IN THE UNITED STATES COURT OF
Agency decision
Ask Donna
What actually matters in this document.
Text
Case: 24-1936
Document: 62
Page: 1
Filed: 09/06/2024
No. 24-1936
IN THE UNITED STATES COURT OF
APPEALS FOR THE FEDERAL CIRCUIT
–––––––––––––––––––––––––––––––––––––––––––––
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.,
NORTON (WATERFORD) LTD., TEVA PHARMACEUTICALS USA,
INC.,
Plaintiffs-Appellants,
v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
AMNEAL IRELAND LTD., AMNEAL PHARMACEUTICALS LLC,
AMNEAL PHARMACEUTICALS INC.,
Defendants-Appellees.
–––––––––––––––––––––––––––––––––––––––––––––
On Appeal from the United States District Court
for the District of New Jersey,
No. 23-cv-20964 (Hon. Stanley R. Chesler)
–––––––––––––––––––––––––––––––––––––––––––––
BRIEF FOR THE FEDERAL TRADE COMMISSION
AS AMICUS CURIAE IN SUPPORT OF APPELLEES
SUPPORTING AFFIRMANCE
–––––––––––––––––––––––––––––––––––––––––––––
Of Counsel:
HANNAH GARDEN-MONHEIT
Director, Office of Policy
Planning
JORDAN T. KLIMEK
BRADLEY J. VETTRAINO
Attorneys
FEDERAL TRADE COMMISSION
Washington, D.C. 20580
ANISHA S. DASGUPTA
General Counsel
ANUPAMA SAWKAR
MATTHEW M. HOFFMAN
Attorneys
FEDERAL TRADE COMMISSION
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580
(202) 779-6023
asawkar@ftc.gov
Case: 24-1936
Document: 62
Page: 2
Filed: 09/06/2024
TABLE OF CONTENTS
TABLE OF AUTHORITIES.......................................................................ii
INTEREST OF THE FEDERAL TRADE COMMISSION .......................1
INTRODUCTION .......................................................................................4
STATEMENT..............................................................................................7
A. The Hatch-Waxman Framework .........................................................7
B. Listing Criteria for the Orange Book ................................................10
C. The Orange Book Listings at Issue Here ..........................................12
D. Proceedings in This Case ...................................................................14
ARGUMENT.............................................................................................15
I. Improper Orange Book Patent Listings Can Harm
Competition and May Violate the Antitrust Laws. ..........................15
II. Teva’s Device and Device Component Patents Do Not Meet the
Listing Criteria Established by Congress. ........................................21
A. Drug-Agnostic Device Patents Are Not “Drug Product
(Formulation or Composition)” Patents. .....................................22
B. Drug-Agnostic Device Patents Do Not Claim the NDA
Product. .........................................................................................28
C. The Court Should Enforce the Policy Choices Congress
Made in the OBTA To Prevent Improper Orange Book
Listings.......................................................................................... 33
CONCLUSION .........................................................................................34
i
Case: 24-1936
Document: 62
Page: 3
Filed: 09/06/2024
TABLE OF AUTHORITIES
Cases
Apotex, Inc. v. Thompson,
347 F.3d 1335 (Fed. Cir. 2003) ........................................................... 31
Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S,
566 U.S. 399 (2012) ............................................................................... 2
Cesar Castillo, Inc. v. Sanofi-Aventis U.S., LLC (In re Lantus
Direct Purchaser Antitrust Litig.),
950 F.3d 1 (1st Cir. 2020) ....................................................... 11, 29, 32
Exxon Chem. Patents, Inc. v. Lubrizol Corp.,
64 F.3d 1553 (Fed. Cir. 1995) ............................................................. 24
FTC v. AbbVie Inc.,
976 F.3d 327 (3d Cir. 2020) .................................................................. 1
FTC v. Actavis, Inc.,
570 U.S. 136 (2013) ........................................................................... 1, 8
FTC v. Shkreli,
581 F. Supp. 3d 579 (S.D.N.Y. 2022) .................................................... 1
Impax Labs., Inc. v. FTC,
994 F.3d 484 (5th Cir. 2021) ................................................................. 1
In re Lipitor Antitrust Litig.,
855 F.3d 126 (3d Cir. 2017) ................................................................ 15
Jazz Pharm., Inc. v. Avadel CNS Pharm., LLC,
60 F.4th 1373 (Fed. Cir. 2023) .................................................. 5, 11, 32
King Drug Co. of Florence, Inc. v. Cephalon, Inc.,
88 F. Supp. 3d 402 (E.D. Pa. 2015) ...................................................... 1
NLRB v. SW Gen., Inc.,
580 U.S. 288 (2017) ............................................................................. 23
Obduskey v. McCarthy & Holthus LLP,
586 U.S. 466 (2019) ............................................................................. 27
ii
Case: 24-1936
Document: 62
Page: 4
Filed: 09/06/2024
Phillips v. AWH Corp.,
415 F.3d 1303 (Fed. Cir. 2005) ........................................................... 31
PIN/NIP, Inc. v. Platte Chem. Co.,
304 F.3d 1235 (Fed. Cir. 2002) ........................................................... 24
Sanofi-Aventis Deutschland GmbH v. Glenmark Pharm. Inc.,
748 F.3d 1354 (Fed. Cir. 2014) ........................................................... 24
Schwarz Pharma, Inc. v. Paddock Labs., Inc.,
504 F.3d 1371 (Fed. Cir. 2007) ........................................................... 24
Takeda Pharm. U.S.A., Inc. v. W.-Ward Pharm. Corp.,
785 F.3d 625 (Fed. Cir. 2015) ............................................................. 10
Unigene Labs., Inc. v. Apotex, Inc.,
655 F.3d 1352 (Fed. Cir. 2011) ........................................................... 25
United Food & Com. Workers Loc. 1776 v. Takeda Pharm. Co.
