News, Resources, and Events Tagged "Intellectual Property"
A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways
Complete author list: Louise C. Druedahl, Anna Birna Almarsdóttir, Sofia Kälvemark Sporrong, Marie Louise De Bruin, Hans Hoogland, Timo Minssen (Former Visiting Scholar), Marco van de…
Eighth Annual Health Law Year in P/Review
At the Petrie-Flom Center's eighth annual Health Law Year in P/Review, leading experts discussed major developments in health law and policy during 2019 and what to watch out for…
FDA admits it goofed when granting orphan status to an opioid addiction treatment
In an unusual move, the Food and Drug Administration has acknowledged a mistake and revoked orphan drug status for an opioid addiction treatment that was approved two years ago, clearing…
Who Owns H.I.V.-Prevention Drugs? The Taxpayers, U.S. Says: In an unexpected lawsuit, federal officials claim that Gilead Sciences willfully disregarded government patents on medicines necessary to end the AIDS epidemic.
After years of prodding by patient advocates, federal officials on Wednesday sued the drug maker Gilead Sciences, charging that it had infringed government patents on the idea of preventing H…
The Complexity of the CRISPR Patent Licensing Landscape for Agriculture
Prof. Jacob Sherkow presented his talk, "The Complexity of the CRISPR Patent Licensing Landscape for Agriculture," in Keystone, Colorado, for a conference jointly hosted by Colorado State University and OECD.…
10x Genomics Showing ‘Little Concern’ for Patent Lawsuit Consequences, Customers Say
From the article: The permanent injunction is set to take effect Wednesday, Aug. 28. The appeals court is likely to make a ruling on whether it will stay the injunction today…
Call for Abstracts: 2020 bioIP Faculty Workshop, ASLME, Loyola University Chicago School of Law
Full call for abstracts: The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the 5th annual bioIP Faculty Workshop on Friday May 1, 2020, at Loyola University of…
2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies
Couldn't join us for the conference? Join the conversation on Twitter with #DTCgenome! And check out many of our speakers' slide presentations and our "Consuming Genetics" blog symposium! The…
What Should Happen to Our Medical Records When We Die?: Digital Health @ Harvard
Couldn't join us at the event? Check out our presenter's slides! Description Digital innovation is transforming health care, and the amount of digital health care data being generated…
Genome Editing: Rights and Wrongs: A Health Policy and Bioethics Consortium
Gene-editing technologies offer substantial promise in treating disease, but their use raises important ethical and public health questions about how these innovations should be applied and regulated. Different groups have…
Black-Box Medicine: Legal and Ethical Issues: A Health Policy and Bioethics Consortium
Couldn't join us for the event? Check out some of the panelists' slide presentations below! Description Black-box medicine—the use of opaque computational models to make care decisions…
Report blames gaming of patent system for high drug prices: Most drugs named are biologics, and manufacturing trade secrets make competition especially tricky, legal expert says.
[...] The report, “Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices,” was released last week by the nonprofit Initiative for Medicines, Access and…
It’s time to levy penalties for failing to report clinical trial results
From the article: I started my first job as an attorney in the fall of 2007, days after President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA)…
Sixth Annual Health Law Year in P/Review
Couldn't join us? Check out the conversation on Twitter: @PetrieFlom #healthlawpreview2018 and some of our speakers' slide presentations below! Description The Sixth Annual Health Law Year in P/Review…
Health Law Workshop: Rachel E. Sachs
Presentation Topic: "Delinking Reimbursement" This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu. About…
Artificial Intelligence in Health Care: Applications and Legal Issues
From the paper: Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will…
A patent ploy: Allergan’s unusual legal tactic attracts political scrutiny
From the article: [...] The Mohawk tribe argues that it should be treated the same as a state institution. State universities have used sovereign immunity to dismiss challenges brought to the…
The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States
From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in…
Allergan’s deal with the Mohawks raises troubling questions about the future of generics
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…
(Health) Law and Order
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…
Sanofi, Regeneron ask court to shield Dupixent from Amgen patent attack
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…
Looking Forward: The Next Generation of Biosimilars
Couldn't make it to the event? Check out some of the speakers' slides below! Description Many of today’s important medications are biological products made from living organisms,…
Regulating Secrecy
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 regulators…
Promoting healthcare innovation on the demand side
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…
Federal Circuit Court Appeal Cites Rachel E. Sachs
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 LLC, f…
Could Amgen’s Patent Victory Be Bad For Medicine?
