MoFo Life Sciences

October 22, 2020 - AI + Robotics, Licensing + Commercial, FDA, COVID-19, Intellectual Property, Privacy + Data Security
Podcast: Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations
By: Jean Nguyen, Kristen J. Mathews, Matthew Karlyn and Michael Ward Ph.D.
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
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October 15, 2020 - United States, FDA, Regulatory
Bill Proposes Continuation of FDA Rare Pediatric Disease Priority Review Vouchers
Morrison & Foerster Research Analyst Christine Lentz contributed to the writing of this article. The House of Representatives recently passed a proposed bill that encourages treatments for rare pediatric diseases by prolonging the authority of Health and Human Services to issue priority review vouchers.
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October 13, 2020 - Licensing + Commercial, FDA, COVID-19, Intellectual Property, Privacy + Data Security
Podcast: Unpacking the Science and Legal Considerations of COVID-19 Testing
By: Matthew Karlyn, Kristen J. Mathews and Michael Ward Ph.D.
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
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October 07, 2020 - United States, FDA, Litigation, Intellectual Property
Navigating The CRISPR Patent Landscape and Understanding The FDA and its Process
By: Michael Ward Ph.D.
“What can be a better day to talk about the complex CRISPR/Cas9 patent landscape than the big day that the Nobel Prize was awarded to pioneers of this revolutionary technology? The story of the continuing dispute on the fundamental CRISPR/Cas9 patents offers a lot
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September 22, 2020 - Licensing + Commercial, United States, FDA, Startup, Data Analytics, Intellectual Property
GSAS Harvard Biotech Club and Morrison & Foerster’s Patent Course Off to a Roaring Start!
By: Michael Ward Ph.D., Matthew Karlyn, Janet Xiao, Matthew A. Chivvis, Jie Zhou, Anna Yuan and Jillian A. Pesin-Fulop
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
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September 18, 2020 - United States, FDA, COVID-19, Product Liability + Class Action, Healthcare
First Decisions Limit PREP Act Immunity in Coronavirus Context
By: Erin M. Bosman and Julie Y. Park
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
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September 09, 2020 - United States, FDA, Biotech, Healthcare, Pharma, Intellectual Property, Cell + Gene Therapy
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
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July 08, 2020 - United States, FDA, COVID-19
FDA Establishes Clear Requirements for COVID-19 Vaccine
By: Matthew Karlyn
On June 30, 2020, the U.S. Food and Drug Administration released its much anticipated guidance on the licensure of COVID-19 (SARS-CoV-2) vaccines. According to the New York Times , there are currently over 145 COVID-19 vaccines in development across the globe with 20 in
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June 08, 2020 - FDA, COVID-19, Product Liability + Class Action
How FDA Is Monitoring the COVID-19 Product Market
By: Erin M. Bosman and Julie Y. Park
FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products, including drugs, test kits, and PPE sold online with unproven claims. It is working
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May 26, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Healthcare
FDA Signals Flexibility with COVID-19 Tests
By: 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
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Topic Archives: FDA

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

By: Jean Nguyen, Kristen J. Mathews, Matthew Karlyn and Michael Ward Ph.D.

Bill Proposes Continuation of FDA Rare Pediatric Disease Priority Review Vouchers

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

By: Matthew Karlyn, Kristen J. Mathews and Michael Ward Ph.D.

Navigating The CRISPR Patent Landscape and Understanding The FDA and its Process

By: Michael Ward Ph.D.

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

By: Michael Ward Ph.D., Matthew Karlyn, Janet Xiao, Matthew A. Chivvis, Jie Zhou, Anna Yuan and Jillian A. Pesin-Fulop

First Decisions Limit PREP Act Immunity in Coronavirus Context

By: Erin M. Bosman and Julie Y. Park

Pediatric Exclusivity for Biologics

FDA Establishes Clear Requirements for COVID-19 Vaccine

By: Matthew Karlyn

How FDA Is Monitoring the COVID-19 Product Market

By: Erin M. Bosman and Julie Y. Park

FDA Signals Flexibility with COVID-19 Tests

By: Erin M. Bosman and Julie Y. Park