Case 2:23-cv-20964-SRC-MAH Document 61-1 Filed 03/22/24 Page 1 of 47 PageID: 1975
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Case 2:23-cv-20964-SRC-MAH Document 61-1 Filed 03/22/24 Page 1 of 47 PageID: 1975
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
TEVA BRANDED
PHARMACEUTICAL PRODUCTS
R&D, INC., NORTON
(WATERFORD) LTD., AND TEVA
PHARMACEUTICALS USA, INC.
Civil Action No. 2:23-cv-20964-JXNMAH
Plaintiffs,
v.
AMNEAL PHARMACEUTICALS OF
NEW YORK, LLC, AMNEAL
IRELAND LIMITED, AMNEAL
PHARMACEUTICALS LLC, AND
AMNEAL PHARMACEUTICALS
INC.
Defendants.
FEDERAL TRADE COMMISSION’S BRIEF AS AMICUS CURIAE
Case 2:23-cv-20964-SRC-MAH Document 61-1 Filed 03/22/24 Page 2 of 47 PageID: 1976
TABLE OF CONTENTS
INTRODUCTION .....................................................................................................1
INTEREST OF THE FEDERAL TRADE COMMISSION......................................3
BACKGROUND .......................................................................................................8
I. The Statutory and Regulatory Framework .......................................................8
II. Teva Continues to Improperly List Patents in the Orange Book—Including
the Asserted Patents—Despite FTC Staff Warnings............................................14
ARGUMENT ...........................................................................................................16
I. Drug Manufacturers Cannot Lawfully List Device Patents That Are Not
Limited to Either the Active Ingredient or the Approved Product.......................17
II. Improper Orange Book Patent Listings Harm Competition ..........................25
III. Improper Orange Book Listings May Constitute Illegal Monopolization
Under Section 2 of the Sherman Act ....................................................................30
IV. The Narrow Trinko Exception Does Not Immunize Improper Orange Book
Listings From Antitrust Scrutiny ..........................................................................33
CONCLUSION ........................................................................................................39
i
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TABLE OF AUTHORITIES
Cases
Apotex v. Thompson,
347 F.3d 1335 (Fed. Cir. 2003) .............................................................. 12, 22, 37
Arlington Cent. Sch. Dist. Bd. of Educ. v. Murphy,
548 U.S. 291 (2006) .............................................................................................25
Bayer AG v. Biovail Corp.,
279 F.3d 1340, 1350 (Fed. Cir. 2002) .................................................................11
Ben Venue Lab. v. Novartis Pharm. Corp.,
10 F. Supp. 2d 446 (D.N.J. 1998) ........................................................................25
Br. for the U.S. as Amicus Curiae, Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S,
No. 10-844, 2011 WL 3919720 (U.S. Sept. 6, 2011); .........................................37
Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S,
566 U.S. 399 (2012) .........................................................................................9, 37
Decision & Order, In re Biovail Corp.,
FTC Dkt. No. C-4060 8 (Oct. 2, 2002)............................................................4, 32
Def.’s Answer, Affirmative Defenses, and Countercl. to Pl.s’ First Am. Compl.,
ECF No. 12 .................................................................................................. passim
Def.'s Br. In Supp. Mot.,
ECF No. 48 .................................................................................................. passim
Eastman Kodak Co. v. Image Tech. Servs., Inc.,
504 U.S. 451 (1992) .............................................................................................31
eBay Inc. v. MercExchange, L.L.C.,
547 U.S. 388 (2006) .............................................................................................11
Fed. Defs.’ Mem. in Opp’n to Pls.’ Mot. for Prelim. Injunction, Mylan v.
Thompson, 139 F. Supp. 2d 1 (D.D.C. 2001) ......................................................36
FTC v. AbbVie Inc.,
976 F.3d 327 (3d Cir. 2020) ................................................................. 3, 9, 10, 39
FTC v. Actavis, Inc.,
570 U.S. 136 (2013) ...............................................................................................3
FTC v. Shkreli,
581 F. Supp. 3d 579 (S.D.N.Y. 2022) ...................................................................3
ii
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Impax Labs, Inc. v. FTC,
994 F.3d 484 (5th Cir. 2021) .................................................................................3
In re Gabapentin Pat. Litig.,
649 F. Supp. 2d 340 (D.N.J. 2009) ......................................................................32
In re Lantus Direct Purchaser Antitrust Litig.,
950 F.3d 1 (1st Cir. 2020) ............................................................................ passim
In re Loestrin 24 Fe Antitrust Litig.,
433 F. Supp. 3d 274 (D.R.I. 2019) ............................................................... 13, 32
In re Remeron Antitrust Litig.,
335 F. Supp. 2d 522 (D.N.J. 2004) ................................................... 13, 32, 34, 36
King Drug Co. of Florence, Inc. v. Cephalon, Inc.,
88 F. Supp. 3d 402 (E.D. Pa. 2015) .......................................................................3
Mem. of Law for Fed. Trade Comm’n as Amici Curiae, Mylan Pharms. Inc. v.
Sanofi-Aventis U.S. LLC, No. 2:23-cv-00836, ECF No. 64 (W.D. Pa. Nov. 21,
2023) ......................................................................................................................4
Mem. of Law for Fed. Trade Comm’n as Amicus Curiae, In re: Buspirone Patent
Litig., No. 1:01-md-1410, ECF No. 31 (S.D.N.Y. Jan. 8, 2002) ...........................4
Mem. of Law for Fed. Trade Comm’n as Amicus Curiae, Jazz Pharms., Inc. v.
Avadel CNS Pharms., LLC, No. 1:21-cv-691, ECF No. 227 (D. Del. Nov. 15,
2022) ......................................................................................................................4
Organon Inc. v. Mylan Pharms., Inc.,
293 F. Supp. 2d 453 (D.N.J. 2003) ............................................................... 12, 36
Otter Tail Power Co. v. United States,
410 U.S. 366 (1973) .............................................................................................39
Pl.’s Am. Compl.,
ECF No. 7 ............................................................................................................15
Pl.’s Br. In Supp. Mot.,
ECF No. 28 .................................................................................................. passim
SmithKline Corp. v. Eli Lilly & Co.,
575 F.2d 1056 (3rd Cir. 1978). ............................................................................34
Steward Health Care Sys., LLC v. Blue Cross & Blue Shield,
997 F. Supp. 2d 142 (D.R.I. 2014) ............................................................... 34, 36
Town of Concord v. Bos. Edison Co.,
915 F.2d 17 (1st Cir. 1990) ..................................................................................31
iii
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United Food & Com. Workers Loc. 1776 & Participating Emps. Health & Welfare
Fund v. Takeda Pharm. Co. Ltd., 11 F.4th 118 (2d Cir. 2021) .............. 20, 21, 32
United States v. Griffith,
334 U.S. 100 (1948) .............................................................................................31
United States v. Grinnell Corp.,
384 U.S. 563 (1966) .............................................................................................31
Verizon Commc’ns, Inc. v. Trinko, LLP,
540 U.S. 398 (2004). ......................................................................... 33, 34, 35, 36
Verizon Communications Inc. v. FCC,
535 U.S. 467 (2002) .............................................................................................35
Statutes
Drug Price Competition and Patent Term Restoration Act of 1984,
Pub. L. No. 98-417, 98 Stat. 1585 (1984)........................................................8, 11
15 U.S.C. §§ 41-58.....................................................................................................3
21 U.S.C. § 355(b)(1)(A) ................................................................................. passim
21 U.S.C. § 355(c)(2) ...............................................................................................12
21 U.S.C. § 355(c)(3)(D)(ii) ....................................................................................13
21 U.S.C. § 355(j) ......................................................................................................9
21 U.S.C. § 355(j)(2)(A)(vii) ...................................................................................10
21 U.S.C. § 355(j)(5)(B)(iii) ....................................................................................11
21 U.S.C. § 355(j)(5)(C)(ii) ............................................................................. passim
21 U.S.C.S. §§ 355(b)(1) (LexisNexis 2019) ..........................................................21
Other Authorities
Bradley S. Albert et al., Overview of FTC Actions in Pharm. Products and Distrib.,
Fed Trade Comm’n (Jan. 2024), ............................................................................3
Brandon J. Demkowicz et al., Patenting Strategies on Inhaler Delivery Devices,
164 Chest 450 (2023) ...........................................................................................29
Fed. Trade Comm’n, Federal Trade Commission Statement Concerning Brand
Drug Manufacturers’ Improper Listing of Patents in the Orange Book (Sept. 14,
2023) ............................................................................................................ passim
Fed. Trade Comm’n, Generic Drug Entry Prior to Patent Expiration: An FTC
Study (2002).............................................................................................. 4, 13, 32
iv
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Herbert Hovenkamp, Antitrust and the Patent System: A Reexamination,
76 Ohio St. L.J. 467 (2015) .................................................................................26
Judge Douglas Ginsburg & Josh Wright, Reimagining Antitrust Institutions: A
(Modest?) Proposal (George Mason L. & Econ. Rsch. Paper No. 23-22 2023)
(forthcoming, Rev. L. Econ.) ...............................................................................36
Letter from Rahul Rao, Dep. Dir., Bur. Competition, Fed. Trade Comm’n to Glaxo
Group Ltd (Nov. 7, 2023) ....................................................................................14
Letter from Rahul Rao, Dep. Dir., Bur. Competition, Fed. Trade Comm’n to
GlaxoSmithKline Intell. Prop. Dev. Ltd (Nov. 7, 2023) .....................................14
Letter from Rahul Rao, Dep. Dir., Bur. Competition, Fed. Trade Comm’n to
Norton (Waterford) Ltd. Regarding Improper Orange Book-Listed Patents for
QVAR RediHaler (Nov. 7, 2023) ................................................................ passim
Letter from Rahul Rao, Dep. Dir., Bur. Competition, Fed. Trade Comm’n to Teva
Branded Pharm. Prods.R&D, Inc. Regarding Improper Orange Book-Listed
Patents for QVAR 40, ProAir HFA, ProAir DigiHaler (Nov. 7, 2023) ...... passim
Letter from Sen. Bernie Sanders et al. to Emma Walmsley, Chief Exec. Off., GSK
(Jan. 8, 2024),.........................................................................................................7
Letter from Sen. Bernie Sanders et al. to Hubertus von Baumbach, Chairman of the
Bd. of Managing Dirs., Boehringer Ingelheim Int’l GmbH (Jan. 8, 2024) ...........7
Letter from Sen. Bernie Sanders et al. to Pascal Soriot, Exec. Dir. & Chief Exec.
