Patents for Restasis Are Invalidated, Opening Door to Generics

New York Times, October 16, 2017
by Katie Thomas

A federal judge in Texas invalidated four key patents for the dry-eye treatment Restasis on Monday, dealing a blow to its manufacturer, Allergan, which had sought to protect its patents by transferring… Read More

Allergan’s deal with the Mohawks raises troubling questions about the future of generics

STAT , September 11, 2017
by By Ed Silverman, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] Legal experts, however, say that tribal sovereignty may also thwart generic drug makers from filing a conventional lawsuit. If so, the ramifications may be far-reaching and ominous… Read More

How to Protect a Drug Patent? Sell it to a Native American Tribe

New York Times, September 8, 2017
by Katie Thomas

The drugmaker Allergan announced Friday that it had transferred its patents on a best-selling eye drug to the Saint Regis Mohawk Tribe in upstate New York — an unusual gambit to protect the drug… Read More

(Health) Law and Order

Beyond the Microscope Podcast, March 28, 2017
by Mumu Xu, interviewing Rachel E. Sachs (Academic Fellow Alumna)

We’ve got a special episode today for all you STEM/legal nerds. Our guest is Rachel Sachs, an Associate Professor at the Washington University in St. Louis School of Law. Rachel works at… Read More

Sanofi, Regeneron ask court to shield Dupixent from Amgen patent attack

FiercePharma, March 21, 2017
by Tracy Staton, citing blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...]Amgen has caught fire for its aggressive stance on its PCSK9 patents, which also protect its own drug in the class, Repatha. Market watchers note that a similar patent fight—Merck… Read More

Regulating Secrecy

Washington Law Review, 2016, Vol. 91, Nr. 4
by W. Nicholson Price II (Academic Fellow Alumnus)

Abstract: Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the… Read More

Promoting healthcare innovation on the demand side

Journal of Law and the Biosciences, January 16, 2017 (online first)
by W. Nicholson Price II (Academic Fellow Alumnus) and Rebecca S. Eisenberg

Abstract: Innovation policy often focuses on fortifying the incentives of firms that develop and sell new products by offering them lucrative rights to exclude competitors from the market. Regulators also… Read More

Federal Circuit Court Appeal Cites Rachel E. Sachs

U.S. Court of Appeals for the Federal Circuit, January 13, 2017, No. 17-1480
by Paul D. Clement et al., citing work by Rachel E. Sachs (Academic Fellow Alumna)

No. 17-1480 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT   AMGEN INC., AMGEN MANUFACTURING, LTD., and AMGEN USA, INC., Plaintiffs-Appellees, v. SANOFI, SANOFI-AVENTIS U.S. LLC, AVENTISUB… Read More

Could Amgen’s Patent Victory Be Bad For Medicine?

Forbes, January 6, 2017
by Matthew Herper, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Last night, in a nearly unprecedented move, a federal judge ordered a cholesterol medicine that is on the market and used by patients to be withdrawn because it infringes on the patents… Read More

The International Intellectual Property Law Podcast on blinding expert witnesses to reduce bias

by JurisDiction, featuring Christopher Robertson (Academic Fellow alumnus)

Click here to listen to the podcast featuring Prof. Christopher Robertson of the University of Arizona on blinding expert witnesses to reduce bias: Bias in Litigation Science and Blind… Read More

5 reasons why no one has built a better EpiPen

STAT, September 9, 2016
by Meghana Keshavan, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] But critics say Mylan has little incentive to improve EpiPens: “If you’re the monopolist, and you’ve got a product that expires every year, and it’s not super easy to… Read More

How Mylan cornered the consumer epinephrine market

MedCityNews, September 8, 2016
by Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The New York state attorney general’s office announced Tuesday it will investigate Mylan to determine whether it introduced “anticompetitive terms” into school contracts.STAT recently… Read More

Euro Drug Pricing’s Tradeoffs May Limit Appeal In US

Law360, September 8, 2016
by Dani Kass, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] Going forward, an influx of bills targeting drug prices could be introduced, but few are likely to pass, according to Joshua P. Cohen, a researcher at the Tufts Center for the Study of Drug… Read More

Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics

Petrie-Flom Center, Course begins September 6, 2016. Register now!

Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics An introduction to the study of bioethics and the application of legal and ethical reasoning. Course begins on September… Read More

Call for Proposals: BioIP Faculty Workshop
ASMLE, Loyola University of Chicago School of Law

Deadline: October 16, 2016

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the second annual bioIP Faculty Workshop on May 5, 2017 at Loyola University of Chicago School of Law in Chicago,… Read More

Health Law Professor
University of Pittsburgh School of Law

Deadline: October 15, 2016

The University of Pittsburgh School of Law invites applications for a tenure-stream position beginning in the 2017-2018 academic year. For this position, we seek candidates interested in teaching courses… Read More

The Relationship Between Bioethics and U.S. Health Law

In The Oxford Handbook of U.S. Healthcare Law, I. Glenn Cohen, Allison K. Hoffman, and William M. Sage, eds., July 2016 (online), January 2017 (print)
by I. Glenn Cohen (Faculty Director)

Abstract: This chapter explores the way bioethics is taught as part of U.S. health law. It begins with an overview of changes in several major textbooks in the field that cover bioethics and the law,… Read More

Divided Infringement and the Doctor-Patient Relationship

IP Theory, 2016 (Forthcoming)
by Rachel E. Sachs (Academic Fellow)

Abstract:       With its recent en banc decision in Akamai v. Limelight, the Federal Circuit has displayed its willingness to expand the scope of divided infringement liability… Read More

Resolving Reverse-Payment Settlements with the Smoking Gun of Stock Price Movements

81 Iowa Law Review 1581, 2016
by Thomas G. McGuire, Keith Drake, Einer Elhauge (Founding Faculty Director), Raymond S. Hartman, Martha Starr

Abstract: The Supreme Court recently held that in reverse-payment settlements of drug patent disputes, anticompetitive effects can be inferred if the reverse payment exceeds the patent holder’s… Read More

Prizing Insurance: Prescription Drug Insurance as Innovation Incentive,

Harvard Journal of Law and Technology, Vol. 30, No. 1 (forthcoming)
by Rachel E. Sachs

Abstract:  A problem perennially facing scholars of both intellectual property and health law is the need to incentivize appropriately the development of new pharmaceuticals. Although physicians have… Read More

Promoting Healthcare Innovation on the Demand Side

U of Michigan Law & Econ Research Paper No. 16-008; U of Michigan Public Law Research Paper No. 503
by Rebecca Eisenberg and W. Nicholson Price II (Academic Fellow Alumnus)

Abstract: Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products in… Read More

2016 Global School Health Rights Litigation Course
O’Neill Institute and Harvard FXB

Deadline: June 1, 2016

Join the O’Neill Institute and Harvard FXB for the 2016 Global School Health Rights Litigation course from June 13th - 17th at Georgetown University Law Center in Washington, DC! This one-week… Read More

Academic Fellow Alumnus W.Nicholson Price II to Join Faculty at University of Michigan School of Law

Petrie-Flom Center, March 31, 2016

We are pleased to announce that Petrie-Flom Center Academic Fellow Alumnus W. Nicholson Price II has been appointed an Assistant Professor at the University of Michigan School of Law. Nicholson… Read More

New Journal of Law & Biosciences featuring Harvard student work

Journal of Law and the Biosciences (JLB), Vol. 3, Issue 1 (April 2016)

The Journal of Law and the Biosciences, the open-access journal launched in 2014 by the Petrie-Flom Center and Harvard Law School in partnership with Duke University and Stanford University, has… Read More

How to Make the Most of Drugs We Already Have

The Upshot, New York Times, February 22, 2016
by By Austin Frakt, citing Ben Roin (Academic Fellow alumnus)

From the article [...] Moreover, if a drug company cannot ascertain the problem for which a prescription is written, it lacks the means by which it can enforce its new patent. Therefore, it cannot recoup,… Read More

The Unpatentable Microbiome

New England Regional Junior Faculty Scholarship Workshop, February 12, 2016
by Rachel E. Sachs (Academic Fellow)

Presentation Abstract:  Scientists have recently begun to appreciate the important role played by the human microbiome, the community of microbes that live within each of our bodies and outnumber… Read More

Academic Fellow Rachel E. Sachs to Join Faculty at Washington University School of Law

Petrie-Flom Center, February 17, 2016

We are pleased to announce that Petrie-Flom Center Academic Fellow Rachel E. Sachs has been appointed an Associate Professor at the Washington University in St. Louis School of Law.  At Washington… Read More

Visiting Health/IP Law Professor
Indiana University Robert H. McKinney School of Law

Deadline: February 18, 2016

The Indiana University Robert H. McKinney School of Law invites applications for a 2016-17 visiting assistant professor position, for one or two semesters. The position would primarily involve… Read More

Health Law, Policy, and Bioethics: Cross-Registration Opportunity for Harvard Students
Harvard Medical School

Deadline: January 15, 2016

Cross-registration is available for "Health Law, Policy, and Bioethics," a new course being offered as part of the HMS Master’s program in bioethics. A course description is provided below. Interested… Read More

Jaharis Faculty Fellow in Health Law and Intellectual Property
DePaul University College of Law

