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. ^

Assessing construction and demolition waste on masonry works to avoid future generation

The difficulty of dealing with construction and demolition waste (CDW) on construction sites is not new and continues to be a significant environmental problem. Currently the CDW collection system in Spain is done in a decentralized manner by each sub-contracted company, being necessary to implement effective waste management measures ensuring a correct management and minimization. During the last years several measures have been launched in order to improve and encourage the reuse and recycling of CDW. A widespread solution for CDW recovery is using them as a landscaping aggregate or for road bases and sub-bases. However, measures encouraging onsite prevention still need to be enhanced. This paper studies the major work stage generating CDW and analyses the categories of CDW produced during its execution. For this, several real building sites have been analysed in order to quantify the estimation of CDW generated. Results of this study show that a significant contributor to the CDW generation on building construction sites in Spain are the masonry works. Finally, a Best Practices Manual (BPM) is proposed containing several strategies on masonry works aimed not only at CDW prevention, but also at improving their management and minimization. The use of this BPM together with the Study and Plan of CDW management --required by law--, promotes the environmental management of the company, favouring the cohesion of the construction process organization at all stages giving rise to establishing responsibilities in the field of waste and providing a greater control over the process. Keywords: construction and demolition waste, management, masonry works, good practice measures, prevention.

Improving the evidence base on public health assets—the way ahead: a proposed research agenda

The aim of this commentary is to set out a priority research agenda which will make more systematic the evidence base about why investing in a range of 'public health assets' is important for population health. It will rehearse in brief some of the issues that have been raised over the past few years as experience has grown about how to apply the idea to public health practice.

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