By: Bethany J. Hills, Erin M. Bosman, and Julie Y. Park
A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy.
Consistent with this, FDA has taken various steps to …›
By: Sejin Ahn, Desmond P. O'Sullivan, and James J. Mullen III
The United States Patent and Trademark Office (USPTO) announced a Prioritized Examination Pilot Program for COVID-19-related patent applications. To qualify, an applicant must be a small entity or micro-entity and the application must contain at least one claim covering products or process that are …›
By: Amanda Elisabeth Casale, Anna Yuan, and Karen G Potter
The increase in AI-related patent filings in the past few years has given rise to unique questions about the current patent system. In particular, the question of whether an AI system can or should be named as an inventor on a patent application has …›
By: Bethany J. Hills, Erin M. Bosman, and Julie Y. Park
Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been …›
By: David Chan, James J. Mullen III, and Desmond P. O'Sullivan
Patent applicants facing a funds shortage because of COVID-19 may be glad to hear that many patent offices have extended certain patent prosecution deadlines. For example, the U.S. Patent Office has extended various patent deadlines until June 1, 2020 and the European Patent Office …›
By: Nicholas J. Spiliotes, Charles L. Capito, Panagiotis C. Bayz, Joseph A. Benkert, Amy S. Josselyn, and Jonathan M. Babcock
The U.S. Department of the Treasury announced that on Friday, May 1, 2020, the first-ever filing fees will become effective for joint voluntary notices submitted to the Committee on Foreign Investment in the United States (CFIUS). Notices submitted to CFIUS on or after May …›
By: Erin M. Bosman, Julie Y. Park, and Bethany J. Hills
FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more …›
As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern. Last week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for …›
By: Bethany J. Hills, Julie Y. Park, Anastasiya V. Menshikova, and Hilary R. Hoffman
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel …›
By: Miriam H. Wugmeister, Lloyd W. Aubry, Jr., and Eric Gebert
As employers begin considering return to work strategies, many are wondering whether they should permit or require individuals to wear facemasks at work. It may be surprising to many companies, but the Occupational Safety and Health Administration (“OSHA”) has published detailed standards and guidance …›
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