. . . Viewed in this light, the court’s extended analysis of “drug” versus “device” components of an approved drug product may thus introduce unnecessary inconsistencies and complications in future evaluations of Orange Book listing eligibility for device-dependent drug patents. . . .
Introduction
In Teva v. Amneal, No. 2024-1936 (Fed. Cir. Dec. 20, 2024) (“Decision”), the United States Court of Appeals for the Federal Circuit provided new guidance on the criteria for patents that are eligible for listing in the FDA’s “Orange Book”—especially for patents with claims to device components comprising the approved drug product. The Orange Book functions as a public registry where brand-name drug manufacturers are required to list certain patents that pertain to their approved drug products. This registry identifies patents potentially relevant to generic drug manufacturers seeking FDA approval for generic versions of the branded drugs and triggers specific procedural consequences aimed at resolving disputes regarding the listed patents.
At issue in the case were five Teva patents directed to the “dose-counter” mechanism in Teva’s ProAir® HFA inhaler, which is approved to alleviate “bronchospasms” in certain patients. Teva’s inhaler combines the active ingredient albuterol sulfate with a propellant that is controlled by the product’s device components. Although the ProAir® HFA inhaler has both drug and device components, the FDA formally approved the inhaler as a drug because its therapeutic action is derived from delivery of the product’s active ingredient.
Amneal, a generic drug manufacturer, filed an application seeking FDA approval of a generic version of Teva’s inhaler. After receiving notice of Amneal’s FDA application, Teva filed a patent infringement lawsuit against Amneal in the U.S. District Court for the District of New Jersey, alleging Amneal’s infringement of each of the inhaler patents. Among other rulings, the district court determined that Teva’s inhaler patents were not properly listed in the Orange Book because the patents failed to claim the drug’s active ingredient, formulation, or approved method of use. The Federal Circuit affirmed the district court’s ruling, clarifying the criteria for Orange Book patents that claim a combination of both drugs and devices.
Background
The Hatch-Waxman Act Framework
The 1984 Hatch-Waxman Act was designed to balance incentives for drug innovation with the need to increase access to affordable generic medications. Before the Act, generic drug manufacturers faced significant hurdles, as they were required to repeat costly and time-consuming clinical trials undertaken by the brand manufacturer to gain FDA approval. The Act introduced a streamlined approval standard, allowing generic applicants to demonstrate the generic drug’s “bioequivalence” to the branded drug rather than duplicating the original clinical trials. Bioequivalence means that the generic drug delivers the chemically equivalent active ingredient into the patient’s bloodstream at the same rate and to the same extent as the branded drug.
This simplified process, combined with the creation of the Abbreviated New Drug Application (ANDA), reduced the time and expense required for generic drug approval. By demonstrating bioequivalence, the generic drug manufacturer relies on the clinical testing already performed by the brand manufacturer when applying for the original New Drug Application (NDA). When bioequivalence is demonstrated, the FDA presumes that the generic drug has the same safety and efficacy profile as the approved branded drug. Additionally, the Act established a specific procedural pathway to facilitate resolution of patent disputes between the brand and generic drug makers before market entry of the generic drug.
A central feature of the Hatch-Waxman Act was the creation of the FDA’s Orange Book and rules governing the listing of patents in the Orange Book by branded drug manufacturers. To specify how generic drug manufacturers should address Orange Book listed patents, the Act introduced four certification options under 21 U.S.C. § 355(j)(2)(A)(vii), each under separate paragraphs of that statute:
Paragraph I: The ANDA applicant certifies that no patent information has been listed in the Orange Book for the branded “reference drug.” In such cases, the FDA can approve the ANDA without further patent-related delays.
Paragraph II: The ANDA applicant certifies that all Orange Book listed patents have already expired. This certification also allows immediate FDA approval once other regulatory requirements are met.
Paragraph III: The applicant certifies that it will not market the generic drug until after expiration of the Orange Book listed patents. In this situation, the FDA grants tentative approval but withholds final approval until the patents expire.
Paragraph IV: The applicant certifies that the Orange Book listed patent is invalid, unenforceable, or not infringed by the generic drug product. This certification initiates a complex legal process.
The filing of an ANDA with a corresponding Paragraph IV certification constitutes an “artificial act of infringement” under 35 U.S.C. § 271(e)(2), allowing the branded manufacturer to assert patent infringement claims preemptively. The filing of the ANDA is considered an “artificial act of infringement,” because upon filing of the application, no infringing generic drug product has been sold. By defining the ANDA filing as an act of infringement, the Act allows any patent-related dispute to proceed in parallel with the FDA’s review of the ANDA.
The generic drug manufacturer is required to notify the branded drug manufacturer of the Paragraph IV certification, and if the brand manufacturer files suit within 45 days of receiving the notice, a 30-month stay is triggered, during which the FDA cannot approve the generic drug product. The purpose of the 30-month stay is to allow time for judicial resolution of the patent disputes.
