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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 23, 2023 - Biotech, Pharma, Licensing + Commercial, Asia, Regulatory
China Eyes New Export Controls for Life Sciences Technologies
By: Tyler Xiu, Bu Yin Ph.D., Gordon A. Milner, Chuan Sun and Janet Xiao Ph.D.
China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“ MOFCOM ”) issued the proposed amendment to the country’s Catalogue of Technologies Prohibited and Restricted for Export (the
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March 21, 2023 - European Union, FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force
By: Robert Grohmann
On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “ Regulation ”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions
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March 15, 2023 - Agtech, Intellectual Property, United States
USDA PVP Office Waives Deposit Requirement for Asexually Reproduced Plants
By: Edith A. Pierre-Jerome Ph.D., Liz Freeman Rosenzweig Ph.D. and Cory Ellison Ph.D.
The U.S. Department of Agriculture (USDA) Plant Variety Protection Office (PVPO) has waived the deposit requirement for asexually reproduced plants until further notice due to “continued and ongoing technical challenges and infeasibilities.” The announcement specified that any future requirements for a deposit will not
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March 13, 2023 - Healthcare, Litigation, Intellectual Property, United States
Don’t Cry Over Spilled Milk: Federal Circuit Finds Milk Vitamin Patent Invalid
By: Meghan McLean Poon Ph.D.
In ChromaDex Inc. v. Elysium Health Inc. ,[1] the Federal Circuit found U.S. Patent No. 8,197,807 (the “’807 patent”), which is directed to a dietary supplement comprising an isolated vitamin, invalid for lack of subject matter eligibility under 35 U.S.C. § 101. ChromaDex, a
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March 10, 2023 - Agtech, Intellectual Property, United States
USDA and USPTO Promoting Fair Competition and Innovation in the Seed Marketplace
By: Michael Ward Ph.D. and Claire L. Bendix Ph.D.
Update : USDA announced on March 23, 2023 that the Interagency Working Group on Competition and Intellectual Property in Seeds and Other Agricultural Inputs was officially launched. On March 6, 2023, the U.S. Department of Agriculture (USDA) released its report on “ More and
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March 01, 2023 - Healthcare, Pharma, Regulatory, Litigation, United States
States Extend Scope of Regulatory Oversight of Health Care Entities
The proliferation of private investor-backed management of health care practices continues to draw scrutiny from regulators into the impact on patient care, health care costs, and access to services. State regulators play a key role in monitoring and challenging anticompetitive behavior at the local
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February 28, 2023 - Healthcare, Pharma, Litigation, Regulatory, United States
CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program
The Inflation Reduction Act of 2022 (IRA) was signed into law on August 16, 2022 and includes several provisions to lower prescription drug costs for Medicare beneficiaries and reduce drug spending by the federal government. One provision of the IRA requires drug manufacturers to
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February 16, 2023 - COVID-19, United States, FDA, Medical Devices + Diagnostics, Healthcare, Pharma
Ending the COVID-19 Public Health Emergency – What Happens Next
The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023. COVID-19 EUA medical products and policies As FDA has clarified in its draft transition guidance for medical devices
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February 08, 2023 - FDA, Pharma, Medical Devices + Diagnostics, Rare Disease, United States
FDORA Passage Brings Significant Changes to FDA’s Drug, Device, and Cosmetic Authorities
By: Brigid DeCoursey Bondoc
The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug, and Cosmetic Act (FDCA) governing drugs, medical
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February 08, 2023 - Privacy + Data Security, Pharma, Healthcare, United States, Digital Health
FTC Brings First Enforcement Action of the Health Breach Notification Rule
By: Melissa M. Crespo
The Federal Trade Commission (FTC) has enforced its Health Breach Notification Rule (the “HBNR”) for the first time since it was enacted in 2009. On February 1, the FTC announced a first-of-its-kind proposed order (the “Order”) with digital health platform GoodRx Holdings Inc. (“GoodRx”),
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