MoFo Life Sciences

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, 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 and Karen G Potter
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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December 20, 2022 - European Union, Healthcare, Intellectual Property, Medical Devices + Diagnostics
EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures
By: Wolfgang Schönig and Robert Grohmann
Concerns over possible medical device shortages in the EU have led to two recent developments that will affect the implementation of the Medical Device Regulation [1] ( MDR ) and In Vitro Diagnostic Medical Device Regulation [2] ( IVDR ) : The EU Employment,
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December 14, 2022 - Intellectual Property, Pharma, Regulatory, European Union
Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers
By: Robert Grohmann
In two recent landmark decisions, Novartis v. Abacus (C ‑ 147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union ( CJEU ) strengthened the position of drug manufacturers against repackaging practices of parallel importers. The court held that, based
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April 08, 2022 - Litigation, European Union, Intellectual Property
A Long Courtship for Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About a Unitary Supplementary Protection Certificate Gain Momentum
By: Wolfgang Schönig
After a myriad of challenges , delays , and hurdles, the setting up of the pan-European patent court, the Unified Patent Court (UPC), is finally gaining traction. On January 19, 2022, the UPC came into existence as an international organization. This date marks the
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May 26, 2021 - Litigation, European Union
The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16
By: Wolfgang Schönig
Summary The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in awe. A study recently published by the European Commission (“Commission”)
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Topic Archives: European Union

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, 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 and Karen G Potter

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

EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures

By: Wolfgang Schönig and Robert Grohmann

Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers

By: Robert Grohmann

A Long Courtship for Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About a Unitary Supplementary Protection Certificate Gain Momentum

By: Wolfgang Schönig

The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16

By: Wolfgang Schönig