While the stay provides brand manufacturers an opportunity to assert their patent rights before market entry of the generic drug products, the Hatch-Waxman Act includes certain procedural safeguards for generic drug manufacturers, such as the counterclaim provision under 21 U.S.C. § 355(j)(5)(C)(ii), which enables generic drug manufacturers to seek delisting of Orange Book ineligible patents.
The Orange Book Patent Listing Rules
Central to the Hatch-Waxman framework is the requirement for NDA holders to list patents in the FDA’s Orange Book. Codified in 21 U.S.C. § 355(b)(1)(A), this provision mandates the listing of patents that claim the active ingredient, the formulated drug product, or an approved method of its use. In this way, the Orange Book dictates which patents a generic drug applicant must address in its ANDA through its certifications and identifies the patents subject to the Hatch-Waxman litigation procedures.
Over time, the Orange Book listing rules have been subject to amendments, including the Orange Book Transparency Act (OBTA) of 2021. The OBTA clarified that NDA holders are required to list any patent 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). The OBTA further expressly forbids the listing of any patent not included in the foregoing categories. Id. at § 355(c)(2). Thus, the OBTA is said to set both “a floor and a ceiling” for Orange Book eligible patents. Decision at 11.
The FDA’s role in this process remains ministerial. The FDA generally lacks authority to independently assess the accuracy or relevancy of listed patents. Enforcement of the Orange Book listing rules therefore has largely been left up to the courts.
Procedural History
After filing its ANDA seeking approval for a generic version of ProAir® HFA together with its Paragraph IV certification alleging non-infringement of the listed patents, Amneal sent a notice of its filing to Teva on August 24, 2023. Teva responded by initiating an infringement suit within the 45-day deadline, triggering a 30-month stay of FDA approval for Amneal’s product.
Amneal counterclaimed, alleging that the five asserted Teva patents did not meet the statutory criteria for Orange Book inclusion because they did not claim the drug’s active ingredient, formulation, or method of use but were instead directed to device components. According to Amneal, had the patents not been listed in the Orange Book, Amneal could have included a Paragraph I certification in its ANDA, thereby permitting the FDA to immediately review and approve its ANDA without regard to any patent dispute.
Amneal then moved for judgement on the pleadings with respect to its counterclaim. The district court granted Amneal’s motion, agreeing that the patents were improperly listed in the Orange Book. Teva appealed the district court’s ruling to the Federal Circuit.
The Federal Circuit’s Analysis
On appeal, Teva made two key arguments. First, Teva asserted that a patent “claims the drug” if the claim reads on the approved drug—in other words, Orange Book listing is proper if the NDA drug product itself would infringe the patent’s claim. By equating “claims” with “infringes,” Teva argued that its patents were properly listed because its patents’ claims for a dose counter and a canister read on the approved NDA drug product, the ProAir® HFA inhaler.
Second, Teva relied on the Food Drug & Cosmetics Act’s (FDCA) broad definition of the legal term “drug” to argue that any component of an approved drug product, device or otherwise, that can treat disease meets the statutory definition of a “drug.” Under this theory, Teva maintained that its patents “claim the drug” because they cover components of the approved ProAir® HFA drug product, which therefore satisfies the statute’s Orange Book listing eligibility requirement.
Issue 1: “claiming v. infringing”
In analyzing Teva’s first argument, the Federal Circuit began by noting that the listing provision in 21 U.S.C. § 355(b)(1)(A)(viii)(I) distinguishes between “infringing” and “claiming” as separate criteria—a listed patent must both “claim the drug” and be one “for which a claim of patent infringement could reasonably be asserted.” Decision at 19. By equating “claims” with “infringes,” the court concluded that Teva’s interpretation would render parts of the statute redundant. As the court noted, “When interpreting a statute, ‘we are obliged to give effect, if possible, to every word Congress used.’” Decision at 20. (quoting Reiter v. Sonotone Corp., 442 U.S. 330, 339 (1979)).
The court emphasized the distinct roles of proving what is claimed in a patent and demonstrating what is infringed under the patent law. To illustrate that “claims and infringement have different analytical focal points,” the court referred to numerous examples of its prior interpretations of Patent Act sections 271(a), 112(a), and 156(a)(4) to showcase that “claiming” is generally understood as defining the invention’s subject matter in the patent document, while “infringement” concerns determining whether the use or sale of a particular product violates the Patent Act. See Decision at 21-23.
As an illustration, the court pointed to its prior decision in Hoechst-Roussel Pharmaceuticals, Inc. v. Lehman, 109 F.3d 756, 759 (Fed. Cir. 1997), where the court found that administration of tacrine hydrochloride to patients infringed patent claims to a chemically distinct compound, 1-hydroxy-tacrine, because after administration, tacrine hydrochloride metabolizes to infringing 1-hydroxy-tacrine. See Decision at 23-24. According to the court, this is one example where the infringing product is distinct from the claimed invention. Id. As a further example, the court noted that it has long been recognized that under the doctrine of equivalents, “one can infringe a patent without literally meeting all of the claim elements.” Decision at 21-22 (citing Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 21(1997)). “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.’” Decision at 22 (quoting VLSI Tech. LLC v. Intel Corp., 87 F.4th 1332, 1341 (Fed. Cir. 2023)).
