The opinion
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
______________________
2024-1936
______________________
Appeal from the United States District Court for the
District of New Jersey in No. 2:23-cv-20964-SRC-MAH,
Judge Stanley R. Chesler.
______________________
Decided: December 20, 2024
______________________
WILLIAM M. JAY, Goodwin Procter LLP, Washington,
DC, argued for plaintiffs-appellants. Also represented by
JORDAN BOCK, CHRISTOPHER T. HOLDING, LOUIS LOBEL,
THOMAS MCTIGUE, DARYL L. WIESEN, Boston, MA; NATASHA
ELISE DAUGHTREY, Los Angeles, CA.
STEVEN ARTHUR MADDOX, Procopio, Washington, DC,
2 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
argued for defendants-appellees. Also represented by
JEREMY JON EDWARDS, BRETT M. GARRISON.
______________________
Before PROST, TARANTO, and HUGHES, Circuit Judges.
PROST, Circuit Judge.
When a generic drugmaker applies to market a drug
using the same active ingredient as a branded drug, the
Food and Drug Administration (“FDA”) cannot approve the
generic company’s application if the generic company’s
drug would infringe the brand-name manufacturer’s
patent. The FDA checks for whether the generic company’s
drug would infringe by looking at which patents the brand-
name manufacturer listed in a publication called the
Orange Book. If the brand-name manufacturer lists a non-
expired patent that the brand-name manufacturer
purports claims its drug, the FDA will not approve the
generic company’s application. Instead, simply by listing a
patent as claiming a drug, the brand-name manufacturer
can make the FDA withhold approval of the generic
company’s application for thirty months. The brand-name
manufacturer’s decision on which patents to list, then, can
make the difference between the FDA granting the generic
company’s application and the FDA withholding approval.
In this case, Amneal1 alleges that Teva2 improperly
listed patents in the Orange Book and delayed the entry of
generic products onto the market. The district court agreed
with Amneal and ordered Teva to delist its patents from
1 Amneal Pharmaceuticals of New York, LLC,
Amneal Ireland Limited, Amneal Pharmaceuticals LLC,
and Amneal Pharmaceuticals, Inc.
2 Teva Branded Pharmaceutical Products R&D, Inc.,
Norton (Waterford) Ltd., and Teva Pharmaceuticals USA,
Inc.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 3
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
the Orange Book on the ground “that the Inhaler Patents
contain no claim for the active ingredient at issue,
albuterol sulfate,” but instead “are directed to components
of a metered inhaler device.” Teva Branded Pharm. Prods.
R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 23-20964,
-- F. Supp. 3d --, 2024 WL 2923018, at *6, *7 (D.N.J. June
10, 2024) (“Delisting Order”). Teva appealed, and we
stayed the district court’s order pending our resolution of
this case. We now lift the stay and affirm the district
court’s delisting order.
BACKGROUND
Congress has set up a complicated scheme regulating
how the FDA approves applications to market drugs.
Understanding whether Teva properly listed its patents in
the Orange Book, a question presented by this appeal,
requires an appreciation of where the Orange Book fits into
this regime. We thus lay out the statutory and regulatory
background before turning to the specifics of this case.
I
The Federal Food, Drug, and Cosmetic Act (“FDCA”)
governs the FDA’s regulation of medical products. Before
a company can market a drug, it must submit a new drug
application (“NDA”). See 21 U.S.C. § 355(a), (b).3 The NDA
must include, among other things, full reports on
investigations showing that the drug is safe and effective,
a full description of the components and manufacturing
process for the drug, the proposed labeling for the drug, and
information on patents claiming the drug. Id.
§ 355(b)(1)(A). If the applicant shows that the drug
described in the NDA is safe and effective, the FDA
3 Although the parties refer to brands and generics,
for precision we refer to the brand as the NDA
holder/patent owner and the generic as the generic
company or applicant.
4 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
approves the drug. Id. § 355(d). The applicant typically
demonstrates safety and efficacy through time-consuming
and expensive clinical trials.
This NDA process is the typical one for a new name
drug containing a new active ingredient. Before 1984, a
company seeking approval for a generic drug “that contains
the same active ingredient[]” as the brand-name drug
manufacturer had to file its own NDA with its own clinical
trials, even though the FDA already determined that the
active ingredient is safe and effective. See United States v.
Generix Drug Corp., 460 U.S. 453, 454, 461 (1983). Another
aspect of the NDA process made approval of a generic drug
costly and time-intensive before 1984: conducting
experiments to prepare the materials for a generic-drug
NDA often constituted infringement of one or more patents
on the NDA holder’s drug. Roche Prods., Inc. v. Bolar
Pharm. Co., 733 F.2d 858, 863 (Fed. Cir. 1984), superseded
by statute, Warner-Lambert Co. v. Apotex Corp., 316 F.3d
1348, 1358 (Fed. Cir. 2003).
In 1984, Congress enacted the Hatch-Waxman Act,
which changed the landscape for generic approval in order
to bring generic products to market faster. See Drug Price
Competition and Patent Term Restoration Act of 1984,
Pub. L. No. 98-417, 98 Stat. 1585.
One major innovation in the Hatch-Waxman Act was
the introduction of an abbreviated new drug application
(“ANDA”). See 21 U.S.C. § 355(j). If a generic company
wants to market a drug using the same active ingredient
and label as a drug subject to an approved NDA, it no
longer has to conduct separate clinical trials showing
safety and efficacy; rather, if it submits an ANDA, the
generic applicant only has to make a showing of
bioequivalence. Id. § 355(j)(2)(A)(ii), (iv). Congress also
created a safe harbor granting immunity from patent
infringement “solely for uses reasonably related to the
development and submission” of information to the FDA.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 5
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
35 U.S.C. § 271(e)(1). This provision overturned our
decision in Roche. In tandem, the ANDA and the safe
harbor provisions helped “speed the introduction of low-
cost generic drugs to market.” Caraco Pharm. Labs., Ltd.
v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012).
Clinical testing by NDA holders as well as FDA review
time also resulted in the NDA holder’s patent being issued
well before the FDA approves an NDA, thus depriving the
NDA holder of anything close to the statutory period of
marketing exclusivity. The FDA often took longer to
approve an NDA than the PTO took to approve a patent on
the drug. Thus, Congress also included in the Hatch-
Waxman Act a patent-term extension (“PTE”) for patents
claiming an FDA-approved product. See 35 U.S.C.
§ 156(a).
While these changes sped up the process for generic
market entry, they did not deal with the litigation risk that
could come from a generic company marketing a drug
arguably covered by an NDA holder’s patent. Congress
thus decided to create “a new (and somewhat artificial) act
of infringement” that would resolve patent disputes pre-
approval. Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661,
676 (1990). Under this new provision, it is an act of
infringement to submit an ANDA. 35 U.S.C. § 271(e)(2)(A).
Upon a finding of infringement, one remedy is to set the
effective date of approval no earlier than the date the
brand’s patent would expire. Id. § 271(e)(4)(A).
Congress did not just leave the approval timeline to the
courts, though; it also prohibited the FDA from approving
an ANDA that would infringe a patent. The FDA decides
whether a generic drug would infringe a patent by looking
at the Orange Book,4 the linchpin of this entire scheme.
4 The full name of this publication is Approved Drug
Products with Therapeutic Equivalence Evaluations.
6 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
When an NDA holder that owns a patent submits an NDA,
it must submit information on “the patent number and
expiration date of each patent” meeting several
requirements. 21 U.S.C. § 355(b)(1)(A)(viii). When the
Hatch-Waxman Act was enacted, this listing provision
required that “[t]he applicant shall file with the application
the patent number and the expiration date of any patent
which claims the drug for which the applicant submitted
the application or which claims a method of using such
drug and with respect to which a claim of patent
infringement could reasonably be asserted if a person not
licensed by the owner engaged in the manufacture, use, or
sale of the drug.” Hatch-Waxman Act, sec. 102(a)(1),
§ 505(b), 98 Stat. at 1592 (emphasis added).
