Biden Administration Proposes Novel Use of Price as Justification for Agency Exercise of March-In Rights for Government-Funded Inventions
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.
- Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government “march-in” authority under the Bayh-Dole Act. The... ›
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... ›Digitalization of German Healthcare System to Receive Legislative Boost in 2024
By: Robert Grohmann
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... ›- - United States, FDA
Comment on Morphing U.S. Biotechnology Regulations
By: Michael Ward Ph.D., 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... › 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... ›- - 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... › - - 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... › - - 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... › 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 |... ›- - 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... ›