In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC , the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug Administration (FDA) Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations), and decided that the “device” patents at issue were not properly listable.
The decision follows recent action in this space by the Federal Trade Commission (FTC), including a general policy statement issued in late 2023, and challenges to more than 100 specific patent listings related to inhaler devices, multidose eyedrop bottles, and autoinjectors. The Patents at Issue The patents at issue were five patents Teva had listed in the Orange Book for its ProAir® HFA (albuterol sulfate) Inhalation Aerosol. The patents are described in the Federal Circuit opinion as relating to “improvements in the device parts of inhalers—specifically, the dose counter.
” According to the Federal Circuit opinion, “None of the claims ...
explicitly require the presence of an active drug” as an element of the claimed product. The ANDA Proceedings and Delisting Counterclaim Amneal filed an Abbreviated New Drug Application (ANDA) seeking approval for a generic version of Teva’s ProAir® HFA product. Amneal’s ANDA included a paragraph IV certification against the Orange Book-listed patents at issue.
After Teva sued for infringement, Amneal filed a counterclaim seeking delistin.