MoFo Life Sciences

March 15, 2023 - Agtech, Intellectual Property, United States
USDA PVP Office Waives Deposit Requirement for Asexually Reproduced Plants
By: Edith A. Pierre-Jerome, Liz Freeman Rosenzweig and Cory Ellison
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 and Josephine A. Garban
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 R. Ward and Claire L. Bendix
On March 6, 2023, the U.S. Department of Agriculture (USDA) released its report on “ More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs ,” which was prepared in consultation with the U.S. Patent and Trademark
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March 01, 2023 - Healthcare, Pharma, Regulatory, Litigation, United States
States Extend Scope of Regulatory Oversight of Health Care Entities
By: Wendy C. Chow and Rachel Park
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
By: Wendy C. Chow and Rachel Park
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
By: Stacy Cline Amin, Wendy C. Chow and Keunbong (KB) Do
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 and Rachel Park
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 and Libby Strichartz
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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February 07, 2023 - FDA, Regulatory, Pharma, Healthcare, United States
Supreme Court Denies Review of Cost Sharing Assistance Program
By: Stacy Cline Amin, Adam L. Braverman, Wendy C. Chow, Will Baker and Seth W. Lloyd
The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible Medicare patients who need tafamidis, the only approved drug by the Food
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February 06, 2023 - Healthcare, Litigation, Antitrust, United States
DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing
By: Alexander Okuliar, Lisa M. Phelan, Joseph Charles Folio III, Margaret A. Webb and Jamis Barcott
On February 2, 2023, the Principal Deputy Assistant Attorney General for the U.S. Department of Justice’s (DOJ) Antitrust Division, Doha Mekki, announced that the DOJ was withdrawing three policy statements outlining safe harbors for information sharing in the healthcare industry, and suggested that DOJ’s
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Topic Archives: United States

USDA PVP Office Waives Deposit Requirement for Asexually Reproduced Plants

By: Edith A. Pierre-Jerome, Liz Freeman Rosenzweig and Cory Ellison

Don’t Cry Over Spilled Milk: Federal Circuit Finds Milk Vitamin Patent Invalid

By: Meghan McLean Poon and Josephine A. Garban

USDA and USPTO Promoting Fair Competition and Innovation in the Seed Marketplace

By: Michael R. Ward and Claire L. Bendix

States Extend Scope of Regulatory Oversight of Health Care Entities

By: Wendy C. Chow and Rachel Park

CMS Releases Guidance on the Medicare Prescription Drug Inflation Rebate Program

By: Wendy C. Chow and Rachel Park

Ending the COVID-19 Public Health Emergency – What Happens Next

By: Stacy Cline Amin, Wendy C. Chow and Keunbong (KB) Do

FDORA Passage Brings Significant Changes to FDA’s Drug, Device, and Cosmetic Authorities

By: Brigid DeCoursey Bondoc and Rachel Park

FTC Brings First Enforcement Action of the Health Breach Notification Rule

By: Melissa M. Crespo and Libby Strichartz

Supreme Court Denies Review of Cost Sharing Assistance Program

By: Stacy Cline Amin, Adam L. Braverman, Wendy C. Chow, Will Baker and Seth W. Lloyd

DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing

By: Alexander Okuliar, Lisa M. Phelan, Joseph Charles Folio III, Margaret A. Webb and Jamis Barcott