In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies.
...more
2/13/2019
/ Abbreviated New Drug Application (ANDA) ,
Exclusivity ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation
The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more
9/4/2015
/ Amgen ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Injunctions ,
Patent Dance ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more
6/10/2015
/ Abbreviated New Drug Application (ANDA) ,
Classen Immunotherapies ,
Clinical Trials ,
Elan Pharmaceuticals ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Labeling ,
Medical Devices ,
Merck ,
Patent Infringement ,
Safe Harbors ,
Vaccinations
The United States District Court for the Southern District of Indiana joined the District of Delaware and the Eastern District of Texas in finding specific jurisdiction based on receipt of a Paragraph IV Notice Letter. See...more
In This Issue:
- I. Traditional Use of General Jurisdiction in Hatch-Waxman Cases
- II. Amenability to General Jurisdiction May Be Waning
- III. Freedom from Jurisdiction Could Be An Advantage
-...more