Ltd.,
11 F.4th 118 (2d Cir. 2021) ........................................................... 11, 32
Statutes
15 U.S.C. § 2 ............................................................................................... 3
15 U.S.C. § 45 ......................................................................................... 1, 3
21 U.S.C. § 355.................................................. 3, 5, 8, 9, 11, 22, 23, 27, 28
35 U.S.C. § 271............................................................................................ 9
Pub. L. No. 108-173 .................................................................................... 3
Pub. L. No. 116-290 .................................................................................. 10
Regulations
21 C.F.R. § 314.3 ....................................................................................... 26
21 C.F.R. § 314.53 ....................................................................................... 8
iii
Case: 24-1936
Document: 62
Page: 5
Filed: 09/06/2024
Other Authorities
Rasha Alhiary et al., Delivery Device Patents on GLP-1 Receptor
Agonists,
331 JAMA 794 (2024).......................................................................... 20
American College of Allergy, Asthma, and Immunology, Asthma
Facts (2023) ......................................................................................... 18
Andrew Clerman, FDA, Post-Approval Impact of Generic
Fluticasone Propionate & Salmeterol Inhalation Powder (RLD:
Advair Diskus) (Sept. 14, 2023) .......................................................... 17
Brandon J. Demkowicz et al., Patenting Strategies on Inhaler
Delivery Devices,
164 Chest 450 (2023)..................................................................... 19, 20
FDA, Generic Competition and Drug Prices: New Evidence Linking
Greater Generic Competition and Lower Generic Drug Prices
(2019) ................................................................................................... 17
Robin Feldman et al., Empirical Evidence of Drug Pricing
Games—A Citizen’s Pathway Gone Astray,
20 Stan. Tech. L. Rev. 39 (2017) ......................................................... 17
William B. Feldman et al., Manufacturer Revenue on Inhalers
After Expiration of Primary Patents, 2000-2021,
329 J. Amer. Med. Assoc. 1 (2023) ..................................................... 20
FTC, Federal Trade Commission Statement Concerning Brand
Drug Manufacturers’ Improper Listing of Patents in the Orange
Book (Sept. 14, 2023) ............................................................................ 3
FTC, Generic Drug Entry Prior to Patent Expiration: An FTC
Study (July 2002) .............................................................................. 2, 3
Simon Gaisford, Preformulation, in REMINGTON: THE SCIENCE AND
PRACTICE OF PHARMACY 283 (Adeboye Adejare et al. eds., 23rd
ed. 2021) .............................................................................................. 25
H.R. Rep. No. 116-47 (2020) ..................................................................... 15
iv
Case: 24-1936
Document: 62
Page: 6
Filed: 09/06/2024
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) ........ 18
Shashank Upadhye, Generic Pharmaceutical Patent and FDA
Law,
§ 3:13 Formulations (rev. ed. 2022) .................................................... 24
v
Case: 24-1936
Document: 62
Page: 7
Filed: 09/06/2024
INTEREST OF THE FEDERAL TRADE COMMISSION
This case presents the question of whether a pharmaceutical
company has improperly listed certain patents in the government
publication known as the “Orange Book.” Improper Orange Book
listings disrupt the careful balance between brand rights and generic
competition that Congress established in the Drug Price Competition
and Patent Term Restoration Act of 1984 (“Hatch-Waxman Act”) and
may violate the antitrust laws.
The Federal Trade Commission, which is charged with preventing
unfair methods of competition, see 15 U.S.C. § 45(a), has extensive
experience policing practices that harm competition in the
pharmaceutical industry.1 The Commission has a strong interest in
ensuring that the Orange Book listing criteria established by Congress
are applied as written so that generic competition is not improperly
stifled. The Commission has long been involved in enforcement actions
and advocacy to address improper Orange Book listings. In 2002 and
1 See, e.g., FTC v. Actavis, Inc., 570 U.S. 136 (2013); 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); King
Drug Co. of Florence, Inc. v. Cephalon, Inc., 88 F. Supp. 3d 402 (E.D. Pa.
2015).
Case: 24-1936
Document: 62
Page: 8
Filed: 09/06/2024
2003, the Commission entered administrative consent orders requiring
two pharmaceutical companies to delist improperly listed patents.2
Additionally, the Commission has filed amicus briefs regarding
improper Orange Book listings in numerous private lawsuits, including
in the district court proceedings here.3
The Commission has also played a key role in advising Congress
on amending the Hatch-Waxman scheme to prevent improper Orange
Book listings and other abuses. In 2002, the Commission published a
detailed study of Hatch Waxman-related anticompetitive practices that
included recommendations for legislative action. See FTC, Generic Drug
Entry Prior to Patent Expiration: An FTC Study ii-xii (July 2002).4 In
2 Decision and Order, In re Bristol-Myers Squibb Co., FTC Dkt. No. C-
4076 (April 14, 2003); Decision and Order, In re Biovail Corp., FTC Dkt.
No. C-4060 (Oct. 2, 2002).
3 See Mylan Pharm. Inc. v. Sanofi-Aventis U.S. LLC, No. 2:23-cv-00836,
Dkt. No. 64 (W.D. Pa. Nov. 21, 2023); Jazz Pharm., Inc. v. Avadel CNS
Pharm., LLC, No. 1:21-cv-691, Dkt. No. 227 (D. Del. Nov. 15, 2022); In
re Buspirone Patent Litig., No. 1:01-md-1410, Dkt. No. 31 (S.D.N.Y. Jan.
8, 2002); SmithKline Beecham Corp. v. Apotex Corp., No. 99-cv-4304,
Dkt. No. 92 (E.D. Pa. Jan. 29, 2003).
4 See also Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S.
399, 400, 408 (2012) (citing Commission study findings as “evidence …
that some brands were exploiting [the Hatch Waxman] statutory
scheme to prevent or delay the marketing of generic drugs”).
2
Case: 24-1936
Document: 62
Page: 9
Filed: 09/06/2024
particular, the study noted the absence of any mechanism to delist an
improperly listed patent. Id. at v. The Commission’s legislative
proposals served as the basis for 2003 amendments to the HatchWaxman Act that authorized generic companies to assert delisting
counterclaims, such as the counterclaim at issue in this case. See Pub.
L. No. 108-173, tit. XI (2003) (enacting 21 U.S.C. § 355(j)(5)(C)(ii)(I)).
More recently, the Commission issued an enforcement policy
statement underscoring that improper Orange Book listings may
constitute illegal monopolization under the Sherman Act, 15 U.S.C. § 2,
and an unfair method of competition under the FTC Act, id. § 45(a).
FTC, Federal Trade Commission Statement Concerning Brand Drug
Manufacturers’ Improper Listing of Patents in the Orange Book (Sept.
14, 2023). The Commission’s Bureau of Competition also sent notice
letters to several companies, including Teva, concerning improperly
listed patents.5 The Commission is currently investigating whether
5 In response to the notice letters, four companies delisted fourteen
patents across six NDAs. Three additional companies announced that
they would reduce patient out-of-pocket costs for all of their asthma
inhalers to $35 a month. 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://shorturl.at/fpGY1; Press
3
Case: 24-1936
Document: 62
Page: 10
Filed: 09/06/2024
Teva has violated the FTC Act through improper Orange Book
listings—including those at issue in this case.6
INTRODUCTION
Improper Orange Book listings have the potential to cause serious
harm to competition. By listing a patent in the Orange Book, a brand
pharmaceutical company can gain the ability to block generic
competition for 30 months simply by filing a lawsuit, without having to
respond to patent invalidity assertions or to show that a proposed
generic product would actually infringe the brand company’s patents.
