Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express
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.
- 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... ›
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... ›- - Agtech
CRISPR’s Next 10 Years: From Lab To Plate?
By: Michael Ward Ph.D. and Sarah E. Bloch Ph.D.
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... › IN VINEIS VERITAS: NO SOUR GRAPES AS EGYPTIAN COURT ORDERS REMOVAL OF ILLEGAL VINES
By: Liz Freeman Rosenzweig Ph.D.
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... ›EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)
By: 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... ›FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests
By: Stacy Cline Amin
Lindy Pittman, Summer Associate in Washington, D.C., contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions... ›EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 2 OF 3)
By: Wolfgang Schönig and Robert Grohmann
Research assistant Nicole Gebert contributed to this article. After having discussed the general purpose and background of the IVDR, the new definition of IVDs, and the conformity assessment in light of the new risk classification as well as the role of notified bodies in... ›EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 1 OF 3)
By: Wolfgang Schönig and Robert Grohmann
Research assistant Nicole Gebert contributed to this article. In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public... ›Senators Call for Report on State of Psychedelic Research
By: Stacy Cline Amin
Thanks to our Life Sciences Transactions + Licensing Group, including Matthew Karlyn, Mai Zymaris, and Hannah Koo, for contributing to this post. Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and... ›The USPTO Proposes to Establish Permanent Electronic Filing for Patent Term Extension Applications
By: Lisa N. Silverman Ph.D. and Yuying (Kate) You Ph.D.
On May 6, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice, proposing to amend the Rules of Practice in Patent Cases to allow electronic submissions of patent term extension (PTE) applications, interim PTE applications, and any related submissions to the... ›