UNITED STATES OF AMERICA

UNITED STATES OF AMERICA

FEDERAL TRADE COMMISSION

WASHINGTON, D.C. 20580

Bureau of Competition

May 21, 2025

Elizabeth McGee

General Counsel

Novartis Pharmaceuticals Corp.

1 Health Plaza, East Hanover,

New Jersey 07936

Elizabeth.mcgee@novartis.com

Re:

Improper Orange Book Patent Listings for Seebri and Utibron

Dear Ms. McGee,

I write regarding Novartis Pharmaceuticals Corp.’s (“Novartis”) 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 a letter identifying a non-exhaustive list of

patents that Novartis 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 Federal

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 April 30, 2024 Letter from R. Rao, Deputy Director, Bureau of Competition, to Novartis Pharmaceuticals

Corp., https://www.ftc.gov/system/files/ftc_gov/pdf/novartis-seebri-and-utibron-4302024.pdf.

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

Product(s)

207923

207930

1

1

Proprietary

Name

Seebri

Utibron

Patent Number

Listing Type

8182838

DP

DP

8182838

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 Novartis patents, it is

Novartis’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 that result from this.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

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.