Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Experts Question FDA Approval of Remdesivir for COVID-19

By Sravya Chary

Experts are calling into question the recent decision of the U.S. Food and Drug Administration (FDA) to approve remdesivir (sold under the brand name Veklury) for the treatment of COVID-19 and casting scrutiny as to whether the decision is truly in the public’s interest.

Evaluating and approving an effective treatment for SARS-CoV-2 virus has been a top priority for regulatory authorities, especially in the absence of a viable vaccine. On October 22, 2020, the FDA approved Veklury for the treatment of COVID-19 in adult and pediatric patients requiring hospitalization.

The FDA cited three randomized, controlled clinical trials as the evidence supporting its decision to approve Veklury. The findings from the three studies were as follows: first, that the median time to recovery from COVID-19 was 5 days sooner in the Veklury group compared to the placebo group. Second, that the odds of a research subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day treatment group than the standard of care group (the 10-day treatment group did not show a statistically significant difference from the standard of care group). Third, that there were no statistically significant differences in recovery or mortality rates between subjects in the five-day Veklury group versus the ten-day Veklury group.

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Vaccine.

Compulsory Licensing for Pharmaceuticals in the EU: A Reality Check

By Caranina (Nina) Colpaert

As pharma races to develop a COVID-19 vaccine, researchers and governments are working in parallel to pinpoint strategies to secure its widespread access.

To that end, many countries plan to seek refuge in a long-existing strategy: compulsory licensing.

In the European Union (EU), however, compulsory licensing is not as self-evident as it might seem. This blog post focuses on four specific challenges that come with compulsory licensing in the EU and potential alternative solutions.

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Researcher works at a lab bench

Deconstructing Moderna’s COVID-19 Patent Pledge

By Jorge L. Contreras, JD

On October 8, Cambridge-based biotech company Moderna, Inc., a leading contender in the race to develop a COVID-19 vaccine, publicly pledged not to enforce its COVID-19 related patents against “those making vaccines intended to combat the pandemic.”

It also expressed willingness to license its intellectual property for COVID-19 vaccines to others after the pandemic. In making this pledge, Moderna refers to its “special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.”

Moderna holds seven issued U.S. patents covering aspects of an mRNA-based candidate vaccine directed to COVID-19 which entered Phase III clinical trials in July. The potential market for a COVID-19 vaccine is potentially enormous. As of this writing, the U.S. government has committed approximately $1.5 billion to acquire 100 million doses of Moderna’s vaccine if it proves to be safe and effective (with an option for 100 million more), and the Canadian government has agreed to purchase 20 million doses for an undisclosed amount.

In the high-stakes market for COVID-19 vaccines, it is worth considering the full range of factors that might motivate a private firm to relinquish valuable intellectual property rights for the public good. A better understanding of these factors could help policymakers to secure additional pledges from firms that have not yet volunteered their intellectual property in the fight against the pandemic.

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Journal of Law and the Biosciences Continues to Have an Impact

The COVID-19 pandemic has underscored the importance of the biosciences in our world, as well as the legal, ethical, and regulatory choices that shape the development and implementation of innovations from the biosciences.

The Journal of Law and the Biosciences (JLB) offers high-quality, open-access scholarship at the intersection of the biosciences and law as the first fully open-access, peer-reviewed, legal journal to focus on these issues.

Recently, the Journal of Law and the Biosciences received an updated impact factor of 2.275, highlighting its relevance and influence in law, medicine, and ethics. JLB ranks 25th out of 154 law journals, second of sixteen legal medicine journals, and third out of sixteen medical ethics journals.

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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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