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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.

December 04, 2023 - Healthcare
Digitalization of German Healthcare System to Receive Legislative Boost in 2024
By: Robert Grohmann and Philip Radlanski
It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German population. At the end of August, the current German Government agreed
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December 04, 2023 - United States, FDA
Comment on Morphing U.S. Biotechnology Regulations
By: Michael Ward Ph.D., Stacy Cline Amin, Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig Ph.D. and Owen Grayson Hosseinzadeh
The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the opportunity to influence government policy regarding federal and international biotechnology regulations that will affect anyone sourcing
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November 14, 2023 - Licensing + Commercial
Patent Prosecution Strategies to Avoid Pitfalls in Post-grant Proceedings
By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.
On October 26, 2023, the U.S. Court of Appeals for the Federal Circuit in Monterey Research, LLC v. STMicroelectronics, Inc. [1] affirmed a pair of final written decisions at the Patent Trial and Appeal Board (PTAB)[2] that invalidated challenged patent claims owned by Monterey
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October 25, 2023 - FDA, United States
Golden State Crackdown—Unpacking California’s Landmark Food Safety Act
By: Claudia M. Vetesi, Stacy Cline Amin, Brigid DeCoursey Bondoc, Lena Gankin and Marcus Grimes
Update: On November 2, FDA issued a proposed rule to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. FDA is basing the proposed rule on studies it conducted that FDA says demonstrate adverse health effects in animals approximating real-world human
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October 24, 2023 - FDA, Healthcare
New FDA Guidance on COVID-19 Vaccines
By: Brigid DeCoursey Bondoc and Stacy Cline Amin
Last week, the U.S. Food and Drug Administration (FDA) published its new guidance on the Development and Licensure of Vaccines to Prevent COVID-19 (the “Guidance”). FDA provided a preview of a new COVID-19 vaccines guidance back in March 2023 , when it announced that
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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 Matthew 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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October 23, 2023 - Intellectual Property, Regulatory
Top 10 Considerations in Licensing Cleantech Innovations
By: Matthew A. Ferry, Anita Choi and Emily Jane Roberts Ph.D.
Spurred by both planetary and economic needs, the industry commonly referred to as “cleantech”—short for “clean technology”—has been on the rise. Current estimates predict clean energy technologies could dominate oil and gas by as early as 2030 (Global cleantech market size by country 2030 |
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October 11, 2023 - FDA
FDA Issues New Draft Guidance on Demonstrating Substantial Evidence of Effectiveness with One Clinical Investigation and Confirmatory Evidence
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. The draft guidance expands on Section 115 of the Food and Drug Administration Modernization
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October 11, 2023 - Intellectual Property
Retaining Your Patent Priority Date in Europe: Formal Priority Given a Rebuttable Presumption in Favor of Applicant/Patentee
By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.
On October 10, 2023, the Enlarged Board of Appeal of the European Patent Office (EPO) issued a groundbreaking decision that reflects a major change in how formal priority is assessed at the EPO during examination and in post-grant opposition proceedings, to the benefit of
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September 15, 2023 - Litigation, Intellectual Property, United States
Patent Term Adjustment Takes a Hit in Cellect Decision
By: Meghan McLean Poon Ph.D. and Zachary A. Nora Ph.D.
Recently, the Federal Circuit addressed a significant issue of first impression with respect to obviousness-type double patenting (ODP), holding that ODP applies to patent claims that claim priority to the same application and have different expiration dates due only to patent term adjustment (PTA).
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Welcome to Mofo Life Sciences

Digitalization of German Healthcare System to Receive Legislative Boost in 2024

By: Robert Grohmann and Philip Radlanski

Comment on Morphing U.S. Biotechnology Regulations

By: Michael Ward Ph.D., Stacy Cline Amin, Brigid DeCoursey Bondoc, Liz Freeman Rosenzweig Ph.D. and Owen Grayson Hosseinzadeh

Patent Prosecution Strategies to Avoid Pitfalls in Post-grant Proceedings

By: Ashley E. Sperbeck and Mark D. McBriar Ph.D.

Golden State Crackdown—Unpacking California’s Landmark Food Safety Act

By: Claudia M. Vetesi, Stacy Cline Amin, Brigid DeCoursey Bondoc, Lena Gankin and Marcus Grimes

New FDA Guidance on COVID-19 Vaccines

By: Brigid DeCoursey Bondoc and Stacy Cline Amin

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

By: Wolfgang Schönig and Matthew Karlyn

Top 10 Considerations in Licensing Cleantech Innovations

By: Matthew A. Ferry, Anita Choi and Emily Jane Roberts Ph.D.

FDA Issues New Draft Guidance on Demonstrating Substantial Evidence of Effectiveness with One Clinical Investigation and Confirmatory Evidence

By: Stacy Cline Amin and Brigid DeCoursey Bondoc

Retaining Your Patent Priority Date in Europe: Formal Priority Given a Rebuttable Presumption in Favor of Applicant/Patentee

By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.

Patent Term Adjustment Takes a Hit in Cellect Decision

By: Meghan McLean Poon Ph.D. and Zachary A. Nora Ph.D.