In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation...more
1/16/2025
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
Patent owners generally look to secondary indicia to bolster their nonobvious defenses when prior art and/or knowledge of a person of ordinary skill in the art (“POSA”) seem to make the obviousness decision a close call. This...more
11/26/2024
/ Amgen ,
Amgen v Sandoz ,
Bristol-Myers Squibb ,
Claim Construction ,
Clinical Trials ,
Hatch-Waxman ,
Obviousness ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Teva Pharmaceuticals