{"title":"Patents with an \"I\" = patients.","authors":"Alice O Martin, Sendil K Devadas","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The authors address how patent protection in the United States is often quite narrow in scope, difficult to obtain, and insufficient in duration, thus stifling research and development of potential breakthrough pharmaceuticals. The authors further posit that countries that have enacted stronger intellectual property rights and research incentives have seen tremendous increases in foreign direct investment. In addressing critics of the current patent system, the authors show that alternatives to biotechnology patents would not demonstrably improve innovation and development of beneficial medicines. The authors conclude that given the substantial evidence of the patent system's benefits, and the mere speculation that patents have a deleterious effect on patients, no suggestions currently proposed to replace or improve the patent system will have the same beneficial effects for patients.</p>","PeriodicalId":79788,"journal":{"name":"Annals of health law","volume":"18 2","pages":"261-80, 7 p. preceding 7"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30168823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Legal, ethical, and conceptual bottlenecks to the development of useful genomic tests.","authors":"Michael Tomasson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article discusses advances in genomic research in the context of the debate surrounding gene patent rights and the limited rights of patient-participants in translational research. In addition, the author explores statutory and regulatory hurdles to advances in disease diagnosis, such the Bayh-Dole Act, Medicare Legislation, and the Health Insurance Portability and Accountability Act. The author questions the effectiveness of increasingly commercialized academic research and the limited success of the private sector in genomic research. The author concludes that future genomic research will require significantly increased patient participation, which may necessitate a reshaping of the pharmaceutical approach to medicine and the limited stake that patients have in the breakthroughs developed through their participation in the process.</p>","PeriodicalId":79788,"journal":{"name":"Annals of health law","volume":"18 2","pages":"231-60, 8 p. preceding i"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30168822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Prizes for innovation of new medicines and vaccines.","authors":"James Love, Tim Hubbard","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article argues that prizes can help stimulate medical innovation, control costs and ensure greater access to new medicines and vaccines. The authors explore four increasingly ambitious prize options to reward medical innovation, each addressing flaws in the current patent system. The first option promotes innovation through a large prize fund linked to the impact on health outcomes; the second option rewards the sharing of knowledge, data, and technology with open source dividends; the third option awards prizes for interim benchmarks and discrete technical problems; and the final option removes the exclusive right to use patented inventions in upstream research in favor of prizes. The authors conclude that a system of prizes to reward drug development would break the link between R&D incentives and product prices, and that such a reform is needed to improve innovation and access to new medicines and vaccines.</p>","PeriodicalId":79788,"journal":{"name":"Annals of health law","volume":"18 2","pages":"155-86, 8 p. preceding i"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30167828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Patents & the progress of personalized medicine: biomarkers research as lens.","authors":"Matthew Herder","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article addresses the barriers to personalized medicine, focusing on the burgeoning field of biomarkers research. The author begins by framing intellectual property issues as more than a product of industry incentives and suggests that these issues are deeply entangled with other barriers facing personalized medicine such as regulatory framework deficiencies. The author proposes a set of future research questions to more fully define the barriers to biomarkers research and to uncover which corrective measures may be effective. The author concludes by recommending an integration of regulatory and patent reforms, with a call to action by scholars, scientists, representatives of the biopharmaceutical industry, and policy-makers.</p>","PeriodicalId":79788,"journal":{"name":"Annals of health law","volume":"18 2","pages":"187-229, 8 p. preceding i"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30167829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Annals of Health Law. Foreword.","authors":"Maura Ward, Lawrence Singer, John Blum","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":79788,"journal":{"name":"Annals of health law","volume":"17 1","pages":"i-iii"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27343209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Patenting medical devices: the economic implications of ethically motivated reform.","authors":"Kristen Nugent","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article explores whether the current patent system strikes the optimal balance between providing incentives to inventors to bring new medical devices to the marketplace and promoting public health by ensuring that these medical devices are widely available at a reasonable price. After providing an overview of the relationship of patent law to medical devices, the author explains how ethical and economic considerations suggest the need for an alternative patent system for medical devices and notes the difficulties with this proposal. The author concludes that a combination of alternatives to the current system most equitably account for the interests and needs of both healthcare device consumers and producers.</p>","PeriodicalId":79788,"journal":{"name":"Annals of health law","volume":"17 1","pages":"135-74, table of contents"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27343220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"\"Body property\": challenging the ethical barriers in organ transplantation to protect individual autonomy.","authors":"Charles C Dunham","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>One of two articles related to the current organ shortage, this article advocates the need for legislation to recognize organs and tissues separated from the body as a distinct category of personal property. After addressing the legislative history of organ procurement and psychological barriers to donor consent, the article examines the importance of separating the lifetime rights of ownership in our own bodies from postmortem rights. Ultimately, the author proposes a futures market approach to this problem in which individuals before death, or surviving family members after death, are permitted sell the decedent's organs in a private contract.</p>","PeriodicalId":79788,"journal":{"name":"Annals of health law","volume":"17 1","pages":"39-65, table of contents"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27343214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Tax policy as a lifeline: encouraging blood and organ donation through tax credits.","authors":"Joseph B Clamon","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article, the second concerning the organ donation crisis, proposes the use of tax policy to encourage blood and organ donation. After critiquing the ethical and logistical problems posed by other commercial and non-commercial solutions, the author demonstrates how tax credits can be used as an effective and ethical solution to address the shortage of donors. The author also offers two model statutes that provide guidance as to how a nonrefundable tax credit for blood and organ donation might operate in the tax code.</p>","PeriodicalId":79788,"journal":{"name":"Annals of health law","volume":"17 1","pages":"67-99, table of contents"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27343218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The jurisdictional bar provision: who is an appropriate relator?","authors":"Carolyn V Metnick","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>After explaining the role of the qui tam litigation and demonstrating its importance to fighting Medicare fraud and abuse, this article provides a detailed explanation of various court interpretations of the jurisdictional bar provision of the False Claims Act, a common and contentious statutory pitfall for qui tam litigators. The author provides a thorough evaluation of the law among different circuits to assist litigators in choosing favorable jurisdictions to increase their likelihood of success.</p>","PeriodicalId":79788,"journal":{"name":"Annals of health law","volume":"17 1","pages":"101-33, table of contents"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27343219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Harold J Krent, Nicholas Gingo, Monica Kapp, Rachel Moran, Mary Neal, Meghan Paulas, Puneet Sarna, Sarah Suma
{"title":"Whose business is your pancreas? Potential privacy problems in New York City's mandatory diabetes registry.","authors":"Harold J Krent, Nicholas Gingo, Monica Kapp, Rachel Moran, Mary Neal, Meghan Paulas, Puneet Sarna, Sarah Suma","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article examines a recent New York City health regulation that mandates the compilation and storage of individual medical data from nearly all diabetics in a centralized registry. The authors distinguish this novel registry from prior health registries and scrutinize its potential to compromise individual privacy. In order to address privacy and other concerns, the authors offer suggestions for changes to the current statutory framework of the registry that will also be useful when considering the creation of similar public health registries in other cities.</p>","PeriodicalId":79788,"journal":{"name":"Annals of health law","volume":"17 1","pages":"1-37, table of contents"},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"27343212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}