Deadline: January 01, 2016

Jaharis Faculty Fellow in Health Law and Intellectual Property A new endowment at the DePaul University College of Law will expand and strengthen scholarly and educational programs in an area where two… Read More

Heidi Williams wins MacArthur “genius grant”

MIT News, September 29, 2015
by Peter Dizikes, on Heidi Williams (Student Fellow Alumna)

From the article: MIT economist Heidi Williams, whose scholarly work looks at the effects of patent policies and technology on medical research and health care, has been granted a 2015 MacArthur Fellowship.… Read More

How Patent Law Can Block Even Lifesaving Drugs

New York Times, September 28, 2015
by Austin Frakt, quoting Benjamin Roin (Former Faculty Co-Director & Academic Fellow; Current Affiliated Faculty)

From the article: To see evidence of this, just look at the behavior of pharmaceutical firms. When Benjamin Roin, assistant professor of technological innovation, entrepreneurship, and strategic management… Read More

Big Data, Patents, and the Future of Medicine

Cardozo Law Review, Forthcoming , September 13, 2015
by W. Nicholson Price II (Academic Fellow Alumnus)

Abstract:  Big data has tremendous potential to improve health care. Unfortunately, intellectual property law isn’t ready to support that leap. In the next wave of data-driven medicine, black-box… Read More

Review of Innovation Law and Policy: Preserving the Future of Personalized Medicine

Written Description Blog, July 27, 2015
by Lisa Ouellette

From the review: I highly recommend two recently posted articles on declining innovation incentives for diagnostic tests, particularly due to changes in patentable subject matter doctrine. In Innovation… Read More

Will clinical trial data disclosure reduce incentives to develop new uses of drugs?

Nature Biotechnology, July 2015, Vol. 33, No. 7
by W Nicholson Price II (Academic Fellow alumnus) & Timo Minssen (past Visiting Scholar)

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the University of New Hampshire School of Law, and past Visiting Scholar Timo Minnsen, Associate… Read More

Innovation Law and Policy

U. C. Davis Law Review, Forthcoming 2016
by Rachel E. Sachs

Academic Fellow Rachel E. Sachs has a new article forthcoming in 2016 on law and the future of personalized medicine. From the article: Personalized medicine is the future of health care, and as such incentives… Read More

Are trade secrets delaying biosimilars?

Science, April 10, 2015
by W. Nicholson Price II (Academic Fellow Alumnus) and Arti K. Rai

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the University of New Hampshire School of Law, has recently published an article in Science on the cost and… Read More

Academic Fellow Rachel Sachs Presents at 2015 Works-in-Progress in Intellectual Property Colloquium

Petrie-Flom Center, February 7, 2015

Petrie-Flom Academic Fellow Rachel Sachs presented her paper, "Innovation Law and Policy: Preserving the Future of Personalized Medicine," at the 2015 Works-in-Progress in Intellectual Property (WIPIP)… Read More

Third Annual Health Law Year in P/Review collaborative blogging with Health Affairs

Petrie-Flom, February 5, 2015

The Third Annual Health Law Year in P/Review was a big success!  Video will be posted on our website shortly, but our presenters will be posting on their respective topics in a collaborative blog… Read More

Clinical Trial Recruitment: Problems, Misconceptions, and Possible Solutions,

Petrie-Flom Center, February 5, 2015

On January 19 - 21, 2015, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst |… Read More

The Future of Personalized Medicine

Hosted by The Future Society at the Harvard Kennedy School, January 28, 2015
by Rachel E. Sachs

On January 28, 2015, Academic Fellow Rachel E. Sachs spoke to the Future Society at the Harvard Kennedy School of Government on "The Future of Personalized Medicine." The talk addressed a range of… Read More

Academic Fellow Rachel Sachs Guest Lecturing in Reading Group at Harvard Law School

Petrie-Flom Center, January 22, 2015

Petrie-Flom Academic Fellow Rachel E. Sachs will be a regular guest lecturer in a reading group at Harvard Law School, co-taught by with Professors Terry Fisher and Mark Wu in Spring 2015,… Read More

First biosimilar drug set to enter US market

Nature, January 13, 2015
by Heidi Ledford, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The FDA is expected to make a final decision by May. But even as Sandoz prepares to sell its drug in the United States, it is embroiled in a patent fight with Amgen. By US law, Sandoz had to reveal… Read More

The New Model of Interest Group Representation in Patent Law

Yale Journal of Law and Technology, October 1, 2014
by Rachel Sachs (Academic Fellow)

From the article: Traditional public choice theory postulates that interest group representation is primarily responsible for the passage of legislation in a variety of areas. Intellectual property scholars… Read More

Call for Submissions: Journal of Law and the Biosciences

Deadline: August 29, 2014

Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, responses, essays, and book reviews devoted to the examination of issues related to the intersection of law and… Read More

Welcome 2014-2016 Academic Fellow Rachel Sachs!

