On March 6, 2025, the National Institutes of Health (NIH) announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within its Center for...more
On October 11, 2024, Edwards filed a petition for a writ of certiorari with the U.S. Supreme Court. The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely...more
A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American Medical Association, reviews the history of artificial intelligence (AI) regulation by the U.S. Food...more
Judge Andrews of the District of Delaware recently denied Novartis’s request for a preliminary injunction against MSN Pharmaceuticals. Novartis Pharm. Corp. v. MSN Pharm. Inc., Civil Action No. 20-md-2930-RGA, Dkt. No. 1456...more
On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. ...more
3/25/2024
/ Biotechnology ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Protection ,
National Institute of Health (NIH) ,
Over The Counter Drugs (OTC) ,
Patent Examinations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Prior Art ,
Training Requirements ,
USPTO
In Baxalta Incorporated v. Genentech, Inc., 2022-1461, the Federal Circuit affirmed the district court’s decision granting Genentech’s motion for summary judgment that claims 1-4, 9, and 20 of U.S. Patent No. 7,033,590 (“the...more
The new Post-Prosecution Pilot ("P3") program provides a pathway for patent applicants to make an in-person presentation to a panel of patent examiners as an alternative to existing options for responding to final rejections....more