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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.

September 23, 2022 - Healthcare, FDA, Regulatory, Medical Devices + Diagnostics, United States
New Opportunities for Test Developers: Monkeypox Diagnostics
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post. For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of
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September 12, 2022 - Agtech, Regulatory, United States, Intellectual Property
Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process
By: Liz Freeman Rosenzweig
On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered plant under the SECURE rule. APHIS concluded that a new genetically engineered tomato
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September 09, 2022 - AI + Robotics, Intellectual Property, Medical Devices + Diagnostics
The Importance of Patents for ML-Based Medical Device Inventions
By: Christopher E. Gloria
The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies. The benefits provided by ML are wide-ranging and include providing earlier and more accurate diagnoses
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August 29, 2022 - Intellectual Property, Litigation, FDA, Regulatory
Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements
By: Meghan McLean Poon, Kelsey J Roberts Kingman and Stacy Cline Amin
On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the duties of disclosure and “reasonable inquiry” for proceedings
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August 26, 2022 - Agtech
Partnering with the Alternative Protein Sector
By: Michael R. Ward
Originally published on the Future Food-tech Alternative Proteins website. Morrison Foerster recent participated in the Future Food-Tech Alternative Proteins Summit, where investors, brands, and start-ups met to unlock new partnership opportunities and showcase innovation across plant-based, cell-based, and microbial fermentation. Ahead of the summit,
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August 25, 2022 - Intellectual Property, Litigation, Medical Devices + Diagnostics
Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express
By: Brian R. Matsui
Our Federal Circuitry blog recently discussed the Court's decision in Hologic, Inc. v. Minerva Surgical, Inc. , No. 19-2054. You should read this case if: you want to know how the Federal Circuit will treat assignor estoppel post- Minerva You have to feel a little
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August 25, 2022 - Pharma, Intellectual Property, Litigation
Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation
By: Brian R. Matsui
Our Federal Circuitry blog recently discussed the Court's decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc. , No. 21-2342. You should read this case if: you have an ANDA case involving “actual, real-world evidence” that might conflict with what the ANDA says For our
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August 08, 2022 - Agtech
CRISPR’s Next 10 Years: From Lab To Plate?
By: Michael R. Ward and Sarah E. Bloch
Originally published on the World Agri-tech website. 10 years on from its discovery, CRISPR’s potential for agricultural adaptation has started to gather momentum. In advance of the 2022 World Agri-tech Innovation Summit in London, the industry’s leading specialists weighed in on what new frontiers
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July 18, 2022 - Agtech, Asia, Global, Intellectual Property, Litigation
IN VINEIS VERITAS: NO SOUR GRAPES AS EGYPTIAN COURT ORDERS REMOVAL OF ILLEGAL VINES
By: Hannah Alexandra Bethany Whitmore and Liz Freeman Rosenzweig
The Beni Suef Economic Court in Egypt has recently ordered the removal of nearly five hectares of illegally grown Early Sweet™ grapevines, totaling 9000 vines and associated seedlings. The farm owner did not have a license to grow or commercialize the Early Sweet™ grapes
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June 13, 2022 - Global, FDA, Medical Devices + Diagnostics, Healthcare, Regulatory
EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)
By: Dr. Wolfgang Schönig and Robert Grohmann
Research assistant Nicole Gebert contributed to this article. Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system, conformity assessments, and
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Welcome to Mofo Life Sciences

New Opportunities for Test Developers: Monkeypox Diagnostics

By: Stacy Cline Amin and Brigid DeCoursey Bondoc

Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process

By: Liz Freeman Rosenzweig

The Importance of Patents for ML-Based Medical Device Inventions

By: Christopher E. Gloria

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

By: Meghan McLean Poon, Kelsey J Roberts Kingman and Stacy Cline Amin

Partnering with the Alternative Protein Sector

By: Michael R. Ward

Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express

By: Brian R. Matsui

Last Week in the Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt to Read Anda Application in Isolation

By: Brian R. Matsui

CRISPR’s Next 10 Years: From Lab To Plate?

By: Michael R. Ward and Sarah E. Bloch

IN VINEIS VERITAS: NO SOUR GRAPES AS EGYPTIAN COURT ORDERS REMOVAL OF ILLEGAL VINES

By: Hannah Alexandra Bethany Whitmore and Liz Freeman Rosenzweig

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)

By: Dr. Wolfgang Schönig and Robert Grohmann