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 …

3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom

Evan R. Youngstrom

Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must be …

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.

Trazos Y Reflexiones En Torno A La Marca Farmacéutica, Javier André Murillo Chávez

Javier André Murillo Chávez

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) …

The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah W. Brennan

Hannah W Brennan

The United States spends nearly $1,000 per person annually on drugs—40 percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, the crucial role that intellectual property laws play in inhibiting access to cheaper, generic medications is among one of the best documented. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different exclusivity—trademark law. New …

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.

The Plain Packaging Of Tobacco Products: A Submission To The New Zealand Parliament, Matthew Rimmer Dr

Matthew Rimmer

RECOMMENDATIONSRecommendation 1 New Zealand should introduce the plain packaging of tobacco products in order to implement the World Health Organization Framework Convention on Tobacco Control 2003 – in particular, Articles 11 and 13 of the agreement, and the accompanying guidelines.Recommendation 2 New Zealand should implement plain packaging of tobacco products, without delay or hesitation. There is no good reason to wait for the resolution of the five disputes between Australia and other countries in the World Trade Organization. Australian Government has a strong case. Its opponents have been seeking to stall and delay the disputes.Recommendation 3 In my expert opinion, …

Rebuttable Presumption Of Public Interest In Protecting The Public Health—The Necessity For Denying Injunctive Relief In Medically Related Patent Infringement Cases After Ebay V. Mercexchange, Lance E. Wyatt Jr.

Lance E Wyatt Jr.

The public’s interest in medicine and good health is substantial. However, this interest is harmed when important medical devices or pharmaceuticals, although infringing on valid patents, are suddenly taken off the market after a court grants a permanent injunction. While permanent injunctions were automatically granted by the Federal Circuit before the Supreme Court’s holding in eBay v. MercExchange, courts now have more discretion to deny injunctive relief. Now that courts have this newfound discretion after eBay, the public should no longer expect to be harmed by the sudden removal of medical supplies. Unfortunately, this has not been the course that …

The Empire Of Cancer: Gene Patents And Cancer Voices, Matthew Rimmer

Matthew Rimmer

In his book, The Emperor of All Maladies, Siddhartha Mukherjee writes a history of cancer — ‘It is a chronicle of an ancient disease — once a clandestine, “whispered-about” illness — that has metamorphosed into a lethal shape-shifting entity imbued with such penetrating metaphorical, medical, scientific, and political potency that cancer is often described as the defining plague of our generation’.Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis

Kenneth C. Louis

No abstract provided.

A Submission To The House Of Representatives Standing Committee On Social Policy And Legal Affairs On The Intellectual Property Laws Amendment Bill 2013 (Cth), Matthew Rimmer

Matthew Rimmer

The amendments contained in the Intellectual Property Laws Amendment Bill 2013 (Cth) are designed to provide safeguards in relation to patent law and the public interest.In the 2012 case on plain packaging, the Chief Justice of the High Court of Australia, Robert French, emphasized that the role of intellectual property law is to promote public objectives. His Honour observed: ‘There are and always have been purposive elements reflecting public policy considerations which inform the statutory creation of intellectual property rights.’ Discussing the role of patent law, Chief Justice Robert French commented:The Patents Act 1990 (Cth) provides that a patent gives …

Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker

Chad I Brooker

Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …

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.

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

Pirates Of The Australian Election, Matthew Rimmer

Matthew Rimmer

“Pirate parties” have proliferated across Europe and North America in the past decade, championing issues such as intellectual property (IP), freedom of speech, and the protection of privacy and anonymity.This year, the movement hit Australian shores: The Pirate Party Australia was officially registered by the Australian Electoral Commission in January 2013. (You can read its principles and platform here.)“More than ever before, there is a necessity in Australia for a party that holds empowerment, participation, free culture and openness as its central tenets”, Pirate Party founder Rodney Serkowski said in a press release announcing the group’s successful registration. Their first …

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.