When a new drug is first approved by the U.S. Food and Drug Administration (FDA), the drug is entitled to a period of market exclusivity. For a subset of these new drugs, the FDA will determine that the product has the...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
Chinese patent prosecution recently made worldwide headlines when the press announced that the Chinese Patent Office (SIPO) rejected a Gilead Sovaldi prodrug patent. Sovaldi (sofosbuvir) is a breakthrough drug used to treat...more
On May 28, 2015, the U.S. District Court for the District of Columbia vacated and remanded the U.S. Food and Drug Administration's (FDA) administrative decision denying five years of new chemical entity exclusivity for Amarin...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On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...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