Make it Work!:: Breyer on Patents in the Life Sciences

Harvard Law Review 128, 2014
I. Glenn Cohen (Faculty Co-Director)

This short essay is part of a Harvard Law Review Symposium honoring Justice Breyer on his 20th Year on The Supreme Court. It examines Breyer's opinions and impact on the law of patents in the life sciences, and shows how these writings reflect deeper elements of his judicial philosophy and method.

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An Empirical Method for Materiality: Would Conflict of Interest Disclosures Change Patient Decisions?

American Journal of Law and Medicine, Forthcoming, 2014
Roy G. Spece Jr., David V. Yokum, Andrea-Gale Okoro, and Christopher T. Robertson (Petrie-Flom Affiliated Faculty; Former Petrie-Flom Academic Fellow)

Abstract: The law has long been concerned with the agency problems that arise when advisors, such as attorneys or physicians, put themselves in financial relationships that create conflicts of interest. If the financial relationship is “material” to the transactions…

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Was the Medicaid Expansion Coercive?

Routledge, 2014
I. Glenn Cohen (Petrie-Flom Faculty Co-Director)

In The Affordable Care Act Decision: Philosophical and Legal Implications, Fritz Allhoff and Mark Hall, eds. In this book chapter on the ACA decision, NFIB v. Sebelius, I focus on the Court's holding that the Medicaid expansion was unconstitutional. I ask by what…

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The “Problem” with the European Problem/Solution Approach to Inventive Step

Los Angeles Intellectual Property Law Association, Wegner's Writings, February 24, 2014
Harold C. Wegner, reviewing Timo Minssen (Petrie-Flom Visiting Scholar)

From the review: Patent applicants seeking to gain global patent protection beyond their home country borders need a better comparative knowledge of key elements of the patent laws of the several countries. Professor Timo Minssen in his superb doctoral thesis directly challenges…

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Patent Trolling: Why Bio & Pharmaceuticals are at Risk

Robin Feldman and W. Nicholson Price II (Petrie-Flom Academic Fellow)

Abstract: Patent trolls — also known variously as non-practicing entities, patent assertion entities, and patent monetizers — are a top priority on legislative and regulatory reform agendas. In the modern debates, however, the biopharmaceutical industry goes conspicuously…

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Will your clothing spy on you?: A scholar warns of the potential for wearable technology to annihilate privacy for good.

Fortune, February 13, 2014
David Whitford, on I. Glenn Cohen (Petrie-Flom Faculty Co-Director)

[...] Like it or not, we have entered the era of assumed ubiquitous snooping, and we have not begun to parse the implications. That was my takeaway from Cohen's lecture, "The Ethicist's and the Lawyer's New Clothes: The Law and Ethics of Smart Clothes," which will be available for free…

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Undocumented Injustice?: Medical Repatriation and the Ends of Health Care

NEJM, February 13, 2014
Michael J. Young, M.Phil. (Petrie-Flom Academic Fellow), and Lisa Soleymani Lehmann, M.D., Ph.D.

Quelino Jimenez came to the United States at 18 years of age, seeking work to provide financial support to his family of 11 in Mexico. Jimenez found a construction job in Chicago, where he worked without a legal work or residence permit for more than a year until he sustained injuries after a 20-ft…

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Religious groups to back Obamacare contraceptive mandate: Face dilemma over freedom, government rules on women

Washington Post, February 4, 2014
Tom Howell, Jr. quoting Holly Fernandez Lynch (Petrie-Flom Executive Director)

[...] In its filing, the AJC said the case presents a rare instance in which they see a clash between religious liberty and the equal rights of women. They said the government’s mandate ultimately promotes women’s health “in the least restrictive means available.” …

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Ethics and Ontology in Deep Brain Stimulation

Neuroscience, January 30, 2014
Michael J. Young (Petrie-Flom Student Fellow)

Rapid advancements in the fields of neurology and neuroscience over the past decade have enabled unprecedented progress toward the development of brain-modulating technologies and therapeutics. Central to these advancements are cross-disciplinary translational research efforts to engineer systems…

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Legal Aspects of Biobanking as Key Issues for Personalized Medicine & Translational Exploitation

