The Federal Circuit's upcoming case, Teva v. Amneal, may redefine Orange Book patent listing rules, potentially impacting how device patents are categorized under Hatch-Waxman.
The case focuses on five patents related to Teva’s inhaler product, which do not directly mention albuterol sulfate yet are listed in the FDA's Orange Book.
The outcome will determine whether device patents can be listed in the Orange Book, influencing pathways for generic drug approvals and their market entry.
This case emphasizes the balancing act of the Hatch-Waxman Act, aiming to stimulate pharmaceutical innovation while expediting the entry of lower-cost generic alternatives.
Collection
[
|
...
]