Off., AstraZeneca PLC (Jan. 8, 2024) ...................................................................7
Letter from Sen. Bernie Sanders et al. to Richard Francis, Pres. & Chief Exec. Off.,
Teva Pharm. Indus. Ltd. (Jan. 8, 2024) .................................................................7
Minal R. Patel et al., Improving the Affordability of Prescription Medications for
People with Chronic Respiratory Disease: An Official American Thoracic
Society Policy Statement, 198 Amer. J. of Respiratory & Critical Care Med.
1367 (2018) ..........................................................................................................28
Reed F. Beall et al., Is Patent “Evergreening” Restricting Access to
Medicine/Device Combination Products?, 11 PLOSE ONE 3 (2016)................29
Robin Feldman et al., Empirical Evidence of Drug Pricing Games—A Citizen's
Pathway Gone Astray, 20 Stan. Tech. L. Rev. 39, 46 (2017) .............................26
U.S. Dep’t Health & Hum. Servs., Food & Drug Admin., Approved Drug Products
with Therapeutic Equivalence Evaluations (44th ed. 2024)..................... 2, 15, 16
U.S. Dep’t Health & Hum. Servs., Food & Drug Admin., Approved Drug Products
with Therapeutic Equivalence Evaluations (7th ed. 1987) ..................................15
v
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U.S. Food & Drug Admin., Generic Competition and Drug Prices (Dec. 2019) ....26
U.S. Food & Drug Admin., Patent Listing Disputes
(current through Mar. 8, 2024) ............................................................................14
U.S. Food & Drug Admin., Report to Congress: The Listing of Patent Information
in the Orange Book (Jan. 2022) ...........................................................................12
U.S. Patent No. 3,644,353........................................................................................15
U.S. Patent No. 7,500,444........................................................................................14
U.S. Patent No. 8,113,199........................................................................................14
U.S. Patent No. 8,161,968........................................................................................14
U.S. Patent No. 8,534,281........................................................................................14
William B. Feldman et al., Manufacturer revenue on inhalers after expiration of
primary patents, 2000-2021, 329 J. Amer. Med. Assoc. 1 (2023) ............... 29, 30
Regulations
Abbreviated New Drug Applications and 505(b)(2) Applications, 81 Fed. Reg.
69580, 69631 (Oct. 6, 2016). ...............................................................................18
Applications for FDA Approval to Market a New Drug: Patent Submission and
Listing Requirements and Application of 30-Month Stays on Approval of
Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug
Is Invalid or Will Not Be Infringed,
68 Fed. Reg. 36676 (June 18, 2003) ......................................................... 9, 19, 23
21 C.F.R. § 314.3 .....................................................................................................18
21 C.F.R. § 314.3(b) ......................................................................................... 18, 24
21 C.F.R. § 314.53(b)(1) ............................................................................. 17, 18, 24
21 C.F.R. § 314.53(b)(1) (2003) ....................................................................... 11, 21
21 C.F.R. § 314.53(f) ......................................................................................... 12,13
21 C.F.R. § 314.95(a)...............................................................................................10
vi
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INTRODUCTION
Listing a patent in the Orange Book gives a brand pharmaceutical company
a powerful tool—the ability to trigger a 30-month stay of approval of a generic
competitor product. The Federal Trade Commission (FTC or Commission) has a
long history of working to address improper Orange Book patent listings because
of how those listings thwart competition from lower-cost generic drugs.
Amneal alleges that Teva’s improper listing of patents for dose counters and
inhaler devices in the Orange Book is delaying entry of its less expensive generic
asthma inhalers from summer 2024 to early 2026.1 Millions of Americans rely on
asthma inhalers for life-saving treatment, and the patent on the active ingredient in
many asthma inhalers—albuterol—expired in 1989. Although albuterol has long
been off-patent, there remains little generic competition in the market for asthma
inhalers, in part because brand manufacturers improperly list patents that claim
device-related aspects of asthma inhalers, like dose counters, to block competition.
As a result, asthma inhalers often cost hundreds of dollars, although they would
likely cost significantly less in a more competitive market.
Because improper Orange Book listings can effectively block competition,
Congress carefully prescribed what types of patents must be listed in the Orange
See Def.’s Answer, Affirmative Defenses, and Countercl. to Pl.s’ First Am.
Compl., ECF No. 12 ¶¶ 121-22, 130 (“Amneal Countercl.”). At this stage in the
proceedings, these allegations are accepted as true.
1
1
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Book, permitting only drug substance, drug product, and method of use patents on
Food and Drug Administration (FDA) approved drugs to be listed. Here, however,
Teva has triggered a 30-month stay based on inhaler and dose counter device
patents that, on their face, are not specific to any FDA-approved drug. Indeed, one
of the asserted patents (U.S. Patent No. 10,561,808) has been listed in the Orange
Book for 21 different products spanning six separate new drug applications (NDA)
and four active ingredients.2
In the FTC’s view, device patents that do not mention any drug in their
claims do not meet the statutory criteria for Orange Book listing, and a device
patent that is improperly listed in the Orange Book must be delisted. Should a
brand manufacturer not voluntarily delist an improperly listed device patent, it is
well within the powers of a district court to compel delisting. Here, Teva has listed
device patents in the Orange Book that do not mention any drug in their claims. If
the Court agrees that such patents do not meet the listing requirements, it should
grant Amneal’s motion for judgment on the pleadings and order Teva to delist the
patents at issue—clearing the way for Americans to access less expensive asthma
inhalers.
See U.S. Dep’t Health & Hum. Servs., Food & Drug Admin., Approved Drug
Products with Therapeutic Equivalence Evaluations ADA 7, 39-40, 178-188 (44th
ed. 2024) (“Orange Book”).
2
2
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Teva’s arguments opposing delisting are unavailing and inconsistent with
the statute. Indeed, in a strikingly similar case, the First Circuit rightly held it
improper to list a device patent that did not mention the active ingredient or the
drug product in the claims. Moreover, Teva’s novel argument that the delisting
provision immunizes its conduct from the antitrust laws is wrong. Courts and the
FTC, the expert body charged with protecting fair competition in pharmaceutical
markets, have long recognized that improper Orange Book listings can be
actionable under the antitrust laws.
INTEREST OF THE FEDERAL TRADE COMMISSION
The FTC is an independent agency charged by Congress with enforcing
competition and consumer protection laws.3 It exercises primary responsibility for
federal antitrust enforcement in the pharmaceutical industry. 4 The Commission has
substantial experience evaluating pharmaceutical competition under the HatchWaxman Act and has brought numerous enforcement actions challenging
anticompetitive abuses of the Hatch-Waxman framework. 5
15 U.S.C. §§ 41-58.
For a recent summary of the FTC’s actions in the pharmaceutical industry, see
Bradley S. Albert et al., Overview of FTC Actions in Pharm. Products and Distrib.,
Fed Trade Comm’n (Jan. 2024),
https://www.ftc.gov/system/files/ftc_gov/pdf/Overview-Pharma.pdf.
5
See, e.g., FTC v. Actavis, Inc., 570 U.S. 136 (2013); King Drug Co. of Florence,
Inc. v. Cephalon, Inc., 88 F. Supp. 3d 402 (E.D. Pa. 2015); Impax Labs, Inc. v.
FTC, 994 F.3d 484 (5th Cir. 2021); FTC v. AbbVie Inc., 976 F.3d 327 (3d Cir.
2020); FTC v. Shkreli, 581 F. Supp. 3d 579 (S.D.N.Y. 2022).
3
4
3
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The FTC has long been concerned about abusive Orange Book listings
because of how improper listings may delay and deter competition from less
expensive generic drugs. The Commission first examined the effect of Orange
Book listings on competition as part of a 2002 study, identifying numerous
instances in which companies used the 30-month stay to block competition.6
Around the same time, the FTC successfully settled an action under the antitrust
laws against Biovail Corporation for, among other things, wrongfully listing a
patent in the Orange Book to block generic competition. 7
The FTC has also regularly filed amicus briefs in private litigation,
explaining how improper Orange Book listings can violate the antitrust laws.8 In
September 2023, the FTC issued a policy statement, supported by the FDA,
warning that improperly listing patents in the Orange Book may constitute illegal
See Fed. Trade Comm’n, Generic Drug Entry Prior to Patent Expiration: An
FTC Study, 39-52 (2002) (“FTC Study on Generic Drug Entry Before Patent
Expiration”), https://www.ftc.gov/reports/generic-drug-entry-prior-patentexpiration-ftc-study.
7
Decision & Order, In re Biovail Corp., FTC Dkt. No. C-4060 8 (Oct. 2, 2002).
