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Welcome to Mofo Life Sciences

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 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 and Bu Yin
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 27, 2023 - AI + Robotics, Licensing + Commercial, Regulatory, Intellectual Property
10 Considerations When Licensing AI for Drug Discovery
By: Stephanie Lynn Sharron, Wolfgang Schönig and Annalisa Elizabeth Cooper
While the traditional process of discovering a new drug is long and expensive, artificial intelligence drug development platforms can help reduce time and money by efficiently analyzing vast data sets within the drug discovery process. Researchers can use such AI platforms for identifying new
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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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April 25, 2023 - European Union, Regulatory, Pharma, Healthcare, Privacy + Data Security
Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation
By: Robert Grohmann, Alex van der Wolk and Marta Hovanesian
Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a Clinical Trial from Turning into a Criminal Trial , the United
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April 21, 2023 - Intellectual Property, Litigation, Pharma, Biotech, United States
Is DOE Now in Vogue?
By: Matthew A. Chivvis and Qiwen Zhong
On March 27, 2023, the U.S. Supreme Court heard oral arguments in Amgen Inc. v. Sanofi , a closely watched case on the issue of enablement under 35 U.S.C. § 112(a). Though not the main point of contention, the doctrine of equivalents (DOE) was
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April 12, 2023 - Intellectual Property, United States
USPTO to Launch New Patent Issue Procedure on April 18: What You Need to Know
By: Meghan McLean Poon and Stephen Diego Frausto
In a recent press release, the U.S. Patent and Trademark Office (USPTO) announced that, starting on April 18, 2023, the Office would begin issuing electronic patent grants (eGrants) to patent recipients. This process delivers the official copy of patent grants in an electronic format,
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April 10, 2023 - Agtech, Intellectual Property, United States
U.S. Plant Variety Protection Office Invited Comments on UPOV Test Guidelines and Is Aligning Exhibit C Forms with UPOV
By: Claire L. Bendix, Deborah A. Pohlmann and Michael Ward Ph.D.
On April 3, 2023, the U.S. Plant Variety Protection Office (PVPO) held a preparatory session for the International Union for the Protection of New Varieties of Plants (UPOV) Technical Working Party for Vegetables (TWV) and Technical Working Party for Agricultural Crops (TWA) virtual meetings
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