business methods. The contentious issue of the moment is one at whose heart lies the important distinction between what is a mere abstract idea and what is properly an invention deserving of the monopoly protection afforded by a patent. That question is whether purely intangible inventions, being methods that do not involve a physical aspect or effect or cause a physical transformation of matter, constitute patentable subject matter. This paper goes some way to addressing these uncertainties by considering how the Australian approach to the question can be informed by developments arising in the United States of America, and canvassing some of the possible lessons we in Australia might learn from the approaches taken thus far in the United States.

Development and evaluation of hydrocarbon sorbent materials with the aid of chemometrics

Hydrocarbon spills on roads are a major safety concern for the driving public and can have severe cost impacts both on pavement maintenance and to the economy through disruption to services. The time taken to clean-up spills and re-open roads in a safe driving condition is an issue of increasing concern given traffic levels on major urban arterials. Thus, the primary aim of the research was to develop a sorbent material that facilitates rapid clean-up of road spills. The methodology involved extensive research into a range of materials (organic, inorganic and synthetic sorbents), comprehensive testing in the laboratory, scale-up and field, and product design (i.e. concept to prototype). The study also applied chemometrics to provide consistent, comparative methods of sorbent evaluation and performance. In addition, sorbent materials at every stage were compared against a commercial benchmark. For the first time, the impact of diesel on asphalt pavement has been quantified and assessed in a systematic way. Contrary to conventional thinking and anecdotal observations, the study determined that the action of diesel on asphalt was quite rapid (i.e. hours rather than weeks or months). This significant finding demonstrates the need to minimise the impact of hydrocarbon spills and the potential application of the sorbent option. To better understand the adsorption phenomenon, surface characterisation techniques were applied to selected sorbent materials (i.e. sand, organo-clay and cotton fibre). Brunauer Emmett Teller (BET) and thermal analysis indicated that the main adsorption mechanism for the sorbents occurred on the external surface of the material in the diffusion region (sand and organo-clay) and/or capillaries (cotton fibre). Using environmental scanning electron microscopy (ESEM), it was observed that adsorption by the interfibre capillaries contributed to the high uptake of hydrocarbons by the cotton fibre. Understanding the adsorption mechanism for these sorbents provided some guidance and scientific basis for the selection of materials. The study determined that non-woven cotton mats were ideal sorbent materials for clean-up of hydrocarbon spills. The prototype sorbent was found to perform significantly better than the commercial benchmark, displaying the following key properties: • superior hydrocarbon pick-up from the road pavement; • high hydrocarbon retention capacity under an applied load; • adequate field skid resistance post treatment; • functional and easy to use in the field (e.g. routine handling, transportation, application and recovery); • relatively inexpensive to produce due to the use of raw cotton fibre and simple production process; • environmentally friendly (e.g. renewable materials, non-toxic to environment and operators, and biodegradable); and • rapid response time (e.g. two minutes total clean-up time compared with thirty minutes for reference sorbents). The major outcomes of the research project include: a) development of a specifically designed sorbent material suitable for cleaning up hydrocarbon spills on roads; b) submission of patent application (serial number AU2005905850) for the prototype product; and c) preparation of Commercialisation Strategy to advance the sorbent product to the next phase (i.e. R&D to product commercialisation).

Gene transfer to plants by diverse species of bacteria

Agrobacterium is widely considered to be the only bacterial genus capable of transferring genes to plants. When suitably modified, Agrobacterium has become the most effective vector for gene transfer in plant biotechnology1. However, the complexity of the patent landscape2 has created both real and perceived obstacles to the effective use of this technology for agricultural improvements by many public and private organizations worldwide. Here we show that several species of bacteria outside the Agrobacterium genus can be modified to mediate gene transfer to a number of diverse plants. These plant-associated symbiotic bacteria were made competent for gene transfer by acquisition of both a disarmed Ti plasmid and a suitable binary vector. This alternative to Agrobacterium-mediated technology for crop improvement, in addition to affording a versatile ‘open source’ platform for plant biotechnology, may lead to new uses of natural bacteria– plant interactions to achieve plant transformation.

Good results for early treatment of clinically isolated syndrome prior to multiple sclerosis with interferon beta-1b and glatiramer

Background: The first sign of developing multiple sclerosis is a clinically isolated syndrome that resembles a multiple sclerosis relapse. Objective/methods: The objective was to review the clinical trials of two medicines in clinically isolated syndromes (interferon β and glatiramer acetate) to determine whether they prevent progression to definite multiple sclerosis. Results: In the BENEFIT trial, after 2 years, 45% of subjects in the placebo group developed clinically definite multiple sclerosis, and the rate was lower in the interferon β-1b group. Then all subjects were offered interferon β-1b, and the original interferon β-1b group became the early treatment group, and the placebo group became the delayed treatment group. After 5 years, the number of subjects with clinical definite multiple sclerosis remained lower in the early treatment than late treatment group. In the PreCISe trial, after 2 years, the time for 25% of the subjects to convert to definite multiple sclerosis was prolonged in the glatiramer group. Conclusions: Interferon β-1b and glatiramer acetate slow the progression of clinically isolated syndromes to definite multiple sclerosis. However, it is not known whether this early treatment slows the progression to the physical disabilities experienced in multiple sclerosis.

Potential of St John's Wort for the treatment of depression : the economic perspective

The burden of rising health care expenditures has created a demand for information regarding the clinical and economic outcomes associated with complementary and alternative medicines. Meta-analyses of randomized controlled trials have found Hypericum perforatum preparations to be superior to placebo and similarly effective as standard antidepressants in the acute treatment of mild to moderate depression. A clear advantage over antidepressants has been demonstrated in terms of the reduced frequency of adverse effects and lower treatment withdrawal rates, low rates of side effects and good compliance, key variables affecting the cost-effectiveness of a given form of therapy. The most important risk associated with use is potential interactions with other drugs, but this may be mitigated by using extracts with low hyperforin content. As the indirect costs of depression are greater than five times direct treatment costs, given the rising cost of pharmaceutical antidepressants, the comparatively low cost of Hypericum perforatum extract makes it worthy of consideration in the economic evaluation of mild to moderate depression treatments.

Dealing with the problem of cybercrime

Lack of a universally accepted and comprehensive taxonomy of cybercrime seriously impedes international efforts to accurately identify, report and monitor cybercrime trends. There is, not surprisingly, a corresponding disconnect internationally on the cybercrime legislation front, a much more serious problem and one which the International Telecommunication Union (ITU) says requires „the urgent attention of all nations‟. Yet, and despite the existence of the Council of Europe Convention on Cybercrime, a proposal for a global cybercrime treaty was rejected by the United Nations (UN) as recently as April 2010. This paper presents a refined and comprehensive taxonomy of cybercrime and demonstrates its utility for widespread use. It analyses how the USA, the UK, Australia and the UAE align with the CoE Convention and finds that more needs to be done to achieve conformance. We conclude with an analysis of the approaches used in Australia, in Queensland, and in the UAE, in Abu Dhabi, to fight cybercrime and identify a number of shared problems.