Podcast: Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations

In this second of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and …›

Podcast: Unpacking the Science and Legal Considerations of COVID-19 Testing

In this first of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and …›

GSAS Harvard Biotech Club and Morrison & Foerster’s Patent Course Off to a Roaring Start!

More than 120 life sciences graduate students, post-docs and industry professionals attended the first class of a six part Patent Law Course offered by Morrison & Foerster and the GSAS Harvard Biotech Club on September 16, 2020. The Harvard Biotech Club is a student organization …›

First Decisions Limit PREP Act Immunity in Coronavirus Context

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act …›

Pediatric Exclusivity for Biologics

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights. At the …›

FDA Signals Flexibility with COVID-19 Tests

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 …›