Intellectual Property Law Commons^™

The Quantified Self Movement: Legal Challenges And Benefits Of Personal Biometric Data Tracking, Timothy S. Hall

Timothy S. Hall

This article explores some of the potential pitfalls associated with collection of detailed individual biometric or health-related information, and demonstrates that current laws and regulations are not well designed to protect users of these devices and apps from unauthorized use or misuse of their data. Health information is among the most sensitive, intimate, and potentially damaging personal information one may possess, and health policymakers have made health information privacy a priority for decades for good reason. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was one of the major health policy legislative achievements of the 1990s. However, HIPAA …

Intellectual Property And Public Health: A White Paper, Katharine A. Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health - A White Paper, Ryan Vacca, James Ming Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, The University of Akron School of Law's Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants, and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to confirm …

Can Dna Be Speech?, Jorge R. Roig

Jorge R Roig

On The Importance Of Intellectual Property Rights For E-Science And The Integrated Health Record, Giuseppina D'Agostino, Chris Hinds, Marina Jirotka, Charles Meyer

Giuseppina D'Agostino

An integrated health record (IHR) that enables clinical data to be shared at a national level has profound implications for medical research. Data that have been useful primarily within a single clinic will instead be free to move rapidly around a national network infrastructure. This raises challenges for technologists, clinical practice, and for the governance of these data. This article considers one specific issue that is currently poorly understood: how intellectual property (IP) relates to the sharing of medical data for research on large-scale electronic networks. Based on an understanding of current practices, this article presents recommendations for the governance …

Regulatory Competitive Shelters, Yaniv Heled

Yaniv Heled

This Article identifies an array of seemingly disparate federal exclusivity regimes as belonging to an increasingly prevalent and relatively new class of highly valuable government benefits, which it names “regulatory competitive shelters” (RCSs). It characterizes RCSs and distinguishes them from other, more traditional kinds of government-instituted properties. The Article then proceeds to describe a particular brand of RCSs established in federal statutory frameworks whose aim—much like patents—is to create incentives for technological innovation. Identifying several common motifs of such RCS regimes, the Article offers a taxonomy of these RCSs and describes the mechanisms by which RCSs instituted under such regimes …

Should All Drugs Be Patentable?: A Comparative Perspective, Cynthia M. Ho

Cynthia M Ho

Although there has been substantial discussion of the proper scope of patentable subject matter in recent years, drugs have been overlooked. This Article begins to address that gap with a comparative perspective. In particular, this Article considers what is permissible under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as how India and Canada have utilized TRIPS flexibilities in different ways to properly reward developers of valuable new drugs, while also considering the social harm of higher prices beyond an initial patent term on drugs. This Article brings valuable insight into this area at a critical …

Exploring Innovations And Positive Disruptions In The Supply Chain For Second Line Drugs, Peter Yu

Peter K. Yu

No abstract provided.

Promoting “Academic Entrepreurship” In Europe And The United States: Creating An Intellectual Property Regime To Facilitate The Efficient Transfer Of Knowledge From The Lab To The Patient, Constance Bagley, Christina Tvarno

Constance E. Bagley

In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the EU needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (PPPPs) …

On Patenting Human Organisms Or How The Abortion Wars Feed Into The Ownership Fallacy, Yaniv Heled

Yaniv Heled

The idea of ominous technologies that put human individuals or parts of their bodies under someone else's control has been stirring emotions and terrifying people for centuries. It was a recent offshoot of this idea--the notion of “patenting humans”--that mobilized certain members of Congress to pass legislation prohibiting the issuance of patent claims “directed to or encompassing a human organism.” The values underlying this legislation may well have been agreeable, even admirable. Yet, the actual motivation for it was misguided; its execution, deeply flawed; its potential outcomes, hazardous

This Article reviews the history and background of this prohibition. It fleshes …

Response To 'Pervasive Sequence Patents Cover The Entire Human Genome', Shine Tu, Yaniv Heled

Yaniv Heled

In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.

Drugged Out: How Cognitive Bias Hurts Drug Innovation, Cynthia M. Ho

Cynthia M Ho

No abstract provided.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Inoculation Inventions: The Interplay Of Infringement And Immunity In The Development Of Biodefense Vaccines, Cynthia M. Ho

Cynthia M Ho

No abstract provided.

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

Jonathan R. K. Stroud

No abstract provided.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Frank A. Pasquale

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Energy And Environment Policy Case For A Global Project, Thomas A. Faunce

Thomas A Faunce

A policy case is made for a global project on artificial photosynthesis including its scientific justification, potential governance structure and funding mechanisms.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Yaniv Heled

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Symposium: Comments On Panel 2, Peter Jaszi

Peter Jaszi

No abstract provided.

