Teva Branded Pharmaceutical Products R&D,Inc. v. Amneal Pharmaceuticals of New York,LLC

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). 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 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, 103 S.Ct. 1298, 75 L.Ed.2d 198 (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 Cir. 1984), superseded by statute, Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1358 (Fed.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. 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, 132 S.Ct. 1670, 182 L.Ed.2d 678 (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, 110 S.Ct. 2683, 110 L.Ed.2d 605 (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, the linchpin of this entire scheme. 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). 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).

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 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, 132 S.Ct. 1670.

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, 132 S.Ct. 1670. The state of play was thus that there was no way to force an NDA holder to remove inappropriately listed patents.

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 the difference between a thirty-month stay in approval or immediate approval.

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 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

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.

I.

We start by rejecting Teva’s interpretation of the word “claims” in the listing and counterclaim/delisting provisions. 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, 99 S.Ct. 2326, 60 L.Ed.2d 931 (1979). Accepting Teva’s 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, 138 S.Ct. 617, 199 L.Ed.2d 501 (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, 116 S.Ct. 1384, 134 L.Ed.2d 577 (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, 139 S.Ct. 628, 202 L.Ed.2d 551 (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 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, 24 L.Ed. 235 (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 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, 117 S.Ct. 1040, 137 L.Ed.2d 146 (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, 84 S.Ct. 1526, 12 L.Ed.2d 457 (1964). Simply put, a claim to a product is 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.

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 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 that is reasonably likely to be used by a hypothetical infringer.” 347 F.3d at 1344. 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, 108 S.Ct. 2166, 100 L.Ed.2d 811 (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 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. 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 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, 81 S.Ct. 599, 5 L.Ed.2d 592 (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 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 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, 120 S.Ct. 1291. 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, 120 S.Ct. 1291 (first quoting Gustafson v. Alloyd Co., 513 U.S. 561, 569, 115 S.Ct. 1061, 131 L.Ed.2d 1 (1995), then quoting FTC v. Mandel Bros., Inc., 359 U.S. 385, 389, 79 S.Ct. 818, 3 L.Ed.2d 893 (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, 128 S.Ct. 999, 169 L.Ed.2d 892 (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 Amendments of 1976. Riegel, 552 U.S. at 315–16, 128 S.Ct. 999. 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, 128 S.Ct. 999 (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, 128 S.Ct. 999 (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.

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, 89 S.Ct. 1410, 22 L.Ed.2d 726 (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 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 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 provision it enacted to fit within the statutory scheme.” Caraco, 566 U.S. at 416–17, 132 S.Ct. 1670.

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 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 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 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 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.