8
See Mem. of Law for Fed. Trade Comm’n as Amicus Curiae, In re: Buspirone
Patent Litig., No. 1:01-md-1410, ECF No. 31 (S.D.N.Y. Jan. 8, 2002); Mem. of
Law for Fed. Trade Comm’n as Amicus Curiae, Jazz Pharms., Inc. v. Avadel CNS
Pharms., LLC, No. 1:21-cv-691, ECF No. 227 (D. Del. Nov. 15, 2022); Mem. of
Law for Fed. Trade Comm’n as Amici Curiae, Mylan Pharms. Inc. v. SanofiAventis U.S. LLC, No. 2:23-cv-00836, ECF No. 64 (W.D. Pa. Nov. 21, 2023).
6
4
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monopolization under section 2 of the Sherman Act as well as an unfair method of
competition under section 5 of the FTC Act. 9
Last November, the FTC’s Bureau of Competition sent warning letters to ten
drug manufacturers notifying them of more than 100 Orange Book patent listings
that FTC staff believes to be improper (“warning letters”). 10 The warning letters
identified patents listed on 13 inhaler products and four epinephrine injector pens,
among other FDA-approved products. Two of the warning letters were sent to
Teva and identified the five patents at issue in this case (the “asserted patents”) as
See Fed. Trade Comm’n, Federal Trade Commission Statement Concerning
Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book, at 5-6
(Sept. 14, 2023) (“FTC Orange Book Policy Statement”),
https://www.ftc.gov/system/files/ftc_gov/pdf/p239900orangebookpolicystatement0
92023.pdf; see also Fed. Trade Comm’n, Press Release, FTC Issues Policy
Statement on Brand Pharmaceutical Manufacturers’ Improper Listing of Patents in
the Food and Drug Administration’s ‘Orange Book’ (Sep. 14, 2023) (“FTC Press
Release re: Orange Book Policy Statement”), https://www.ftc.gov/newsevents/news/press-releases/2023/09/ftc-issues-policy-statement-brandpharmaceutical-manufacturers-improper-listing-patents-food-drug (“The FDA
appreciates and supports the FTC’s efforts to examine whether brand drug
companies are impeding generic drug competition by improperly listing patents in
the Orange Book,’ said FDA Commissioner Robert M. Califf, M.D.”).
10
See Fed. Trade Comm’n, Press Release, FTC Challenges More Than 100
Patents As Improperly Listed in the FDA’s Orange Book (Nov. 7, 2023) (FTC
Press Release re: Improper Orange Book Listings”), https://www.ftc.gov/newsevents/news/press-releases/2023/11/ftc-challenges-more-100-patents-improperlylisted-fdas-orange-book.The patents identified in the warning letters should not be
interpreted as an exclusive or exhaustive list of patents that the FTC believes are
wrongfully listed, and companies that did not receive a letter in November 2023
should not assume the FTC views their listings as proper. The FTC continues to
scrutinize whether additional patents are improperly listed, and all companies have
an ongoing responsibility to ensure their listings are lawful.
9
5
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well as 37 additional Teva patent listings on inhalers.11 The letters notified Teva
and other drug companies that the FTC was utilizing FDA’s regulatory patent
listing dispute process to challenge the improper listings, while retaining the right
to take further action against the companies that the public interest may require,
including investigating the conduct as an unfair method of competition under
section 5 of the FTC Act.
In response to the warning letters, several companies, including
GlaxoSmithKline, Kaleo, Inc., and Impax Laboratories LLC, delisted 14 patents
across six NDAs. Meanwhile, AstraZeneca, Boehringer Ingelheim, and
GlaxoSmithKline announced that they would reduce patient out-of-pocket costs for
all of their asthma inhalers to $35 a month.12 Following the warning letters,
See Letter from Rahul Rao, Dep. Dir., Bur. Competition, Fed. Trade Comm’n
to Teva Branded Pharm. Prods. R&D, Inc. Regarding Improper Orange BookListed Patents for QVAR 40, ProAir HFA, ProAir DigiHaler (Nov. 7, 2023)
(“Teva Warning Letter”), https://www.ftc.gov/system/files/ftc_gov/pdf/tevabranded-pharma-orange-book.pdf (disputing propriety of 35 patent listings,
comprised of 18 patents across 3 inhaler products); Letter from Rahul Rao, Dep.
Dir., Bur. Competition, Fed. Trade Comm’n to Norton (Waterford) Ltd. Regarding
Improper Orange Book-Listed Patents for QVAR RediHaler (Nov. 7, 2023)
(“Norton Warning Letter”), https://www.ftc.gov/system/files/ftc_gov/pdf/nortonorange-book.pdf (disputing propriety of 7 patent listings on 1 inhaler product).
12
See Press Release, AstraZeneca, AstraZeneca caps patient out-of-pocket costs
at $35 per month for its US inhaled respiratory portfolio (Mar. 18, 2024),
https://www.astrazeneca-us.com/media/press-releases/2024/astrazeneca-capspatient-out-of-pocket-costs-at-35-per-month-for-its-us-inhaled-respiratoryportfolio.html; Press Release, Boehringer Ingelheim, Boehringer Ingelheim caps
patient out-of-pocket costs for its inhaler portfolio at $35 per month (Mar. 7,
11
6
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numerous members of Congress also launched inquiries into the drug companies’
Orange Book listings and other potentially anticompetitive practices.13
The warning letters to Teva explained FTC staff’s belief that the patents at
issue in this case—plus many others—are improperly listed in the Orange Book.
2024), https://www.boehringer-ingelheim.com/us/press-releases/boehringeringelheim-caps-patient-out-of-pocket-costs-inhaler-portfolio; Press Release,
GlaxoSmithKline, GSK announces cap of $35 per month on U.S. patient out-ofpocket costs for its entire portfolio of asthma and COPD inhalers (Mar. 20, 2024),
https://us.gsk.com/en-us/media/press-releases/gsk-announces-cap-of-35-permonth-on-us-patient-out-of-pocket-costs-for-its-entire-portfolio-of-asthma-andcopd-inhalers. While the Commission welcomes voluntarily reductions in patients’
out-of-pocket costs, doing so is not a substitute for removing improper patent
listings, as such listings may delay competition from generics with lower list
prices.
13
See Press Release, U.S. Sen. Comm. On Health, Educ. Labor and Pensions,
Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee
Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of
Asthma Inhalers (Jan. 8, 2024),
https://www.help.senate.gov/chair/newsroom/press/news-chairman-sandersbaldwin-lujan-markey-launch-help-committee-investigation-into-efforts-bypharmaceutical-companies-to-manipulate-the-price-of-asthma-inhalers; Letter
from Sen. Bernie Sanders et al. to Pascal Soriot, Exec. Dir. & Chief Exec. Off.,
AstraZeneca PLC (Jan. 8, 2024), https://www.sanders.senate.gov/wpcontent/uploads/2024.01.08-HELP-Committee-Letter-to-AstraZeneca.pdf; Letter
from Sen. Bernie Sanders et al. to Hubertus von Baumbach, Chairman of the Bd.
Of Managing Dirs., Boehringer Ingelheim Int’l GmbH (Jan. 8, 2024),
https://www.sanders.senate.gov/wp-content/uploads/2024.01.08-HELPCommittee-Letter-to-Boehringer-Ingelheim.pdf; Letter from Sen. Bernie Sanders
et al. to Emma Walmsley, Chief Exec. Off., GSK (Jan. 8, 2024),
https://www.sanders.senate.gov/wp-content/uploads/2024.01.08-HELPCommittee-Letter-to-Boehringer-Ingelheim.pdf; Letter from Sen. Bernie Sanders
et al. to Richard Francis, Pres. & Chief Exec. Off., Teva Pharm. Indus. Ltd. (Jan. 8,
2024), https://www.sanders.senate.gov/wp-content/uploads/2024.01.08-HELPCommittee-Letter-to-Teva.pdf.
7
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Rather than heed this warning, Teva re-certified the propriety of the 42 patentlistings identified in the warning letter, including each of the five patents listed for
ProAir HFA that Teva asserts in this case.14 Moreover, Teva re-certified those
Orange Book listings despite the underlying device patents’ failure to mention any
drug at all in their claims. According to Amneal’s counterclaims, Teva is using
these improper Orange Book listings to restrict competition and delay Amneal
from making less expensive generic inhalers available to the American public.15
The FTC submits this amicus brief because device patents improperly listed
in the Orange Book can undermine fair competition, shutting out generics from the
market and depriving Americans of access to lower-cost drugs.16
BACKGROUND
I.
The Statutory and Regulatory Framework
Congress passed the Drug Price Competition and Patent Term Restoration
Act of 1984, known as the Hatch-Waxman Act, 17 with the aim of “balanc[ing] two
See Teva Warning Letter, supra note 11; Norton Warning Letter, supra note 11.
Amneal Countercl., ECF No. 12 ¶¶ 101-05; 120-25.
16
As the FTC stated in its policy statement, the Commission will “use all its tools
to halt unlawful business practices that contribute to high drug prices.” FTC
Orange Book Policy Statement, supra note 9. In filing this amicus brief, the FTC
does not disclaim or waive its right to bring an enforcement action against Teva or
any other company that the FTC believes may continue to improperly list patents
in the Orange Book.
17
Pub. L. No. 98-417, 98 Stat. 1585 (1984).