Settlement Of India/Eu Wto Dispute Re Seizures Of In-Transit Medicines: Why The Proposed Eu Border Regulation Isn't Good Enough, Brook Baker

Brook K. Baker

European Customs officials have used fictive patent rights to justify the seizure of lawful generic medicines produced in India and destined for non- European markets. Following a public outcry and initiation of two WTO complaints, the EU has proposed amendments to Border Regulations Measure 1383/2003. The Proposed Border Regulation in its current form will not adequately resolve the risk of interception in Europe of medicines lawfully manufactured and exported from India and destined for lawful import and consumption in a non-EU country. This analysis concludes that multiple weaknesses remain in the Border Regulations, including: (1) continued coverage of alleged patent …

Acta - Risks Of Third-Party Enforcement For Access To Medicines, Brook Baker

Brook K. Baker

In its current near-final draft form, the Anti-Counterfeiting Trade Agreement [ACTA] being negotiated plurilaterally—and largely secretly—by a self-selected group of countries proposes to allow preliminary and final injunctive relief against third parties (third-party enforcement) to prevent infringement of intellectual property rights and/or to prevent infringing goods from entering into the channels of commerce. There is lingering uncertainty whether the relevant civil enforcement section will apply to the entire range of intellectual property rights or whether patents will be excluded. If patents are excluded, the dangers in ACTA would be reduced but not eliminated—new globalized forms of third-party enforcement would still …

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …

Governing Planetary Nanomedicine: Environmental Sustainability And A Unesco Universal Declaration On The Bioethics And Human Rights Of Natural And Artificial Photosynthesis (Global Solar Fuels And Foods)., Thomas A. Faunce

Thomas A Faunce

Environmental and public health-focused sciences are increasingly characterised as constituting an emerging discipline—planetary medicine. From a governance perspective, the ethical components of that discipline may usefully be viewed as bestowing upon our ailing natural environment the symbolic moral status of a patient. Such components emphasise, for example, the origins and content of professional and social virtues and related ethical principles needed to promote global governance systems and policies that reduce ecological stresses and pathologies derived from human overpopulation, selfishness and greed— such as pollution, loss of biodiversity, deforestation and greenhouse gas emissions, as well as provide necessary energy, water and …

A Bad Trip For Health-Related Human Rights: Implications Of Momcilovic V The Queen (2011) 85 Aljr 957, Tim Vines, Thomas A. Faunce

Thomas A Faunce

Momcilovic v The Queen (2011) 85 ALJR 957 [PDF] ; [2011] HCA 34 arose from a prosecution for drug trafficking brought under the Drugs, Poisons and Controlled Substances Act 1981 (Vic) . The Australian High Court held that the Charter of Human Rights and Responsibilities Act 2006 (Vic) (the Charter) validly conferred a power on the Victorian Supreme Court and Court of Appeal to interpret legislation in a manner consistent with a defined list of human rights. By a slim majority it also held that the Charter validly created a judicial power to "declare" a law inconsistent with one or …

Challenges To Australia’S National Health Policy From Trade And Investment Agreements, Thomas A. Faunce

Thomas A Faunce

Recent federal trade policy commitments concerning the Trans-Pacific Partnership Agreement (TPPA) negotiations (against changes to the Pharmaceutical Benefits Scheme (PBS) and against inclusion of an investor state provision) could protect Australia’s tobacco control legislation and Australia's sovereign capacity to regulate public health and environmental policy

The Proposed Ban On Certain Nanomaterials For Electrical And Electronic Equipment In Europe: Global Security Implications, Thomas A. Faunce, Hitoshi Nasu

Thomas A Faunce

International collaboration on nanotechnology governance has so far paid little attention to security implications of regulating the use of nanotechnology. For example, the Coalition of Non-Governmental Organizations (initiated by the International Centre for Technological Assessment) developed 'Principles for the Oversight of Nanotechnologies and Nanomaterials' to provide a set of ethical standards for nanotechnology research and development (Kimbrell, 2009). Similar initiatives are observed at the national level, as has been seen in the Swiss Retailers Association Code of Conduct and the UK's Responsible NanoCode (Bowman and Hodge, 2009, pp.149-152). The Organization for Economic Co-operation and Development (OECD) has also been active …

Leaked Tpp Investment Chapter Presents A Grave Threat To Access To Medicines, Brook K. Baker

Brook K. Baker

The leaked Trans-Pacific Partnership Investment Chapter has been analyzed extensively with respect to its dangerous intellectual property protections and enhanced enforcement mechanisms and its equally dangerous extra-judicial investor-state dispute settlement (ISDS) provisions. In contrast, this analysis focuses on the particular risks of the Investment Chapter with respect to access to medicines because of the direct and indirect inclusion of IPRs in the Chapter’s coverage. These risks are cumulative because of other provisions in the proposed US IP chapter that would strengthen, broaden, and lengthen intellectual property rights with respect to pharmaceutical patent, data, and pricing provisions and that would expand …