UNITED STATES OF AMERICA (2025)

UNITED STATES OF AMERICA

FEDERAL TRADE COMMISSION

WASHINGTON, D.C. 20580

Bureau of Competition

May 21, 2025

Norton (Waterford) Limited

Attn: Legal Counsel

Waterford Industrial Park

Unit 301, Cork Rd

Waterford, X91 WK68, Ireland

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 QVAR RediHaler

Dear Mr. Savage,

I write regarding Norton (Waterford) Limited’s and Teva Pharmaceuticals’ (“Teva”)

ongoing obligation to ensure the propriety of 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, and April 30, 2024, the FTC’s Bureau of Competition (the “Bureau”) sent Teva letters

identifying non-exhaustive lists of patents that had been improperly submitted for listing in the

Orange Book and explained how improper Orange Book listings may harm competition.2 Since

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 Nov. 7, 2023 Letter from R. Rao, Deputy Director, Bureau of Competition, to Norton (Waterford) Ltd.,

https://www.ftc.gov/system/files/ftc_gov/pdf/norton-orange-book.pdf; Apr. 30, 2024 Letter from R. Rao, Deputy

Director Bureau of Competition, to Norton (Waterford) Ltd., https://www.ftc.gov/system/files/ftc_gov/pdf/tevanorton-qvar-redihaler-4302024.pdf.

those letters were sent, the 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 letters remain in the Orange Book as of the date of this letter, including the following:

NDA

207921

Product(s)

1,2

Proprietary

Name

QVAR

RediHaler

Patent Number

Listing Type

10022509

DP

10022510

DP

10086156

DP

10695512

DP

11865247

DP

11896759

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

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.

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