Biobank donation in search of public benefits and the potential impact of intellectual property rights over access to health-technologies developed: A focus on the bioethical implications.

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.

Patenting a living microbial cell: 40th anniversary of US Supreme Court decision Diamond versus Chakrabarty.

Patents for microbiology and biotechnology are generally for a process (for example DNA cloning; and polymerase chain reaction, PCR) and not for the microbe itself. The patent for oil degrading bacteria was different in that it covered the modified microbial cell itself, a Pseudomonas strain with laboratory-assembled plasmids that encoded the bacterial degradation of multiple components of crude oil. It was first applied for in 1972, initially refused by the patent office on the basis that it was a living organism, and then eight years later in June 1980 allowed by the US Supreme Court ruling that this did not matter and the only issue was whether it was a novel manufactured product.

Medical Methods Patents in Neuromodulation.

There is a rapidly growing number of patents on methods of modulating brain regions. Despite this trend, and the massive potential of neuromodulation for treating patients, researchers and physicians who use neuromodulation techniques and technologies often have little idea of the significant ways these patents could affect their work. This article describes medical method patents, including a brief history of their development, and analyzes their potential direct and indirect effects on neuromodulation treatment and research efforts. As neuromodulation rapidly matures into a commercial and medical reality it is important to consider these effects in a forward thinking and value driven manner. The paper concludes with recommendations concerning how neuromodulation method patents may be used, or not, depending on the values of the inventor.

[SCHWABE Company's patent portfolio of Ginkgo biloba preparation].

SCHWABE Company in German is the first and largest manufacturer of Ginkgo biloba preparation. The company not only has leading technology in this field, but also protects its own market effectively through the high quality of patent drafting and exactly patent layout. Based on multi-angle analysis for patent portfolio of G. biloba preparation at application time, legal status, globally layout, Chinese layout, the article provides technical reference of research and development of G. biloba, also provides valuable experience of traditonal Chinese medicine patent portfolio layout for Chinese enterprises.

[Global patent overview of Ginkgo biloba preparation].

With related global patent data as analysis samples, worldwide patent overview of Ginkgo biloba preparation is analyzed in application, applicant, technical distribution and so on. This research shows that the most important areas of G. biloba preparation are Europe and China. The European applicants start earliest along with developing smoothly, moreover, their patents have best quality. The Chinese applicants start late along with the fastest growing, and have already certain research capabilities, moreover, their patents' quality needs to be improved. This research result provides reference for development of G. biloba preparation. The author suggest that Chinese applicants learn techniques and layout experiences of other's patents fully to enhance the level of new drug development and patent protection.

[Current service invention patents and growth pathways on basis of cluster analysis].

This study aims for enhancing quantity and quality of patents of traditional Chinese medicine compounds of traditional Chinese medicine enterprises, traditional Chinese medicine colleges and relevant institutions while building an efficient pathway for patent protection using simple statistics and cluster analysis, with service invention patent holders of traditional Chinese medicine compounds as the study object.

[Regional development of patents of traditional Chinese medicine compounds on basis of cluster analysis].

OBJECTIVE: To study current regional development and optimization schemes of patents of traditional Chinese medicine compounds. METHOD: Simple statistics and cluster analysis were adopted for calculating application quantity, maintenance quantity and quantity of scientific research papers related to patents of traditional Chinese medicine compounds in different regions. On that basis, cluster analysis was used for studying current development patents of traditional Chinese medicine compounds in different regions. RESULT: The 34 regions, including Chinese mainland, Hong Kong, Macau and Taiwan, were divided into four groups by cluster analysis according to the difference in quantities of patents and research papers. The first and third region are better, the second region is medium, while the forth region is not ideal. CONCLUSION: Different regions shall adopt suitable development schemes for the development of traditional Chinese medicine compounds according to their actual situations. Reasonable regional alliance is helpful for inter-regional win-win and co-flourishing.

[Cluster analysis on authorized patents of compound traditional Chinese medicines with different efficacy in 2010].

OBJECTIVE: To discuss the authorized patent of compound traditional Chinese medicines with different efficacy in 2010, in order to provide reference for R&D of relevant compounds and patent protection. METHOD: Literatures for patents of compound traditional Chinese medicines were searched to screen relevant data and create a sample space. The samples were classified by hierarchical cluster procedures and iterative partitioning procedures using "authorized percentage" and "authorized time interval" as variable quantities. The comprehensive results generated by the two clustering methods were used to draw a conclusion. RESULT: The samples were classified into four groups by clustering methods, each has significant difference in authorized patents' number and authorized time interval with others. CONCLUSION: Among compounds showing therapeutic advantage of traditional Chinese medicines, patents with short authorization period and in less number can be given most attention for patent application. Those with longer authorization period and in less number can be given more attention. While those with shorter authorization period and in large number can also be given attention for information guidance for traditional Chinese medicine science and technology and commercialization of patent achievements.

[Medical inventions: developments and approaches in employer-employee [correction of worker-employee] relations].

The past twenty years have witnessed a huge increase in research activity on the government health system in Israel. Consequently, a number of questions of enhanced importance arise: to whom the resultant IP (intellectual property) belongs?--to the researcher or the employer? and what compensation should the researcher receive for his inventive efforts? The government found many cases where the IP was registered in the name of the inventor/researcher, thus denying the government ownership of the IP. In 2009, the government sued Omryx over ownership of such an IP. Following these developments, the government issued new rules for management of IP in the government health system. They came into effect in November 2010. In many respects, the new rules are more stringent than the Israeli Patent Law in respect of the inventor. However, the stipulation of awards to the inventor in the new rules is generous. In order for the new rules to be enforceable, the following guidelines are recommended: The new rules should be more aligned with the Patent Law and with the meaning given to the Law by the judicial system, and There is need for the assent and awareness of health system workers to the conditions set out in the new rules, preferably in the form of new work contracts that clearly and concurrently delineate the worker's duties, particularly those pertaining to IP.

