Announcements

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.

April 21, 2023 - Intellectual Property, Litigation, Pharma, Biotech, United States
Is DOE Now in Vogue?
By: Matthew A. Chivvis and Qiwen Zhong Ph.D.
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
... ›
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 Ph.D.
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,
... ›
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 Ph.D., Deborah A. Pohlmann Ph.D. 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
... ›
April 03, 2023 - Bioinformatics, Healthcare, Litigation, Privacy + Data Security, United States
Applying BIPA’s Health Care Exemption to Virtual Try-On Technologies in Light of Dior Dismissal
By: Melissa M. Crespo and Morgan O'Neill Mitruka
A recent putative class action case against luxury brand Christian Dior sheds light on the health care exemption in the Illinois Biometric Privacy Act (BIPA). In Delma Warmack-Stillwell v. Christian Dior Inc ., the plaintiff alleged Dior’s virtual try-on feature for sunglasses violated BIPA’s
... ›
March 30, 2023 - COVID-19, FDA, Healthcare, Regulatory, Digital Health, Medical Devices + Diagnostics, United States
FDA Issues Final Transition Guidances for COVID-19 Devices
By: Brigid DeCoursey Bondoc
This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1)
... ›
March 29, 2023 - Digital Health, FDA, Healthcare, Regulatory, United States
FDA Publishes Digital Health Technology Framework
By: Brigid DeCoursey Bondoc
On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “ Framework for the Use of Digital Health Technologies in Drug and Biological Product Development ” (Framework) by the Center for Drug Evaluation and Research (CDER) and the
... ›
March 28, 2023 - United States, Asia, European Union, Litigation, Intellectual Property
Recent Updates on Use of Post-filing Data as Evidence to Support Patentability
By: Liz Newman Ph.D. and Karen G Potter Ph.D.
In a “first to file” patent system as exists in the United States and in most countries throughout the world, timing of when to file a patent application is critically important but must be balanced by patentability requirements such as nonobviousness and enablement. This
... ›
March 27, 2023 - FDA, Regulatory, Litigation, Product Liability + Class Action, United States
FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives
By: Brigid DeCoursey Bondoc, William F. Tarantino and Claudia M. Vetesi
Update 5/1/2023 : FDA is reopening the comment period on the draft guidance published February 23, 2023 (88 FR 11449); the new deadline for comments is July 31, 2023. In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,”
... ›
March 24, 2023 - Pharma, Healthcare, United States
CMS Announces Part B Prescription Drugs with Lower Coinsurance Amounts for Q2 2023
The Inflation Reduction Act of 2022 requires drug companies to pay rebates to Medicare when prescription drug prices increase faster than the rate of inflation for certain drugs. This inflation rebate applies to Medicare Part B rebatable drugs, which are single-source drugs and biological
... ›
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
... ›