When a generic company submits an ANDA, it must
make certifications about the patents that the patent
owner listed on its NDA drug product. For patents that the
NDA holder asserts claim the drug, the generic applicant
makes one of four certifications. See 21 U.S.C.
§ 355(j)(2)(A)(vii).5 The first, called a paragraph I
certification, is when “such patent information has not
been filed.” Id. § 355(j)(2)(A)(vii)(I). The second, called a
paragraph II certification, is when “such patent has
expired.” Id. § 355(j)(2)(A)(vii)(II). The third, called a
paragraph III certification, contains “the date on which
such patent will expire.” Id. § 355(j)(2)(A)(vii)(III). And
the fourth, called a paragraph IV certification, certifies
“that such patent is invalid or will not be infringed by the
manufacture, use, or sale of the new drug for which the
application is submitted.” Id. § 355(j)(2)(A)(vii)(IV).
5 There are other statements a generic applicant can
make about patents claiming methods of using the drug,
called section viii statements. See 21 U.S.C.
§ 355(j)(2)(A)(viii); Caraco, 566 U.S. at 406. We do not
discuss them here.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 7
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
Which certification a generic applicant makes
determines when the FDA may approve the generic
applicant’s ANDA. If a generic applicant makes a
paragraph I or II certification, “the approval may be made
effective immediately,” assuming the FDA is otherwise
ready to approve the generic’s ANDA. Id. § 355(j)(5)(B)(i).
For a paragraph III certification, the FDA will not approve
the ANDA until the relevant patent expires. Id.
§ 355(j)(5)(B)(ii).
A paragraph IV certification leads to a much more
complicated path. After the generic applicant sends the
patent owner a paragraph IV notice, the patent owner has
forty-five days to decide whether to file an infringement
suit. Id. § 355(j)(5)(B)(iii). If the patent owner sues the
generic company for patent infringement within forty-five
days of receiving the notice, “the approval shall be made
effective upon the expiration of the thirty-month period
beginning on the date of the receipt of the notice” (subject
to various exceptions). Id. If the patent owner does not sue
within forty-five days, “the approval shall be made effective
immediately.” Id.
As the foregoing suggests, whether the FDA approves
an ANDA immediately or in thirty months depends on
which, if any, patents the NDA holder lists. If the NDA
holder does not list a patent, the generic applicant can file
a paragraph I certification, and approval can be effective
immediately. If, however, the NDA holder lists a patent
that has not expired and that the NDA holder purports
claims the drug, the generic applicant has to file a
paragraph IV certification, which delays approval for thirty
months if the patent owner sues for infringement. This
regime works as intended only if the NDA holder lists those
patents required by the listing provision and no more.
The attractiveness of the thirty-month stay might
arguably provide an NDA holder significant incentives to
improperly list patents in the Orange Book as purporting
8 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
to claim the drug, even if they do not actually claim the
drug. And this concern is not illusory. “In the late 1990’s,
evidence mounted that some brands were exploiting this
statutory scheme to prevent or delay the marketing of
generic drugs” with the “submission of inaccurate patent
information to the FDA.” Caraco, 566 U.S. at 408.
So what happens if the NDA holder does submit
inaccurate patent information? The FDA does not police
this process, as it has long taken the position that it lacks
patent-law expertise and thus cannot determine whether
the patents that a patent owner lists in the Orange Book
are properly included. Abbreviated New Drug Application
Regulations; Patent and Exclusivity Provisions, 59 Fed.
Reg. 50,338, 50,345 (Oct. 3, 1994) (“FDA does not have the
resources or the expertise to review patent information for
its accuracy and relevance to an NDA.”). Thus, it
effectively plays only a “ministerial” role and does not
substantively review patents before publishing them in the
Orange Book. 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. 36,676, 36,683 (June 18, 2003). Several courts
have concluded that the FDA’s position is a reasonable
understanding of the statutory framework. See Apotex,
Inc. v. Thompson, 347 F.3d 1335, 1347–50 (Fed. Cir. 2003);
aaiPharma Inc. v. Thompson, 296 F.3d 227, 238–43 (4th
Cir. 2002). Certain generic companies, in the face of no
help from the FDA, tried another argument—that the
FDCA provides an implied cause of action to delist an
improperly listed patent. We threw cold water on that
position and rejected it in Mylan Pharmaceuticals, Inc. v.
Thompson, 268 F.3d 1323, 1332 (Fed. Cir. 2001),
superseded by statute, Caraco, 566 U.S. at 408. The state
of play was thus that there was no way to force an NDA
holder to remove inappropriately listed patents.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 9
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
In 2003, Congress provided a partial fix regarding this
matter. If the generic company provides the NDA holder
notice of a paragraph IV certification, and if the NDA
holder sues for infringement within forty-five days,
Congress has authorized the generic company to bring a
counterclaim that can require the NDA holder to fix its
listed patent information in the Orange Book. See
Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Pub. L. No. 108-173, sec.
1101(a), § 505(j), 117 Stat. 2066, 2452. The counterclaim
provision states:
In general.—If an owner of the patent or the holder
of the approved application under subsection (b) for
the drug that is claimed by the patent or a use of
which is claimed by 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 submitted by the holder under
subsection (b) or (c) on the ground that the patent
does not claim either—
(aa) the drug for which the application was
approved; or
(bb) an approved method of using the drug.
21 U.S.C. § 355(j)(5)(C)(ii)(I) (emphasis added). A generic
company cannot seek a delisting order “other than [with] a
counterclaim described in subclause (I).” Id.
§ 355(j)(5)(C)(ii)(II). This counterclaim is a limited but
potent tool. If the NDA holder lists patents, if the generic
company files a paragraph IV certification, and if the NDA
holder sues for infringement, the counterclaim can make
10 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
the difference between a thirty-month stay in approval or
immediate approval.6
Adding the counterclaim was not, however, Congress’s
last word addressing which patents should be listed in the
Orange Book. In 2021, Congress amended the listing
provision in the Orange Book Transparency Act (“OBTA”),
Pub. L. No. 116-290, 134 Stat. 4889 (2021). In so doing,
Congress observed that “some branded drug
manufacturers may choose not to submit every patent on a
product to the FDA, and others are submitting patents
potentially for the purpose of blocking generic
competition.” H.R. Rep. No. 116-47, at 4 (2019).
Before the OBTA, the Hatch-Waxman Act required an
NDA holder to file “the patent number and the expiration
date of any patent which claims the drug for which the
applicant submitted the application or which claims a
method of using such drug and with respect to which a
claim of patent infringement could reasonably be asserted
if a person not licensed by the owner engaged in the
manufacture, use, or sale of the drug.” Hatch-Waxman Act,
sec. 102(a)(1), § 505(b), 98 Stat. at 1592 (emphasis added).
In the OBTA, among other changes, Congress amended the
listing provision to further specify the class of patents that
an NDA holder must list. The amended listing provision,
with emphasis indicating the language Congress added in
the OBTA, requires that the NDA holder list:
the patent number and expiration date of each
patent for which a claim of patent infringement
could reasonably be asserted if a person not
6 As described above, this immediate approval
happens either if the generic company makes a paragraph
I or paragraph II certification or if the NDA holder does not
sue after the generic company makes a paragraph IV
certification.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 11
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
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.
21 U.S.C. § 355(b)(1)(A)(viii) (emphasis added). The OBTA
also added language specifying that patent information on
patents other than the ones specified above “shall not be
submitted.” Id. § 355(c)(2). In other words, the amended
language sets both a floor and a ceiling for what patents an
NDA holder must list.
