Miriam Goldgeil Authors ABA Article on the Federal Circuit Ruling in Teva v. Amneal
Published by the American Bar Association (ABA)
Senior Research Analyst Miriam Goldgeil recently authored an American Bar Association (ABA) article providing an overview of the US Court of Appeals for the Federal Circuit’s December 2024 ruling in Teva v. Amneal.
The article details the background of the case, including the US District Court for the District of New Jersey’s initial decision as well as the Federal Circuit’s decision and opinion. The Federal Circuit affirmed the district court’s order requiring Teva to delist five patents from the US Food and Drug Administration (FDA) Orange Book, which includes all FDA-approved drugs to be marketed in the US, including patent and exclusivity information. The opinion noted that the Teva patents in question – related to the pharmaceutical company’s FDA-approved HFA Inhalation Aerosol product – claimed inhaler devices but did not claim albuterol sulfate, the active ingredient used in the ProAir HFA Inhalation Aerosol product. According to the Federal Circuit, in order for a patent to be properly listed in the Orange Book, it must claim the drug from the applicant’s submitted and approved drug application.
The full article, “Federal Circuit Affirms Device Patent Delisting in Teva v. Amneal,” is available on the ABA website to ABA members.
