Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^

Transmission and Transport of Energy in the Western U.S. and Canada: A Law and Policy Road Map

This collection of short essays arose from the inaugural meeting of the Idaho Symposium on Energy in the West, which was held in November, 2014. The topic for this first Symposium was Transmission and Transport of Energy in the Western U.S. and Canada: A Law and Policy Road Map. The essays in this collection provide a notable introduction to the major energy issues facing the West today. Topics include: building a resilient legal architecture for western energy production; natural gas flaring; transmission planning for wind energy; utilities and rooftop solar; special considerations for western states and the Clean Power Plan; the Clean Power Plan's implications for the western grid; siting renewable energy on public lands; and implications of utility reform in New York and Hawaii for the Northwest.

London, England : Poor Law unions, 1884 (Raster Image)

This layer is a georeferenced raster image of the historic paper map entitled: Map of London and its environs : shewing the boundary of the jurisdiction of the metropolitan board of work, also the boundaries of the city of London, and of the Poor Law unions. It was published by Edward Standford, April 21, 1884. Scale [ca. 1:31,680]. This map is part of a 5 map set showing various thematic districts and boundaries of the London region. The image inside the map neatline is georeferenced to the surface of the earth and fit to the British National Grid coordinate system (British National Grid, Airy Spheroid OSGB (1936) Datum). All map collar and inset information is also available as part of the raster image, including any inset maps, profiles, statistical tables, directories, text, illustrations, index maps, legends, or other information associated with the principal map. This map shows features such as roads, railroads, drainage, selected private and public buildings, towns and villages, cemeteries, parks, farms, Poor Law unions, and more. Relief is shown by hachures. This layer is part of a selection of digitally scanned and georeferenced historic maps from The Harvard Map Collection as part of the Imaging the Urban Environment project. Maps selected for this project represent major urban areas and cities of the world, at various time periods. These maps typically portray both natural and manmade features at a large scale. The selection represents a range of regions, originators, ground condition dates, scales, and purposes.

Access to environmental information in an Open European Society - Directive 2003/4. Research Paper in Law 5/2003

[From the Introduction]. Information gives knowledge and knowledge gives power. Though in all EC Member States, the task to protect the environment is given to the administration, it is obvious that the administration is not the owner of the environment. The environment is everybody's. It is for this reason that administrative decisions which affect the environment must be transparent, open and must strike a balance between the general interest to preserve, protect and improve the quality of the environment on the one hand, the satisfying of specific private or public interests on the other hand. In order to allow at least a certain control of whether the administration strikes the right balance between the need to protect the environment and other legitimate or less legitimate needs, it appears normal and self-evident that information on the environment which is in the hands of public authorities, be also made available to the public and to citizens.

Exploitative Abuses: Which Competition Policy, Which Public Policy? Research Papers in Law, 2/2007

As the final session of the day, my aim in this paper is to briefly outline the nature of exploitative abuses before turning to the question of the relationship between competition law and intellectual property law in the context of what Teubner calls the regulatory trilemma and from that draw a two-fold conclusion. First, the demands on law from the social phenomenon of markets are more acute when those demands raise issues across the different law domains of IP and competition. Second, where IP law and competition meet, the aim should be for both domains to internalise the values of the other. This however can only happen to the extent but only to the extent that there can be what Collins1 calls productive disintegration. Finally, in the specific context of exploitative abuses the overlap between IP law and competition law arises primarily in relation to claims of excessive pricing in licensing arrangements. Such claims could form the basis of a private action2 or can be made in the context of compulsory dealing decisions such as Microsoft.3 The involvement of competition agencies in pricing decisions goes to the heart of concerns about the nature of competition law and the role of competition agencies and highlights the need for the law to indirectly control rather than inappropriately attempt to directly control markets.

Public Procurement Law and Health care: From Theory to Practice. Research Paper in Law, 2/2010

From the Introduction. This contribution will focus on the core question if, how and to what extent the EU procurement rules and principles (may) affect the national health care systems. We start our analysis by summarizing the applicable EU public procurement legislation, principles and soft law and its exact scope in relation to health care. (section 2). Subsequently, we turn to the parties in a contract, subject to procurement rules in the field of health care, addressing both the definition of contracting authorities and relevant case law (section 3). This will then lead to an analysis of possible justifications for not holding a tender procedure in the field of health care (section 4). Finally, we illustrate the impact of EU public procurement rules on health care by analysing a Dutch case study, in which the question whether public hospitals in the Netherlands qualify as contracting authorities in terms of the Public Sector Directive stood central (section 5). Our conclusions will follow in section 6.

Disclosure of Leniency Materials: A Bridge between Public and Private Enforcement of Antitrust Law. Research Paper in Law 08/2013, December

The disclosure of leniency materials held by competition authorities has recently been under the spot. On the one hand, these documents could greatly help cartel victims to prove the damage and the causation link when filing damage actions against cartelists. On the other hand, future cartelists could be deterred from applying for leniency since damage actions could be brought as a result of the information submitted by themselves. Neither the current legislation nor the case law have attained yet to sufficiently clarify how to deal with this clash of interests. Our approach obviously attempts to strike a balance between both interests. But not only that. We see the current debate as a great opportunity to boost the private enforcement of antitrust law through the positive spillovers of leniency programmes. We hence propose to build a bridge between the public and the private enforcement by enabling a partial disclosure of the documents.