Congress adopted this language to “codify current
[FDA] regulations and practice regarding the types of
patent and exclusivity-related information listed in the
Orange Book.” H.R. Rep. No. 116-47, at 6. The regulatory
provisions that Congress referenced reflect that, since
2003, the FDA has interpreted the class of patents that
claim the drug for which the applicant submitted the
application to “consist of drug substance (active ingredient)
patents, drug product (formulation and composition)
patents, and method-of-use patents.” 21 C.F.R.
§ 314.53(b)(1). The FDA defines “drug substance” to mean
“an active ingredient,” and it defines “drug product” to
mean “a finished dosage form . . . that contains a drug
substance, generally, but not necessarily, in association
with one or more other ingredients.” 21 C.F.R. § 314.3(b).
II
We now turn to the facts of this case. In order, we
discuss Teva’s NDA for its drug, Amneal’s ANDA and
paragraph IV notice, and the district court’s delisting order.
12 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
A
The NDA product for which Teva listed the patents
Amneal sought to delist is the ProAir® HFA Inhalation
Aerosol, described in NDA No. 021457, which was approved
on October 29, 2004. It “provides for the use of albuterol
sulfate HFA Inhalation Aerosol for the treatment or
prevention of bronchospasm with reversible obstructive
airway disease in adults and children 12 years of age or
older.” J.A. 352. The ProAir® HFA combines albuterol
sulfate (the active ingredient) with a propellant, ethanol,
and an inhaler device to administer the drug. J.A. 649.7
Per the approved label, each actuation (or press) of the
inhaler “delivers 108 mcg of albuterol sulfate from the
actuator mouthpiece (equivalent to 90 mcg of albuterol
base).” J.A. 642. The albuterol sulfate is supplied in a
canister containing 200 doses. J.A. 642. In the approved
form, the ProAir® HFA “contains a microcrystalline
suspension of albuterol sulfate in propellant HFA-134a
(1,1,1,2-tetrafluoroethane) and ethanol.” J.A. 649. “The
pharmacologic effects of albuterol sulfate are attributable
to activation of beta2-adrenergic receptors on airway
smooth muscle.” J.A. 649.
Although the FDA approved Teva’s ProAir® HFA as a
drug, the ProAir® HFA contains both drug and device
components (the device components being the physical
machinery of the inhaler). The FDA approved the ProAir®
HFA as a drug, as it does for all metered-dose inhalers,
because the primary mode of therapeutic action comes from
the active ingredient—here, albuterol sulfate. See
J.A. 1052 (FDA guidance stating that “Metered Dose
Inhalers and Actuators are reviewed in the Center for Drug
Evaluation and Research (CDER)”).
7 Albuterol sulfate is called salbutamol sulfate in
other countries. J.A. 649.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 13
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
Teva lists nine non-expired patents in the Orange Book
for its ProAir® HFA. Five are relevant here: U.S. Patent
Nos. 8,132,712 (“the ’712 patent”), 9,463,289 (“the ’289
patent”), 9,808,587 (“the ’587 patent”), 10,561,808 (“the
’808 patent”), and 11,395,889 (“the ’889 patent”). They
expire in 2028, 2031, or 2032. J.A. 810.
These patents are similar but not identical in claimed
subject matter. The ’712 patent relates to “[a] metered dose
inhaler dose counter.” ’712 patent Abstract. A dose counter
lets a user know “how many doses remain” in the inhaler’s
canister. Id. at col. 2 l. 34. The ’712 patent discusses
problems with existing dose counters, including that
existing ones undercount doses used, which “can lead to a
patient believing that there are more doses left within the
inhaler than there actually are.” Id. at col. 5 ll. 8–9. The
other patents also relate to dose counters. The ’289 patent
discusses solutions to the problem opposite of the one
addressed in the ’712 patent—of the dose counter
“count[ing] a dose when the canister has not fired.” ’289
patent col. 2 ll. 20–21. The ’289 patent discloses dose-
counter configurations and methods of assembly that
purport to solve this problem. The ’587, ’808, and ’889
patents have substantially the same specification as the
’289 patent.
These patents relate to improvements in the device
parts of inhalers—specifically, the dose counter—although
their specifications make some reference to active
ingredients being used alongside the dose counter. The
’289 patent, for example, discusses “a medicament-
containing pressurised canister containing a mixture of
active drug and propellant,” but only in the background
section of the patent. Id. at col. 1 ll. 27–29. The ’712 patent
has more specific references to active drugs. In the detailed
description of the invention, it discusses the presence of “a
medicament in the form of an aerosol” in its inhaler. ’712
patent col. 8 ll. 49–50. The specification mentions several
classes of medicaments, including anti-allergic agents,
14 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
anti-inflammatory steroids, bronchodilators, and
anticholinergic agents. Id. at col. 8 ll. 57–67. One
specifically mentioned is a beta2-agonist by the name of
salbutamol, the international name for albuterol. Id. at
col. 8 l. 62.
The claims in these patents focus on the device
components of the inhaler—specifically, the dose counter
and the inhaler canister. One example of the claims in
these patents is claim 1 of the ’289 patent. It recites:
1. An inhaler for metered dose inhalation, the
inhaler comprising:
a main body having a canister housing,
a medicament canister, which is moveable
relative to the canister housing and
retained in a central outlet port of the
canister housing arranged to mate with a
canister fire stem of the medicament
canister, and
a dose counter having an actuation
member having at least a portion thereof
located in the canister housing for
operation by movement of the medicament
canister,
wherein the canister housing has an inner
wall, and a first inner wall canister support
formation extending inwardly from a main
surface of the inner wall, and
wherein the canister housing has a
longitudinal axis X which passes through
the center of the central outlet port,
the inner wall canister support formation,
the actuation member, and the central
outlet port lying in a common plane
coincident with the longitudinal axis X.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 15
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
’289 patent claim 1. Claim 1 of the ’712 patent similarly
recites a collection of physical components that are part of
an inhaler. Claim 16, which depends from claim 1, recites
“[a] metered dose inhaler comprising a medicament
canister, an actuator body for receiving the canister and
having a medicament delivery outlet, and the dose counter
as claimed in claim 1.” ’712 patent claim 16. None of the
claims in the five asserted patents explicitly require the
presence of an active drug, let alone any specific active
drug.
B
Amneal filed an ANDA seeking approval to market a
generic version of Teva’s ProAir® HFA that uses the same
active ingredient. Because Teva listed a number of patents
in the Orange Book as claiming its ProAir® HFA, Amneal
filed a paragraph IV certification asserting that it did not
infringe the nine patents listed for Teva’s ProAir® HFA.
Amneal sent notice of its paragraph IV certification to Teva
on August 24, 2023. Teva sued for infringement of six of
those patents, and it subsequently amended its complaint
to sue for infringement of only the five patents identified
above. J.A. 56.
Amneal filed antitrust counterclaims, counterclaims
for declaratory judgment of noninfringement and
invalidity, and counterclaims seeking an order requiring
Teva to delist the five patents that it asserted against
Amneal. Amneal alleges that Teva’s infringement suit
“triggered a 30-month stay of final FDA approval of
Amneal’s ANDA.” J.A. 298 ¶ 23. Further, it alleges that,
had Teva not listed the five asserted patents in the Orange
Book, Amneal would have filed a paragraph I certification
and no 30-month stay would be imposed. J.A. 313 ¶ 102.
C
Teva moved to dismiss Amneal’s antitrust and delisting
counterclaims. Amneal cross-moved for a motion for
16 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
judgment on the pleadings on the ground that Teva
improperly listed the asserted patents. The district court
denied Teva’s motion, granted Amneal’s motion, and
ordered Teva to delist the five asserted patents. The other
counterclaims and Teva’s infringement claims remain
pending before the district court.