Brand companies thus have a powerful financial incentive to list
patents regardless of whether the listing meets the statutory criteria
Congress has established. That is why Congress—on the Commission’s
Release, Boehringer Ingelheim, Boehringer Ingelheim caps patient outof-pocket costs for its inhaler portfolio at $35 per month (Mar. 7, 2024),
https://shorturl.at/2K1cP; Press Release, GlaxoSmithKline, GSK
announces cap of $35 per month on U.S. patient out-of-pocket costs for
its entire portfolio of asthma and COPD inhalers (Mar. 20, 2024),
https://shorturl.at/AP7h1. While the Commission welcomes voluntary
reductions in patients’ out-of-pocket costs, these are not substitutes for
removing improper patent listings, as such listings may delay
competition from generic products with lower prices.
6 Teva has publicly disclosed the investigation in filings with the
Securities and Exchange Commission. This brief is not based on any
information that the FTC has learned in its investigation.
4
Case: 24-1936
Document: 62
Page: 11
Filed: 09/06/2024
recommendation—created a statutory delisting mechanism. To
effectuate Congress’s intent and preserve competition, courts should
order prompt delisting of patents that do not meet the statutory listing
criteria, as this Court did just last year. See Jazz Pharm., Inc. v. Avadel
CNS Pharm., LLC, 60 F.4th 1373, 1376 (Fed. Cir. 2023).
This case illustrates these concerns. Amneal has alleged that the
relevant Teva patents are invalid and not infringed by Amneal’s
proposed generic version of Teva’s ProAir HFA product. Amneal has
also alleged that Teva’s improper listing of these patents in the Orange
Book threatens to delay the launch of Amneal’s generic product and the
competition that would result from that launch.
Not every brand patent that might be infringed by a generic is
listable. In the Orange Book Transparency Act of 2020 (“OBTA”),
Congress amended the Hatch Waxman Act to clarify that a non-methodof-use patent is listable only if (1) it is a “drug substance (active
ingredient) patent or a drug product (formulation or composition)
patent,” and (2) it “claims the drug” for which the brand obtained
approval from the FDA. 21 U.S.C. § 355(b)(1)(A)(viii)(I); see also id.
§ 355(c)(2) (requiring submission of information about listable patents
5
Case: 24-1936
Document: 62
Page: 12
Filed: 09/06/2024
for publication in the Orange Book after NDA approval and providing
that information on other patents “shall not be submitted”).
Although Teva listed the patents at issue here as “drug product”
patents, they do not meet either of the statutory criteria. They are drugagnostic patents directed to mechanical devices—inhalers and dose
counters for inhalers—and do not claim any particular active ingredient
or any drug formulation or composition. Nor do the patents claim the
approved product marketed by Teva—a metered dose inhaler
containing the active ingredient albuterol sulfate. Indeed, Teva has
listed these same patents for numerous other drug-device combination
products, many containing entirely different active ingredients.
Teva advances an overbroad reading of the listing statute that
invites gamesmanship to foreclose the very kind of competition the
Hatch-Waxman Act was designed to promote. Notwithstanding the
restrictions Congress placed in the statutory text, Teva asserts that the
statute permits the listing of device and device component patents
devoid of a relationship to any particular drug substance or formulation
or composition. But that approach would allow brand manufacturers to
turn a scheme that Congress designed to facilitate generic competition
6
Case: 24-1936
Document: 62
Page: 13
Filed: 09/06/2024
into a means for perpetually forestalling generic entry—i.e., by
patenting narrow changes to the mechanical components of a device and
listing the new patents in the Orange Book. Teva’s proposed rewriting
of the statute could thus impair the ability of millions of Americans to
obtain life-saving drugs at affordable prices.
Manufacturers of branded inhalers face limited generic
competition today. With large amounts of money at stake, branded
manufacturers in this space have a strong financial incentive to abuse
the statutory regime to block generic competition long after patent
protection for the active ingredient(s) has expired. As outlined below,
delays in generic entry for inhaler products—as with other drug
products—can result in higher prices for consumers for lifesaving drugs.
The Court should enforce the statute Congress wrote and reject
Teva’s attempt to redraft that statute. To protect competition, it should
affirm the order requiring delisting of Teva’s improperly listed patents.
STATEMENT
A.
The Hatch-Waxman Framework
Generic drugs provide important benefits to American consumers
and the health care system. They contain the same active ingredients as
their brand-name counterparts and are just as safe and effective but are
7
Case: 24-1936
Document: 62
Page: 14
Filed: 09/06/2024
typically available at far lower cost. Congress enacted the HatchWaxman Act to “speed the introduction of low-cost generic drugs to
market, thereby furthering drug competition.” FTC v. Actavis, Inc., 570
U.S. 136, 142 (2013) (cleaned up).
Under the Hatch-Waxman Act, a company seeking approval for a
new drug must file a New Drug Application (“NDA”), a lengthy and
costly process requiring evidence that the drug is safe and effective for
its proposed use(s). 21 U.S.C. § 355(b). The NDA holder must submit
information about certain patents relevant to the approved drug for
listing in the FDA’s Orange Book.7 Id. § 355 (c)(2) see also id.
§355(b)(1)(A)(viii). After an NDA is approved, another company may
seek to market a generic version by filing an Abbreviated New Drug
Application (“ANDA”). Id. § 355(j). The streamlined ANDA process
lowers barriers to generic entry by eliminating the need to submit
safety and efficacy studies. Instead, an ANDA filer must demonstrate
that its generic product is bioequivalent to the referenced NDA drug
product and meets certain sameness criteria—including that it contains
7 The Orange Book’s formal name is “Approved Drug Products with
Therapeutic Equivalence Evaluations.” See 21 U.S.C.
§ 355(b)(1)(A)(viii); 21 C.F.R. § 314.53(b).
8
Case: 24-1936
Document: 62
Page: 15
Filed: 09/06/2024
the same active ingredient(s) in the same amount(s) and works in the
body the same way.
If an ANDA filer seeks to market a generic product before the
expiration of a patent listed in the Orange Book for the NDA reference
drug prior to the ANDA filing, it must include a “paragraph IV”
certification in its application asserting that the patent is invalid or will
not be infringed by the generic product. 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
Such a certification is deemed an act of infringement. 35 U.S.C.