14
15
8
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competing interests.” 18 On the one hand, the Hatch Waxman Act “encourag[es]
research and innovation” by protecting brand drug companies’ patent interests
associated with drugs approved through the NDA.19 On the other, the Act seeks to
facilitate getting lower-cost “generic drugs on the market in a timely fashion”20
through mechanisms like the abbreviated new drug application (ANDA), which
provides an expedited pathway for approval of generic drugs. 21
The Hatch-Waxman framework includes provisions “that encourage the
quick resolution of patent disputes” for certain types of patents.22 The HatchWaxman amendments and FDA regulations instruct brand manufacturers to submit
information about certain patents for their NDA products to the FDA for
publication in a compendium entitled “Approved Drug Products with Therapeutic
Equivalence Evaluations,” commonly referred to as the “Orange Book.”23 Listing a
patent in the Orange Book can be extremely valuable because it gives brand
In re Lantus Direct Purchaser Antitrust Litig., 950 F.3d 1, 5 (1st Cir. 2020)
(citing Applications for FDA Approval to Market a New Drug: Patent Submission
and Listing Requirements and Application of 30-Month Stays on Approval of
Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is
Invalid or Will Not Be Infringed, 68 Fed. Reg. 36676 (June 18, 2003)
19
Id.
20
Id. at 11 (citing 68 Fed. Reg. at 36676).
21
See 21 U.S.C. § 355(j).
22
AbbVie, 976 F.3d at 339.
23
See Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405-6
(2012).
18
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manufacturers the power to trigger an automatic delay of FDA approval of
competing generic products, generally for 30 months.
When a drug company seeks to market a generic version of a brand drug for
which there are patents listed in the Orange Book, the company must provide a
“certification” for each listed patent “which claims the listed drug . . . or which
claims a use for such listed drug for which the applicant is seeking approval.” 24 For
non-expired patents, the generic company can file a “paragraph IV” certification
asserting that the brand company’s patent is invalid or will not be infringed by the
generic drug. 25 Notice of the certification triggers an immediate right for the brand
manufacturer to sue for infringement.26 When a brand manufacturer brings such an
infringement suit within 45 days after receiving notice for a patent that was
submitted to FDA prior to the submission of the ANDA, as Teva did here, the
FDA’s approval of the generic manufacturer’s ANDA is automatically stayed for
21 U.S.C. 355(j)(2)(A)(vii); see also 21 C.F.R. § 314.95(a).
See 21 U.S.C. § 355(j)(2)(A)(vii). If the generic is not contending the patents
are invalid or not infringed, it would simply file a “paragraph III” certification
signifying it will wait to come to market until patent expiry. See id.
26
There is no right to file an infringement suit in response to a paragraph IV
certification if the patent was obtained by fraud on the U.S. Patent and Trademark
Office or if the infringement suit would be objectively baseless. See, e.g., AbbVie
Inc., 976 F.3d at 361 (“[W]e must not immunize a brand-name manufacturer who
uses the Hatch-Waxman Act’s automatic, 30-month stay to thwart competition.
Doing so would excuse behavior that Congress proscribed in the antitrust laws.”).
24
25
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30 months. 27 Unlisted patents can still be enforced after the generic product
launches. 28
Given the significant consequences of listing a patent in the Orange Book,
Congress put strict limits on the types of patents that may be listed. The HatchWaxman Act included Orange Book listing provisions that require brand
manufacturers to submit listing information for specific types of patents.29 For over
two decades, FDA regulations have further specified that patents eligible for listing
“consist of drug substance (active ingredient) patents, drug product (formulation
and composition) patents, and method-of-use patents.”30 More recently, Congress
enacted the Orange Book Transparency Act of 2020 (OBTA), which amended the
listing provisions to state that a patent should be listed only if a “claim of patent
infringement could reasonably be asserted” and the patent:
(I) claims the drug for which the applicant submitted the
application and is a drug substance (active ingredient)
patent or a drug product (formulation or composition)
patent; or
21 U.S.C. § 355(j)(5)(B)(iii). If the patent is held infringed, that stay of
approval is automatically extended until the patent’s expiration date; compare
eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 390-1 (2006) (holding
prevailing patent plaintiff must normally meet traditional four-factor test to obtain
permanent injunction).
28
See Bayer AG v. Biovail Corp., 279 F.3d 1340, 1350 (Fed. Cir. 2002) (denying
collateral estoppel because “infringement under [35 U.S.C] § 271I(2)(A) by
submission of an ANDA is not synonymous with infringement under § 271(a) by a
commercial product”).
29
Pub. L. No. 98-417, Stat. 1585.
30
21 C.F.R. § 314.53(b)(1) (2003).
27
11
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(II) claims a method of using such drug for which
approval is sought or has been granted in the
application. 31
Further, the listing provisions provide that information on patents that do not meet
these requirements “shall not be submitted.” 32
NDA holders have a responsibility to ensure that Orange Book patent
listings meet the statutory requirements. The FDA considers its role in this listing
process to be “purely ministerial.”33 It does not “police the listing process by
analyzing whether the patents listed by NDA applicants actually claim the subject
drugs or applicable methods of using those drugs.”34
Although the FDA does not independently evaluate the patents submitted for
listing in the Orange Book, it provides a process under which any person may
“dispute[] the accuracy or relevance of patent information submitted.” 35 Under that
process, the FDA relays the dispute statement to the brand manufacturer. The
brand manufacturer must respond within 30 days by instructing the FDA to delist
the patent or amend the patent information, or by re-certifying under penalty of
21 U.S.C. § 355(b)(1)(A)(viii).
Id. § 355(c)(2).
33
Organon Inc. v. Mylan Pharms., Inc., 293 F. Supp. 2d 453, 458-59 (D.N.J.
2003); see also U.S. Food & Drug Admin., Report to Congress: The Listing of
Patent Information in the Orange Book, at 5 (Jan. 2022).
https://www.fda.gov/media/155200/download (“FDA serves a ministerial role with
regard to the listing of patent information”).
34
Apotex v. Thompson, 347 F.3d 1335, 1349 (Fed. Cir. 2003).
35
21 C.F.R. § 314.53(f).
31
32
12
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perjury the propriety of the listings. 36 The FDA does not assess or take any other
action on the dispute and will not change or remove the Orange Book listing unless
the brand manufacturer instructs the FDA to do so in its response. 37
In 2003, Congress authorized generic manufacturers that are sued for
infringement of Orange Book-listed patents to bring a counterclaim seeking to
remove the listing. 38 In addition to this delisting counterclaim, courts and the FTC
have long recognized (both before and after the adoption of the delisting
counterclaim provision) that improper Orange Book listings can also be actionable
under the antitrust laws.39 The FDA supports the FTC’s efforts to examine whether
brand drug companies are impeding generic drug competition by improperly listing
patents in the Orange Book.40
36
See id.
See id.
38
See 21 U.S.C. § 355(j)(5)(C)(ii)(I).
39
See, e.g., Lantus, 950 F.3d at 6-7, 15 (finding improper listing of component
device patent may support Section 2 Sherman Act claim); In re Loestrin 24 Fe
Antitrust Litig., 433 F. Supp. 3d 274, 315 (D.R.I. 2019) (ruling “sham Orange
Book listing claim” under Section 2 of the Sherman Act may proceed to trial); In
re Remeron Antitrust Litig., 335 F. Supp. 2d 522, 531 (D.N.J. 2004) (“there exists
no regulatory scheme [for Orange Book listings] so extensive as to supplant
antitrust laws”); see also FTC Study on Generic Drug Entry Before Patent
Expiration, supra note 6, at 1; FTC Orange Book Policy Statement, supra note 9,
at 1.
40
See FTC Press Release re: Orange Book Policy Statement, supra note 9.
37
13
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II.
Teva Continues to Improperly List Patents in the Orange Book—
Including the Asserted Patents—Despite FTC Staff Warnings
In November 2023, the FTC’s Bureau of Competition sent letters to ten
brand manufacturers informing them that FTC staff have opted to use the FDA’s
process to dispute over 100 Orange Book listings.41
In response, four brand drug manufacturers requested that the FDA remove
from the Orange Book virtually all their patent listings identified by the FTC.42
Several of those companies delisted asthma inhaler device patents and device
component patents with claims that resemble the asserted patents in this case (i.e.,
device or device component patents that do not mention the active ingredient or the
drug product that is the subject of the NDA in the patent claims). 43
FTC Press Release re: Improper Orange Book Listings, supra note 10.
See U.S. Food & Drug Admin., Patent Listing Disputes (current through Mar.
8, 2024), https://www.fda.gov/media/105080/download (noting changes in the
patent listings for Kaleo Inc., Impax Laboratories LLC, GlaxoSmithKline
Intellectual Property Development Limited, and Glaxo Group Limited). All told,
these four manufacturers voluntarily delisted fourteen patents across six NDAs,
with one patent being listed for three different applications.
43
For example, GSK removed listings for patents on an “actuation indicator”
(U.S. Patent No. 7,500,444), a “dose counter for use with a medicament dispenser”
(U.S. Patent No. 8,113,199), a “medicament dispenser” (U.S. Patent No.
8,161,968), and a “manifold for use in a medicament dispenser” (U.S. Patent No.
8,534,281). Compare Letter from Rahul Rao, Dep. Dir., Bur. Competition, Fed.
Trade Comm’n to GlaxoSmithKline Intell. Prop. Dev. Ltd (Nov. 7, 2023),
https://www.ftc.gov/system/files/ftc_gov/pdf/glaxosmithkline-orange-book.pdf,
and Letter from Rahul Rao, Dep. Dir., Bur. Competition, Fed. Trade Comm’n to
Glaxo Group Ltd (Nov. 7, 2023),
https://www.ftc.gov/system/files/ftc_gov/pdf/glaxo-group-orange-book.pdf, with
41
42
14
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Teva, however, did not delist or amend any of the 42 patent-listings disputed
by the FTC, including the asserted patents in this case.44 Each of the asserted
patents were listed in the Orange Book during the period from 2012 to 2022. 45 The
patents are device or device component patents that claim a dose counter or an
inhaler that includes a dose counter.46 On their face, none of these patents mention
any drug in their claims, much less the active ingredient in ProAir HFA, albuterol
sulfate.47 Notably, the patent covering albuterol sulfate expired in 1989.48
Patent No.
