A number of important changes have occurred in the cannabis, hemp, and cannabidiol (CBD) spaces. This alert presents a snapshot of significant developments and selected future predictions....more
2/7/2019
/ Amended Legislation ,
Amended Regulation ,
Cannabidiol (CBD) oil ,
Controlled Substances Act ,
DEA ,
Decriminalization of Marijuana ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Farm Bill ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Hemp ,
Marijuana ,
Marijuana Related Businesses ,
Patents ,
Utility Patents
On July 21, 2015, the U.S. Court of Appeals for the Federal Circuit issued its holding in Amgen Inc. v. Sandoz Inc., 2015-1499 (Fed. Cir. 2015). The Federal Circuit's decision is the latest development in the long-running...more
7/24/2015
/ Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Counterclaims ,
Disclosure ,
First Impression ,
Food and Drug Administration (FDA) ,
Notice Provisions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen ,
Unfair Competition
Drug Approval and Patent Listing Process -
Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more
On March 19, 2015, Judge Seeborg of the Northern District of California handed a significant victory to Sandoz's efforts to bring the first biosimilar product to market by denying Amgen's partial judgment on the pleadings and...more
Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more
On November 11, 2013, the U.S. District Court for the Northern District of California in Sandoz, Inc. v. Amgen, Inc. and Hoffman-La Roche, Inc., Docket No. C-13-2904, made the first-ever judicial interpretation of the...more