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…
The International Intellectual Property Law Podcast on blinding expert witnesses to reduce bias
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 Expertise.
Health Law Workshop: W. Nicholson Price II
Presentation Topic: "Regulating Black-Box Medicine" This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu. …
5 reasons why no one has built a better EpiPen
[...] 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…
How Mylan cornered the consumer epinephrine market
[...] 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 reported…
Euro Drug Pricing’s Tradeoffs May Limit Appeal In US
[...] 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…
Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics: New EdX Course from Faculty Director Glenn Cohen
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 6, 2016.…
The Relationship Between Bioethics and U.S. Health Law: Past, Present, and Future
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…
Divided Infringement and the Doctor-Patient Relationship
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 for method claims under 35…
Resolving Reverse-Payment Settlements with the Smoking Gun of Stock Price Movements
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 anticipated…
Prizing Insurance: Prescription Drug Insurance as Innovation Incentive,: New Article from Academic Fellow 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 an arsenal of…
Promoting Healthcare Innovation on the Demand Side
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…
Health Law Workshop: Robert Cook-Deegan
About the Presenter Robert Cook-Deegan is a research professor in the Sanford School of Public Policy at Duke University, with secondary appointments in Internal Medicine (School of Medicine), and Biology …
Academic Fellow Alumnus W.Nicholson Price II to Join Faculty at University of Michigan School of Law
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…
The Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration
The Petrie-Flom Center celebrated its first decade and kicked off the next by looking at the future of health law and policy! The Center brought together Petrie-Flom and other prominent…
Health Law Workshop: Michael Frakes
Presentation Download the Presentation (two files): "Does Medical Malpractice Law Improve Health Care Quality?" and Appendix About the Presenter In Spring 2016, Michael Frakes was an Associate Professor of Law at…
New Journal of Law & Biosciences featuring Harvard student work
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 published…
How to Make the Most of Drugs We Already Have
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.…
Academic Fellow Rachel E. Sachs to Join Faculty at Washington University School of Law
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…
Fourth Annual Health Law Year in P/Review
Couldn't attend in person? Learn more about the event: Learn more about the presentations - check out select speakers' slides below! Check out the collaborative blog series on the…
Academic Fellow Rachel Sachs featured in Politico’s “Prescription Pulse”: Weekly round-up of pharma news includes Sachs on 'march-in' rights
REALITY CHECK ON 'MARCH-IN'-RIGHTS — 50 House Democrats wrote HHS and NIH last week that the government should exercise its march-in rights — handing over the patents on some high-priced…
Heidi Williams wins MacArthur “genius grant”
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…
How Patent Law Can Block Even Lifesaving Drugs
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 at M…
Health Law Workshop: Jessica L. Roberts
Presentation Download the paper: "Theories of Genetic Ownership" About the Presenter Jessica L. Roberts is the Director of the Health Law and Policy Institute and an Associate Professor of Law…
Big Data, Patents, and the Future of Medicine
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…
Review of Innovation Law and Policy: Preserving the Future of Personalized Medicine: by Rachel Sachs
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 Law and…
Will clinical trial data disclosure reduce incentives to develop new uses of drugs?
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 Professor at the University…
Innovation Law and Policy: Preserving the Future of Personalized Medicine
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,…
Health Law Workshop: Rachel E. Sachs
Presentation Topic: "Rethinking the Incentives/Access Dichotomy: Prescription Drug Reimbursement as Innovation Incentive." This paper is not available for download. To request a copy, please contact Jennifer Minnich at jminnich…
Are trade secrets delaying biosimilars?
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…
FDA’s Impact on Pharmaceutical Innovation: A lecture by Neil Flanzraich
Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussed the balance between speed and safety in FDA’s regulation of pharmaceutical products. Topics included how FDA’s…
Health Law Workshop: Amy Kapczynski
Presentation Professor Kapczynski's presentation, "Order Without Intellectual Property Law: The Flu Network as a Case Study in Open Science," is available upon request. Please contact Jennifer Minnich (jminnich@law…
Academic Fellow Rachel Sachs Presents at 2015 Works-in-Progress in Intellectual Property Colloquium
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) Colloquium. Held this year on…
Third Annual Health Law Year in P/Review collaborative blogging with Health Affairs
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…
Clinical Trial Recruitment: Problems, Misconceptions, and Possible Solutions,: A Conference
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 | The Harvard…
Third Annual Health Law Year in P/Review
Couldn't make it in person? Check out the individual sessions in the videos linked above and the collaborative blog series on the Health Affairs Blog (links below)! The Third…
The Future of Personalized Medicine
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…
Academic Fellow Rachel Sachs Guest Lecturing in Reading Group at Harvard Law School
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…
First biosimilar drug set to enter US market: But such cheaper, generic versions of biological drugs face scientific, regulatory and patent hurdles.
