The listing of patents in the Orange Book has an important role in intellectual property protection for pharmaceuticals. Patents listed in the Orange Book can include, without question, patents covering compositions or methods of use for pharmaceuticals. But for years, questions have been raised as to whether drug delivery devices or drug/device combinations can be listed.
In the trial court, five Teva patents were at issue. Each patent was directed to a “metered dose inhaler,” “an inhaler for metered dose inhalation,” or “a dose counter for an inhaler.” Teva alleged that the patents cover aspects of Teva’s ProAir® HFA (albuterol sulfate) Inhalation Aerosol. Amneal filed an ANDA application, including a Paragraph IV certification, asserting that its proposed product would not infringe any valid claims of Teva’s inhaler patents. Importantly, after Teva filed suit, Amneal filed counterclaims, including claims asking the court to order Teva to remove the inhaler patents from the Orange Book.
Teva argued that the inhaler patents were properly listed as drug product patents. There was no dispute, however, that the patents contained no claim for the active ingredient at issue, albuterol sulfate. Amneal argued that the patents, therefore, do not meet a requirement that they claim the relevant drug. Teva made a number of arguments as to why the inhaler patents are properly listed, but ultimately, the trial court held that the patents do not meet the requirements of the relevant statute because the patents do not “claim[] the drug for which [Teva] submitted [its drug] application” with the Food and Drug Administration.
The case is currently on appeal to the United States Court of Appeals for the Federal Circuit. The Federal Circuit’s decision in this case may be very important for branded pharmaceutical manufacturers because it may affect which patents to devices or combination products can be listed in the Orange Book. The Federal Circuit’s decision—however it is decided—will likely affect patent drafting and claims strategy relating to pharmaceutical delivery device patents.
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The Federal Circuit case is Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals, Appeal Number: 2024-1936.
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