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 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