§ 271(e)(2)(A). If the patentee—typically, the brand company that holds
the NDA—files suit within 45 days after receiving notice of the
certification, FDA approval of the ANDA is stayed for 30 months, unless
the lawsuit is resolved earlier. 21 U.S.C. § 355 (j)(5)(B)(iii).
Under this scheme, the owner of an Orange Book-listed patent has
extraordinary rights that are not available to ordinary patentees.
Ordinarily, a patentee trying to block a competitor from coming to
market during the pendency of litigation must seek a preliminary
injunction, which requires among other things showing that the
patentee is likely to succeed on the merits of its infringement claim. See,
e.g., Takeda Pharm. U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d
9
Case: 24-1936
Document: 62
Page: 16
Filed: 09/06/2024
625, 630 (Fed. Cir. 2015). The owner of an Orange Book-listed patent,
however, can block FDA approval of a competing generic drug for 30
months simply by filing an infringement lawsuit, without showing that
the proposed generic product is likely to infringe or responding to
invalidity assertions. This ability to block generic competition for twoand-a-half years can be enormously lucrative for brand drugmakers.
B.
Listing Criteria for the Orange Book
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. In 2020, Congress unanimously passed the Orange Book
Transparency Act (“OBTA”), Pub. L. No. 116-290, which amended the
Hatch-Waxman Act to clarify what kinds of patents are eligible for
listing in the Orange Book. As amended, the statute requires
submission for listing of:
each patent for which a claim of patent infringement could
reasonably be asserted if a person not licensed by the owner of the
patent engaged in the manufacture, use, or sale of the drug, and
that—
(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
(II) claims a method of using such drug for which approval is
sought or has been granted in the application.
10
Case: 24-1936
Document: 62
Page: 17
Filed: 09/06/2024
21 U.S.C. § 355(b)(1)(A)(viii) (hereinafter the “Listing Statute”)
(emphasis added); see also id. § 355(c)(2) (requiring submission of
patent information after NDA approval). If a patent does not meet these
requirements, it must not be submitted for listing in the Orange Book.
See id. (information on other patents “shall not be submitted”).
The FDA does not evaluate whether the patents submitted for
listing in the Orange Book meet the statutory criteria, nor does it
remove patent information without a request from the NDA holder. See,
e.g., Jazz, 60 F.4th at 1378. But there are several other routes by which
other actors can redress improper listings, including delisting
counterclaims by ANDA filers, see 21 U.S.C. § 355(j)(5)(C)(ii)(I);
enforcement actions by the Commission under the FTC Act, see supra at
2-3; and lawsuits by private parties under the Sherman Act, see United
Food & Com. Workers Loc. 1776 v. Takeda Pharm. Co. Ltd., 11 F.4th
118, 134-38 (2d Cir. 2021) (“UFCW”); Cesar Castillo, Inc. v. SanofiAventis U.S., LLC (In re Lantus Direct Purchaser Antitrust Litig.), 950
F.3d 1, 7-15 (1st Cir. 2020).
11
Case: 24-1936
C.
Document: 62
Page: 18
Filed: 09/06/2024
The Orange Book Listings at Issue Here
Teva holds an approved NDA for albuterol sulfate HFA Inhalation
Aerosol, known as “ProAir HFA.”8 The approved product is a drugdevice combination product: an inhaler device that delivers a metered
dose of the active ingredient albuterol sulfate in aerosol form. Albuterol
sulfate has been off patent since 1989, and Teva’s Orange Book entry
for this NDA currently lists only drug-agnostic device patents. Five of
those patents (the “Asserted Patents”) are at issue in this case. None of
these patents is directed to a drug formulation or composition. Nor do
the patents claim the approved product marketed by Teva—a metered
aerosol containing the active ingredient albuterol sulfate.
x Patent No. 8,132,712 (the “’712 patent”) claims a “dose counter for
a metered dose inhaler” and a “metered dose inhaler” comprising
the claimed dose counter.
x Patent No. 10,561,808 (the “’808 patent”) claims a “dose counter
for an inhaler,” and Patent No. 11,395,889 (the “’889 patent”)
claims “an incremental dose counter for a metered dose inhaler.”
8 “HFA” refers to hydrofluoroalkane, which is used as a propellant.
12
Case: 24-1936
Document: 62
Page: 19
Filed: 09/06/2024
x Patent Nos. 9,463,289 (the “’289 patent”) and 9,808,587 (the “’587
patent”) both claim “an inhaler for metered dose inhalation.”
None of the patents contains claims that recite any species or genus of
active ingredient to be administered via the inhaler.
The NDA for ProAir HFA was approved in 2004, but the Asserted
Patents were submitted and listed in the Orange Book long afterwards,
one as recently as August 2022. The expiration dates of these patents
range from September 2028 to January 2032—almost 28 years after the
NDA was approved. Each of the patents is also listed for other Teva
products, many of which contain different active ingredients from
ProAir HFA. For example, the ’808 patent is listed in the Orange Book
for seven different products currently being marketed, spanning four
separate NDAs and three different active ingredients/combinations of
active ingredients. Teva also lists the Asserted Patents in conjunction
with numerous other NDA products that Teva no longer markets. The
Orange Book listings for these patents have the potential to extend
Teva’s market exclusivity on multiple products by many years.9
9 For example, a pending antitrust class action alleges that Teva’s
improper listing of the Asserted Patents in conjunction with different
13
Case: 24-1936
D.
Document: 62
Page: 20
Filed: 09/06/2024
Proceedings in This Case
Amneal filed an ANDA with a paragraph IV certification seeking
to market a generic version of ProAir HFA before expiration of Teva’s
Orange Book-listed patents, asserting that the patents are not infringed
by Amneal’s proposed product and are invalid. Teva sued Amneal for
infringement, triggering the 30-month Hatch-Waxman stay of FDA
approval of Amneal’s product. Amneal asserted a delisting
counterclaim. The district court held that the Asserted Patents were not
properly listed because they do not claim the “drug for which the
applicant submitted the application” and ordered Teva to delist them.
Appx33-34. This Court has stayed the delisting injunction but expedited
this appeal; Amneal has represented to this Court that it might receive
tentative FDA approval as early as November 2024.
products (QVAR beclomethasone dipropionate-based inhalers) has
contributed to delayed entry of those generic products. Memorandum
and Order on Motion to Dismiss, Iron Workers District Council of New
England Health and Welfare Fund et al. v. Teva, No. 1:23-cv-11131,
Dkt. No. 49 at 5 (D. Mass. May 1, 2024).
14
Case: 24-1936
Document: 62
Page: 21
Filed: 09/06/2024
ARGUMENT
I.