Petrie-Flom Center, April 17, 2014

The Petrie-Flom Center is pleased to announce the new 2014-2016 Academic Fellow, Rachel Sachs. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was… Read More

Make it Work!:

Harvard Law Review 128, 2014
by 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… Read More

2014-2015 Student Fellowship
Petrie-Flom Center, Harvard Law School

Deadline: May 19, 2014

The Center and Student Fellowship.  The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly… Read More

Academic Fellow W. Nicholson Price II Appointed Asst. Professor at UNH School of Law

Petrie-Flom Center, March 13, 2014

Petrie-Flom Academic Fellow Nicholson Price has been appointed as an Assistant Professor at the University of New Hampshire School of Law, where he will research and teach on intellectual… Read More

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

Los Angeles Intellectual Property Law Association, Wegner's Writings, February 24, 2014
by 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… Read More

Patent Trolling

by 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.… Read More

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

by 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… Read More

NEW BOOK: Science and Technology in International Economic Law

Routledge, 2014
by 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… Read More

Do Fixed Patent Terms Distort Innovation?

Public Health Law & Policy e-Journal 5, no. 64, December 4, 2013
by 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")… Read More

Genes without Patents

Harvard Gazette, November 14, 2013
by Alvin Powell, featuring I. Glenn Cohen

As Supreme Court Justice Elena Kagan questioned Myriad Genetics’ attorney about patenting genes, Chris Hansen rejoiced. The attorney said that yes, genes should be patentable. But it was only under… Read More

Chris Hansen on “Dis-Owning Nature: The BRCA Gene Patents and the Supreme Court”

Program on Science, Technology, & Society at HKS, November 12, 2013
by Featuring I. Glenn Cohen as a discussant

ABOUT THE SPEAKER Chris Hansen joined the ACLU in 1973. He spent 10 years at the NYCLU specializing in complex litigation seeking reform of the mental retardation and mental health systems. He then spent… Read More

Pharma manufacturing woes dog industry

Chemistry World, October 23, 2013
by Sarah Moulton, quoting W. Nicholson Price II

[...] While many of these problems arise from quality control failures, according to Nicholson Price from Harvard Law School’s Petrie-Flom centre for health law policy, biotechnology and… Read More

Praise for “Making Do in Making Drugs” by W. Nicholson Price II

Written Description: Patent & IP Blog, Reviewing Recent Scholarship on Patent Law, IP Theory, and Innovation, September 28, 2013
by Camilla Alexandra Hrdy

"'M&M chocolate candies are made with a precision far beyond the capabilities of many drug manufacturers.' This is the intriguing opening to a thorough critique of innovation in pharmaceutical… Read More

Making Do in Making Drugs

Boston College Law Review, forthcoming
by W. Nicholson Price II

Abstract:   Drug recalls, contamination events, and shortages are on the rise, but drug companies still rely on decades-old manufacturing plants and processes. Contrary to widespread perceptions,… Read More

Association for Molecular Pathology v. Myriad Genetics

by Oyez Project

In June 2013, the Supreme Court held that naturally occurring gene sequences and their naturally occurring derivatives are not patent eligible.  This link includes a brief summary of the case, as… Read More

Myriad Gene Patent Litigation

Genomics Law Report

This link provides several viewpoints regarding the Myriad Genetics case. Read More

7 Takeaways from Supreme Court’s Gene Patent Decision

Daily News, National Geographic

Shortly after the Supreme Court ruling in Myriad, this article summarizes the implications of the decision and its influence on the biotech industry. Read More

Gene Patents

The Hastings Center Bioethics Briefing Book
by Robert Cook-Deegan

Intended for a lay audience, this chapter outlines key issues in the debate about gene patents and summarizes historical developments in the field. Read More

Patents in Genomics and Human Genetics

Annual Review of Genomics and Human Genetics
by Robert Cook-Deegan and Christopher Heaney

This article provides a more detailed and scholarly overview of the issues. Read More

Debunking the Myth that Whole-Genome Sequencing Infringes Thousands of Gene Patents

Nature Biotechnology
by Christopher M. Holman

This article addresses misconceptions regarding gene patents and whole-genome sequencing. Read More

Mayo Collaborative Services v. Prometheus Laboratories

by Oyez Project

In this case, the Supreme Court held that the processes involved in a test for proper dosages of drug treatments are unpatentable laws of nature. Read More

Mayo v. Prometheus: Implications for Patents, Biotechnology, and Personalized Medicine

by Congressional Research Service

This article discusses the implications of the Mayo v. Prometheus decision, including its potential impact on gene patents.  It also suggests possible routes that Congress can take on the issue of… Read More