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 ...

Two appeals came from the Federal Circuit regarding the court’s application of Hatch-Waxman’s safe harbor ... provision applies when the infringing act, here the importation of Meril’s ...

With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent ...

Under provisions in the Hatch-Waxman Act, the FDA permits marketing of generics for older indications that no longer have patent protection, even if the brand-name drug develops new, patented uses.

Philanthropists Alfred and Gail Engelberg sold their lakefront Palm Beach home for $23.8 million, a steep discount from its ...

Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s ...

"We are dedicated to supporting parties involved in ANDA litigation," said WIT's Hatch-Waxman Chair Michael Crowe. "Our team has worked with hundreds of testifying experts in cases before district ...

The generics manufacturer Teva Pharmaceuticals has failed to persuade a Federal Circuit appeals court to maintain 180 days of exclusivity for a generic version of Pfizer's antidepressant ...