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What are the challenges in developing information around mixing-and-matching COVID-19 vaccines and therapies? image

What are the challenges in developing information around mixing-and-matching COVID-19 vaccines and therapies?

Rachel Sachs (Former Academic Fellow), Jacob S. Sherkow (Former Fellow-in-Residence), Lisa Larrimore Ouellette, and Nicholson Price
Written Description

The FDA has now authorized three vaccines and several treatments (including both monoclonal antibodies and small-molecule drugs) for the prevention and treatment of COVID-19. But the initial evidence supporting these…

Problematic Interactions Between AI and Health Privacy

Nicholson Price (Former Academic Fellow)
Utah Law Review

The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens…

Negative innovation image

Negative innovation: When patents are bad for patients

Robin C. Feldman, David A. Hyman, W. Nicholson Price II (Academic Fellow Alumnus), and Mark J. Ratain
Nature Biotechnology

Incentives in patent law have driven innovation into spaces that are affirmatively harmful to patients, and patentees are discouraged from taking steps to improve the product so as to prevent…

Are patents the cause of—or solution to—COVID-19 vaccine innovation problems? (No!) image

Are patents the cause of—or solution to—COVID-19 vaccine innovation problems? (No!)

Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs
Written Description

Full author list: Jacob Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow), Lisa Larrimore Ouellette, Nicholson Price (Former Academic Fellow), and Rachel Sachs (Former Academic Fellow) Are patents…

New Innovation Models in Medical AI image

New Innovation Models in Medical AI

W. Nicholson Price II (Former Academic Fellow), Rachel Sachs (Former Academic Fellow), and Rebecca Eisenberg
SSNR

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those which resemble traditional medical devices in…

Clearing Opacity Through Machine Learning image

Clearing Opacity Through Machine Learning

W. Nicholson Price II (Former Academic Fellow) and Arti Rai
Iowa Law Review

A substantial literature has arisen around worries that machine learning and artificial intelligence are opaque, or “black boxes.” Many of these worries are legitimate. But a focus on…

Why aren’t therapeutic antibodies being used more to treat COVID-19? image

Why aren’t therapeutic antibodies being used more to treat COVID-19?

W. Nicholson Price II, Rachel Sachs, Jacob S. Sherkow, and Lisa Larrimore Ouellette
Written Description

Complete author list: W. Nicholson Price II (Former Academic Fellow), Rachel Sachs (Former Academic Fellow), Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow), and Lisa Larrimore…

An Administrative Fix for Manufacturing Process Patent Thickets image

An Administrative Fix for Manufacturing Process Patent Thickets

Arti Rai and W. Nicholson Price II (Former Academic Fellow)
Nature

Biosimilar manufacturing process patent applications first filed more than a year after the biologic is approved, which represent the largest source of patent assertions in biosimilar litigation, could be addressed…

Risks and Remedies for Artificial Intelligence in Health Care image

Risks and Remedies for Artificial Intelligence in Health Care

W. Nicholson Price II (Academic Fellow Alumnus)
Brookings

Artificial intelligence (AI) is rapidly entering health care and serving major roles, from automating drudgery and routine tasks in medical practice to managing patients and medical resources. As developers create…

How logically impossible patents block biosimilars

By W. Nicholson Price (Academic Fellow Alumnus) and Arti K. Rai
Nature Biotechnology

From the article: As the public outcry over drug prices continues, biologics play a prominent role. Biologics—products such as Humira (adalimumab), Enbrel (etanercept) and Avastin (bevacizumab)—are…

CVS, Walgreens Look to the Chronically Ill for a Pharmacy Cure

Aisha Al-Muslim and Sharon Terlep, quoting W. Nicholson Price (Academic Fellow Alumnus)
Wall Street Journal

From the article: America’s two biggest pharmacy chains are attempting to reverse their sagging fortunes by becoming go-to treatment centers for people with chronic illnesses. CVS Health Corp.…

Can You Sue An Algorithm For Malpractice?

Forbes AI, interviewing W. Nicholson Price (Academic Fellow Alumnus)
Forbes AI

From the article: "What’s in the box? The “black box,” that is. Increasingly, doctors are relying on sophisticated, and at times inscrutable, algorithms to make healthcare…

Privacy in the age of medical big data

W. Nicholson Price (Academic Fellow Alumnus) and I. Glenn Cohen (Faculty Director)
Nature Medicine

From the article: "Big data has come to medicine. Its advocates promise increased accountability, quality, efficiency, and innovation. Most recently, the rapid development of machine-learning techniques and artificial intelligence (AI)…

In The Battle To Control Drug Costs, Old Patent Laws Get New Life

Shefali Luthra, quoting Rachel Sachs and W. Nicholson Price (Academic Fellow Alumni)
Kaiser Health News

From the article: Simply taking a patent doesn’t bring down prices, either. There are other ways manufacturers gain favorable market positioning for specific drugs, said Rachel Sachs, an…

Who’s to blame when a machine botches your surgery?

Robert David Hart (quoting W. Nicholson Price II, Academic Fellow Alumnus)
Quartz

From the article: Determining the levels of legal responsibility for AIs as a whole is a fairly new area and one that has yet to be seriously tested in court.…

We Have to Be Smart About Artificial Intelligence in Medicine: When the technology is complicated, opaque, changing, and absolutely vital to the health of a patient, how do we make sure it works as promised?

W. Nicholson Price II (Academic Fellow Alumnus)
Slate

From the article: For millions of people suffering from diabetes, new technology enabled by artificial intelligence promises to make management much easier. Medtronic’s Guardian Connect system promises to…

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.

