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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.

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, 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
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 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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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: 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.
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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August 29, 2023 - Intellectual Property, Medical Devices + Diagnostics, United States
A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States
By: Michelle Celine Bradley Ph.D. and John D Chapman Ph.D.
Should the recent bill entitled the Patent Eligibility Restoration Act of 2023 (PERA) become law, it would override the existing jurisprudence and redefine which inventions are eligible for patenting under 35 U.S.C. § 101. By way of the Patent Act of 1952, the United
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August 14, 2023 - Intellectual Property, United States
Biden Executive Order Has Potential to Discourage U.S. Company Participation in Federal Research
By: Tina D. Reynolds
A new Biden administration Executive Order proposes to enforce more rigorously U.S. manufacturing requirements attendant to federally funded inventions. While the aim of the Executive Order is to support domestic manufacturing and jobs, the policy could have the unintended effect of discouraging U.S. company
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Welcome to Mofo Life Sciences

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, Brigid DeCoursey Bondoc, Lena Gankin and Marcus Grimes

New FDA Guidance on COVID-19 Vaccines

By: Brigid DeCoursey Bondoc

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

By: Wolfgang Schönig and Matt 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: 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.

A Glimmer of Hope for Simplified Patenting of Medical Diagnostics in the United States

By: Michelle Celine Bradley Ph.D. and John D Chapman Ph.D.

Biden Executive Order Has Potential to Discourage U.S. Company Participation in Federal Research

By: Tina D. Reynolds