Improper Orange Book Patent Listings Can Harm
Competition and May Violate the Antitrust Laws.
Through the Hatch-Waxman Act, Congress “attempted to balance
the goal of making available more low-cost generic drugs with the value
of patent monopolies in incentivizing beneficial pharmaceutical
advancement.” In re Lipitor Antitrust Litig., 855 F.3d 126, 134 (3d Cir.
2017) (cleaned up). Orange Book listing requirements play a key part in
this careful balance. One reason Congress enacted the OBTA was to
clarify which patents are eligible for listing because of concern that
“some branded drug manufacturers … are submitting patents
potentially for the purpose of blocking generic competition.” H.R. Rep.
No. 116-47 at 4 (2020).
When a brand company improperly submits a patent for listing
that does not meet the statutory listing criteria, the careful balance that
Congress struck is disrupted. The listing allows the brand to keep a
would-be generic competitor out of the market for two-and-a-half years
without any showing that the brand is likely to succeed on the merits of
an infringement action. Teva itself has acknowledged that improper
listings inhibit competition and is litigating antitrust claims against
15
Case: 24-1936
Document: 62
Page: 22
Filed: 09/06/2024
another company based on that company’s allegedly improper Orange
Book listings.10
Improper listings may also deter potential competitors from
developing generic products in the first place or otherwise distort their
decision-making about what investments to make and how to bring a
competing product to market.11 Rewriting the Orange Book listing
criteria to encompass drug-agnostic device patents may incentivize the
use of such patents to delay competition.
When competition is impaired, drug purchasers—including
patients, hospitals, health plans, and taxpayers—are forced to pay
higher prices for brand drugs that should be available in generic form.
Researchers have found that with robust competition, most drug prices
10 See Complaint, Teva Pharm. U.S.A, Inc. v. Corcept Therapeutics, Inc.
et al., No. 24-cv-03567, Dkt. No. 1 at 21 (N.D. Cal. June 13, 2024).
11 See, e.g., Memorandum and Order, Iron Workers District Council of
New England Health and Welfare Fund et al. v. Teva, No. 1:23-cv11131, Dkt. No. 49 at 8 (D. Mass. May 1, 2024) (noting allegations “that
Teva has improperly listed device-only patents in the Orange Book to
deter would-be competitors from launching a generic version of QVAR”);
Complaint, Mylan Pharm. Inc. v. Sanofi-Aventis, U.S. LLC, No. 2:23-cv00836, Dkt. No. 1 at 39 (W.D. Pa. May 17, 2023) (alleging that NDAholder’s listing of device patents in the Orange Book “short-circuited
Mylan’s original aspirations for timing to the market”).
16
Case: 24-1936
Document: 62
Page: 23
Filed: 09/06/2024
“eventually fall[] to 80–85% below the original brand-name cost.” See,
e.g., 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 FDA, Generic Competition and Drug Prices: New Evidence
Linking Greater Generic Competition and Lower Generic Drug Prices at
2 (2019) (finding that average manufacturer price for a generic is 39%
lower than the brand price before generic entry when there is one
generic, 54% lower when there are two generics, and 79% lower when
there are four generics).12
Lack of access to low-priced generics may also have adverse
consequences for patient health, because it may deter patients from
adhering to medication dosing regimens. In 2018, the American
Thoracic Society (“ATS”) found that the high cost of inhalers and other
medicines has led to higher out-of-pocket expenses and harmed patient
12 Generic competition has been shown to lower prices for inhalers like
those at issue here. For example, one year after the first generic for
Advair Diskus entered the market, the averaged unit cost for the
generic was $115 compared to $169 for the authorized generic and $334
for the brand name. See Andrew Clerman, FDA, Post-Approval Impact
of Generic Fluticasone Propionate & Salmeterol Inhalation Powder
(RLD: Advair Diskus) at 18-19 (Sept. 14, 2023) at
https://www.fda.gov/media/173393/download?attachment.
17
Case: 24-1936
Document: 62
Page: 24
Filed: 09/06/2024
health. 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, 1367-68 (2018). The ATS
concluded that higher out-of-pocket expenses can increase stress, reduce
medication adherence, and lead to worse health outcomes, including
unnecessary hospitalizations, and noted that these problems have been
“exacerbated by a paucity of generic alternatives”—i.e., lack of
competition. Id. at 1367.
Lack of competition for asthma inhalers is particularly
concerning. These potentially lifesaving products are used by millions of
Americans. According to the American College of Allergy, Asthma, and
Immunology, approximately 7.7% of Americans have asthma, including
20.2 million adults and 4.6 million children.13 Although the patents on
many of the active ingredients used in asthma inhalers have been
expired for decades, only 5 of the 37 brand-name inhalers currently on
13 See American College of Allergy, Asthma, and Immunology, Asthma
Facts (2023), https://acaai.org/asthma/asthma-101/facts-stats/.
18
Case: 24-1936
Document: 62
Page: 25
Filed: 09/06/2024
the U.S. market face independent generic competition. Lack of
competition keeps prices high.
Listing of device patents directed solely to the mechanical
components of an inhaler—i.e., patents that do not claim the active
ingredient or a drug formulation or composition—appears to be
widespread. A recent study examined all 53 asthma and chronic
obstructive pulmonary disease (“COPD”) inhaled medications approved
by the FDA from 1986 to 2020 and found that 39 of these products
collectively listed 137 device patents, many claiming inhaler
components such as the nozzle, canister, valve, piston pumping system,
and dose counter. Brandon J. Demkowicz et al., Patenting Strategies on
Inhaler Delivery Devices, 164 Chest 450, 452 (2023). Many of these
device patents did not mention any active ingredient in their claims,
and such drug-agnostic device patents were the last patents to expire
for 25 inhalers. Id. at 454. These patents extended patent protection for
a median of 7.5 years past the last non-device patent to expire, with the
19
Case: 24-1936
Document: 62
Page: 26
Filed: 09/06/2024
longest period of protection extending over 21 years past the last to
expire non-device patent. Id. at 454, 457.14
These tactics and harms are not confined to inhaled
asthma/COPD medications. The Commission’s Bureau of Competition
has identified hundreds of drug-agnostic device patent listings for other
lifesaving medications, including epinephrine injector pens and
treatments for diabetes and weight loss.15 Researchers have similarly
documented such device patent listings with respect to medications for
diabetes and weight loss. See Rasha Alhiary et al., Delivery Device
Patents on GLP-1 Receptor Agonists, 331 JAMA 794, 794-96 (2024). For
example, they found that NDA-holders listed a total of 107 patents on
14 A recent academic study of FDA-approved asthma/COPD inhaled
medications shows that brand companies can continue to earn large
profits long after patents on their drugs’ active ingredients expire if
they have secondary patents, including device and device component
patents. See William B. Feldman et al., Manufacturer Revenue on
Inhalers After Expiration of Primary Patents, 2000-2021, 329 J. Amer.
