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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

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)).

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

Product(s)

1, 2, 3

4, 5, 6

Proprietary

Name

AirDuo

Respiclick

AirDuo

Digihaler

Patent Number

Listing Type

8651103

8714149

8978966

9216260

9463288

9731087

10022510

10124131

10765820

8651103

8714149

8978966

9216260

9463288

9731087

9782550

9782551

10022510

10124131

10569034

10765820

11000653

11266796

11351317

11357935

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

1, 2, 3, 7

4, 5, 6, 8

ArmonAir

Respiclick

ArmonAir

Digihaler

11439777

11464923

8651103

8714149

8978966

9216260

9463288

9731087

10022510

10124131

10765820

8651103

8714149

8978966

9216260

9463288

9731087

9782550

9782551

10022510

10124131

10569034

10765820

11000653

11266796

11351317

11357935

11439777

11464923

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

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.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.