FDA’s Impact on Pharmaceutical Innovation:
A lecture by Neil Flanzraich

Tuesday, April 14, 2015 12:00 PM
Lectures and Panels
2014-2015
Griswold Hall, 110
Harvard Law School, Cambridge, MA

The Petrie-Flom Center will host a lecture by Neil Flanzraich, who graduated from HLS in 1968 and was appointed by Dean Martha Minow…

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Health Law Workshop: Rachel Sachs

Monday, April 13, 2015 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Presentation Title: "Prescription Drug Reimbursement as Innovation Incentive" Rachel Sachs is an Academic Fellow at the Petrie-Flom Center. She earned her…

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Health Law Workshop: Amy Kapczynski

Monday, February 23, 2015 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Amy Kapczynski is an Associate Professor of Law at Yale Law School and director of the Global Health Justice Partnership. She…

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UPDATED AGENDA: Third Annual Health Law Year in P/Review

Friday, January 30, 2015 7:45 AM - 5:00 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Please join us for the Third Annual Health Law Year in P/Review symposium, with leading experts discussing major developments during…

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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, on…

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Supreme Court Rules in Favor of Teva Over Patent for Multiple Sclerosis Drug

New York Times, January 20, 2015
by Reuters

WASHINGTON — The Supreme Court on Tuesday ruled that Teva Pharmaceutical Industries could still benefit from patent protection for a multiple sclerosis drug, dealing a blow to makers of generic…

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Gilead’s India Patent Snag May Spur More Low-Cost Sovaldi Copies

Bloomberg, January 15, 2015
by Ketaki Gokhale

The Indian patent office’s rejection of a key patent for Gilead Sciences Inc. (GILD)’s Hepatitis C treatment Sovaldi may pave the way for more low-cost copies in the country, potentially aiding…

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Johnson & Johnson Will Make Clinical Data Available to Outside Researchers

New York Times, January 14, 2015
by Katie Thomas

The health care giant Johnson & Johnson has agreed to make detailed clinical trial data on its medical devices and diagnostic tests available to outside researchers through a collaboration with Yale University, making…

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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…

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FDA Advisory Panel Backs First Potential ‘Copycat’ Drug

Kaiser Health News, January 8, 2015

KHN Morning Briefing: Summaries of health policy coverage from major news organizations. If the government accepts the recommendation, it could mean millions in savings for consumers who need expensive drugs.…

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Legal and Ethical Issues in Healthcare Start-Ups
(followed by Petrie-Flom's 2014 Open House)

Monday, October 06, 2014 4:00 - 5:30 PM
Lectures and Panels
2014-2015
Wasserstein Hall, Milstein West AB
1585 Massachusetts Ave., 2nd floor, Cambridge, MA

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit…

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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 have largely…

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Health Law Workshop: Benjamin Roin

Monday, September 29, 2014 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Download the Presentation Topic Paper: "Solving the Problem of New Uses by Creating Incentives for Private Industry to Repurpose Off-Patent Drugs"…

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Health Law Workshop: Thomas McGuire

Monday, September 22, 2014 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Download the Presentation Topic Paper: Do "Reverse Payment" Settlements of Brand-Generic Patent Disputes in the Pharmaceutical Industry Constitute an Anticompetitive Pay…

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Post-Trial Responsibilities:
Ethics and Implementation

Thursday, September 18, 2014 7:30 AM - 5:30 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Ave., Cambridge, MA

Conference Description Who: Clinical research sponsors, investigators, funders, regulators, trial participants, and other stakeholders Introduction / Background:The term “post-trial access” is…

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Call for Submissions: Journal of Law and the Biosciences

Call for Submissions: Journal of Law and the Biosciences

Deadline: Rolling admission.