Med. Assoc. 1, 1-3 (2023).
15 See, Press Release, FTC, FTC Expands Patent Listing Challenges,
Targeting More Than 300 Junk Listings for Diabetes, Weight Loss,
Asthma and COPD Drugs (April 30, 2024), https://www.ftc.gov/legallibrary/browse/warning-letters/85231; Press Release, FTC, FTC
Challenges More Than 100 Patents as Improperly Listed in the FDA’s
Orange Book (Nov. 7, 2023), https://www.ftc.gov/legallibrary/browse/warning-letters/81927.
20
Case: 24-1936
Document: 62
Page: 27
Filed: 09/06/2024
GLP-1 delivery devices, none of which included claims mentioning
active ingredients, chemical structures, or therapeutic classes. Id. at
794. The researchers observed that removal of these device patents
from the Orange Book “may substantially reduce barriers to generic
entry by decreasing the number of patents that generic firms must
contest ahead of FDA approval.” Id.
II.
Teva’s Device and Device Component Patents Do Not Meet
the Listing Criteria Established by Congress.
Enforcing the OBTA’s limits on Orange Book listings would
protect competition as Congress intended. Under the plain language of
the Listing Statute, drug-agnostic device patents such as the Asserted
Patents are ineligible for submission for listing in the Orange Book. A
non-method-of-use patent that may be infringed by a generic product is
listable only if (1) it is “a drug substance (active ingredient) patent or a
drug product (formulation or composition) patent” and (2) it “claims the
drug for which the [NDA] applicant submitted the application.” 21
21
Case: 24-1936
Document: 62
Page: 28
Filed: 09/06/2024
U.S.C. § 355(b)(1)(A)(viii)(I); see also id. § 355(c)(2).16 Under the plain
language of the statute, both criteria must be satisfied.
The district court held that the Asserted Patents are not listable
because they do not “claim” ProAir HFA, without addressing whether
they are “drug product (formulation or composition) patents.” Appx33.
In fact, Teva’s drug-agnostic device patents do not satisfy either prong
of the test. That does not mean that Teva is unable to enforce its device
patents against a potentially infringing generic product. It simply
means that Teva is not entitled to list those patents in the Orange Book
and obtain a 30-month stay on that basis.
A.
Drug-Agnostic Device Patents Are Not “Drug Product
(Formulation or Composition)” Patents.
By enacting the OBTA, Congress made clear that not all patents
that might be infringed by the manufacture, use, or sale of a generic
drug are properly listable in the Orange Book. A non-method-of-use
patent is listable only if it is directed to a “drug substance (active
ingredient)” or a “drug product (formulation or composition).” 21 U.S.C.
16 A patent is also listable if it “claims a method of using such drug for
which approval is sought or has been granted in the application,” 21
U.S.C. § 355(b)(1)(A)(viii)(II), but that provision is not at issue here.
22
Case: 24-1936
Document: 62
Page: 29
Filed: 09/06/2024
§ 355(b)(1)(A)(viii)(I). Teva concedes that the Asserted Patents are not
“drug substance (active ingredient)” patents. But they do not qualify as
“drug product (formulation or composition)” patents either.17 Teva’s
argument that drug-agnostic patents directed to inhaler devices meet
this criterion disregards the statutory language and would enable even
minor device inventions unrelated to the actual medicine in a drug to
trigger an automatic 30-month delay of competition.
Teva’s argument ignores the words “formulation or composition,”
defying the “cardinal principle of statutory construction” that a court
must “give effect, if possible, to every clause and word of a statute.”
NLRB v. SW Gen., Inc., 580 U.S. 288, 304 (2017). The parenthetical
phrase “formulation or composition” plainly modifies the words “drug
17 Teva’s argument that failure to satisfy the “drug product (formulation
or composition) patent” prong is not a proper basis for a delisting
counterclaim (Teva Br. 50) is waived because Teva did not raise that
argument before the district court. Furthermore, reading the statute to
preclude a delisting counterclaim on this basis would frustrate
Congress’s intent in the OBTA to limit the types of patents that are
eligible for listing. However, if the Court finds that the Asserted
Patents meet the “claims the drug” prong but finds delisting
counterclaims unavailable on the “drug product (formulation or
composition) patent” prong, it should make clear that it is not reaching
the merits of whether the Asserted Patents are properly listed under
the latter so as to avoid any adverse impact on antitrust or FTC
enforcement actions based on improper Orange Book listings.
23
Case: 24-1936
Document: 62
Page: 30
Filed: 09/06/2024
product”; thus a patent is properly listable under this prong only if it is
directed to a formulation or composition.
Whatever the precise boundaries of those terms may be, they
clearly do not encompass mechanical devices. Both “composition” and
“formulation” plainly require that the patent be directed to a mixture of
different substances—e.g., a combination of two active ingredients, see,
e.g., Sanofi-Aventis Deutschland GmbH v. Glenmark Pharm. Inc., 748
F.3d 1354, 1358 (Fed. Cir. 2014), or an active ingredient and various
excipients, see, e.g., Schwarz Pharma, Inc. v. Paddock Labs., Inc., 504
F.3d 1371, 1372 (Fed. Cir. 2007).18
For example, as this Court has held, “[t]he term ‘composition’ in
chemistry is well-established. It generally refers to mixtures of
substances.” PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1244
(Fed. Cir. 2002); see also Exxon Chem. Patents, Inc. v. Lubrizol Corp., 64
F.3d 1553, 1558 (Fed. Cir. 1995) (“[A] chemical composition exists at the
moment the ingredients are mixed together. Before creation of the
mixture, the ingredients exist independently.”). “Formulation,” in the
18 See also Shashank Upadhye, Generic Pharmaceutical Patent and
FDA Law, § 3:13 Formulations (rev. ed. 2022) (providing examples of
formulation patents).
24
Case: 24-1936
Document: 62
Page: 31
Filed: 09/06/2024
pharmaceutical context, refers to “a material or mixture prepared
according to a particular formula.” Formulation, Oxford English Dict.
(2d ed. 1989).19 The terms “composition” and “formulation” are often
used together in pharmaceutical patents and this Court’s case law. See,
e.g., Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1361 (Fed. Cir.
2011) (“In this case, the patent claims a new composition or formulation
to deliver an FDA-approved active ingredient.”).
