# UNITED STATES OF AMERICA (2025) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/agency%3Aftc%3Ada8d999f3637af57 ## 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 Mylan Specialty LP Attn: Legal Counsel Corporation Service Co. 251 Little Falls Dr. Wilmington, New Castle, DE 19808 Re: Brian Roman Global General Counsel Viatris Inc. 1000 Mylan Blvd. Canonsburg, PA 15322 Brian.Roman@viatris.com Improper Orange Book Patent Listings for EPIPEN and EPIPEN Jr. Dear Mr. Roman: I write regarding Mylan Specialty LP’s (“Mylan”) 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 November 7, 2023, the FTC’s Bureau of Competition (the “Bureau”) sent a letter identifying a non-exhaustive list of patents that Mylan 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 See November 7, 2023 Letter from R. Rao, Deputy Director, Bureau of Competition, to Mylan Specialty LP, https://www.ftc.gov/system/files/ftc_gov/pdf/mylan-specialty-orange-book.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 The following patents included in the Bureau’s prior delisting letter remain in the Orange Book as of the date of this letter: NDA 19430 19430 Product(s) 1 2 Proprietary Name EPIPEN EPIPEN JR Patent Number Listing Type 7449012 DP 7794432 DP 8048035 DP 9586010 DP 7449012 DP 7794432 DP 8048035 9586010 DP 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 Mylan patents, it is Mylan’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 remainvigilant to promote competition and protect the American public from the harms that flow from anticompetitive practices in the pharmaceutical industry. 3 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.”). 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. Sincerely, /s/ Kelse Moen Kelse Moen Deputy Director Bureau of Competition --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/agency%3Aftc%3Ada8d999f3637af57. Public record. Not legal advice.