New Jersey District Court orders removal of Teva inhaler patents from Orange Book | A&O Shearman

On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute and ordered the Teva plaintiffs to strike certain inhaler patents from the Orange Book. Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLCNo. 23-cv-20964 (SRC) __ F. Supp. 3d __ (DNJ, 10 June 2024).

Teva Branded Pharmaceutical Products R&D, Inc., Norton (Waterford) Ltd. and Teva Pharmaceuticals USA, Inc. (collectively, “Teva”) own approved New Drug Application (“NDA”) No. 021457 for an inhaler called ProAir® HFA (albuterol sulfate) Inhalation Aerosol (the “ProAir® HFA Inhaler”). Several of Teva’s patents purporting to cover the ProAir® HFA inhalers are listed in the Orange Book, a publication of the Food and Drug Administration (“FDA”) that among other thingsidentifies drugs approved based on their safety and effectiveness and provides other information about the drugs, such as which patents cover the drugs, exclusivity information, etc. (The FDA does not directly oversee the Orange Book; its role in administering the Orange Book is purely ministerial.)

Amneal Pharmaceuticals of New York, LLC, Amneal Ireland Limited, Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals Inc. (collectively, “Amneal”) had filed New Drug Application (“ANDA”) No. 211600 to manufacture and sell a generic version of the ProAir® HFA inhaler.

After Amneal notified Teva of its intention to manufacture and sell a generic version of the ProAir® HFA inhaler, Teva filed suit against Amneal, claiming infringement of the following “inhaler patents” listed in the Orange Book: U.S. Patent Nos. 8,132,712, 9,463,289, 9,808,587, 10,561,808, and 11,395,889. In response to Teva’s infringement claims, Amneal counterclaimed that among other thingsalleged antitrust violations and sought declarations directing Teva to strike the inhaler patents from the Orange Book on the grounds that the Listing Statute, 21 USC § 355, does not permit listing of Teva’s inhaler patents in the Orange Book. Teva moved to dismiss these counterclaims on the grounds that among other thingsthat no such valid counterclaim for cancellation of patents existed, and Amneal moved for partial judgment on the basis of the statements of claim relating to its counterclaims for cancellation of patents.

21 USC § 355(b)(1)(A)(viii) provides that three types of patents are eligible for listing in the Orange Book: “substance patents, drug patents, and method of use patents.” Notably, in September 2023, the Federal Trade Commission (“FTC”) issued a policy statement that essentially warned companies against abusing the system by improperly listing patents in the Orange Book. (The FTC filed an amicus curiae brief asking the court to remove Teva’s inhaler patents from the list.)

In analyzing the parties’ arguments, the District Court first denied Teva’s motion to dismiss Amneal’s counterclaims on the grounds that those counterclaims were permissible and rejected Teva’s argument that this case was analogous to Verizon Communs., Inc. v. Law Offices of Curtis V. Trinko, LLP540 U.S. 398 (2004), in which the Supreme Court held that allegations of violation of certain provisions of the Telecommunications Act of 1996 do not give rise to a claim under antitrust law.

The district court then addressed Amneal’s motion for partial judgment on the pleadings. Teva objected to Amneal’s motion, claiming that the inhaler patents were properly listed as “drug patents” under § 355(b)(1)(A)(viii)(I). This section requires that the patent: (1) “claim the drug for which the applicant filed the application” and (2) be directed to a drug ingredient or drug product. The district court found that the dispute hinged on the interpretation of the former. According to FDA, the drug for which Teva filed the NDA is “albuterol sulfate HFA inhalation aerosol.” But even though the subject matter of the NDA is albuterol sulfate HFA inhalation aerosol, the district court found that none of the claims in the inhaler patents are actually directed to albuterol sulfate—the active ingredient in question—but rather to the inhaler device technology. The district court then rejected Teva’s argument that the term “drug” as used in the statute should be interpreted broadly, so that a drug need only fall within the scope of the claim in question. Rather, the district court explained, the statutory requirement is that the patent claim the drug itself for which the applicant filed the application. Here, “Because the inhaler patents clearly do not consider an ‘albuterol sulfate HFA inhalation aerosol’ to be what was invented, they do not claim the drug for which the applicant (Teva) filed the NDA application.”

The District Court therefore entered partial judgment on Amneal’s counterclaims for removal of the inhaler patents from the Orange Book and ordered Teva to remove the inhaler patents from the Orange Book.

On June 11, 2024, Teva filed an appeal with the U.S. Court of Appeals for the Federal Circuit (“CAFC”) and notified the district court that it intends to seek a stay pending appeal.

On June 13, 2024, Judge Chesler ordered a 30-day stay of his ruling to give the CAFC time to decide on Teva’s request for a stay.

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