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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.

March 19, 2024 - COVID-19
Non-Lab Diagnostics: Consumer and User Agreements
By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo
CONSUMER/USER ISSUES[1] The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional health care
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March 18, 2024 - Agtech, European Union, Regulatory
February 2024 Update on Commission Plans Liberalization of New Genomic Techniques (NGTS) in the EU
By: Wolfgang Schönig and Liz Freeman Rosenzweig Ph.D.
Research assistant Sarah Baumann substantially contributed to this article. On February 7, 2024, the European Parliament approved the draft regulating plants obtained by certain new genomic techniques (NGT) like CRISPR-Cas. The members of the European Parliament (MEPs) voted to divide NGT plants into two
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March 15, 2024 - FDA
New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants
By: Brigid DeCoursey Bondoc and Liz Freeman Rosenzweig Ph.D.
On February 22, 2024, FDA released a final guidance [1] detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The new guidance applies FDA’s 1992 policy regarding Foods Derived from New Plant
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February 07, 2024 - United States, Regulatory, Antitrust, FDA
2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies
By: Adam L. Braverman, Kate Driscoll, Nathaniel R. Mendell and Brigid DeCoursey Bondoc
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance and Enforcement Group for a 2024 preview, and here is
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February 07, 2024 - FDA
FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents
By: Lisa N. Silverman Ph.D., Brigid DeCoursey Bondoc and Qiwen Zhong Ph.D.
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November 7, 2023, challenges to more than 100 patent listings by brand
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February 07, 2024 - Regulatory
How To Operate In The AI Compliance Vacuum
By: Brigid DeCoursey Bondoc and Melissa M. Crespo
The use of artificial intelligence (AI) in healthcare has grown significantly in recent years. The global market estimate for AI in healthcare was over $15 billion in 2022, and that market is expected to grow exponentially. The COVID-19 pandemic accelerated this global demand 167%
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February 07, 2024 - United States, FDA
FDA's Lab-Developed Test Rule May Bring Historic Challenges
At the end of September, the U.S. Food and Drug Administration released a proposed rule that sounds mundane — its plan to regulate laboratory-developed tests — but was the administrative law equivalent of Taylor Swift announcing her Eras tour. Read the full blog.
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January 29, 2024 - European Union, United States, Regulatory
New Regulations Rooted in Evidence: Looking Back on How EPA and USDA Updated Engineered Plant Regulations and Labeling in 2023
By: Abby C. Burrus Ph.D., Deborah A. Pohlmann Ph.D., Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc, William F. Tarantino and Michael Ward Ph.D.
Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year. The year 2023 witnessed dramatic shifts in this regulation around the world. Within the U.S.,
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January 12, 2024 - Litigation, United States, Intellectual Property
USPTO Enablement Guidelines After Amgen v. Sanofi
By: Karen G Potter Ph.D., Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.
On January 10, 2024, the USPTO released new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al. The guidelines clarify that the USPTO’s framework for assessing enablement is
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December 22, 2023 - Litigation
Biden Administration Proposes Novel Use of Price as Justification for Agency Exercise of March-In Rights for Government-Funded Inventions
By: Tina D. Reynolds and Daisuke Alexander Gatanaga
Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government “march-in” authority under the Bayh-Dole Act. The
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Welcome to Mofo Life Sciences

Non-Lab Diagnostics: Consumer and User Agreements

By: Brigid DeCoursey Bondoc, Matthew A. Ferry, Matt Karlyn and Hannah Koo

February 2024 Update on Commission Plans Liberalization of New Genomic Techniques (NGTS) in the EU

By: Wolfgang Schönig and Liz Freeman Rosenzweig Ph.D.

New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

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

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

By: Adam L. Braverman, Kate Driscoll, Nathaniel R. Mendell and Brigid DeCoursey Bondoc

FTC Alleges Improper Orange Book Listing of Drug Delivery Device Patents

By: Lisa N. Silverman Ph.D., Brigid DeCoursey Bondoc and Qiwen Zhong Ph.D.

How To Operate In The AI Compliance Vacuum

By: Brigid DeCoursey Bondoc and Melissa M. Crespo

FDA's Lab-Developed Test Rule May Bring Historic Challenges

New Regulations Rooted in Evidence: Looking Back on How EPA and USDA Updated Engineered Plant Regulations and Labeling in 2023

By: Abby C. Burrus Ph.D., Deborah A. Pohlmann Ph.D., Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc, William F. Tarantino and Michael Ward Ph.D.

USPTO Enablement Guidelines After Amgen v. Sanofi

By: Karen G Potter Ph.D., Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.

Biden Administration Proposes Novel Use of Price as Justification for Agency Exercise of March-In Rights for Government-Funded Inventions

By: Tina D. Reynolds and Daisuke Alexander Gatanaga