MoFo Life Sciences

June 30, 2023 - Agtech, United States, European Union, Regulatory
The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?
By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.
After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post. Here, we provide a brief overview of U.S. regulation of
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June 21, 2023 - Litigation, Healthcare, United States
Supreme Court: U.S. Government Has Broad Discretion to Dismiss False Claims Act Suits
By: J. Alex Ward, Demme Doufekias, Adam L. Braverman and Joseph R. Palmore
On June 16, 2023, the Supreme Court issued a decision in United States ex rel. Polansky v. Executive Health Resources, Inc. , giving the United States government broad power to dismiss qui tam FCA lawsuits even when it has initially declined to intervene. We have
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June 16, 2023 - Intellectual Property, Litigation, United States, Biotech, Pharma
Five Questions after Amgen v. Sanofi
By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.
The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants. Here are five areas to watch: 1. What is the impact on
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June 13, 2023 - Intellectual Property, United States
USPTO Releases 2022‒2026 Strategic Plan
By: Kelsey J. Roberts Kingman Ph.D. and Meghan McLean Poon Ph.D.
Last week, the USPTO released its 2022‒2026 Strategic Plan. The Strategic Plan outlines the USPTO’s overarching goals for the coming years. How are these initiatives likely to affect patent applicants and owners? 1. Improving patent application pendency The USPTO is continuing its efforts to
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June 12, 2023 - Intellectual Property, Litigation, Digital Health, Healthcare, United States
United States Supreme Court: Look to Defendant's Subjective Beliefs to Decide Whether It "Knowingly" Submitted False Claim
By: Joseph R. Palmore, J. Alex Ward and Adam L. Braverman
On June 1, 2023, the Supreme Court issued a decision in United States ex rel. Schutte v. SuperValu, Inc. , clarifying when a defendant “knowingly” submits a false claim for payment under the False Claims Act (FCA). The Court held that a defendant that submits
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May 25, 2023 - Announcements, Healthcare, Regulatory, United States
New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways
By: Wendy C. Chow
On May 3, 2023, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions”
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May 11, 2023 - AI + Robotics, FDA, Regulatory, Digital Health, United States
FDA on Use of AI/ML in Drug Development: Five Key Takeaways
By: Brigid DeCoursey Bondoc
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “ Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products .” The discussion paper aims to facilitate a discussion
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May 10, 2023 - Agtech, Intellectual Property, Licensing + Commercial, United States
IP Implications of USDA Research Collaborations
By: Tina D. Reynolds, Liz Freeman Rosenzweig Ph.D. and Bu Yin Ph.D.
Many stakeholders in the AgTech industry are interested in collaborating with or obtaining funding from the United States Department of Agriculture (USDA), but are unsure what implications such collaborations may have on their intellectual property (IP) obligations, opportunities, and strategy. Here, we summarize key
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May 03, 2023 - Announcements, Healthcare, Litigation, Regulatory, United States, FDA
FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims
By: Brigid DeCoursey Bondoc and Claudia M. Vetesi
On April 13, 2023, the Federal Trade Commission (FTC) sent approximately 670 notices of penalty offenses to various companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional foods, placing them on notice that they could incur significant civil penalties
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April 26, 2023 - AI + Robotics, FDA, Medical Devices + Diagnostics, Regulatory, United States
FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions
By: Brigid DeCoursey Bondoc and Brandy A. Guarda
On April 3, 2023, FDA released the draft guidance titled “ Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions ” (hereinafter “draft guidance”) proposing an approach to support iterative improvement through modifications to a machine
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Topic Archives: United States

The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?

By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.

Supreme Court: U.S. Government Has Broad Discretion to Dismiss False Claims Act Suits

By: J. Alex Ward, Demme Doufekias, Adam L. Braverman and Joseph R. Palmore

Five Questions after Amgen v. Sanofi

By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.

USPTO Releases 2022‒2026 Strategic Plan

By: Kelsey J. Roberts Kingman Ph.D. and Meghan McLean Poon Ph.D.

United States Supreme Court: Look to Defendant's Subjective Beliefs to Decide Whether It "Knowingly" Submitted False Claim

By: Joseph R. Palmore, J. Alex Ward and Adam L. Braverman

New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways

By: Wendy C. Chow

FDA on Use of AI/ML in Drug Development: Five Key Takeaways

By: Brigid DeCoursey Bondoc

IP Implications of USDA Research Collaborations

By: Tina D. Reynolds, Liz Freeman Rosenzweig Ph.D. and Bu Yin Ph.D.

FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims

By: Brigid DeCoursey Bondoc and Claudia M. Vetesi

FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

By: Brigid DeCoursey Bondoc and Brandy A. Guarda