8,132,712
9,463,289
9,808,587
10,561,808
11,395,889
Patent Title
Metered-dose inhaler
Dose counters for inhalers, inhalers
and methods of assembly thereof
Dose counter for inhaler having an
anti-reverse rotation actuator
Dose counter for inhaler having an
anti-reverse rotation actuator
Dose counter for inhaler having an
anti-reverse rotation actuator
List Date
Mar. 27, 2012
Nov. 8, 2016
Nov. 16, 2017
Mar. 19, 2020
Aug. 19, 2022
U.S. Food & Drug Admin., Patent Listing Disputes, supra note 42, and Delisted
Patents, U.S. Food & Drug Admin.,
https://www.accessdata.fda.gov/scripts/cder/ob/search_patent.cfm?listed=delisted
(last updated Mar. 20, 2024).
44
Compare Teva Warning Letter, supra note 11 and Norton Warning Letter,
supra note 11 with U.S. Food & Drug Admin., Patent Listing Disputes, supra note
42.
45
Pl.’s Am. Compl., ECF No. 7, Exs. A-E.
46
See id.
47
See id.; see also Orange Book (44th ed. 2024), supra note 2, at ADA 7(listing
active ingredient of ProAir HFA as albuterol sulfate).
48
Orange Book AD 6 (7th ed. 1987) (referencing U.S. Patent No. 3,644,353) (on
file with Hyman, Phelps, & McNamara PC, The Orange Book Archives, 1987, 7th
Ed., https://thefdalawblog.com/wp-content/uploads/2020/06/OB-Annual-1987-7thEd.pdf).
15
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Each of the asserted patents is also listed in the Orange Book for other Teva
products.49 For example, Teva has listed U.S. Patent No. 10,561,808 on a dose
counter in the Orange Book for 21 different approved drugs, many of which
contain entirely different active ingredients from ProAir HFA. 50
Despite receiving warning letters from the FTC’s Bureau of Competition,
Teva continues to list device and device component patents that, on their face, do
not mention any drug in their claims. As a result, Teva can trigger—and here, has
in fact triggered—a 30-month stay that blocks competition from less expensive
generic inhalers solely based on these patents. In this case, Amneal submitted its
ANDA seeking approval to market a generic version of ProAir HFA on August 24,
2023, and alleges that absent the 30-month stay, it could launch its less expensive
competitor asthma inhaler as early as this summer.
ARGUMENT
The FTC believes this Court should grant Amneal’s motion for a judgment
on the pleadings as to counterclaim counts 1-5 regarding Teva’s improper Orange
Book listings. To aid the court in its analysis of the other federal law
counterclaims, the FTC also explains how improper Orange Book listings harm
49
50
Amneal Countercl., ECF No. 12 ¶ 86.
See Orange Book (44th ed. 2024), supra note 2, at ADA 7, 39-40, 178-188.
16
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fair competition and can trigger antitrust liability, and why Trinko does not apply
to Amneal’s counterclaims.
I.
Drug Manufacturers Cannot Lawfully List Device Patents That Are Not
Limited to Either the Active Ingredient or the Approved Product
The statutory listing provisions and related regulations require that, to be
properly listed in the Orange Book, a patent must “claim[] the drug for which the
applicant submitted the [NDA]” and also be either “a drug substance (active
ingredient) patent or a drug product (formulation or composition) patent.” 51
Alternatively, the patent may claim a “method of using such drug for which
approval is sought or has been granted in the application.” 52 Here, Teva listed the
asserted patents in the Orange Book as “drug product” patents,53 and it is
undisputed that these patents are not “drug substance” or “method of use” patents.
Teva contends that the asserted patents qualify for the second category—
drug product. However, a device or device component patent that does not mention
any drug in its claims is not a “drug product (formulation or composition) patent.”
Rather, FDA regulations instruct manufacturers to “submit information only on
those patents that claim the drug product, as is defined in [21 C.F.R.] § 314.3, that
21 U.S.C. § 355(b)(1)(A)(viii). See also 21 C.F.R. § 314.53(b)(1).
Id.
53
Pl.’s Br. In Supp. Mot., ECF No. 28, at 6 (“There are nine unexpired patents
listed in the Orange Book for ProAir® HFA, each listed as a drug product patent.”)
(“Teva Br.”).
51
52
17
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is described in the pending or approved NDA.” 54 In turn, § 314.3 defines “drug
product” as “a finished dosage form, e.g., tablet, capsule, or solution, that contains
a drug substance, generally, but not necessarily, in association with one or more
other ingredients.” 55 Together, these provisions mean that brand drug
manufacturers may list as “drug product (formulation or composition) patents”
only those that claim the finished dosage form containing the drug substance of the
relevant NDA.56 The asserted patents do not meet this criterion because they are
device and device component patents untethered from any drug—much less the
ProAir HFA albuterol sulfate formulation.57
As the FDA stated in its 2003 rulemaking on patent submissions and listing
requirements, for drug product patent listings, “[t]he key factor is whether the
patent being submitted claims the finished dosage form of the approved drug
21 C.F.R. § 314.53(b)(1).
21 C.F.R. § 314.3(b) (emphasis added).
56
21 C.F.R. § 314.53(b)(1). The FDA’s 2016 regulations made some “Technical
Corrections to Regulatory Concepts” including modifying the text of
§ 314.53(b)(1) to reference “the drug product” instead of “a drug product.” This
was intended “to clarify that for patents that claim a drug product, the applicant
must submit information only on those patents that claim the drug product, as is
defined in § 314.3, that is described in the pending or approved NDA.” See
Abbreviated New Drug Applications and 505(b)(2) Applications, 81 Fed. Reg.
69580, 69631 (Oct. 6, 2016).
57
Amneal argues device patents are not listable in the Orange Book. Def.'s Br. In
Supp. Mot., ECF No. 48, at 14-21 (“Amneal Br.”). Setting aside for present
purposes whether device patents are ever listable, the FTC’s view is that device
and device component patents that do not claim the active ingredient or drug
product that is the subject of the NDA are not listable.
54
55
18
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product.” 58 Here, the drug substance that was the subject of Teva’s NDA for
ProAir HFA is albuterol sulfate, and its finished dosage form is “metered
aerosol.”59 The claims of the asserted patents mention neither albuterol sulfate nor
the ProAir HFA albuterol sulfate metered aerosol. A comparison to one of Teva’s
actual formulation patents—which expired long ago—is illuminating. For
example, claim 2 of U.S. Patent No. 5,695,743 claims “[a]n aerosol formulation
comprising: (a) a therapeutically effective amount of [albuterol]; and (b) a
propellant . . . comprising 1,1,1,2-tetrafluoroethane . . . .” This patent appears to
have been properly listed, as this claim specifies the particular drug product—a
metered aerosol formulation including the drug substance—for which Teva
received approval. In contrast, the asserted patents do not even mention any
elements of the formulation.
The First Circuit’s decision in In re Lantus Direct Purchaser Antitrust
Litigation, which similarly considered a device component patent and held its
listing improper, is instructive.60 In Lantus, the First Circuit considered an Orange
Book listing for a combination drug/device product called Lantus SoloSTAR, a
68 Fed. Reg. at 36680 (emphasis added).
Orange Book: Approved Drug Products with Therapeutic Equivalence
Evaluations, Product Details for NDA 021457, U.S. Food & Drug Admin.,
https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N
&Appl_No=021457#22991 (last visited Mar. 21, 2024).
60
950 F.3d at 1.
58
59
19
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“pre-filled drug delivery system” that dispenses insulin glargine to the patient—
i.e., an insulin injector pen. 61 That patent claimed “aspects of a ‘drive mechanism’
that serves as a part of the SoloSTAR drug injector pen.”62 The claims of the patent
listed in the Orange Book for SoloSTAR did not mention the active ingredient
insulin glargine or the drug product for which the NDA was submitted, Lantus
SoloSTAR. 63 The First Circuit held that Sanofi’s patent was improperly listed,
reasoning that “[t]he statute and regulations clearly require that only patents that
claim the drug for which the NDA is submitted should be listed in the Orange
Book” and a patent that “neither claims nor even mentions the [active ingredient]
or the [approved drug], does not fit the bill.” 64 The Teva listings at issue here are
strikingly similar to those the First Circuit held improper in Lantus.
The Second Circuit recently followed Lantus’s reasoning in a case where a
brand manufacturer listed patents claiming methods of treatment using a
combination of two active ingredients, even though the relevant NDA product
contained only one of those two active ingredients. 65 The Second Circuit
concluded that under Lantus “[a] patent claim that fails to explicitly include the
Id. at 4, 7.
Id. at 5.
63
Id. at 10.
64
Id.
65
United Food & Com. Workers Loc. 1776 & Participating Emps. Health &
Welfare Fund v. Takeda Pharm. Co. Ltd. (Actos), 11 F.4th 118, 127, 134-35 (2d
Cir. 2021).
61
62
20
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drug actually makes neither type of claim on the drug” permitted under the listing
provisions. 66
Teva’s other arguments that its patents are properly listed are unavailing.
