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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

May 14, 2020 - United States, FDA, COVID-19, Intellectual Property
Free Prioritized Examination for COVID-19 Patent Applications
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
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May 12, 2020 - AI + Robotics, United States, Intellectual Property
The USPTO Says No to Naming AI as a Patent Inventor
By: Anna Yuan and Karen G Potter Ph.D.
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
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May 08, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action
COVID-19 Alert: FDA updates antibody test policy
By: 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
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May 06, 2020 - United States, COVID-19, United Kingdom, European Union, Intellectual Property
Patent Offices Extend Certain Deadlines, but Proceed With Caution
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
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May 04, 2020 - United States, CFIUS
CFIUS Filing Fees Become Reality
By: Charles L. Capito, Joseph A. Benkert 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
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May 01, 2020 - United States, FDA, COVID-19, Product Liability + Class Action
COVID-19 UPDATE: FDA AUTHORIZES FIRST AT-HOME COLLECTION KIT
By: Erin M. Bosman and Julie Y. Park
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
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May 01, 2020 - COVID-19, Asia
COVID-19: Excusing Performance Using Force Majeure Clauses Under Japanese Law
By: Chie Yakura and Yukihiro Terazawa
On April 7, 2020, Prime Minister Shinzo Abe declared a state of emergency in response to the spread of COVID19. As a result, an increasing number of businesses are unable to continue operating and are having difficulty performing their contractual obligations. Their business partners
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April 28, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Healthcare
Mental Health during COVID-19: FDA Waivers for Digital Health Devices
By: Jean Nguyen Ph.D.
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 treating
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April 22, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
FDA Uses EUAs Broadly In The Fight Against Covid-19
By: Julie Y. Park
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
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April 21, 2020 - FDA, COVID-19, Product Liability + Class Action, Healthcare
HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation
By: Erin M. Bosman and Julie Y. Park
On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19. The PREP Act grants tort
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