Timo Minssen (Petrie-Flom Visiting Scholar) and Jens Schovsbo

Abstract: This perspective-article provides an overview on selected legal aspects of biobanking. It discusses these issues with a focus on public biobanks in a university setting and the specific challenges posed by personalized medicine (PM). We conclude that any decisions as…

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NEW BOOK: Science and Technology in International Economic Law: Balancing Competing Interests

Routledge, 2014
Bryan Mercurio and Kuei-Jung Ni (Petrie-Flom Visiting Scholar), editors

Science and technology plays an increasingly important role in the continued development of international economic law. This book brings together well-known and rising scholars to explore the status and interaction of science, technology and international economic law. The book reviews the place of…

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Defining mental illnesses: can values and objectivity get along?

BMC Psychiatry 13:346, December 24, 2013
Dominic Sisti, Michael Young (PFC Student Fellow), and Arthur Caplan

Abstract Background The creation of each edition of the Diagnostic and Statistical Manual (DSM) of psychiatry has proven enormously controversial. The current effort to revise the ‘bible’ of disorder definitions for the field of mental health is no exception. The controversy…

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Do Fixed Patent Terms Distort Innovation?: Evidence from Cancer Clinical Trials

Public Health Law & Policy e-Journal 5, no. 64, December 4, 2013
Eric B. Budish, Benjamin N. Roin, and Heidi Williams

Abstract: Patents award innovators a fixed period of market exclusivity, e.g., 20 years in the United States. Yet, since in many industries firms file patents at the time of discovery ("invention") rather than first sale ("commercialization"), effective patent terms vary: inventions…

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Petrie-Flom Center to collaborate with Harvard Catalyst: on second Clinical and Translational Science Award

Official Press Release:  Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics will launch a novel Ethics and Law initiative as part of the Regulatory Foundations, Ethics, and Law Program of Harvard…

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The Jurisdiction of the D.C. Circuit

Cornell Journal of Law and Public Policy, Vol. 23, No. 1, 2013
Eric M. Fraser, David K. Kessler, Matthew J.B. Lawrence, and Stephen Calhoun

Abstract: The U.S. Court of Appeals for the D.C. Circuit is unique among federal courts. It is well known for its unusual caseload, which is disproportionally weighted toward administrative law. What explains the unusual caseload? This Article explores the inputs into the D.C.…

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Now Available: Bioethical Prescriptions: To Create, End, Choose, and Improve Lives

Oxford University Press, 2013
Frances Kamm

Bioethical Prescriptions collects Frances M. Kamm's articles on bioethics, which…

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Announcing the New Journal of Law and the Biosciences

Oxford University Press, Forthcoming 2014
Petrie-Flom Center and HLS, Duke University, and Stanford University

The Petrie-Flom Center and Harvard Law School are delighted to announce our partnership with Duke University, Stanford University, and Oxford University Press to launch a new peer-reviewed, open access, online journal in 2014: Journal…

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VIDEO NOW AVAILABLE: Stem Cell Therapies:: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings

Institute of Medicine, November 18, 2013
Co-organized by I. Glenn Cohen

Stem cells hold tremendous potential to advance health and medicine. Through replacement of damaged cells and organs or supporting intrinsic repair, stem cell offer promising treatments for debilitating diseases and conditions such as Parkinson’s disease, diabetes, and spinal cord injury. Currently,…

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Informed consent for return of incidental findings in genomic research

Genetics in Medicine, October 24, 2013
Paul S. Appelbaum, Cameron R. Waldman, Abby Fyer, Robert Klitzman, Erik Parens, Josue Martinez, W. Nicholson Price II, & Wendy K. Chung

Purpose: Researchers face the dilemma of how to obtain consent for return of incidental findings from genomic research. We surveyed and interviewed investigators and study participants, with the goal of providing suggestions for how to shape the consent process. Methods: We…

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Plan B: access to emergency contraception in the legal and political cross hairs

Association of Reproductive Health Professionals, Contraception Journal, October 2013
I. Glenn Cohen, Lisa Sullivan, Eli Y. Adashi

The 8-year legal feud over access to emergency contraception between reproductive health advocates and the Food and Drug Administration (FDA) took multiple unexpected turns before coming to an abrupt end on June 10, 2013.1,2,3 On that day, after mounting legal setbacks and obstacles, the US Attorney…

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