None of the Asserted Patents are directed to any mixture of
substances, much less the specific albuterol sulfate aerosol formulation
used in ProAir HFA. Instead, these patents are directed to devices—a
dose counter or an inhaler—that can be used as part of a combination
drug-device product, without reference to any particular
pharmaceutical formulation or composition delivered by the device.
A contrast to one of Teva’s expired Orange Book formulation
patents on ProAir HFA is instructive. Claim 2 of U.S. Patent No.
19 See also Simon Gaisford, Preformulation, in REMINGTON: THE SCIENCE
AND PRACTICE OF PHARMACY 283 (Adeboye Adejare et al. eds., 23rd ed.
2021) (“Drugs are never administered to patients as pure chemical
substances; rather, they are combined with excipients to create a
medicinal product. The process of creating a medicinal product is
termed formulation . . . .”).
25
Case: 24-1936
Document: 62
Page: 32
Filed: 09/06/2024
5,695,743, which expired in 2014, is directed to an “aerosol formulation”
comprising (a) a “therapeutically effective amount of” salbutamol
(another name for albuterol) or other specified active ingredients and
(b) HFA as a propellant. This is an example of a “drug product
(formulation or composition) patent” because it is directed to a mixture
of chemical substances, one of which is the active ingredient of ProAir
HFA.
Even setting aside the words “formulation or composition,” Teva’s
drug-agnostic device patents still could not be classified as “drug
product” patents. The term “drug product” originates in FDA
regulations, which define “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.” 21 C.F.R. § 314.3(b) (emphasis added). A “dosage form” is
“the physical manifestation containing the active and inactive
ingredients that delivers a dose of the drug product.” Id. The definitions
of “drug product” and “dosage form” include an active ingredient.
Accordingly, the Asserted Patents, which do not recite any active
ingredient in their claims, are not directed to a “drug product.”
26
Case: 24-1936
Document: 62
Page: 33
Filed: 09/06/2024
Furthermore, the words “a drug substance (active ingredient)
patent or a drug product (formulation or composition) patent”—which
Congress specifically added to the statute in 2020—must mean
something different than a patent that “claims the drug for which the
applicant submitted the application.” 21 U.S.C. § 355(b)(1)(A)(viii)(I).
Courts “generally presum[e] that statutes do not contain surplusage,”
Obduskey v. McCarthy & Holthus LLP, 586 U.S. 466, 476 (2019), and a
reading that would nullify the OBTA amendments should be rejected.
Teva is also incorrect in suggesting that under the Commission’s
reading, there would have been no need for Congress to distinguish
between a “drug substance (active ingredient) patent” and a “drug
product (formulation or composition) patent.” Teva Br. 53. The two
categories are distinct. A “drug substance (active ingredient) patent” is
directed to an active ingredient. A “drug product (formulation or
composition) patent,” as discussed above, is directed to a mixture of
substances that includes at least one active ingredient. A device patent
that does not recite any species or genus of active ingredient in its
claims is neither a drug substance nor a drug product patent within the
meaning of the Listing Statute.
27
Case: 24-1936
Document: 62
Page: 34
Filed: 09/06/2024
Contrary to Teva’s argument (Teva Br. 53-54), no claim
construction is required to resolve whether the Asserted Patents are
listable. The “drug product (formulation or composition) patent[s]”
prong of the statute limits the types of patents that are listable. No
claim construction is needed here to conclude that on their face, the
Asserted Patents are device and device component patents not “drug
product (formulation or composition) patents.”
B.
Drug-Agnostic Device Patents Do Not Claim the NDA
Product.
Because the Asserted Patents are not “drug product (formulation
or composition) patents,” they are not properly listable regardless of
whether they “claim the drug for which [Teva] submitted the [NDA].” 21
U.S.C. § 355(b)(1)(A)(viii)(I). But the district court correctly held that
the Asserted Patents do not satisfy the “claims the drug” requirement
either. As the district court held, a device patent that does not recite
any active ingredient in its claims cannot be said to “claim” a particular
drug product.
Teva attempts to rewrite the language of the Listing Statute in
arguing that a patent “claims the drug” approved in the NDA if it
“reads on” the NDA drug—i.e., if the unauthorized use, manufacture, or
28
Case: 24-1936
Document: 62
Page: 35
Filed: 09/06/2024
sale of the NDA drug would infringe the patent—even if the patent
claims do not mention an active ingredient. Teva Br. 21. The First
Circuit correctly disposed of this precise issue in Lantus, which involved
an injector pen containing a type of insulin. See 950 F.3d at 5-10. The
court held that a patent on the drive mechanism component of the pen
device did not “claim the drug” for which the brand’s application was
approved because the patent “neither claims nor even mentions insulin
glargine or the Lantus SoloSTAR”—the active ingredient and the
approved drug product, respectively. Id. at 10. The same analysis
applies here, where the Asserted Patents do not mention albuterol
sulfate, any genus of compounds that includes albuterol sulfate, or
indeed, any active ingredient at all, and are listed across many different
NDAs for products with different active ingredients.
The example given by the First Circuit in Lantus is illustrative.
Suppose a patent contains claims reciting a transmission system for use
in automobiles. The patent would “read on” a car that incorporated that
transmission system. But one would not say the patent on the
transmission “claims” the car. See Lantus, 950 F.3d at 8 (“One would
not think . . . that a patent claiming only a transmission system must
29
Case: 24-1936
Document: 62
Page: 36
Filed: 09/06/2024
be read as also claiming any car in which it is used.”). So too here. Even
if an unauthorized copy of ProAir HFA might literally infringe the
patents, on their face, the patents do not claim “the drug for which
[Teva] submitted the [NDA],” which was “albuterol sulfate HFA
Inhalation Aerosol.” Appx34.20
Regardless, as discussed above, under the statutory text, it is not
a sufficient condition for proper listing that the patent “claims the
drug.” The statutory text allows listing only of a non-method-of-use
patent that “claims the drug . . . and is a drug substance (active
ingredient) patent or a drug product (formulation or composition).”
Teva’s interpretation of the Listing Statute would render superfluous
20 Teva wrongly asserts (Teva Br. 48) that the Commission’s position is
an “about-face” from what it said in its district court amicus brief in
Jazz. In Jazz, the Commission said in a footnote that “[t]o claim the
drug for which the NDA was submitted, a patent must contain a
product claim that reads on the drug that is the subject of the NDA.”
