How To Operate In The AI Compliance Vacuum
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.
- The use of artificial intelligence (AI) in healthcare has grown significantly in recent years. The global market estimate for AI in healthcare was over $15 billion in 2022, and that market is expected to grow exponentially. The COVID-19 pandemic accelerated this global demand 167%... ›
- - United States, FDA
FDA's Lab-Developed Test Rule May Bring Historic Challenges
By: Stacy Cline Amin
At the end of September, the U.S. Food and Drug Administration released a proposed rule that sounds mundane — its plan to regulate laboratory-developed tests — but was the administrative law equivalent of Taylor Swift announcing her Eras tour. Read the full blog.... › 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.,... ›USPTO Enablement Guidelines After Amgen v. Sanofi
By: Karen G Potter Ph.D., Meghan McLean Poon Ph.D. and Kelsey J. Roberts Kingman Ph.D.
On January 10, 2024, the USPTO released new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al. The guidelines clarify that the USPTO’s framework for assessing enablement is... ›Biden Administration Proposes Novel Use of Price as Justification for Agency Exercise of March-In Rights for Government-Funded Inventions
By: Tina D. Reynolds and Daisuke Alexander Gatanaga
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 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... ›- - 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... › 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, 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... ›