Traditional knowledge and intellectual property.

Biotechnological inventions are sometimes based upon the traditional knowledge of indigenous communities about the beneficial properties of plants and animals. Some institutions have adopted the uniqueness of traditional knowledge approach, which maintains that the indigenous communities have sui generis rights to a share of the profits from these inventions. Others have adopted the protection of inventive steps approach, which maintains that the inventors are entitled to the full profits from the invention if it involves a non-obvious and novel inventive step. The article analyzes this debate at the Convention on Biological Diversity, at the World Intellectual Property Organization, and at the World Trade Organization. It concludes that the adherents of the uniqueness of traditional knowledge approach have not justified their claims.

Judicial developments in the US Hatch-Waxman infringement safe harbor.

Life science companies often seek guidance on whether certain current or proposed activities fall within the Hatch-Waxman safe harbor, which exempts from infringement the making, using, offering to sell or sale within the US, or the importation into the US, of "a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs ...". In 2005, the US Supreme Court provided some clarity as to the scope of this safe harbor. In Merck KGaA v. Integra Lifesciences I, Ltd, the Court held that the exemption from infringement can reach certain preclinical experiments, outlining one test by which such preclinical experiments can be shown to be sufficiently 'reasonably related' to FDA submission as to qualify for the safe harbor. On remand of the case from the Supreme Court, the Court of Appeals added further explanatory detail. In late 2008, however, much of that hard-won clarity was lost when the Court of Appeals, in Proveris Scientific Corp. v. Innovasystems, Inc., addressed the 'patented invention' language of the statutory exemption, and articulated a two part test that is, in the opinion of the authors, unnecessary, unwarranted and unworkable.

Patenting bioactive molecules from biodiversity: the Brazilian experience.

The use of natural compounds from biodiversity, as well as ethnobotanical knowledge, for the development of new drugs is the gate leading to support the conservation of natural resources in developing countries. Recent technological advances and the development of new methods are revolutionizing the screening of natural products and offer a unique opportunity to replace natural products as major source of drug leads. Over the past decades, the Brazilian government established a legislation aiming to grant patent protection in all technological fields. The Convention on Biological Diversity, an international agreement that recognizes the sovereign rights of States over their natural resources, and the Brazilian legislation (Decreto n degree 2186-12/01) set for legislative, administrative or policy measures regarding the share of research and product development benefits could be the key for progress in issues related to rational employment of the Brazilian biodiversity and economy, but are far from being effective. Based on literature review, this article provides a brief description of the Brazilian legislation policy regarding intellectual property and biodiversity access, places natural drug discovery in context, analyzes patent cases and highlights critical key issues responsible for the drawback of the whole process that has a direct impact on industrial and research development, nature protection and benefit share with our society.

Patents of drugs extracted from Brazilian medicinal plants.

BACKGROUND: Plants synthesise a vast repertoire of chemicals with various biological activities. Brazilian enormous botanical diversity facilitates the development of novel ethical drugs for the treatment of diseases in humans. OBJECTIVE: To present therapeutic patent applications comprising Brazilian native plants published in the 2003-2008 period in light of legal aspects of patentability of biodiversity and public health concerns. METHODS: Therapeutic patent applications related to Brazilian medicinal plants available at both the European Patent Office and the Brazilian National Institute of Industrial Property databases were reviewed. RESULTS/CONCLUSION: Twenty-five patents are presented, most of which concern inflammatory, allergic, parasitic, infectious or digestive diseases, including extracts from Carapa guianensis, Copaifera genus, Cordia verbenacea, Erythrina mulungu, Physalis angulata and other pharmaceutical compositions with antileishmanial, antimalarial or trypanocidal activity. Brazilian research centres and universities are responsible for most of these inventions.

Removing barriers? An overview of the Canadian Access to Medicines Regime.

As a result of significant public health issues in the developing world, there has been a strong desire to increase access to available treatments. In 2005, Canada amended its Patent Act to create the Canadian Access to Medicines Regime ("CAMR") to provide a mechanism whereby a Canadian manufacturer could produce patented pharmaceutical products for export to countries experiencing public health crises. As one of the first countries to enact such a detailed legislative regime, Canada attempted to create a model for addressing the problems created by the intersection of public health and patents. In 2007, Rwanda indicated its intention to import an HIV-drug from the Canadian generic manufacture Apotex. Rwanda's application marked the first time a country had utilized the CAMR in order to obtain essential medicines. This article examines the Canadian CAMR model, its origins, and its effectiveness to date.

Short patent lives jeopardize drug and patient safety.

Exposure of patients to new medications carries potential safety hazards during widespread clinical practice. These are often detected only after a substantial period of use. Thus, there is considerable need for measures reducing drug-related morbidity and mortality, such as adequate, active postmarketing drug-safety surveillance systems with obligatory follow-up studies of suspected safety problems, or even an additional "Phase IV" safety study before marketing. However, drug development processes erode substantially into the useful patent life of a new drug. Therefore, we suggest that the potential benefits of patent life prolongation should be considered, under certain conditions for the sake of patient safety.