The district court concluded that Teva’s patents “do not
claim the drug for which the applicant submitted the
application” and thus ordered Teva to delist its patents
from the Orange Book. Delisting Order, 2024 WL 2923018,
at *6, *9. The district court based its conclusion on the fact
that Teva’s patents “contain no claim for the active
ingredient at issue, albuterol sulfate.” Id. Rather, the
district court concluded that the patents “are directed to
components of a metered inhaler device, but do not claim
or even mention albuterol sulfate or the ProAir® HFA.” Id.
at *7.
In reaching its conclusion, the district court rejected
two arguments from Teva. The first was Teva’s argument
that “a patent ‘claims’ a product if the patent would be
infringed by the product.” Id. Rather, the district court
concluded that “a patent claims only that subject matter
that it has particularly pointed out as the invention, and
no more”—which “is inconsistent with Teva’s contention
that a patent claims all products that are infringing.” Id.
(emphasis in original). The second was Teva’s argument
that, because the five patents “claim articles intended for
use as a component of the ProAir® HFA (albuterol sulfate)
Inhalation Aerosol,” the patents were properly listed. Id.
at *8. The district court concluded that Teva’s argument
failed to account for the statutory phrase “for which the
applicant submitted the application,” which required the
claim to include albuterol sulfate. Id.; 21 U.S.C.
§ 355(b)(1)(A)(viii)(I).
Teva timely appealed the district court’s interlocutory
delisting order, and we have jurisdiction under 28 U.S.C.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 17
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
§ 1292(a)(1) and (c)(1). Shortly after Teva filed its appeal,
we issued a stay of the district court’s order pending our
review. ECF No. 29.
DISCUSSION
Statutory interpretation is an issue of law that we
review de novo. Cal. Institute of Tech. v. Broadcom Ltd.,
25 F.4th 976, 985 (Fed. Cir. 2022). “In statutory
construction, we begin ‘with the language of the statute.’”
Kingdomware Techs., Inc. v. United States, 579 U.S. 162,
171 (2016) (quoting Barnhart v. Sigmon Coal Co., 534 U.S.
438, 450 (2002)). In doing so, we focus on “the language
itself, the specific context in which that language is used,
and the broader context of the statute as a whole.” Caraco,
566 U.S. at 412 (2012) (quoting Robinson v. Shell Oil Co.,
519 U.S. 337, 341 (1997)). And we remain mindful that, in
resolving disputes about the meaning of the text,
“[u]ltimately, context determines meaning.” Johnson v.
United States, 559 U.S. 133, 139 (2010). To this end, we
evaluate the meaning of the words in a statute “with a view
to their place in the overall statutory scheme.” FDA v.
Brown & Williamson Tobacco Corp., 529 U.S. 120, 133
(2000) (quoting Davis v. Mich. Dep’t of Treasury, 489 U.S.
803, 809 (1989)).
In sum, as described in more detail below, Teva argues
that the district court erred by interpreting the listing
provision to permit the listing of only a small class of
patents claiming at least the active ingredient. Rather,
Teva argues on appeal, as it did before the district court,
that a patent can (and indeed must) be listed in the Orange
Book if the claimed invention is found in any part of its
NDA product. On these facts, Teva’s argument goes as
follows: Teva’s ProAir® HFA metered-dose inhaler, the
approved NDA product in this case, has various features
including an active ingredient, a dose counter, and a
canister (which Amneal does not dispute). Teva’s patents
at issue here have claims to the dose-counter and canister
18 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
parts of a metered-dose inhaler. Since Teva’s ProAir® HFA
has features claimed by these patents—the dose counter
and canister—Teva’s argument is that it properly listed its
patents in the Orange Book.
To support this position, Teva makes two key
interpretive moves. First, in the bulk of its argument on
appeal, Teva asserts that a patent “claims the drug” if the
claim reads on the approved drug—in other words, if the
NDA drug product infringes that claim. If claims means
infringes, as Teva contends, then it properly listed its
patents for a simple reason: its claims for a dose counter
and for a canister read on the ProAir® HFA. Second, Teva
relies on the FDCA’s broad definition of the word “drug” to
argue that any component of an article that can treat
disease meets the statutory definition of a “drug.” If Teva
is right about its interpretation of “drug,” then Teva’s
patents “claim the drug,” as they claim components of the
ProAir® HFA—the dose counter and canister.
As we explain below, we reject Teva’s interpretation as
allowing for the listing of far more patents than Congress
has indicated. In doing so, we first reject Teva’s argument
that a patent claims the drug if it reads on the approved
drug. Instead, a patent claims the drug when it
particularly points out and distinctly claims the drug as the
invention. We then reject Teva’s argument that a patent
claiming any component of a drug is listable. Instead, to
qualify for listing, a patent must claim at least what made
the product approvable as a drug in the first place—its
active ingredient. In other words, Teva cannot list its
patents just because they claim the dose-counter and
canister parts of the ProAir® HFA.
Teva also argues that, even if we reject its statutory
arguments, we must remand for the district court to
construe the claims. We also reject this argument.
Adopting Teva’s proposed construction, we still conclude
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 19
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
that Teva’s patents do not qualify for listing because they
do not claim the active ingredient.
We address each issue in turn—first, rejecting Teva’s
argument that “claims” means “reads on”; second,
explaining why a listable patent is one that claims at least
the active ingredient in the approved drug; and third,
explaining why the district court properly ordered these
specific patents to be delisted.
I
We start by rejecting Teva’s interpretation of the word
“claims” in the listing and counterclaim/delisting
provisions.8 Teva argues that “[t]he scope of what a patent
‘claims’ is effectively coterminous with the products that
infringe a patent.” Appellants’ Br. 21. This argument,
which comprises the bulk of Teva’s briefing on appeal, is
defective.
The most identifiable problem with Teva’s position is
that the listing provision identifies infringing and claiming
as two distinct requirements. Teva must list “the patent
number and expiration date of each patent for which a
claim of patent infringement could reasonably be asserted”
and that “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.” 21 U.S.C. § 355(b)(1)(A)(viii), (I).
When interpreting a statute, we are “obliged to give effect,
if possible, to every word Congress used.” Reiter v.
Sonotone Corp., 442 U.S. 330, 339 (1979). Accepting Teva’s
8 Although the counterclaim provides a mechanism
to “correct or delete the patent information” in the Orange
Book, 21 U.S.C. § 355(j)(5)(C)(ii)(I), this appeal addresses
only the “delete” portion of the counterclaim. We refer to
this portion of the counterclaim as the delisting provision
in the remainder of our analysis.
20 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
interpretation would create a stunning example of
statutory redundancy. If we read claiming to be “effectively
coterminous” with infringing, Congress would have, in
effect, added a separate requirement to the listing
provision that would have essentially no meaning. The
more natural reading is that, in order to be listed, a patent
must both claim the drug and be infringed by the NDA
product. We “reject[] an interpretation of the statute that
would render an entire subparagraph meaningless.” Nat’l
Assn of Mfs. v. Dep’t of Defense, 583 U.S. 109, 128 (2018).
Still, Teva insists that the specialized patent-law
meanings of claiming and infringement compel us to adopt
its interpretation. We disagree and view the Patent Act
and our cases as supporting the opposite interpretation.
While Teva is correct that the words claim and infringe
have a meaning “peculiar to patent law,” Markman v.
Westview Instruments, Inc., 517 U.S. 370, 374 (1996), the
“substantial body of law” illuminating these two terms
confirms that they have distinct meanings, Helsinn
Healthcare S.A. v. Teva Pharms. USA, Inc., 586 U.S. 123,
130 (2019).
We begin with the statutory text. A claim is a
numbered paragraph at the end of the patent document
that “particularly point[s] out and distinctly claim[s] the
subject matter which the inventor or a joint inventor
regards as the invention.” 35 U.S.C. § 112(b); see also
Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868
F.2d 1251, 1258 (Fed. Cir. 1989). And that invention is
what is described in the specification, which “contain[s] a
written description of the invention, and of the manner and
process of making and using it, in such full, clear, concise,
and exact terms as to enable any person skilled in the art
to which it pertains, or with which it is most nearly
connected, to make and use the same.” 35 U.S.C. § 112(a).
