In our previous article, we reported that the Federal Circuit affirmed the district court’s decision requiring Teva to delist certain patents related to its Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange...more
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more
12/23/2024
/ Abbreviated New Drug Application (ANDA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Listing Rules ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Statutory Interpretation ,
Teva Pharmaceuticals
Gene therapies have been the subject of tremendous scientific research and investment. With hundreds of clinical trials in progress and many target applications, the biotechnology, agricultural, and pharmaceutical fields are...more
Last week, a federal court in Delaware unsealed an opinion supporting its grant of summary judgment that U.S. Patent No. 7,033,590 (“the ’590 Patent”) is invalid for lack of enablement. The ’590 Patent is owned by Baxalta...more
In April of 2021, we provided a three-part series relating to the IP and Competitive Landscape for the mRNA market. In this post we provide a 2021 year in review update on mRNA pioneers and key players and offer additional...more