First, Teva contends that the OBTA undermined Lantus by adding “component” or
“composition” in ways that changed the meaning of § 355.67 The OBTA did no
such thing. Each instance of “component” in § 355 was already included in the
statute before OBTA was enacted.68 And “composition” was added to the listing
provisions only to further specify the limits on the scope of listable patents—
codifying limits that existed in FDA regulations (but not the statute) pre-OBTA. 69
Second, Teva argues that even though the asserted patents do not claim the
drug substance listed in the NDA (albuterol sulfate), or even the drug product
listed in the NDA (ProAir HFA Inhalation Aerosol), the Court should find its
Orange Book listings proper because “[t]he Listing Statute Broadly Requires
Listing All Patents that ‘Claim the Drug,’” and the asserted patents purportedly
“read on” the ProAir HFA inhaler—meaning that the ProAir HFA’s inhaler meets
each claim element of at least one claim of the asserted patents. 70 But Teva’s
Id. at 134-35 (citing Lantus, 950 F.3d at 8).
Teva Br., ECF No. 28, at 13-14 (citing 21 U.S.C. §§ 355(b)(1)(A)(ii), (iii), (v),
(viii).
68
21 U.S.C.S. §§ 355(b)(1) (LexisNexis 2019); see also Amneal Br., ECF No. 48,
at 25.
69
21 U.S.C. § 355(b)(1)(A)(viii)(I); cf 21 C.F.R. § 314.53(b)(1) (2003).
70
Teva Br., ECF No. 28, at 9, 14-16.
66
67
21
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argument ignores the statutory text. Even assuming arguendo that the ProAir
device can be considered a part of the “drug,” under the statutory text, it is not a
sufficient condition for proper listing that the patent “claims the drug.” The
statutory text allows only listing of a patent that “claims the drug . . . and is a drug
substance (active ingredient) patent or a drug product (formulation or composition)
patent,” or else claims an approved method of using the drug. 71 Here, Teva’s
device and device component patents are none of those three types.72
Third, Teva argues that “patents claiming drug products or their components
must be listed in the Orange Book.” 73 Teva claims that the definition of “dosage
form” in 21 C.F.R. § 314.3 takes into account “such factors” as “[t]he way the
product is administered” and “[t]he design features that affect frequency of
dosing;” thus, Teva argues, it must list “patents covering any of the components
. . . that contribute” to ProAir HFA’s “finished dosage form” if they “relat[e] to
‘the way the product is administered’ and ‘design features that affect frequency of
dosing.’”74 According to Teva, these include device and device component patents.
21 U.S.C. § 355(b)(1)(A)(viii)(I) (emphasis added).
Teva cites Apotex, 347 F.3d at 1343-44 for its dictum that “[t]he listing decision
thus requires what amounts to a finding of patent infringement, except that the
‘accused product’ is the drug that is the subject of the NDA.” Teva Br., ECF No.
28, at 21. But that statement only occurred in the Court’s analysis of its subjectmatter jurisdiction, and in any event is no longer accurate in view of the OBTA
amendments to the listing provisions.
73
Teva Br., ECF No. 28, at 16 (emphasis added).
74
Id. at 16-17.
71
72
22
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In the FTC’s view, this argument stretches the FDA’s guidance well beyond a fair
reading. As explained above (at 19), the FDA’s guidance on whether to list a “drug
product” patent stated the “key factor is whether the patent being submitted claims
the finished dosage form.”75 Teva offers no authority or even explanation for
widening the FDA’s guidance to allow listing of device or device component
patents that “contribute” in some way to the finished dosage form (rather than
claiming it), or that “relat[e]” to the factors the FDA uses to determine a drug’s
dosage form.76
Indeed, in Lantus, the First Circuit rejected virtually the same argument that
Teva now makes. There, Sanofi argued it could list its device component patent—
claiming the drive mechanism of an insulin injector pen—because it was required
to list patents on “integral components” of the approved drug product. 77 Noting a
“gap between [Sanofi’s] reading of the law and its filing of a patent that does not
claim the listed drug,” the First Circuit concluded there was “nothing in the statute
or regulations that welcomes such a further expansion of the already stretched
statutory terms, whereby an integral part of an injector pen becomes the pen itself,
and in turn is a drug.” 78 The First Circuit ultimately held that the patent was
68 Fed. Reg. at 36680 (emphasis added).
Teva Br., ECF No. 28, at 16-17.
77
Lantus, 950 F.3d at 8.
78
Id.
75
76
23
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improperly listed because, even “assum[ing] for the sake of argument that the
Lantus SoloSTAR is a drug under the statute, there is still a vital link missing: the
‘864 patent does not claim or even mention the Lantus SoloSTAR.” 79 The same
logic applies here.80
Under Teva’s reading of the statute, drug companies could list any patent—
and obtain a 30-month stay of FDA approval of a generic competitor—where the
patent covers even one minor component of a drug-device combination product.
The limits Congress imposed on Orange Book listings reflect a desire to avoid such
an absurd result, in which patents on even minor device components trigger a stay
of FDA approval and delay competition from less expensive generic drug products.
Indeed, Teva’s interpretation is inconsistent with the language of the listing
provisions and would impermissibly render the “drug substance” category in the
79
Id.
Teva briefly argues that any patent not expressly excluded in the listing
regulation may be listed. Teva Br., ECF No. 28, at 17 quoting 21 C.F.R. §
314.53(b)(1) (“Process patents, patents claiming packaging, patents claiming
metabolites, and patents claiming intermediates are not covered by this section, and
information on these patents must not be submitted to FDA.”) (emphasis omitted).
This sweeping argument lacks merit for the reasons identified by Amneal. Amneal
Br., ECF No. 48, at 18 n.7. In addition, 21 C.F.R. § 314.53(b) imposes numerous
requirements for listing drug substance, drug product, and method-of-use patents
that Teva’s argument would read out of the regulation by collapsing all of §
314.53(b) into its final sentence. Teva’s argument would similarly make redundant
the OBTA’s adoption of the “drug substance” and “drug product” requirements in
21 U.S.C. § 355(b)(1)(A)(viii)(I).
80
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listing provisions surplusage. 81 Specifically, if any patent on a “component” of the
drug product—including the active ingredient—is listable as a drug product patent,
then there would be no reason to have a separate “drug substance (active
ingredient)” category. 82 The active ingredient is undoubtedly a “component” of the
“drug product,” along with the inactive ingredients. 83 Thus, the existence of a
separate category of “drug substance” for the active ingredient indicates that “drug
product” patents are not listable unless they claim the entire drug product, not just
components.
In short, the Hatch-Waxman Act does not authorize the listing of the
asserted patents because they do not mention any drug in their claims and are
therefore not “drug product (formulation or composition) patent[s]” under the
listing provisions, as Teva claims.
II.
Improper Orange Book Patent Listings Harm Competition
Improper Orange Book listings harm competition by deterring and delaying
entry of lower-cost generics. As discussed, the Hatch-Waxman framework gives
brand drug manufacturers with patents listed in the Orange Book the ability to
Arlington Cent. Sch. Dist. Bd. of Educ. v. Murphy, 548 U.S. 291, 299 n.1
(2006) (statutory interpretation presumes that “statutes do not contain surplusage”).
82
21 U.S.C. § 355(b)(1)(A)(viii).
83
See Ben Venue Lab. v. Novartis Pharm. Corp., 10 F. Supp. 2d 446, 458 (D.N.J.
1998) (“There can therefore be no serious question that, under 21 C.F.R.
§ 314.53(b), a ‘drug substance’ or ‘active ingredient’ may be a ‘component’ of a
drug product . . . .”).
81
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initiate patent infringement litigation against would-be generic competitors before
the FDA approves their ANDAs, which can lead to a 30-month stay of approval,
regardless of whether the patent is properly listable. 84 Purchasers, like patients,
hospitals, and health plans, are harmed each day that competition is delayed
beyond the point the FDA would have otherwise approved a generic challenger’s
ANDA product. These potential harms—both in terms of higher drug prices and
patient health—are serious.
When generic drugs enter a market, prices tend to fall dramatically. The
following graph from an FDA study illustrates the effects of increased competition
on generic drug prices relative to the brand drug price before entry. 85 Researchers
have found that with robust competition, most drug prices “eventually fall[] to 80–
85% below the original brand-name cost.”86
This is true unless the generic competitor prevails in litigation sooner. But see
Lantus, 950 F.3d at 4 (“[W]hile [the] thirty-month period may be shortened by
resolution of the infringement action or order of the court [], the status quo, the
allocation of burdens, and the life-span of patent litigation can all work against any
such shortening.”).
85
U.S. Food & Drug Admin., Generic Competition and Drug Prices: New
Evidence Linking Greater Generic Competition and Lower Generic Drug Prices 2
(Dec. 2019), https://www.fda.gov/media/133509/download.
86
Robin Feldman et al., Empirical Evidence of Drug Pricing Games—A Citizen's
Pathway Gone Astray, 20 Stan. Tech. L. Rev. 39, 46 (2017); see also Herbert
Hovenkamp, Antitrust and the Patent System: A Reexamination, 76 Ohio St.
L.J. 467, 491 (2015) (“[C]ompetition among generics drives prices to the
competitive level,” which can be “as little as 20% of pre-generic-entry prices.”).
84
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In this case, because the asserted patents have been listed in the Orange
Book, Teva’s suit has triggered the 30-month stay of approval on Amneal’s ANDA
product until February 2026.87 If not for this 30-month stay, Amneal alleges the
FDA could approve its ANDA product as early as next month, April 2024,88 and
pleads that if approved it could come to market as early as this summer. 89 Absent
this Court granting judgment on the pleadings as to counterclaim counts 1–5 and
ordering the asserted patents delisted, Amneal’s product—and the price
competition it would bring—may be delayed by nearly two years. 90
This is true unless Amneal prevails in this litigation sooner.
