On November 18, 2025, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a precedential decision in Duke University, Allergan Sales, LLC v. Sandoz Inc., holding claim 30 of U.S. Patent No. 9,579,270...more
12/11/2025
/ Appeals ,
Biotechnology ,
CAFC ,
Disclosure Requirements ,
Intellectual Property Litigation ,
Life Sciences ,
Patent Invalidity ,
Patent Litigation ,
Patent Prosecution ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 112 ,
Written Descriptions
Effective July 8, 2025, the U.S. Patent and Trademark Office (USPTO) expanded the availability of prioritized examination, increasing the limit on the number of requests from 15,000 to 20,000 in a fiscal year. The 20,000...more
7/10/2025
/ Fast Track Process ,
Fees ,
Filing Requirements ,
Final Rules ,
Life Sciences ,
Patent Applications ,
Patent Examinations ,
Patents ,
Pharmaceutical Patents ,
Prioritized Examination ,
Regulatory Agencies ,
Regulatory Reform ,
Request for Continued Examination ,
USPTO
A recent decision by the Patent Trial and Appeal Board (PTAB) sheds light on certain pitfalls patent applicants may encounter when submitting declarations under 37 C.F.R. § 1.132 (“Rule 132 Declarations”). Rule 132...more
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
11/14/2023
/ Antitrust Division ,
Competition ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Manufacturers ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Policy Statement
On March 27, 2023, the U.S. Supreme Court heard oral arguments in Amgen Inc. v. Sanofi, a closely watched case on the issue of enablement under 35 U.S.C. § 112(a). Though not the main point of contention, the doctrine of...more