Holding: To list a patent in the Orange Book as covering a product that is the subject of an NDA, the patent must claim the drug for which the NDA was submitted and approved. To claim the drug, the patent must at least claim the active ingredient.
Amneal alleges that Teva improperly listed patents in the Orange Book as covering the active ingredient albuterol sulfate, when instead these patents were directed to components of a metered inhaler device. Under the Hatch-Waxman Act, the holder of a New Drug Application (NDA) must submit the patent number and expiration date of each patent that claims the drug for which the applicant submitted the NDA or that claims a method of using the drug. A 30-month stay is placed on approval of any abbreviated new drug application (ANDA) filed by a generic drug manufacturer if the patent owner sues for infringement on any of these listed patents. The FDA does not conduct a substantive examination of the patents listed by the NDA holder to ensure that these patents actually cover the drug substance, drug product, or method of using the drug that is the subject of the NDA.
Teva’s NDA was listed for the ProAir® HFA Inhalation Aerosol, which allows for the treatment or prevention of bronchospasm with reversible obstructive airway diseases by delivering albuterol sulfate as the active ingredient with a propellant, ethanol, and an inhaler device. The FDA approved the ProAir® as a combination product that includes both a drug and the physical machinery of the inhaler. The patents listed in the Orange Book for Teva’s NDA are related to improvements to the device components of the inhaler and do not specifically claim the albuterol sulfate.
Amneal filed an ANDA for a generic version of the ProAir®, asserting that it did not infringe the patents listed in the Orange Book. Teva sued for infringement on five of the listed patents, and Amneal filed a counterclaim seeking an order to delist the five asserted patents as being improperly listed. The district court held that Teva’s patents do not claim the drug that is the subject of the NDA since there is no claim for the active ingredient albuterol sulfate and granted Amneal’s motion to delist the Teva patents. The Federal Circuit upheld the decision to delist the Teva patents.
Teva argued that since the ProAir® inhaler would infringe the patents that are listed in the Orange Book, then these patents are properly listed. This argument was rejected by the Federal Circuit. Instead, the Federal Circuit held that to qualify for listing, a patent must claim at least the active ingredient that is the subject of the NDA, since the active ingredient is what made the product approvable as a drug. Just because a product would infringe a patent does not mean that the patent “claims” that product as required by the Hatch-Waxman Act to be listed in the Orange Book. What a patent claims and what infringes a claim are distinct concepts.
Alternatively, Teva argued that the term “drug” refers to any part of an object used to treat a disease, such as an inhaler. This argument was also rejected by the Federal Circuit. At the FDA, drugs and devices follow separate approval pathways and have distinct regulatory regimes. A product’s classification as a drug or a device guides the process of getting that product to market. A product may be regulated as a drug or a device, but cannot be regulated as both. Those products that are regulated as drugs include an active ingredient that supplies a chemical action or metabolization to treat a disease. In contrast, a product that is regulated as a device is characterized by its purely mechanical nature. Therefore, to claim a drug, a patent must claim an active ingredient. Since Teva’s listed patents only claim the inhaler and not an active ingredient to use with the inhaler, these patents do not claim a “drug” and should not be listed in the Orange Book.
Federal Circuit Precedential 
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