MoFo Life Sciences

September 17, 2024 - European Union
MoForum: Bayer Co.Lab Edition – Charting the Biotech Startup Journey
By: Robert Grohmann and Wolfgang Schönig
On September 12, 2024, Morrison Foerster, in collaboration with Bayer Co.Lab, hosted a pivotal panel discussion under the title “MoForum Charting the Biotech Startup Journey” at Morrison Foerster’s Berlin office. The event provided an in-depth exploration of the biotech startup ecosystem, particularly focusing on
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March 18, 2024 - Agtech, European Union, Regulatory
February 2024 Update on Commission Plans Liberalization of New Genomic Techniques (NGTS) in the EU
By: Wolfgang Schönig and Liz Freeman Rosenzweig Ph.D.
Research assistant Sarah Baumann substantially contributed to this article. On February 7, 2024, the European Parliament approved the draft regulating plants obtained by certain new genomic techniques (NGT) like CRISPR-Cas. The members of the European Parliament (MEPs) voted to divide NGT plants into two
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January 29, 2024 - European Union, United States, Regulatory
New Regulations Rooted in Evidence: Looking Back on How EPA and USDA Updated Engineered Plant Regulations and Labeling in 2023
By: Abby C. Burrus Ph.D., Deborah A. Pohlmann Ph.D., Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc, William F. Tarantino and Michael Ward Ph.D.
Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year. The year 2023 witnessed dramatic shifts in this regulation around the world. Within the U.S.,
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December 22, 2023 - European Union, Asia, Healthcare
Standards for Inventiveness and Disclosure for Antibody Claims Across Jurisdictions
By: Karen G Potter Ph.D., Meghan McLean Poon Ph.D. and Paige Zhang Ph.D.
Standards for patenting antibodies have substantially tightened over the last few years restricting scope of antibody claims—or, in some cases, undermining the validity of granted patents. Most recently, Singapore updated guidelines to add a framework for analysis of antibody patentability. Although not all countries
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June 30, 2023 - Agtech, European Union, Regulatory
Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU
By: Wolfgang Schönig
After undergoing an extensive three-year consultation process, the EU Commission’s proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the “Proposal”) is finally available for consideration (see Proposal ). Although the official presentation is scheduled for July 5, 2023,
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June 30, 2023 - Agtech, United States, European Union, Regulatory
The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?
By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.
After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post. Here, we provide a brief overview of U.S. regulation of
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April 25, 2023 - European Union, Regulatory, Pharma, Healthcare, Privacy + Data Security
Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation
By: Robert Grohmann, Alex van der Wolk and Marta Hovanesian
Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a Clinical Trial from Turning into a Criminal Trial , the United
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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
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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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January 18, 2023 - European Union, Medical Devices + Diagnostics
EU MDR and IVDR Implementation: European Commission Publishes Full Proposal for Amending Transitional Regime
By: Wolfgang Schönig and Robert Grohmann
Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council ( EPSCO ) Meeting, the European Commission ( Commission ) released on January 6, 2023, a proposal ( Proposal ) to amend the transitional regime under the Medical
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Topic Archives: European Union

MoForum: Bayer Co.Lab Edition – Charting the Biotech Startup Journey

By: Robert Grohmann and Wolfgang Schönig

February 2024 Update on Commission Plans Liberalization of New Genomic Techniques (NGTS) in the EU

By: Wolfgang Schönig and Liz Freeman Rosenzweig Ph.D.

New Regulations Rooted in Evidence: Looking Back on How EPA and USDA Updated Engineered Plant Regulations and Labeling in 2023

By: Abby C. Burrus Ph.D., Deborah A. Pohlmann Ph.D., Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc, William F. Tarantino and Michael Ward Ph.D.

Standards for Inventiveness and Disclosure for Antibody Claims Across Jurisdictions

By: Karen G Potter Ph.D., Meghan McLean Poon Ph.D. and Paige Zhang Ph.D.

Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU

By: Wolfgang Schönig

The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?

By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.

Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation

By: Robert Grohmann, Alex van der Wolk and Marta Hovanesian

Recent Updates on Use of Post-filing Data as Evidence to Support Patentability

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

Eu Mdr and Ivdr Implementation: New Transitional Regime Enters Into Force

By: Robert Grohmann

EU MDR and IVDR Implementation: European Commission Publishes Full Proposal for Amending Transitional Regime

By: Wolfgang Schönig and Robert Grohmann