FTC Brief, Jazz Pharm. v. Avadel CNS Pharm., LLC, No. 1:21-cv-691,
Dkt. No. 227 at 16 n.26 (D. Del. Nov. 15. 2022). To “claim” the NDA
product, it is necessary for the patent to “read on” the drug—that is,
every limitation in a particular patent claim must be present in the
NDA drug. But as the example in Lantus illustrates, a patent may
“read on” the device components of a combination product but still not
“claim” the approved product. While it is necessary for the patent to
read on the NDA drug in order to “claim the drug,” it is not always
sufficient.
30
Case: 24-1936
Document: 62
Page: 37
Filed: 09/06/2024
this second requirement in the statute, which the Asserted Patents do
not meet. See supra Section II.A.
Teva’s reliance on dicta from Apotex, Inc. v. Thompson, 347 F.3d
1335 (Fed. Cir. 2003) (Teva Br. 24-25) is misplaced. In that case, the
Court never reached the issue of whether the patents were properly
listed. Id. at 1349. The court’s discussion of the phrase “claims the drug”
as part of its antecedent jurisdictional analysis does not suggest that a
patent claiming only the device components of a drug-device
combination product, with no mention of an active ingredient, can be
said to claim the NDA drug.
Contrary to Teva’s assertion (Teva Br. 45-48), no claim
construction is required with respect to this prong either. The claims in
the Asserted Patents recite only structural elements and do not mention
any chemical or biological substances whatsoever, and thus cannot
plausibly be construed to claim a metered aerosol of albuterol sulfate.21
This Court’s recent decision in Jazz is not to the contrary. Jazz observed
21 Teva proposes claim constructions of the Asserted Patents that would
read in new limitations reciting the use of an unspecified “active drug,”
Teva Br. 45-46, but it is black letter law that new limitations cannot be
imported into the claims. See Phillips v. AWH Corp., 415 F.3d 1303,
1323 (Fed. Cir. 2005) (en banc).
31
Case: 24-1936
Document: 62
Page: 38
Filed: 09/06/2024
that what the patent “claimed” “should be derived using the tools and
framework of patent law, including claim construction,” 60 F.4th at
1379, but it did not conduct a detailed claim construction analysis.
Instead, it held that claims to a “system” could not properly be
construed as claiming a “method.” Id. at 1380. Nor was claim
construction needed in UFCW; on their face, the listed patents there did
not “claim” the NDA drug, because they claimed a combination of two
active ingredients, but the NDA drug contained only one of them.
UFCW, 11 F.4th at 124, 132.
Finally, Teva’s argument that the term “drug” may include
“articles intended for use as a component” of a drug does not support its
position. See Teva Br. 29 (quoting 21 U.S.C. § 321(g)(1)(D)). Lantus
properly rejected an argument identical to Teva’s. 950 F.3d at 9. As the
First Circuit explained, the “plain wording” of the Listing Statute
requires not only that the listed patent “claims a drug,” but that it
“claims the drug . . . ‘for which the applicant submitted’ the [NDA].” Id.
at 8. The drug for which Teva submitted its NDA is “albuterol sulfate
HFA Inhalation Aerosol.” Appx34. Even if a dose counter or an inhaler
device might qualify as “a” drug for some purposes under the FDCA,
32
Case: 24-1936
Document: 62
Page: 39
Filed: 09/06/2024
these components are not “the” drug for which Teva submitted the NDA
because the components may be made and used without albuterol
sulfate. Indeed, Teva has listed the same patents in connection with
several other NDAs containing different active ingredients.
C.
The Court Should Enforce the Policy Choices
Congress Made in the OBTA To Prevent Improper
Orange Book Listings.
Teva conjures a parade of horribles that will supposedly ensue if
courts enforce the statutory criteria for Orange Book listing. Teva Br.
54-56. It is not the role of this Court to second-guess Congress’s policy
judgment. In enacting the OBTA, Congress clarified that the protection
of the 30-month stay does not extend to every patent that an ANDA
product may infringe, but only to specific types of patents. Patents that
merely claim a mechanism for delivering a drug do not qualify.
In any event, Teva’s suggestion that a plain text application of the
listing criteria will effectively nullify the Hatch-Waxman Act and
thereby disincentivize companies from trying to launch generics (Teva
Br. 54-55) is groundless. Brand companies will still be required to list
patents that claim their approved product and are directed to the
relevant drug substance or a formulation or composition of the drug
33
Case: 24-1936
Document: 62
Page: 40
Filed: 09/06/2024
product (or patents that claim a method of use approved in the NDA),
and they will still be entitled to a 30-month stay if a competitor
subsequently files an ANDA seeking to market a generic before
expiration of these properly listed patents. Enforcement of the listing
criteria simply means the statute will function as Congress intended.
CONCLUSION
The district court’s judgment should be affirmed.
34
Case: 24-1936
Document: 62
September 6, 2024
Page: 41
Filed: 09/06/2024
Respectfully submitted,
ANISHA S. DASGUPTA
General Counsel
/s/ Anupama Sawkar
ANUPAMA SAWKAR
MATTHEW M. HOFFMAN
Attorneys
FEDERAL TRADE COMMISSION
600 Pennsylvania Ave., N.W.
Washington, D.C. 20580
(202) 779-6023
asawkar@ftc.gov
Of Counsel:
HANNAH GARDEN-MONHEIT
Director, Office of Policy
Planning
JORDAN T. KLIMEK
BRADLEY J. VETTRAINO
Attorneys
FEDERAL TRADE COMMISSION
Washington, D.C. 20580
35
Case: 24-1936
Document: 62
Page: 42
Filed: 09/06/2024
FORM 19. Certificate of Compliance with Type-Volume Limitations
Form 19
July 2020
UNITED STATES COURT OF APPEALS
FOR THE FEDERAL CIRCUIT
CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMITATIONS
Case Number: 2024-1936
Short Case Caption: Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC
Instructions: When computing a word, line, or page count, you may exclude any
items listed as exempted under Fed. R. App. P. 5(c), Fed. R. App. P. 21(d), Fed. R.
App. P. 27(d)(2), Fed. R. App. P. 32(f), or Fed. Cir. R. 32(b)(2).
The foregoing filing complies with the relevant type-volume limitation of the
Federal Rules of Appellate Procedure and Federal Circuit Rules because it meets
one of the following:
✔
□
the filing has been prepared using a proportionally-spaced typeface
6,802
and includes __________
words.
□
the filing has been prepared using a monospaced typeface and includes
__________ lines of text.
□
the filing contains __________ pages / __________ words / __________
lines of text, which does not exceed the maximum authorized by this
court’s order (ECF No. __________).
09/06/2024
Date: _________________
Signature:
/s/ Anupama Sawkar
Name:
Anupama Sawkar
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.