[...] 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…
Legal and Ethical Issues in Healthcare Start-Ups: (followed by Petrie-Flom's 2014 Open House)
New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the…
The New Model of Interest Group Representation in Patent Law
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…
Health Law Workshop: Benjamin Roin
Presentation Download the Presentation Topic Paper: "Solving the Problem of New Uses by Creating Incentives for Private Industry to Repurpose Off-Patent Drugs" About the Presenter Benjamin N. Roin is Assistant…
Health Law Workshop: Thomas McGuire
Presentation Download the Presentation Topic Paper: Do "Reverse Payment" Settlements of Brand-Generic Patent Disputes in the Pharmaceutical Industry Constitute an Anticompetitive Pay for Delay? About the Presenter Thomas G. McGuire,…
Post-Trial Responsibilities: Ethics and Implementation
Conference Description Who: Clinical research sponsors, investigators, funders, regulators, trial participants, and other stakeholders Introduction / Background: The term “post-trial access” is used broadly to connote a wide range…
Reforming Brazilian Pharmaceutical Patent Policy: Lessons from the Past and the Road for the Future
Description In this lecture by Pedro Paranaguá, he discussed the report issued by the Brazilian House of Representatives in 2013 as part of an effort to revamp the country's…
Welcome 2014-2016 Academic Fellow Rachel Sachs!
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…
Make it Work!:: Breyer on Patents in the Life Sciences
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…
Academic Fellow W. Nicholson Price II Appointed Asst. Professor at UNH School of Law
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,…
The “Problem” with the European Problem/Solution Approach to Inventive Step
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…
Patents Without Patents: Regulatory Incentives for Innovation in the Drug Industry
Couldn't attend the event? Check out the video of the event and select speakers' slides below! In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing…
Patent Trolling: Why Bio & Pharmaceuticals are at Risk
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…
Legal Aspects of Biobanking as Key Issues for Personalized Medicine & Translational Exploitation
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…
NEW BOOK: Science and Technology in International Economic Law: Balancing Competing Interests
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…
Do Fixed Patent Terms Distort Innovation?: Evidence from Cancer Clinical Trials
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 (…
Genes without Patents: ACLU attorney joins discussion of Supreme Court case
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…
Chris Hansen on “Dis-Owning Nature: The BRCA Gene Patents and the Supreme Court”
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…
Pharma manufacturing woes dog industry
[...] 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…
Open Access Week 2013: Promoting Access to Federally Funded Research
2013 has seen many milestones towards improving access to biomedical research. In February, President Obama issued an Executive Order requiring most federal research agencies to implement public access policies; official guidance…
Praise for “Making Do in Making Drugs” by W. Nicholson Price II
"'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…
Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing
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 typically…
Compulsory License and Access to Medicine: The Indian Experience to Date
A lecture by V. Lakshmikumaran. Presented by the Program on the Legal Profession at Harvard Law School, in cooperation with the Universities Allied for Essential Medicines - Harvard Chapter, the…
Issues and Case Studies in Clinical Trial Data Sharing: What Have We Learned?
Objectives: To convene key global stakeholders on a neutral platform to review evidence from recent case studies in clinical trial data disclosure To discuss key areas of learning and potential…
Personalized Medicine Patenting
Pharmaceutical researchers pursue medical treatment and diagnostic methods to target diseases specific to certain demographic groups. Such pursuit is often motivated by commercialization through patenting. Are these research innovations a…
Patent Policy and Innovation
This panel focused on how patent law affects various industries differently. The pharmaceutical and high-tech industries offer perhaps the most vivid examples of this divergence. Panelists discussed whether patent law…
Developments and Implications of New Legislation on Follow-on Biologics
This panel examined current legislative debates concerning the development of regulatory approval processes for follow-on biologics, or large molecule drugs that are created by biological processes, as opposed to medicines…
Medical Prize Funds: An Alternative Reward Mechanism for Medical Innovation
Patenting and other rewards that rely on protected markets to encourage research investment in medical technology do not always provide the right incentives needed to optimize public health. In recent…
Pharmaceutical Research, Development, and Markets
Amidst this larger debate about drug prices and pharmaceutical innovation, there is a growing consensus of a need for reform in the industry and how it is regulated. The substance…