MoFo Life Sciences

August 02, 2024 - Regulatory, Biotech
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
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October 24, 2023 - 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
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July 20, 2023 - Intellectual Property, Litigation, Pharma, Biotech, United States
Obviousness in Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms of Action
By: Mark D. McBriar Ph.D., Bu Yin Ph.D. and Ashley E. Sperbeck
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
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July 10, 2023 - Cell + Gene Therapy, Biotech, Intellectual Property, Litigation, Pharma
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
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June 20, 2023 - Biotech, Pharma, Intellectual Property, Litigation, Cell + Gene Therapy
Practical Strategies for Protecting Innovations Under the Doctrine of Equivalents
By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin 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
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June 16, 2023 - Intellectual Property, Litigation, United States, Biotech, Pharma
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
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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
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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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October 28, 2022 - United States, Healthcare, Regulatory, Digital Health, Biotech
U.S. Government Launches Billion-Dollar Biomedical Agency
By: Tina D. Reynolds
As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). Authorized by Congress in March 2022, the new
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May 12, 2022 - United States, Biotech, Healthcare, Intellectual Property, Cell + Gene Therapy
The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022
By: Liz Newman Ph.D. and Karen G Potter Ph.D.
Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in patent applications are compulsory to satisfy patent office
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Topic Archives: Biotech

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.

MoFo and Bayer Co.Lab Kick-Off Partnership to Advance Cell and Gene Therapy Innovation

By: Wolfgang Schönig and Matt Karlyn

Obviousness in Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms of Action

By: Mark D. McBriar Ph.D., Bu Yin Ph.D. and Ashley E. Sperbeck

Mitigating Patent Risk in Gene Therapy Development

By: Daralyn Durie, Janet Xiao Ph.D. and Katherine E. McNutt

Practical Strategies for Protecting Innovations Under the Doctrine of Equivalents

By: Kelsey J. Roberts Kingman Ph.D. and Bu Yin Ph.D.

Five Questions after Amgen v. Sanofi

By: Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.

Is DOE Now in Vogue?

By: Matthew A. Chivvis and Qiwen Zhong Ph.D.

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.

U.S. Government Launches Billion-Dollar Biomedical Agency

By: Tina D. Reynolds

The “Big Bang” for Sequence Listings: New Requirements in Place July 1, 2022

By: Liz Newman Ph.D. and Karen G Potter Ph.D.