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. ^

Looking twice at the gender equity index for public health impact

Background: It has been shown that gender equity has a positive impact on the everyday activities of people (decision making, income allocation, application and observance of norms/rules) which affect their health. Gender equity is also a crucial determinant of health inequalities at national level; thus, monitoring is important for surveillance of women’s and men’s health as well as for future health policy initiatives. The Gender Equity Index (GEI) was designed to show inequity solely towards women. Given that the value under scrutiny is equity, in this paper a modified version of the GEI is proposed, the MGEI, which highlights the inequities affecting both sexes. Methods: Rather than calculating gender gaps by means of a quotient of proportions, gaps in the MGEI are expressed in absolute terms (differences in proportions). The Spearman’s rank coefficient, calculated from country rankings obtained according to both indexes, was used to evaluate the level of concordance between both classifications. To compare the degree of sensitivity and obtain the inequity by the two methods, the variation coefficient of the GEI and MGEI values was calculated. Results: Country rankings according to GEI and MGEI values showed a high correlation (rank coef. = 0.95). The MGEI presented greater dispersion (43.8%) than the GEI (19.27%). Inequity towards men was identified in the education gap (rank coef. = 0.36) when using the MGEI. According to this method, many countries shared the same absolute value for education but with opposite signs, for example Azerbaijan (−0.022) and Belgium (0.022), reflecting inequity towards women and men, respectively. This also occurred in the empowerment gap with the technical and professional job component (Brunei:-0.120 vs. Australia, Canada Iceland and the U.S.A.: 0.120). Conclusion: The MGEI identifies and highlights the different areas of inequities between gender groups. It thus overcomes the shortcomings of the GEI related to the aim for which this latter was created, namely measuring gender equity, and is therefore of great use to policy makers who wish to understand and monitor the results of specific equity policies and to determine the length of time for which these policies should be maintained in order to correct long-standing structural discrimination against women.

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.