U.S. Patent and Trademark Office building

Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, and the Economy

By Jorge L. Contreras, JD

The U.S. patent system gives inventors a 20-year exclusive right to their inventions to incentivize the creation of new technologies.

But what if you have a great idea for a new technology, but never actually create it, test it, or determine that it works? Is that patentable? Conversely, should the U.S. Patent and Trademark Office (PTO) grant patents covering imaginary, fraudulent and otherwise non-existent inventions? Probably not, but it happens with alarming frequency, and it is causing serious problems.

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Bill of Health is Looking to Amplify BIPOC Voices

Bill of Health strongly affirms that black lives and black voices matter, and we want to do more to feature and amplify the work of BIPOC scholars and students.

Accordingly, we are looking for new, regular contributors to Bill of Health, as well as guest bloggers. Regular contributors generally publish between five and 12 posts per year. Guest bloggers typically contribute two to five posts over the course of a one-month period. We welcome news, commentary, and scholarship in the fields of health law policy, biotechnology, and bioethics. Posts are typically 750 words in length.

If you are interested in becoming a regular contributor or guest blogger, please email editor-in-chief Chloe Reichel.

Special Pandemic Issue of the Journal of Law and the Biosciences

On March 24, 2020, the Journal of Law and the Biosciences, jointly run by Duke UniversityHarvard University Law School, and Stanford University, put out a call for essays and articles on governance in a time of pandemic. Between April 22 and May 28, it published 25 articles, all of which are available at the Journal’s website free of charge. We expect that more than 20 additional pieces will join them over the next month or so. The following is a regularly updated list, organized by date and time of publication, of what has been published in that special issue to date.

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Hands close-up of surgeons holding medical instruments.

COVID-19 and Organ Transplantation

By James W. Lytle

After a banner year for organ transplantation in the United States in 2019, the success became a tattered memory by April 2020, when the COVID-19 pandemic hit major cities in the U.S. with its full fury.

A record number of 39,178 organs were donated in 2019, including 7,397 organs from living donors, also an all-time high.  After several years of adverse media and regulatory scrutiny, LiveOn NY, the organ procurement organization (OPO) that serves the Metropolitan New York City region, proudly reported that a total of 938 organs had been transplanted in 2019, another record that represented more than a fifty percent increase over the transplant total in 2015.

By late April 2020, however, organ transplantation activity in New York State had reportedly declined by ninety percent.

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Doctor or nurse wearing PPE, N95 mask, face shield and personal protective gown standing beside the car/road screening for Covid-19 virus, Nasal swab Test.

COVID-19 Highlights Need for Rights to Repair and Produce in Emergencies

By Joshua D. Sarnoff

In response to the COVID-19 pandemic, companies, organizations, and individuals have sought to address supply chain gaps for needed medical equipment. Spare parts and products created during the COVID-19 pandemic include ventilator tube splitters, nasopharyngeal swabs, and face shields.

In the past, outside of the context of a public health crisis, I have discussed the need to adopt legislation to create a narrow exemption from design patent liability to assure a competitive supply of automobile repair parts. The current pandemic makes a stronger case for the need to explicitly incorporate into our legal system a right to repair and supply products in emergencies.

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New Virtual Issue of Journal of Law and the Biosciences: Editors’ Choice 2020

In this virtual issue from Journal of Law and the Biosciences, we present 17 informative articles, published in 2017-2019, hand-picked by the journal’s three Editors-in-Chief: Nita Farahany from Duke University, Hank Greely from Stanford University, and Glenn Cohen from Harvard Law School.

This specially curated article collection examines a range of matters focusing on the intersection of law and the biosciences, including whether a complete ban on surrogacy is compatible with the American Convention on Human Rights, what role should law play when genetic privacy is concerned, or what opportunities and challenges there are for forensic psychiatry regarding brain-based mind reading.

In selecting articles for this virtual issue, the Editorial Board aims to emphasize the high-quality studies published in Journal of Law and the Biosciences and hopes these will stimulate further research in this new important field.

Check out the full collection!

TeleSitters are entering hospital rooms. How will they change patient care?

By Adriana Krasniansky

In many medical circumstances, clinicians and caregivers may choose not to leave a patient alone. For example, a patient may present a fall risk, experience confusion and agitation, or be at risk of self-harm.  Traditionally, in such situations, a hospital assigns the patient a sitter, or a caregiver who provides patients patient supervision and companionship. 

The need for sitters in hospital settings is rising, as patient loads increase and fewer patients have family members who are able to stay with them for long periods of time. Sitters are also a considerable investment for hospitals; one community hospital reported employing 14 sitters a day, totaling $425,000 in costs annually. Many healthcare networks are exploring the possibility of TeleSitters, or virtual monitoring systems to support patient care. In this article, we review the national adoption of TeleSitters and point out benefits and considerations to their implementation.  Read More

Graph with number of biosimilar approvals on the X axis and years from 1970 until 2018 on the Y axis. The line on the graph represents a generally upward trend.

The Rise of Biosimilars: Success of the BPCIA? (Part I)

By Jonathan Darrow

This is Part I in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already-approved biological medicines.  This Part briefly covers the history of American regulation of biologics and touches briefly on the European experience.

The Biologics Price Competition and Innovation Act (BPCIA), part of the 2010 Affordable Care Act, sought to drive down prices for biologics, much as the 1984 Hatch-Waxman Act did for small-molecule drugs. By allowing manufacturers of follow-on products to rely in part on the clinical data of the brand-name reference product, both laws were designed to lower development costs and attract competitors.

Since the BPCIA’s enactment, however, scholars have compared it unfavorably to the Hatch-Waxman Act, criticized its pathway as “obstructed” and lacking in sufficient incentives, lamented the scarce approvals it has produced, and recommended that it be “abandoned.” Although criticisms of the law are not without basis, their collective implication—that the BPCIA is irredeemably defective and will never yield robust competition—may be wrong.

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Illustration of four people helping each other climb progressively taller stacks of books

What’s Missing From Biotech Graduate Education? With Free Course, RA Capital Attempts to Fill the Gaps

By Jessica Sagers

As a PhD student in the life sciences at Harvard, I attended almost every career seminar that came through my inbox. I had no idea what I wanted to do after finishing my research doctorate, but I was certain that it wasn’t more cell culture.

The walls of my academic bubble were so thick that even as a budding cell biologist, I’d managed to hear almost nothing about Boston’s booming biotech industry. “Going into industry” was regarded as an “alternative career,” to the point where it sounded like taking a job outside of academia was tantamount to abandoning science. Besides, all my training had been in basic science. The coursework I’d excelled in, from neurobiology to biophysics, did not equip me to translate what I’d learned to the business world.

During my final PhD year, curiosity about the biotech sector drove me to accept an internship at RA Capital Management, a life science-focused investment firm in Boston. Dr. Peter Kolchinsky (Harvard Program in Virology, ’01), Founder and Managing Partner of RA Capital, brought me and a group of fellow PhD students on board to help achieve his vision of providing more pragmatic, focused training to scientists and professionals interested in working in biotechnology. Together, we designed a short, advanced course on the business of biotech designed to fit the practical needs of late-stage graduate students and early-career professionals.

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