UNITED STATES OF AMERICA (2025)

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