When the claims and specification are read together, then,
the claims “define the invention to which the patentee is
entitled the right to exclude.” Phillips v. AWH Corp., 415
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 21
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (cleaned up).
This is why the claims are “of primary importance, in the
effort to ascertain precisely what it is that is patented.”
Merrill v. Yeomans, 94 U.S. 568, 570 (1876). In short, the
claims identify the invention. Infringement is a distinct
concept with a different statutory basis. Inventors claim
what they invent, but infringement occurs when others
make, use, or sell the invention without authorization. The
relevant provision states that “whoever without authority
makes, uses, offers to sell, or sells any patented invention,
within the United States or imports into the United States
any patented invention during the term of the patent
therefor, infringes the patent.” 35 U.S.C. § 271(a). With its
reference to “patented invention,” § 271(a) is referring to
what is claimed. But infringing the claimed invention has
several distinct features that differentiate it from claiming
the invention.
First, claims and infringement have different
analytical focal points. Infringement is assessed by
examining a particular thing or series of acts that exists
out in the world. Thus, “[l]iteral infringement of a claim
exists when each of the claim limitations ‘reads on,’ or in
other words is found in, the accused device.” Allen Eng’g
Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1345 (Fed. Cir.
2002). Determining what is claimed, in contrast, requires
examining the intrinsic meaning of the written patent
document, informed by extrinsic evidence about how a
person of ordinary skill in the art would understand the
words of the written instrument. See Phillips, 415 F.3d at
1312–14 (analyzing claim meaning in light of the claims
themselves, the specification, prosecution history, and
extrinsic evidence illuminating the meaning of the words
of a claim).
Second, one can infringe a patent without literally
meeting all of the claim elements. For example,
infringement occurs when, even though “a product or
process . . . does not literally infringe upon the express
22 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
terms of a patent claim,” “there is ‘equivalence’ between the
elements of the accused product or process and the claimed
elements of the patented invention”—what we call
infringement under the doctrine of equivalents. Warner-
Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 21
(1997). “The doctrine of equivalents, by definition, involves
going beyond any permissible interpretation of the claim
language; i.e., it involves determining whether the accused
product is ‘equivalent’ to what is described by the claim
language.” Wilson Sporting Goods Co. v. David Geoffrey &
Assocs., 904 F.2d 677, 684 (Fed. Cir. 1990). Thus, “[t]he
doctrine of equivalents provides a limited exception to the
principle that claim meaning defines the scope of the
exclusivity right in our patent system.” See VLSI Tech.
LLC v. Intel Corp., 87 F.4th 1332, 1341 (Fed. Cir. 2023).
Third, a product whose making, using, offering, sale, or
importation is infringing under 35 U.S.C. § 271—an
“infringing product” in the common shorthand—can, and
often does, contain additional features beyond what the
patent claims. For one thing, the potential presence of
additional features is the bedrock understanding of a
“comprising” claim, which “[i]n the patent claim context”
means “including but not limited to.” CIAS Inc. v. Alliance
Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007)
(internal quotations omitted). “For example, a pencil
structurally infringing a patent claim would not become
noninfringing when incorporated into a complex machine
that limits or controls what the pencil can write.” Stiftung
v. Renishaw PLC, 945 F.2d 1173, 1178 (Fed. Cir. 1991)
(citation omitted). The Supreme Court long ago confirmed
this fundamental point about infringement embodied in
§ 271. The Court explained that it “could” not be
“controverted” that a “patent covering a top-structure for
automobile ‘convertibles’” was infringed “by making and
selling cars embodying the patented top-structures.” Aro
Mfg. Co. v. Convertible Top Replacement Co., 377 U.S. 476,
478, 483 (1964). Simply put, a claim to a product is
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 23
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
infringed by making or selling (or using, offering, or
importing) an article that contains the claimed product,
even though the larger article contains additional
unclaimed features.
Fourth, the requirement that “[t]he specification shall
contain a written description of the invention, and of the
manner and process of making and using it, in such full,
clear, concise, and exact terms as to enable any person
skilled in the art to which it pertains, or with which it is
most nearly connected, to make and use the same” does not
apply to the entirety of an infringing product. 35 U.S.C.
§ 112(a). Rather, it applies to what the patent discloses and
claims as “the invention.” Id. § 112(a), (b). A hypothetical
raised at oral argument illustrates why Teva’s position
equating claiming with infringement is incorrect in view of
their different meanings and requirements. We asked Teva
about a claim to an improved steering wheel, even though
the steering wheel clearly is intended for use in a car. As
all agree, a car incorporating the steering wheel would
infringe the claim. But when asked about whether a patent
claiming the improved steering wheel would need to
describe and enable the car, Teva could not and did not
argue that it must. Oral Arg. at 22:57–25:52.9
The interpretation is consistent with how we have
interpreted the word “claims” in the PTE provisions of the
Hatch-Waxman Act, which provide for extending the term
of a patent that, among other things, “claims a product”
that “has been subject to a regulatory review period before
its commercial marketing or use.” 35 U.S.C. § 156(a)(4). In
Hoechst-Roussel Pharmaceuticals, Inc. v. Lehman, 109 F.3d
756 (Fed. Cir. 1997), we addressed and rejected the
argument “that a patent ‘claims’ an FDA-approved product,
within the meaning of that term as employed in the
9 Available at https://oralarguments.cafc.uscourts.
gov/default.aspx?fl=24-1936_11082024.mp3.
24 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
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statute, if the FDA-approved product would infringe a
claim of that patent.” Id. at 758. We noted that “[t]he term
‘claims’ has been used in patent legislation since the Patent
Act of 1836 to define the invention that an applicant
believes is patentable.” Id. We concluded that “[t]his
concept of a claim is related to, but distinct from, the
concept of infringement.” Id. at 759. Applying this
reasoning, we concluded that Hoechst’s patent, which
claimed 1-hydroxy-tacrine, did not claim the chemically
distinct compound tacrine hydrochloride. Id. This was so
even though “Hoechst may be entitled to exclude others
from administering tacrine hydrochloride to patients”
because, “when administered, tacrine hydrochloride
metabolizes into another product, 1-hydroxy-tacrine,
which Hoechst has claimed.” Id.
Accordingly, both the relevant statutory provisions and
our case law clearly establish that what a patent claims
and what infringes a claim are distinct concepts. A patent
claims something by “particularly pointing out and
distinctly claiming” it as the invention. 35 U.S.C. § 112(b).
A product infringes a claim if each element (or an
insubstantially different version of each element) of the
claim is found in the accused product—in other words, if
the patent claim “reads on” the accused product. Allen
Eng’g, 299 F.3d at 1345. Whether Teva’s NDA infringes
Teva’s patents is separate from the issue of whether those
patents actually claim the drug for which Teva submitted
the application.
Teva’s counterarguments are unpersuasive. Teva’s
first argument is that our precedent has already
conclusively established that the patents that claim the
drug are the same as the patents that the approved drug
would infringe. In support, Teva cites Apotex, Inc. v.
Thompson, where we stated 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 and the ‘accused method’ is a method
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 25
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that is reasonably likely to be used by a hypothetical
infringer.” 347 F.3d at 1344.10 To Teva, reaching a different
conclusion would require overturning Apotex, which we
cannot do as a three-judge panel.