Amneal Br., ECF No. 48, at 3.
89
Amneal Countercl., ECF No. 12 ¶ 122.
90
The entry of Amneal’s product would also increase patient choice.
87
88
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In addition to raising prices, delayed competition from improper Orange
Book listings may in turn harm patient health. In 2018, the American Thoracic
Society (ATS) issued a policy statement observing that the high cost of inhalers
and other medicines for patients with asthma and COPD has led to higher out-ofpocket expenses and harmed patient health. 91 Based on its review of the academic
literature, the ATS concluded that higher out-of-pocket expenses can increase
stress, reduce medication adherence, and lead to worse health outcomes, including
unnecessary hospitalizations.92 The ATS also noted that these problems have been
“exacerbated by a paucity of generic alternatives”—i.e., by a lack of competition.93
Improper Orange Book listings appear to be part of a widespread problem,
particularly with inhaler device and device component patents. As explained
above, the FTC’s Bureau of Competition’s November 2023 warning letters
disputed over 100 Orange Book listings by ten brand drug manufacturers across 13
inhaler products and four epinephrine injector pens.94 With respect to even just
Teva alone, the letters disputed a total of 42 patent-listings across four inhaler
Minal R. Patel et al., Improving the Affordability of Prescription Medications
for People with Chronic Respiratory Disease: An Official American Thoracic
Society Policy Statement, 198 Amer. J. of Respiratory & Critical Care Med. 1367
(2018).
92
Id. at 1368.
93
Id. at 1367.
94
See FTC Press Release re: Improper Orange Book Listings, supra note 10.
91
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products.95 Additionally, a study published just last year examined all 53 asthma
and COPD inhalers approved by the FDA from 1986 to 2020 and found that 39 of
these products collectively listed 137 device patents in the Orange Book, the
majority of which (105, or 77%) failed to reference an active ingredient.96
Further, improper Orange Book listings create barriers to entry that may
deter generic competitors from entering the market in the first place. Faced with
the prospect of a 30-month delay of FDA-approval, a generic competitor may
forgo entry altogether, harming competition.
The revenue generated by brand drug companies from delays in competition
caused by improper Orange Book listings and other practices can be significant. A
recent academic study of FDA-approved asthma/COPD inhalers calculated the
revenue generated by brand manufacturers before and after patents on the active
ingredients expired.97 As illustrated in the graph below, the study found that over
See Teva Warning Letter, supra note 11; Norton Warning Letter, supra note 11.
Brandon J. Demkowicz et al., Patenting Strategies on Inhaler Delivery
Devices, 164 Chest 450, 452 (2023). This is consistent with a prior study that
examined Orange Book patents on asthma/COPD inhalers, epinephrine injectors,
and insulin injectors and concluded that 90% of the drug products studied were
protected by device patents. See Reed F. Beall et al., Is Patent “Evergreening”
Restricting Access to Medicine/Device Combination Products?, 11 PLOSE ONE 3
(2016).
97
See William B. Feldman et al., Manufacturer revenue on inhalers after
expiration of primary patents, 2000-2021, 329 J. Amer. Med. Assoc. 1, 3 (2023).
This study did not measure the revenue obtained from delays in generic approval
specifically due to improper Orange Book listings, but it demonstrates the
95
96
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the 2000–2021 period, brand manufacturers generated $67.2 billion in revenue
while their active ingredient patents were in effect compared with $110.3 billion
after the active ingredient patents expired and the inhalers were protected only by
later-filed secondary patents, including device and device component patents.98
III.
Improper Orange Book Listings May Constitute Illegal Monopolization
Under Section 2 of the Sherman Act
Contrary to Teva’s arguments in its motion to dismiss, the FTC and courts
have long recognized that improper submission of patents for listing in the Orange
Book may constitute illegal monopolization—as well as an illegal course of
monopolistic conduct—under section 2 of the Sherman Act.99
enormous value for brand drug manufacturers in delaying generic competition
through any means—including obtaining 30 month stays through improper listings.
98
Id. at 1.
99
As the FTC’s policy statement explains, improper Orange Book listings are
also actionable under section 5 of the FTC Act, which prohibits unfair methods of
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Monopolization requires proof of “the willful acquisition or maintenance of
[monopoly] power as distinguished from growth or development as a consequence
of a superior product, business acumen, or historic accident.”100 To establish a
section 2 violation, a plaintiff must show “(1) that the defendant possesses
monopoly power in the relevant market, and (2) that the defendant has acquired or
maintained that power by improper means.” 101
Here, Teva seeks dismissal only with respect to the latter “improper means”
element. 102 Demonstrating acquisition or maintenance of monopoly power by
improper means requires proof that the defendant has engaged in anticompetitive
conduct “to foreclose competition, to gain a competitive advantage, or to destroy a
competitor.” 103 As described above, improper Orange Book listings can foreclose
competition and patient access to affordable medications by enabling brand
companies to block generic competition generally for 30 months—regardless of
whether the listed patent is valid or infringed by the competitor’s product.
Moreover, improper Orange Book listings can deter generic drug companies from
competition. See FTC Orange Book Policy Statement, supra note 9, at 5-6. There
is no federal private right of action to enforce Section 5; this case focuses on
Section 2 of the Sherman Act alone.
100
United States v. Grinnell Corp., 384 U.S. 563, 570-71 (1966).
101
Lantus, 950 F.3d at 7 (quoting Town of Concord v. Bos. Edison Co., 915 F.2d
17, 21 (1st Cir. 1990)) (additional citation and internal quotation omitted).
102
See Teva Br., ECF No. 28, at 24.
103
Eastman Kodak Co. v. Image Tech. Servs., Inc., 504 U.S. 451, 482-83 (1992)
(quoting United States v. Griffith, 334 U.S. 100, 107 (1948)).
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entering a market at all, thereby foreclosing competition and depriving patients of
lower-priced competing drugs. Courts (and the FTC) have consistently recognized
that improperly listing patents in the Orange Book may constitute an improper
means of maintaining or acquiring monopoly power—and they have done so both
before and after 2003 when Congress enacted the counterclaim for a delisting
injunction in 21 U.S.C. § 355(j)(5)(C)(ii).104
In this case, Amneal counterclaims that Teva improperly listed the asserted
patents in the Orange Book, thus unlawfully maintaining its monopoly power.105
As described above, these improper listings have enabled Teva to trigger the 30month stay of approval, effectively delaying entry of Amneal’s ANDA product
See Lantus, 950 F.3d at 1, 7, 11-15 (reversing dismissal and holding
allegations regarding improper listing of device patent could support actionable
Sherman Act section 2 claim); Actos, 11 F.4th at 134-138 (affirming denial of
motion to dismiss and remanding for consideration of whether brand drug
manufacturer incorrectly listed patents in Orange Book causing antitrust harm);
Loestrin 24 Fe, 433 F. Supp. 3d at 315 (ruling “sham Orange Book listing claim”
may proceed to jury trial); In re Gabapentin Pat. Litig., 649 F. Supp. 2d 340, 360
n.23 (D.N.J. 2009) (recognizing improper Orange Book listing allegations could
support monopolistic scheme allegations); Remeron, 335 F. Supp. 2d at 532
(allowing plaintiffs to present facts concerning improper listing in support of
monopolistic scheme allegations); Decision & Order, Biovail, FTC Dkt. No. C4060 (settling an action under the antitrust laws against Biovail Corporation for,
among other things, wrongful Orange Book listing); FTC Study on Generic Drug
Entry Before Patent Expiration, supra note 6 at App. H (discussing “three
categories of patents that raise Orange Book listability questions”); FTC Orange
Book Policy Statement, supra note 9.
105
Amneal Countercl., ECF No. 12 ¶ ¶ 120-25, 134-270.
104
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from as early as this summer to February 2026.106 These facts, which at the motion
to dismiss stage must be accepted, establish a plausible violation of section 2.
IV.
The Narrow Trinko Exception Does Not Immunize Improper Orange
Book Listings From Antitrust Scrutiny
Verizon Commc’ns, Inc. v. Trinko, LLP 107 cannot immunize Teva from
antitrust liability for improper Orange Book listings. In Trinko, the Supreme Court
declined to expand Section 2 of the Sherman Act to capture conduct that was “not
a recognized antitrust claim under this Court’s existing refusal-to-deal
precedents,”108 particularly where the federal and state regulatory “regime was an
effective steward of the antitrust function.”109 The antitrust claims and the
regulatory framework at issue here are nothing like those considered in Trinko. As
explained below, Trinko is inapplicable because Amneal’s counterclaims are not an
expansion of antitrust law, the FDA does not directly police the Orange Book, and
the statutory amendment to add a delisting counterclaim does not transform a
patent enforcement framework into an antitrust regulatory scheme.
This Court rightly rejected Teva’s argument, explaining that “there exists no
regulatory scheme [for Orange Book listing] so extensive as to supplant antitrust
See supra Background §§ I, II; Amneal Br., ECF No. 48, at 3; Amneal
Countercl., ECF No. 12 ¶¶ 121-22, 130.
107
540 U.S. 398 (2004).
108
Id. at 410.
109
Id. at 413.
