Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-24-01936/USCOURTS-ca13-24-01936-0/pdf.json

Parties Involved:
Amneal Ireland Ltd.
Appellee
Amneal Pharmaceuticals LLC
Appellee
Amneal Pharmaceuticals of New York, LLC
Appellee
Amneal Pharmaceuticals, Inc.
Appellee
Norton (Waterford) Ltd.
Appellant
Teva Branded Pharmaceutical Products R&D, Inc.
Appellant
Teva Pharmaceuticals USA, Inc.
Appellant

Document Text:

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, 

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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 brandname manufacturer listed in a publication called the 

Orange Book. If the brand-name manufacturer lists a nonexpired 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.

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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.

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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. 

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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 lowcost 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 HatchWaxman 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 preapproval. 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.

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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.

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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 

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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.

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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 

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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.

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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.

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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.

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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 dosecounter 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 medicamentcontaining 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, 

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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.

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’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 

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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. 

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§ 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 

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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 

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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.

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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 

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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 

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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. WarnerJenkinson 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 

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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.

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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 

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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 wellpleaded 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.

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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.

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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 

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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 

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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.

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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 

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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 

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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 

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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 drugdevice 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 drugsubstance 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 

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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

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