Teva both takes the quotation from Apotex out of
context and misreads it. First, as to context, the specific
language Teva cites comes from the section of Apotex
concluding that the Federal Circuit has appellate
jurisdiction over a listing dispute. To exercise jurisdiction,
we had to identify an issue that “necessarily depends on
resolution of a substantial question of federal patent law,
in that patent law is a necessary element of one of the well-
pleaded claims.” Id. at 1342 (quoting Christianson v. Colt
Indus. Operating Corp., 486 U.S. 800, 808–09 (1988)). We
concluded that the listing provision in effect at the time,
which referenced both claiming the drug and reasonably
asserting infringement, required answering at least a
question of patent infringement, which is a question of
patent law. Id. at 1344. Beyond making that point, which
established this court’s jurisdiction, we did not need to, and
did not, interpret the listing provision because we rejected
Apotex’s argument that the FDA had to police the Orange
Book. Id. at 1349.
Second, as to meaning, contrary to Teva’s contention,
we did not say in Apotex that, if something infringes a
10 Apotex analyzed the listing provision before it was
amended by the OBTA. When Apotex was decided, 21
U.S.C. § 355(b)(1) required that a patent must be listed if
it “claims the drug for which the applicant submitted the
application or . . . claims a method of using such drug and
with respect to which a claim of patent infringement could
reasonably be asserted if a person not licensed by the
owner engaged in the manufacture, use, or sale of the
drug.” Hatch-Waxman Act, sec. 102(a)(1), § 505(b), 98 Stat.
at 1592.
26 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
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patent, then the patent claims it—i.e., that, to meet the
requirement that a patent claims something, it suffices to
show that thing infringes the patent. Instead, we
identified one necessary condition for listing—that
determining whether a patent is properly listed “requires
what amounts to a finding of patent infringement.” Id. at
1344 (emphasis added). Even putting aside the
“infringement reasonably could be asserted” language in
the listing provision, this necessary condition of
infringement is met by something that the patent claims.
That is because determining whether a patent claims
something amounts to determining literal infringement, in
that both require the presence of every limitation of a
patent claim. But that does not mean that nothing else
counts as infringement, contrary to what Teva contends.11
The statement in Apotex that Teva cites—that being
claimed can establish infringement—is essentially a
converse of what Teva contends—that infringement can
establish being claimed. Thus, this statement in Apotex,
even aside from its limited context, does not support Teva’s
position.
Teva also seeks refuge in the Second Circuit’s decision
in United Food & Commercial Workers Local 1776 v.
Takeda Pharmaceutical Co., 11 F.4th 118 (2d Cir. 2021). In
Teva’s view, the Second Circuit adopted its interpretation
of the listing provision in United Food by citing the same
language from Apotex that Teva invokes. As it does with
Apotex, Teva misreads United Food. First, although United
Food cites Apotex, the Second Circuit concluded that,
“although the concepts are closely related, ‘the plain
meaning of “claims” is not the same as the plain meaning
of infringement.’” 11 F.4th at 134 (quoting Hoechst-Roussel
Pharms., 109 F.3d at 759). Second, the facts of United Food
11 One example, as we discussed above, is
infringement under the doctrine of equivalents.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 27
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involved the listing of a patent claiming two active
ingredients when the approved drug used only one of the
two. Id. at 127. As the Second Circuit correctly noted, “[a]
long line of Supreme Court case law confirms that a
combination patent, in general, does not ‘claim’ its
constituent parts.” Id. at 131; see also id. (citing Aro Mfg.
Co. v. Convertible Top Replacement Co., 365 U.S. 336, 337–
39, 339–40 (1961)). Those facts do not address the dispute
here about whether patents that claim some, but not all, of
the features in an approved drug product may be listed.
Teva’s second argument is that what a patent claims is
what literally infringes the patent. Appellants’ Br. 21–22;
Appellants’ Reply Br. 7. To Teva, this interpretation
eliminates any redundancy between the requirements of
claiming and infringing because the infringement
requirement still references the doctrine of equivalents.
We find this argument unpersuasive for several reasons.
First, literal infringement and infringement under the
doctrine of equivalents are better understood as separate
“theor[ies] of infringement” that are alternative ways of
satisfying “the statutory basis for direct infringement.”
Wis. Alumni Rsch. Found. v. Apple Inc., 112 F.4th 1364,
1382 (Fed. Cir. 2024). Second, as we explained above,
Hoechst-Roussel rejected the argument that claiming and
literal infringement are coextensive. 109 F.3d at 759.
Third, Teva’s argument does not acknowledge that
claiming and infringement have separate statutory bases
and that the listing provision identifies both as separate
requirements.
In sum, we conclude that a patent “claims the drug for
which the applicant submitted the application,” 21 U.S.C.
§ 355(b)(1)(A)(viii)(I), when it particularly points out and
distinctly claims the drug—not simply when the claim
could somehow be interpreted to read on the drug. In other
words, the fact that an NDA could infringe a patent does
not mean that the patent “claims” the underlying drug
within the meaning of the listing provision. Reaching this
28 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
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conclusion, though, does not answer the second question
raised by Teva’s argument—how much of the drug for
which the applicant submitted the application a patent
must claim to be listed. We now turn to that issue.
II
Teva also argues on appeal that a patent is listable if it
claims any part of its NDA product. One requirement for
listing a patent in the Orange Book is that the patent
“claims the drug for which the applicant submitted the
application.” 21 U.S.C. § 355(b)(1)(A)(viii)(I). Teva’s
argument about what it means to “claim[] the drug for
which the applicant submitted the application” rests on
combining the FDCA’s statutory definition of “drug” with
the listing provision. The FDCA provides two definitions
of the word “drug” relevant here. The first is “articles
intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or other
animals.” 21 U.S.C. § 321(g)(1)(B). The second is “articles
intended for use as a component of any article specified in
clause . . . (B).” Id. § 321(g)(1)(D) (emphasis added).
Putting these definitions together, Teva asserts that the
FDCA defines any part of something used to treat a disease
as a drug. Then, turning to the listing and delisting
provisions, Teva focuses on the common requirement that
listable patents claim the drug in the NDA. Id.
§ 355(b)(1)(A)(viii)(I), (j)(5)(C)(ii)(I)(aa). Thus, so long as a
patent claims any part of the NDA product, even if it only
claims device parts, Teva’s conclusion is that such patents
belong in the Orange Book.
We reject this contention. While Teva’s argument may
have some superficial appeal, its reliance on the FDCA’s
definition of drug fails to account for how the FDCA’s other
provisions inform and limit what kind of medical products
within the FDA’s purview are drugs. Instead, the FDCA’s
broader statutory context leads us to conclude that, for a
patent to “claim[] the drug for which the applicant
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submitted the application,” such a patent must claim at
least the active ingredient identified in the application.
Especially when interpreting a regulatory regime with
as many interlocking parts as the FDCA, we do not “confine
[ourselves] to examining a particular statutory provision in
isolation.” Brown & Williamson, 529 U.S. at 132. Rather,
we “interpret the statute ‘as a symmetrical and coherent
regulatory scheme’ and ‘fit, if possible, all parts into a
harmonious whole.’” Id. at 133 (first quoting Gustafson v.
Alloyd Co., 513 U.S. 561, 569 (1995), then quoting FTC v.
Mandel Bros., Inc., 359 U.S. 385, 389 (1959)). When
looking at how the FDA approves the many different
medical products it regulates, it is apparent that a product
regulatable and approvable as a drug contains an active
ingredient.
In answering the question of what makes something
eligible for approval as a drug by the FDA, it helps to
compare the approval pathway for drugs and devices.
Every new drug must receive premarket approval from the
FDA before it can come to market. 21 U.S.C. § 355(a). An
applicant seeks premarket approval for a drug by
submitting an NDA or ANDA in the processes we described
above. See id. § 355(b), (j).
Devices have a distinct approval pathway. The FDCA
defines a device as, among other things, an instrument that
treats disease or affects the structure of the body and
“which does not achieve its primary intended purposes
through chemical action . . . and which is not dependent
upon being metabolized for the achievement of its primary
intended purposes.” 21 U.S.C. § 321(h)(1). Before 1976,
devices, unlike drugs, did not require premarket approval.
Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008).
Following what many viewed as “the inability of the
common-law tort system to manage the risks associated
with dangerous devices,” Congress established FDA
premarket regulation for devices with the Medical Device
30 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
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Amendments of 1976. Riegel, 552 U.S. at 315–16. Devices
have three levels of oversight with different premarket
approval requirements, depending on the level of risk
associated with using the device. Class I devices are
“subject to the lowest level of oversight: ‘general controls,’
such as labeling requirements.” Id. at 316 (quoting 21
U.S.C. § 360c(a)(1)(A)). Class II devices are “subject in
addition to ‘special controls’ such as performance standards
and postmarket surveillance measures.” Id. at 317
(quoting 21 U.S.C. § 360c(a)(1)(B)). Class III devices
require premarket approval “if it cannot be established
that a less stringent classification would provide
reasonable assurance of safety and effectiveness.” Id.
(citing 21 U.S.C. § 360c(a)(1)(C)(ii)). But even Class III
devices do not necessarily require thorough premarket
review. “A new device need not undergo premarket
approval if the FDA finds it is ‘substantially equivalent’ to
another device exempt from premarket approval” through
what is called the § 510(k) process. Id. (quoting 21 U.S.C.
§ 360c(f)(1)(A)).
These distinct regulatory regimes and approval
pathways mean that a product’s classification as a drug or
device guides the life cycle for how that product comes to
market. These distinct pathways mean that “a product
may be regulated as a drug or a device, but not both, and
while a single product may simultaneously satisfy the
linguistic elements of two definitions [of drug and device],
it is not possible for the FDA to give simultaneous effect to
both.” Genus Med. Techs. LLC v. FDA, 994 F.3d 631, 639
(D.C. Cir. 2021) (emphasis in original). “And no one
suggests that the FDCA requires products meeting both
definitions to be regulated both as drugs and devices, which
would create a breathtaking example of statutory
redundancy.” Id. (emphasis in original). Even though the
FDCA defines “drug” broadly as something that treats
disease, then, the statutory context demonstrates that a
drug is a narrower class of medical product.
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. 31
AMNEAL PHARMACEUTICALS OF NEW YORK, LLC
While it is clear that there is a distinction between
what qualifies as a drug and what qualifies as a device, we
still must identify which features make a product
approvable as a drug rather than as a device. One
touchstone of the distinction between drugs and devices is
that the former are “composed of complex chemical
compounds or biological substances” and the latter are
“characterized more by their purely mechanical nature.”
United States v. Article of Drug, Bacto-Unidisk, 394 U.S.
784, 800 (1969). Put differently, “what distinguishes a drug
from a device under the FDCA is that a device excludes a
product that achieves its primary intended purposes
through either chemical action or metabolization.” Genus
Med., 994 F.3d at 641.
The FDCA uses a specific term for the part of a drug
that supplies the chemical action or metabolization that
treats disease—the active ingredient. And it is the
presence of this active ingredient that makes a product
approvable as a drug. The FDCA’s requirements for drug
approval bear this out. “While the FDA approves [a] drug
as a whole, assessment and study of the active ingredient
is central to the new drug approval process.” Sandoz Inc.
v. Becerra, 57 F.4th 272, 280 (D.C. Cir. 2023). We know this
because the FDA decides whether a drug is safe and
effective “under the conditions prescribed, recommended,
or suggested in the proposed labeling.” 21 U.S.C.
§ 355(d)(1); id. § 355(d)(5) (similar). The label itself focuses
on the active ingredient—it must include the “quantity or
. . . proportion of each active ingredient” in the drug. Id.
§ 352(e)(1)(A)(ii). Notably, the inactive ingredients of the
drug, which do not cause the chemical action or
metabolization that make the drug perform its intended
function, need only be put on the label; their proportion in
the drug does not have to be included. Id.
§ 352(e)(1)(A)(iii).
This statutory focus on the active ingredient is also
reflected in what a generic applicant must show in an
32 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
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ANDA. “An ANDA may be submitted only when the ‘active
ingredient’ of the proposed generic drug ‘is the same as that
of the listed drug.’” Sandoz, 57 F.4th at 281 (quoting 21
U.S.C. § 355(j)(2)(A)(ii)). If an applicant wishes to submit
an ANDA “for a new drug which has a different active
ingredient or whose route of administration, dosage form,
or strength differ from that of a listed drug,” the FDCA
requires the applicant to conduct new investigations on the
different active ingredient, route of administration, dosage
form, or strength if the differences make the FDA unable
to assure itself that the generic drug is still safe and
effective. 21 U.S.C. § 355(j)(2)(C), (4)(C). What these
provisions demonstrate is that the presence of an active
ingredient that is safe and effective is what makes
something approvable as a drug.
Two recent decisions from the D.C. Circuit reinforce
this understanding. First, in Sandoz, the D.C. Circuit
concluded that the FDA did not approve an impurity that
was only sometimes present in the approved version of a
drug. 57 F.4th at 280–81. The Sandoz court reached this
conclusion because the FDA, when approving a new drug,
evaluates the safety and efficacy of a product with a focus
on the active ingredient. The FDA does not, however,
evaluate safety and efficacy with respect to impurities;
rather, the only analysis is whether the presence or
inclusion of the impurities undermine the safety or efficacy
of the drug. Id. at 281–82.
Second, in Ipsen Biopharmaceuticals, Inc. v. Becerra,
the D.C. Circuit evaluated whether a particular medical
product was properly classified as a drug or a biologic. 108
F.4th 836 (D.C. Cir. 2024). In answering this question, the
D.C. Circuit stated that “a drug furnishes pharmacological
activity, but a drug product is the ‘thing’ that is ingested or
administered. Said another way, you must ingest the drug
product to reap the drug’s benefits.” Id. at 842 (emphasis
in original). In determining whether something is a drug
(rather than whether the final drug product is safe and
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effective), Ipsen concluded that such a “decision is made by
looking at the drug’s active ingredient. Full stop.” Id. The
ultimate conclusion was that classification as a drug or
biological product depended on “the active ingredient,” not
the “dosage form.” Id. at 844.
Sandoz and Ipsen Biopharmaceuticals support the
conclusion that what makes something approvable as a
drug is the presence of an active ingredient. Thus, to claim
the drug for which the applicant submitted the application
and for which the application was approved, a patent must
claim an invention containing the active ingredient.
Otherwise, a patent claims something that the FDA could
not have properly regulated as a drug in the first place.
To summarize, our analysis of the numerous relevant
statutory provisions and the relevant case law leads us to
only one conclusion: To list a patent in the Orange Book,
that patent must, among other things, claim the drug for
which the applicant submitted the application and for
which the application was approved. And to claim that
drug, the patent must claim at least the active ingredient.
Thus, patents claiming just the device components of the
product approved in an NDA do not meet the listing
requirement of claiming the drug for which the applicant
submitted the application.
Teva pushes back on this conclusion with two
arguments. We find neither persuasive. First, Teva argues
that this conclusion ignores the FDCA’s explicit definition
of a drug as a component intended for use in an article to
treat disease. We take Teva’s point that a patent need not
claim every aspect of the final approved NDA product and
can indeed claim only parts of it. But Teva’s invocation of
“components,” with respect to the question before us,
ignores the requirement that listable patents must claim
the drug for which approval is sought. That requires
claiming the active ingredient. “And we think that is so
because Congress meant (as it usually does) for the
34 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
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provision it enacted to fit within the statutory scheme.”
Caraco, 566 U.S. at 416–17.
Second, Teva disputes our interpretation of the phrases
“for which the applicant submitted the application” in the
listing provision and “for which the application was
approved” in the delisting provision. Since the FDA
permissibly approved the ProAir® HFA as a drug, Teva
argues that even the device components of an inhaler are
statutorily a drug. For this position, Teva relies on the
FDA’s designation of its ProAir® HFA as a combination
product that should be approved in an NDA. We reject this
argument as well.
