On July 9, 2021, the United States Patent and Trademark Office (USPTO) published a notice in the Federal Register on behalf of Senators Tillis, Hirono, Cotton, and Coons seeking public input for a patent eligibility...more
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
On January 15, 2014, the U.S. Court of Appeals for the Federal Circuit confirmed that patent owners may be entitled to extended patent terms, a finding that is especially important for select pharmaceutical, biotech, and...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