Alaric Dearment, quoting W. Nicholson Price II (Academic Fellow Alumnus)
Med City News

[...] 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…

Drug Approval in a Learning Health System

W. Nicholson Price (Academic Fellow Alumnus)
Minnesota Law Review, Forthcoming

From the article: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and…

Grants

W. Nicholson Price II (Academic Fellow Alumnus)
Berkeley Technology Law Journal

From the paper: Innovation is a primary source of economic growth, and is accordingly the target of substantial academic and government attention. Grants are a key tool in the government…

For Shame: ‘Pharma Bro’ Shkreli Is In Prison, But Daraprim’s Price Is Still High

Shefali Luthra, quoting W. Nicholson Price (Academic Fellow Alumnus)
The Washington Post

From the article: It was 2015 when Martin Shkreli, then CEO of Turing Pharmaceuticals and the notorious “pharma bro,” jacked up the cost of the lifesaving drug Daraprim by 5,000…

Risk and Resilience in Health Data Infrastructure

W. Nicholson Price II (Academic Fellow Alumnus)
Colorado Technology Law Journal

From the journal article: Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad…

Petrie-Flom Center launches Project on Precision Medicine, Artificial Intelligence, and the Law

Q & A with I. Glenn Cohen (Faculty Director)
Harvard Law Today

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen…

The Petrie-Flom Center Launches New Project: Precision Medicine, Artificial Intelligence, and the Law (PMAIL)

Petrie-Flom Center

The Project on Precision Medicine, Artificial Intelligence, and the Law will seek to better understand the frontiers of big data in health care diagnostics, through interdisciplinary analysis of important health…

Regulating Black-Box Medicine

W. Nicholson Price II (Academic Fellow Alumnus)
Michigan Law Review

From the paper: Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated…

The $4,500 injection to stop heroin overdoses

Shefali Luthra, quoting W. Nicholson Price II (Academic Fellow Alumnus)
Washington Post

From the article: Thanks to an infusion of public funding to combat opioid overdoses, other institutional buyers may also be able to afford Evzios. Their budgets are larger right now,…

Promoting healthcare innovation on the demand side

W. Nicholson Price II (Academic Fellow Alumnus) and Rebecca S. Eisenberg
Journal of Law and the Biosciences

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…

5 reasons why no one has built a better EpiPen

Meghana Keshavan, quoting W. Nicholson Price II (Academic Fellow Alumnus)
STAT

[...] 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

Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow Alumnus)
MedCityNews

[...] 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

Dani Kass, quoting W. Nicholson Price II (Academic Fellow Alumnus)
Law360

[...] 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…

EpiPen’s Dominance Driven By Competitors’ Stumbles And Tragic Deaths

Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow alumnus)
NPR

NPR recently called on Petrie-Flom Academic Fellow alumnus Nicholson Price to help explain how Mylan's Epi-Pen has come to dominate the market for epinephrine autoinjectors. From the article: The…

US personalized-medicine industry takes hit from Supreme Court

Heidi Ledford, quoting W. Nicholson Price II (Academic Fellow alumnus)
Nature News

From the article: Rejections for US patents related to personalized medicine have spiked after recent Supreme Court decisions tightened the rules for such claims, an analysis of more than 39,000 patent…

Promoting Healthcare Innovation on the Demand Side

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

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…

Petrie-Flom, 10 years on:: Celebrating the future of health law and policy

Harvard Law Today

On March 29, current and former affiliates of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics were joined by Harvard Law School's Dean Martha Minow and several prominent…

The Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration

March 29, 2016
Watch Videos

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…

Assessing the Viability of FDA’s Biosimilars Pathway

February 18, 2016
Watch Videos

Couldn't attend the event? Check out some of our speakers' slide presentations! Description The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway…

Big Data, Patents, and the Future of Medicine

W. Nicholson Price II (Academic Fellow Alumnus)
Cardozo Law Review, Forthcoming

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…

Congress seeks to quash patent trolls

Heidi Ledford, quoting W. Nicholson Price II (Academic Fellow Alumnus)
Nature News

From the article: Predatory ‘patent trolls’ could soon find it harder to operate in the United States. Legislation to curb frivolous patent lawsuits has regained momentum after lawmakers…

Are trade secrets delaying biosimilars?

W. Nicholson Price II (Academic Fellow Alumnus) and Arti K. Rai
Science

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…

​Nudging the FDA

W. Nicholson Price II (Academic Fellow alumnus) and I. Glenn Cohen (Faculty Director)
The American Interest

From the article: [...] The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view…

How patent reform’s fraught politics have left USPTO still without a boss

Nancy Scola, quoting W. Nicholson Price II (Affiliated Faculty)
The Washington Post

From the article: [...] The controversy began in late June when rumors started to trickle out that the White House would nominate Philip S. Johnson to lead the USPTO [...] And so…

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

Petrie-Flom Center

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,…

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

February 19, 2014

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…

Pharma manufacturing woes dog industry

Sarah Moulton, quoting W. Nicholson Price II
Chemistry World

[...] 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…

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

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

"'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

W. Nicholson Price II
Boston College Law Review

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…

The Food and Drug Administration in the 21st Century: The 2013 Petrie-Flom Center Annual Conference

May 3, 2013
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Conference Description The Food and Drug Administration, the US government’s oldest comprehensive consumer protection agency, bears the monumental task of safeguarding the public health through regulation of food,…