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 biosciences, including bioethics, neuroethics, genetics,…

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Judge Voids Expansion of Discount Drug Program

New York Times, June 8, 2014
by Robert Pear

WASHINGTON — A federal judge has struck down a new rule requiring drug companies to offer certain drugs at discounted prices, saying the Obama administration had no authority to issue…

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Reforming Brazilian Pharmaceutical Patent Policy:
Lessons from the Past and the Road for the Future

Wednesday, April 23, 2014 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 1010
1585 Massachusetts Ave., Cambridge, MA

In this lecture by Pedro Paranaguá, he discussed the report issued by the Brazilian House of Representatives in 2013 as part…

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Vermont Will Require Labeling of Genetically Altered Foods

New York Times, April 23, 2014
by Stephanie Strom

Going further than any state so far, Vermont on Wednesday passed a lawrequiring the labeling of foods that contain genetically engineered ingredients. Though the move came in a tiny state far…

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US judge blocks Mass. ban on painkiller:

Boston Globe, April 15, 2014
by Milton J. Valencia

A federal judge struck down the state’s first-of-its-kind emergency ban on Zohydro on Tuesday, saying Massachusetts had no authority to overrule a federal decision to approve the powerful, controversial painkiller.…

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Ebola Drug Could Be Ready For Human Testing Next Year

NPR, April 11, 2014
by Richard Harris

The Ebola outbreak in West Africa is terrifying because there's no drug to treat this often fatal disease. But the disease is so rare, there's no incentive for big pharmaceutical companies to…

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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 the Articles Chair of…

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Supreme Court to Hear Appeal of Generic Drug Case

New York Times, March 31, 2014
by Andrew Pollack

As the world’s largest maker of generic drugs, Teva Pharmaceutical Industries has been critical of brand-name manufacturers that try to block generic versions of their high-priced medicines. But Teva is…

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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…

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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 property, innovation policy, and…

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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
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…

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Patents Without Patents:
Regulatory Incentives for Innovation in the Drug Industry

Wednesday, February 19, 2014 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge, MA

Watch Event Recordings

In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs.  But patents aren’t the whole…

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Novartis puts pressure on India over patent abuse

Financial Times, February 16, 2014
by Andrew Ward and Amy Kazmin

Novartis has urged US and European governments to “apply pressure” on India to respect intellectual property and warned New Delhi that its stance on patents is deterring investment. Joe Jimenez,…

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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. In the modern…

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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 challenges posed…

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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 interaction…

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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")…

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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…

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GMO food fight brings in big bucks in Washington state

Al Jazeera America, October 28, 2013
by Michael Ames

A bitter fight in Washington state over whether to label foods with ingredients that have been genetically modified has attracted tens of millions of dollars in spending, more than $27…

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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 bioethics, this is not the…

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Open Access Week 2013:
Promoting Access to Federally Funded Research

Monday, October 21, 2013 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall, Room 4063
1585 Massachusetts Ave., Cambridge, MA

2013 has seen many milestones towards improving access to biomedical research. In February, President Obama issued an Executive Order requiring…

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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…

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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 manufacturing by Nicholson…

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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, drug manufacturing is…

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Compulsory License and Access to Medicine:
The Indian Experience to Date

Monday, September 16, 2013 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall, B015
1585 Massachusetts Ave., Cambridge, MA

A lecture by V. Lakshmikumaran. Presented by the Program on the Legal Profession at Harvard Law School, in cooperation with…

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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,…

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Myriad Gene Patent Litigation

Genomics Law Report

This link provides several viewpoints regarding the Myriad Genetics case.

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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.

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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.

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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.

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Issues and Case Studies in Clinical Trial Data Sharing:
What Have We Learned?

Friday, May 17, 2013
Conferences
2012-2013
Wasserstein Hall, Milstein East, Harvard Law School
1585 Massachusetts Ave., Cambridge, MA
Watch Event Recordings

Objectives: To convene key global stakeholders on a neutral platform to review evidence from recent case studies in clinical trial…

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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.

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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.

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Personalized Medicine Patenting

Wednesday, March 06, 2013
Lectures and Panels
2012-2013
Austin Hall 111, Harvard Law School
Watch Event Recordings

Pharmaceutical researchers pursue medical treatment and diagnostic methods to target diseases specific to certain demographic groups. Such pursuit is often motivated…

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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…

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