An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants
- *UPDATE DECEMBER 19, 2024:* USDA-APHIS RESTORES LEGACY PERMITTING AND “AM I REGULATED” PROCESSES FOR GE ORGANISMS USDA Animal and Plant Health Inspection Service (APHIS) announced on December 19, 2024, that it is restoring its legacy framework for permitting and deregulation of genetically engineered (GE)... ›
Life Sciences MoForum 2024 | San Diego: The State of the Life Sciences Industry
By: Erin M. Bosman, Jim Krenn and Karen G Potter Ph.D.
On September 24, 2024, Morrison Foerster hosted another installment of its premier MoForum series at the firm’s San Diego office. Mayor Todd Gloria shared his vision for San Diego’s commitment to the industry. The event featured expert panel discussions on cutting-edge scientific developments, market... ›Microbes, Biotech Investigations, and Impacts: Midsummer Regulatory Updates from USDA-APHIS
By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.
After overhauling its biotechnology regulations for plants developed using genetic engineering , the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its regulatory procedures, both by opening the door to major regulatory changes for microbes developed through... ›- - Biotech
MoFo and Bayer Co.Lab Kick-Off Partnership to Advance Cell and Gene Therapy Innovation
By: Wolfgang Schönig and Matt Karlyn
Morrison Foerster and Bayer Co.Lab are partnering to offer legal programming and support to the next generation of cell and gene therapy (CGT) startups. Bayer Co.Lab is a growing global network of life science incubators that provides entrepreneurs and early-stage companies access to state-of-the-art... › Obviousness in Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms of Action
By: Mark D. McBriar Ph.D.
Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. [1] The Supreme Court emphasized “the need for caution in granting a patent based on the... ›Mitigating Patent Risk in Gene Therapy Development
By: Daralyn Durie, Janet Xiao Ph.D. and Katherine E. McNutt
This article was first published by IAM on June 2, 2023 in its Special Report 2023 Q2: New Frontiers of Pharma and Biotech IP Strategy. Daralyn Durie, Janet Xiao and Katherine McNutt of Morrison Foerster explore strategies to reduce the threat of infringement liability... ›Practical Strategies for Protecting Innovations Under the Doctrine of Equivalents
By: Kelsey J. Roberts Kingman Ph.D.
Recent case law highlights enablement and written description challenges for genus claims.[1] Given the challenges of enforcing genus claims, the doctrine of equivalents (DOE) may become a more important tool for patentees when literal infringement is unavailable. As discussed below, the outlook for successful... ›Five Questions after Amgen v. Sanofi
By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.
The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants. Here are five areas to watch: 1. What is the impact on... ›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... ›China Eyes New Export Controls for Life Sciences Technologies
By: Tyler Xiu, 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... ›