Combination products are yet another innovation in
the FDA’s regulation of medical products. Before 1990, the
definition of “drug” in the FDCA excluded “devices or their
components, parts, or accessories.” FDCA, Pub. L. No. 75-
717, § 201(g), 52 Stat. 1040, 1041 (1938). Recognizing that
certain products regulated by the FDA could have both
drug parts and device parts, like Teva’s ProAir® HFA,
Congress added provisions in the Same Medical Devices
Act of 1990 (“SMDA”) creating a new class of products—
combination products. Pub. L. No. 101-629, sec. 16, § 503,
104 Stat. 4511. They “constitute a combination of a drug,
device, or biological product.” 21 U.S.C. § 353(g)(1)(A).
Although Congress defined a new kind of product, it did not
create a new approval pathway. Instead, the FDA must
“conduct the premarket review of any combination product
under a single application, whenever appropriate.” Id.
§ 353(g)(1)(B). The FDA determines the appropriate
approval pathway—as a drug, device, or biological
product—by looking at the “primary mode of action of the
combination product.” Id. § 353(g)(1)(D). The primary
mode of action is “the single mode of action of a combination
product expected to make the greatest contribution to the
overall intended therapeutic effects of the combination
product.” Id. § 353(g)(1)(C). If the primary mode of action
is that of a drug, the FDA must approve the product as a
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drug. The FDA considers metered-dose inhalers like Teva’s
ProAir® HFA to have a primary mode of action of a drug.
J.A. 1052. Thus, the FDA approved Teva’s ProAir® HFA
with an NDA.
But the fact that the FDA approved Teva’s ProAir®
HFA combination product as a drug does not make the
inhaler’s device parts a drug. They are still devices, just
ones present in the product that was approved, in a single
application, under the NDA pathway. The statutory
structure bears this out. First, the definition itself states
that these products are “a combination of a drug, device, or
biological product.” 21 U.S.C. § 353(g)(1)(A). This
language reflects that the combination product is not a
drug—rather, the drug and device subparts still retain
their identify as drugs and devices, respectively.
Second, the way the FDCA addresses combination
products that use, as subparts, products that the FDA has
already approved reveals that the subparts retain their
separate identity. Combination products can contain “an
approved constituent part.” Id. § 353(g)(3). An approved
constituent part includes a drug that has already been
approved or a device that is available on the market. Id.
§ 353(g)(4)(A), (B). For an approved constituent part that
is a drug, it must be an “approved drug.” Id. § 353(g)(4)(A).
An “approved drug” is “an active ingredient” that meets
several requirements, including that it was identified in an
NDA and that the FDA considered whether the active
ingredient is safe and effective. Id. § 353(g)(5)(B).
Once again, the statutory focus on an active ingredient
reveals that what makes a product a drug is the presence
of an active ingredient giving rise to chemical action. And
including a drug in a combination product does not
transform each and every component of that combination
product into a drug. Instead, each subpart retains its
separate identity. The ultimate approval pathway depends
36 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
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on whether the drug part or device part of the combination
product supplies the primary mode of action.
The Sixth Circuit reached a similar conclusion in
Miller v. Mylan Inc., 741 F.3d 674 (6th Cir. 2014). In Miller,
the Sixth Circuit explained that “[t]he effect of” the SMDA
“was to create a distinction between how a product is
defined and how that product will be regulated.” Id. at 677.
Thus, for “ambiguous products,” it is the primary mode of
action that determines whether a product will be regulated
under the drug or device pathway. Id. In short, a
combination product does not become a drug just because
it is regulated as a drug.
Returning to Teva’s argument, we conclude that a
combination product being approved with an NDA does not
necessarily make every part of the NDA a drug. That is, a
drug-device combination product being approved with an
NDA does not make the device parts a drug. The fact that
the combination product was approved with an NDA just
means that the drug mode of action predominated. On the
facts of this case, the drug for which the application was
submitted and approved is thus not every component of
Teva’s ProAir® HFA. Instead, it is the part of the drug-
device combination that made it regulatable as a drug in
the first place. And that is the active ingredient.
For completeness, we note, but neither adopt nor reject,
Amneal’s additional argument that Teva’s patents are
delistable on the ground that they are not drug-substance
or drug-product patents. In the OBTA in 2021, Congress
added language to the listing provision requiring that a
patent that “claims the drug for which the applicant
submitted the application” also be “a drug substance
(active ingredient) patent or a drug product (formulation or
composition) patent.” 21 U.S.C. § 355(b)(1)(A)(viii)(I).
Amneal argues that patents that are not drug-substance or
drug-product patents are delistable on the ground that
they do not “claim . . . the drug for which the application
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was approved.” Id. § 355(j)(5)(C)(ii)(I)(aa). Because we
concluded above that a patent does not “claim[] the drug
for which the applicant submitted the application” if it does
not claim at least the active ingredient, we do not need to
reach Amneal’s additional argument regarding drug-
substance and drug-product patents.
III
Finally, Teva argues that, even if a patent must claim
at least the active ingredient to be listed in the Orange
Book, its patents do claim an active ingredient. Apart from
the merits of this position, Teva advances a procedural
joust—that remand is needed for the district court to
construe the claims. Once again, we disagree. When
determining what a patent claims for the purpose of the
listing inquiry, we apply the rubric of claim construction.
Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, 60 F.4th
1373, 1379 (Fed. Cir. 2023). But a formal Markman
hearing is not required in every case. Rather, in resolving
an issue as a matter of law at the pleadings stage, we can
“proceed by adopting the non-moving party’s
construction[].” UTTO Inc. v. Metrotech Corp., 119 F.4th
984, 994 (Fed. Cir. 2024) (quoting Aatrix Software, Inc. v.
Green Shades Software, Inc., 882 F.3d 1121, 1125 (Fed. Cir.
2018)). We thus adopt the construction Teva proposes here,
only for the purposes of resolving this appeal.
Turning to the claims themselves, Teva’s proposed
construction is that each patent includes one claim
requiring the presence of “an active drug.” Appellants’
Br. 45–46 (citing J.A. 1589–91). No claim in the patent
requires the presence of such an active drug in the claim
language itself; rather, Teva seeks to import this limitation
into the claims using implicit representations in the
specifications. Teva argues that, even if its patents must
claim at least the active ingredient in its ProAir® HFA, the
requirement of “an active drug” in the claims means that
its patents “claim[] the drug for which the applicant
38 TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v.
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submitted the application” as required by the statute. 21
U.S.C. § 355(b)(1)(A)(viii). Even accepting Teva’s
(somewhat dubious) construction, we conclude that the
district court properly ordered Teva to delist the five
asserted patents.
As we explained above, to claim something, a patent
must particularly point out and distinctly claim what it
purports to be the invention. See 35 U.S.C. § 112(b). And
to qualify for listing, a patent must claim at least the active
ingredient in the application and the approved drug
product. Importantly, the FDA does not approve a medical
product as a drug with reference to some vague active
ingredient in the abstract. Rather, it approves a specific
active ingredient at a specific concentration if that active
ingredient, in combination with other features of the drug
product, is safe and effective. See 21 U.S.C. § 355(b), (d).
A claim requiring the presence of “an active drug” is far
too broad to particularly point out and distinctly claim the
drug approved in Teva’s NDA. Teva’s construction permits
the presence of any active ingredient in any form. As a
matter of law, Teva’s construction does not particularly
point out and distinctly claim what was approved—the
ProAir® HFA with albuterol sulfate as the active
ingredient. We do not and need not decide more.
CONCLUSION
We have considered Teva’s remaining arguments and
find them unpersuasive. For the foregoing reasons, we lift
our stay and affirm the district court’s order requiring Teva
to delist its patents.
AFFIRMED