On June 10, 2024, the New Jersey District Court ordered Teva to remove (or delist) five patents from the Orange Book in a case involving Pro-Air HFA®(albuterol). Of course, the decision analyzed exactly what patents belong in the Orange Book.

The Orange Book – A Quick Primer

Decades ago, FDA established a book where NDA holders can list patents that cover their products. An ANDA filer must certify against these listed patents in its application to FDA. As the publication was originally orange, practitioners refer to it as the Orange Book. Three types of patents are allowed: drug substance (or product), formulation, and method-of-use. Kind of like classifying shells and mollusks, this seems easy enough, but sometimes it raises questions.

What About Drug Products Which Include Devices?

This has been open question for some time. For example, an asthma inhaler has a drug and an inhaler device. Is the delivery device part of the drug substance or formulation? The same might be said for a product with an injector pen. Can the patents covering the device portion be included in the Orange Book?

This was the question the Court in New Jersey considered. ANDA filer Amneal argued that the five patents covered the inhalation device of Pro-Air HFA®(albuterol) and not the drug or its finished product. Judge Chesler agreed, noting that the “Inhalation Patents” did not claim albuterol or its product in finished form. As such, the Court ordered NDA holder Teva to ask FDA to delist and remove them from the Orange Book.

Delisting Patents from the Orange Book

Delisting a patent is rare but not that unusual, but this appears to be the first real challenge to a drug/device product like Pro-Air. Teva appealed, and the Court stayed the balance of the case. The Court of Appeals decision should create some usable standards for other products.