UNITED STATES OF AMERICA (2025)

UNITED STATES OF AMERICA

FEDERAL TRADE COMMISSION

WASHINGTON, D.C. 20580

Bureau of Competition

May 21, 2025

Teva Branded Pharmaceutical

Products R&D, Inc.

Attn: Legal Counsel

c/o Corporate Creations Network Inc.

3411 Silverside Road

Tatnall Building, Ste. 104

Wilmington, New Castle, DE 19810

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 ProAir HFA, ProAir DigiHaler,

ProAir RespiClick, QVAR 40, and QVAR 80

Dear Mr. Savage,

I write regarding Teva Branded Pharmaceutical Products R&D, Inc.’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 November 7,

2023, the FTC’s Bureau of Competition (the “Bureau”) sent Teva a letter identifying a nonexhaustive 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,

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 Teva Branded

Pharmaceutical, https://www.ftc.gov/system/files/ftc_gov/pdf/teva-branded-pharma-orange-book.pdf.

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 letter remain in the Orange Book as of the date of this letter, as well as other improperly

listed patents, including the following:

NDA

21457

205636

205636

3

Product(s)

1

2

1

Proprietary

Name

ProAir HFA

ProAir DigiHaler

ProAir

RespiClick

Patent Number

Listing Type

10022509

DP

10022510

DP

10086156

DP

10695512

DP

8651103

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

8651103

DP

8978966

DP

9216260

DP

9463288

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.”).

9731087

10022510

10124131

020911

1, 2

QVAR 40 & 80

DP

DP

10765820

DP

DP

10022509

DP

10022510

DP

10086156

DP

10695512

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.