106
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laws.”110 As Judge Hochberg explained, “[n]o authority has been cited to support
the proposition that the antitrust laws have been superseded by the Hatch-Waxman
Act or by FDA regulations. Trinko does not bar the instant antitrust claims.”111
First, Amneal does not ask the Court to “recognize an expansion of the
contours of §2” beyond existing precedents. 112 Courts have consistently recognized
that lawsuits based on improperly listed Orange Book patents may constitute an
“improper means” of maintaining or acquiring monopoly power. 113 Even before
the Hatch-Waxman Act, courts recognized that improper use of a patent to exclude
competitors can violate Section 2.114
Second, the FDA’s ministerial role in Orange Book listings is nothing like
the extensive scheme of Federal Communications Commission (FCC) regulation of
telecommunications competition considered in Trinko. In Trinko, the local phone
incumbent, Verizon, allegedly provided poor network access to prospective rivals,
Remeron, 335 F. Supp. 2d at 531.
Id. at 531. Other courts have similarly rejected attempts to extend Trinko to
preclude antitrust claims in other contexts. See, e.g., Steward Health Care Sys.,
LLC v. Blue Cross & Blue Shield, 997 F. Supp. 2d 142, 153 n.6 (D.R.I. 2014)
(rejecting argument that “the heavily regulated nature of health care markets makes
it improper for courts to intervene on antitrust grounds,” explaining “[w]hereas the
telecommunications industry at issue in Trinko was the subject of extensive
antitrust regulation, it cannot be said that the same level of antitrust-focused
regulation exists in health care markets”).
112
Trinko, 540 U.S. at 412.
113
See supra note 105.
114
See, e.g., SmithKline Corp. v. Eli Lilly & Co., 575 F.2d 1056, 1065 (3rd Cir.
1978).
110
111
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leaving them unable to consistently serve the phone customers they sought to take
from Verizon. The Telecommunications Act of 1996 “sought to ‘uproot’ the
incumbent [local phone company’s] monopoly and to introduce competition in its
place.”115 “Central to the scheme of the Act [was] the incumbent [phone
company’s] obligation … to share its network with competitors,” along with “a
complex regime for monitoring and enforcement” by the FCC.116 The New York
Public Service Commission imposed similar network sharing conditions. 117 After
Verizon’s competitors complained about its conduct,118 New York and the FCC
opened parallel investigations; within months, New York issued orders requiring
Verizon to pay $10 million to its rivals, and Verizon paid $3 million under an FCC
consent decree.119
The Supreme Court gave “particular importance” to this “regulatory
structure designed to deter and remedy anticompetitive harm” when it declined the
Trinko plaintiffs’ request to expand Section 2.120 In Trinko, the FCC—an agency
Trinko, 540 U.S. at 402 (quoting Verizon Communications Inc. v. FCC, 535
U.S. 467, 488 (2002)).
116
Id. at 401-02 (citations omitted).
117
Id. at 398.
118
Id. at 403.
119
Id. at 403-04.
120
Id. at 412.
115
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with longstanding competition expertise and statutory enforcement authority 121—
and New York “provided a strong financial incentive for [Verizon’s]
compliance.”122 When Verizon failed to meet its obligations, the regulators
responded quickly, “impos[ing] a substantial fine” and onerous, “daily reporting
requirements” to ensure compliance.123 Collectively, this regulatory “regime was
an effective steward of the antitrust function.”124
Here, however, the FDA’s “purely ministerial” role with Orange Book
patent listings is starkly different from the FCC’s role in Trinko.125 “The FDA’s
mission is to protect the public by ensuring that drugs are safe and effective,” not
to “resolve economic disputes about the coverage of patent claims.”126 And the
See Steward, 997 F. Supp. 2d at 153 n.6 (“the telecommunications industry at
issue in Trinko was the subject of extensive antitrust regulation”); Competition
Policy Division, Wireline Competition Bureau, Fed. Commc’n Comm’n.,
https://www.fcc.gov/general/competition-policy-division-wireline-competitionbureau (last visited Mar. 20, 2024) (“Our primary mission is to foster
competition…”); Judge Douglas Ginsburg & Josh Wright, Reimagining Antitrust
Institutions: A (Modest?) Proposal (George Mason L. & Econ. Rsch. Paper No.
23-22, at 14, 2023) (forthcoming, Rev. L. Econ.) (explaining “[s]ome sectoral
regulators also have sector-specific analogs to the [FTC] Section 5 authority to
prevent ‘unfair methods of competition.’ Agencies with such authority include the
FCC, over cable operators…”).
122
Trinko, 540 U.S. at 413 (citations omitted).
123
Id.
124
Id.
125
Organon, 293 F. Supp. 2d at 458-59.
126
Remeron, 335 F. Supp. 2d at 531-32 (quoting Fed. Defs.’ Mem. in Opp’n to
Pls.’ Mot. for Prelim. Injunction, Mylan v. Thompson, 139 F. Supp. 2d 1 (D.D.C.
2001)).
121
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FDA has stated that it “lack[s] the resources, authority, or expertise to police patent
claims” that delay the entry of generic drugs. 127 As the Federal Circuit has
explained, the FDA does not “police the listing process by analyzing whether the
patents listed by NDA applicants actually claim the subject drugs or applicable
methods of using those drugs.”128 The FDA supported the FTC’s efforts to
scrutinize improper Orange Book patent listings under the antitrust laws.129
Nor does the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA) create a regulatory structure that supplants the need for the
antitrust laws to address anticompetitive harm, as Teva asserts.130 By its plain
terms, the MMA merely provides a mechanism for courts to require delisting of
improper Orange Book patents—i.e., an injunctive relief counterclaim—and does
not limit or displace the availability of antitrust liability, including for damages. 131
Specifically, Subclause I of the relevant provision established a counterclaim
for an ANDA filer to seek removal of an improperly listed patent from the Orange
Book during patent infringement litigation brought under the Hatch-Waxman
Br. for the U.S. as Amicus Curiae, Caraco Pharm. Labs., Ltd. v. Novo Nordisk
A/S, No. 10-844, 2011 WL 3919720, at *17, 27 (U.S. Sept. 6, 2011); see also
Caraco, 566 U.S. at 424 (noting “the FDA’s determination that it cannot police
patent claims.”).
128
Apotex, 347 F.3d at 1349.
129
See FTC Press Release re: Orange Book Policy Statement, supra note 9.
130
Teva Br., ECF No. 28, at 28.
131
See Amneal Br., ECF No. 48, at 39-40 (quoting H.R. Rep. No. 108-391, at 836
(2003)).
127
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Act. 132 Subclause II specifies that the “claim described in subclause (I)” may only
be brought as a counterclaim to a patent infringement suit.133 Nothing in the statute
preempts, or even mentions, the well-established antitrust claims raised by Amneal
here—which are claims authorized by the Sherman Act that in no way depend on
the authority to bring “the claim described in subclause (I)” of the MMA.
Moreover, the MMA counterclaim does not offer any means to remedy the
types of harm to competition from improper Orange Book listings that antitrust
liability addresses. For one, the MMA counterclaim cannot lead to monetary
damages; it may only correct the Orange Book listing and does not allow for any
other remedy.134 Additionally, the counterclaim arises only if and when a branded
drug manufacturer sues a generic drug manufacturer for infringement of a product
covered by an Orange Book listing. Thus, the counterclaim cannot address the
chilling effect of improper patent listings that discourage would-be competitors
from even attempting to enter the market—harming competition and consumers.
Such a mechanism does not constitute a comprehensive antitrust regulatory regime.
21 U.S.C. § 355(j)(5)(C)(ii)(I) (“If an owner of the patent … brings a patent
infringement action against the applicant, the applicant may assert a counterclaim
seeking an order requiring the holder to correct or delete the patent
information...”).
133
21 U.S.C. § 355(j)(5)(C)(ii)(II) (“Subclause (I) does not authorize the assertion
of a claim described in subclause (I) in any civil action or proceeding other than a
counterclaim described in subclause (I).”).
134
See Id. § 355(j)(5)(C)(ii)(II) (Applicants “not [] entitled to damages”).
132
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Indeed, even after the enactment of the MMA counterclaim, courts have
repeatedly and consistently recognized that improper Orange Book listings can
violate Section 2. 135 The FTC is not aware of any case extending Trinko to
preclude antitrust liability for improper Orange Book listings. This Court should
reject Teva’s invitation to become the first. Notably, in a case alleging sham
litigation under the Hatch Waxman Act, the Third Circuit rejected a branded
drugmaker’s Noerr-Pennington argument, holding that courts “must not immunize
a brand-name manufacturer who uses the Hatch-Waxman Act’s automatic, 30month stay to thwart competition. Doing so would excuse behavior that Congress
proscribed in the antitrust laws.”136 Courts have long recognized that antitrust
exemptions are “strongly disfavored and have only been found in cases of clear
repugnancy between the antitrust and regulatory provisions.” 137 No such conflict
exists here.
CONCLUSION
For the foregoing reasons, the Court should grant Amneal’s motion for a
judgment on the pleadings as to counterclaim counts 1-5 and order the asserted
patents delisted. The Court should evaluate the issues consistent with the principles
See supra note 105.
AbbVie Inc., 976 F.3d at 361.
137
Otter Tail Power Co. v. United States, 410 U.S. 366, 372 (1973).
135
136
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described above, including that improper Orange Book listings may cause
substantial harm to competition and may violate the antitrust laws.
Respectfully submitted,
Dated: March 22, 2024
Hannah Garden-Monheit
Director, Office of Policy Planning
Henry Liu
Director, Bureau of Competition
Anisha Dasgupta
General Counsel, Federal Trade
Commission
/s/ Bradley J. Vettraino
Bradley J. Vettraino
Ian Barlow
Rahul Rao
Anupama Sawkar
Matthew Frank
Clarke Edwards
Jordan Klimek
600 Pennsylvania Avenue N.W.
Washington, D.C. 20580
Telephone: (202) 386-2652
40
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.