# UNITED STATES OF AMERICA > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/agency%3Aftc%3Aa46a3e0f1471262d ## Record - **Collection:** Agency decision - **Document type:** Agency decision ## Text UNITED STATES OF AMERICA FEDERAL TRADE COMMISSION WASHINGTON, D.C. 20580 Bureau of Competition May 21, 2025 David R. McAvoy Chief Legal Officer Teva Pharmaceutical Industries Ltd. c/o Teva Pharmaceuticals USA, Inc. 400 Interpace Pkwy, Suite 3 Parsippany, NJ 07054 Re: Brian Savage, SVP and General Counsel Global Litigation Teva Pharmaceuticals USA, Inc. 400 Interpace Pkwy, Suite 3 Parsippany, NJ 07054 brian.savage@tevapharm.com Improper Orange Book Patent Listings for AirDuo Respiclick, AirDuo Digihaler, ArmonAir Respiclick, and ArmonAir Digihaler Dear Counsel, I write regarding Teva Pharmaceutical Industries Ltd.’s (“Teva”) ongoing obligation to ensure the propriety of its patent listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”), particularly in light of the U.S. Court of Appeals for the Federal Circuit’s decision in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, 124 F.4th 898 (Fed. Cir. 2024) (hereinafter “Teva v. Amneal”). The FTC has previously explained that patents improperly listed in the Orange Book may harm competition and delay generic drug entry, as courts have recognized.1 On April 30, 2024, the FTC’s Bureau of Competition (the “Bureau”) sent Teva a letter identifying a non-exhaustive list of patents that Teva had improperly submitted for listing in the Orange Book and explained how improper Orange Book listings may harm competition.2 Since that letter was sent, the 1 Fed. Trade Comm’n, Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book (Sept. 14, 2023), https://www.ftc.gov/system/files/ftc_gov/pdf/ p239900orangebookpolicystatement092023.pdf; Brief for Fed. Trade Comm’n as Amicus Curiae, SmithKline Beecham Corp. v. Apotex Corp., No. 99-CV-4304 (E.D. Pa. Jan. 28, 2003), https://www.ftc.gov/sites/default/files/documents/amicus_briefs/smithkline-beecham-corp.v.apotexcorp./smithklineamicus.pdf; Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 408 (2012); see also Massachusetts Laborers' Health & Welfare Fund v. Boehringer Ingelheim Pharms., Inc., No. 24-CV-10565-DJC, 2025 WL 928747, at *20 (D. Mass. Mar. 27, 2025) (“[Plaintiff’s] alleged injury, having to pay higher prices for drugs it otherwise would not need to but for [Defendants’] allegedly wrongful listing, is the precisely the kind of ‘[t]hreaten[ed] economic harm to consumers [that] is plainly sufficient to authorize injunctive relief.’” (quoting New York ex rel. Schneiderman v. Actavis PLC, 787 F.3d 638, 661 (2d Cir. 2015) (cleaned up)). 2 April 30, 2024 Letter from R. Rao, Deputy Director, Bureau of Competition, to Teva Pharm. Indus., Inc., https://www.ftc.gov/system/files/ftc_gov/pdf/teva-pharm-industries-digis-and-respiclicks-4302024.pdf. Federal Circuit’s ruling in the Teva v. Amneal case has confirmed that the identified patents do not meet applicable Orange Book listing criteria.3 While Teva has requested the delisting of patents specifically at issue in the Federal Circuit’s Teva v. Amneal decision, a number of other patents included in the Bureau’s prior delisting letter remain in the Orange Book as of the date of this letter, including the following: NDA 208799 208799 3 Product(s) 1, 2, 3 4, 5, 6 Proprietary Name AirDuo Respiclick AirDuo Digihaler Patent Number Listing Type 8651103 DP 8714149 DP 8978966 DP 9216260 DP 9463288 DP 9731087 DP 10022510 DP 10124131 DP 10765820 DP 8651103 DP 8714149 DP 8978966 DP 9216260 DP 9463288 DP 9731087 DP 9782550 DP 9782551 DP 10022510 DP 10124131 DP 10569034 DP 10765820 DP 11000653 DP 11266796 DP 11351317 DP 11357935 DP Teva v. Amneal, 124 F.4th at 911 (explaining that a patent claims the drug as required for listing in the Orange Book “when it particularly points out and distinctly claims the drug as the invention.”). 208798 208798 1, 2, 3, 7 4, 5, 6, 8 ArmonAir Respiclick ArmonAir Digihaler 11439777 DP 11464923 DP 8651103 DP 8714149 DP 8978966 DP 9216260 DP 9463288 DP 9731087 DP 10022510 DP 10124131 DP 10765820 DP 8651103 DP 8714149 DP 8978966 DP 9216260 DP 9463288 DP 9731087 DP 9782550 DP 9782551 DP 10022510 DP 10124131 DP 10569034 DP 10765820 DP 11000653 DP 11266796 DP 11351317 DP 11357935 DP 11439777 DP 11464923 DP With the above patents still in the Orange Book, we are, contemporaneously with this letter, submitting patent listing dispute communications to the FDA regarding these patents. Although we have not, at this time, disputed the listing of any other Teva patents, it is Teva’s responsibility to ensure that all of its patent listings comply with the statutory listing requirements, as clarified by Teva v. Amneal. Combatting improper Orange Book patent listings has been a part of the FTC’s longstanding enforcement and advocacy work to challenge anticompetitive conduct that stymies generic drug entry and the resulting substantial cost savings.4 The FTC will remain vigilant to promote competition and protect the American public from the harms that flow from anticompetitive practices in the pharmaceutical industry. Sincerely, /s/ Kelse Moen Kelse Moen Deputy Director Bureau of Competition 4 See, e.g., Biovail Corp., 134 F.T.C. 407 (2002), https://www.ftc.gov/sites/default/files/documents/cases/ 2002/10/biovaildo.pdf; Brief for Fed. Trade Comm’n as Amicus Curiae, Jazz Pharms., Inc. v. Avadel CNS Pharms. No. 1:21-cv-00691 (D. Del. Nov. 10, 2022), ECF No. 222-3; Brief for Fed. Trade Comm’n as Amicus Curiae, Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 24-1936 (Fed. Cir. Sept. 6, 2024), ECF No. 62; see also Mem. of Law of Amicus Curiae the Federal Trade Commission in Opp’n to Defs.’ Mot. to Dismiss, In re: Buspirone Patent Litig., MDL Docket No. 1410 (S.D.N.Y. Jan. 8, 2002), https://www.ftc.gov/sites/default/files/documents/amicus_briefs/re-buspirone-antitrust-litigation/buspirone.pdf; see also Fed. Trade Comm’n, Overview of FTC Actions in Pharmaceutical Products and Distribution (Sept. 2021), https://www.ftc.gov/system/files/attachments/competition-policyguidance/overview_of_ftc_actions_in_pharmaceutical_products_and_distribution.pdf. --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/agency%3Aftc%3Aa46a3e0f1471262d. Public record. Not legal advice.