Following this analysis, the court returned to the fundamental Orange Book listing rule which requires that “a patent ‘claims the drug for which the applicant submitted the application.’” Decision at 27 (quoting 21 U.S.C. § 355(b)(1)(A)(viii)(I)). In doing so, the court specifically held that “the fact that an NDA [product] could infringe a patent does not mean that the patent ‘claims’ the underlying drug within the meaning of the listing provision.” Id. The court acknowledged, however, that this limited reading of the statute, “does not answer the second question raised by Teva’s argument—how much of the drug for which the applicant submitted [in] the [NDA] application [that] a patent must claim to be listed.” Decision at 28.
Issue 2: “What is the drug, and what is not the drug?”
In addressing Teva’s second argument, the Federal Circuit framed its analysis of Teva’s dose-counter patents around the fundamental question—what does the Orange Book listing statute mean by “claims the drug”?
To begin, the court addressed Teva’s reliance on the two broad definitions of “drug” provided in the FDCA. First, Teva pointed to 21 U.S.C. § 321(g)(1)(B), which defines a drug as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” Second, Teva cited 21 U.S.C. § 321(g)(1)(D), which defines a drug to include “a component of any article specified in clause . . . (B).” Decision at 28 (emphasis added). Based on these statutory definitions, Teva thus argued that its patented inhaler device components fit squarely within the FDCA’s definition of a drug, at least as “components” of the statutorily defined drug.
Although the court acknowledged the “superficial appeal” of Teva’s argument, it ultimately disagreed, ruling that the statutory term “drug” in the context of Orange Book listings refers specifically to the active ingredient, not to mechanical components like those in Teva’s ProAir® HFA inhaler. See Decision at 28-29. The court’s reasoning was rooted in the distinct regulatory approval pathways for drugs and devices. Drugs are evaluated for their therapeutic effects, while devices are assessed for their mechanical functionality. See Decision at 29 (quoting 21 U.S.C. § 321(h)(1) (“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’”)). This distinction provided the basis for the court’s conclusion that the device components in Teva’s inhaler are distinct from the inhaler’s drug components. See id. at 29-31.
The court pointed to statements in other judicial decisions to support its conclusion, including prior decisions where “drug” was interpreted to mean the active ingredient itself. See, e.g., Sandoz Inc. v. Becerra, 57 F.4th 272, 280 (D.C. Cir. 2023) (“While the FDA approves [a] drug as a whole, assessment and study of the active ingredient is central to the new drug approval process”); Ipsen Biopharmaceuticals, Inc. v. Becerra, 108 F.4th 836 (D.C. Cir. 2024) (“[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.”). This precedent reinforced the court’s conclusion that only patents claiming the active ingredient “claim the drug” within the meaning of the OBTA and therefore qualify for Orange Book listing.
The court further explained why the mechanical components in Teva’s ProAir® HFA inhaler are properly treated as device components rather than drug components for Orange Book purposes, even though the inhaler as a whole was approved by the FDA as a “drug.” See Decision at 34. More precisely, the court stressed that the FDA approved the inhaler as a “combination product,” which the FDCA defines as “‘a combination of a drug, device, or biological product.’” Decision at 35 (quoting 21 U.S.C. § 353(g)(1)(A) (emphasis added)). This language, the court said, “reflects that the combination product is not a drug—rather, the drug and device subparts still retain their identity as drugs and devices, respectively.” Id.
The court noted that the FDA is faced with a zero-sum decision when deciding whether to approve and regulate a combination product as either a drug or a device—“‘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.’” Decision at 30 (quoting Genus Med. Techs. LLC v. FDA, 994 F.3d 631, 639 (D.C. Cir. 2021) (emphasis in original)). According to the court, “The ultimate approval pathway depends on whether the drug part or device part of the combination product supplies the primary mode of action.” Decision at 35-36. Thus, the fact that Teva’s ProAir® HFA was approved as a combination “drug” product, merely reflected “that the drug mode of action predominated.” Id. at 36.
Based on that analysis, the court reached its penultimate holding: “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.” Decision at 33.
In view of that holding, the Federal Circuit turned to the actual claim language of Teva’s patents, stressing that none of the claims include a limitation requiring the presence of any active ingredient, let alone albuterol sulfate—the active ingredient in Teva’s ProAir® HFA inhaler. For example, claim 1 of Teva’s U.S. Patent No. 9,463,289 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.
Decision at 14 (emphasis added).
Likely by reference to the claim’s recitation of “a medicament canister,” Teva argued that the asserted claims should be construed as “requiring the presence of ‘an active drug.’” Decision at 37. The court disagreed, noting that “[n]o claim in the patent requires the presence of such an active drug in the claim language itself” and that Teva improperly sought to import the limitation from the patent’s specification. Id. The court emphasized that “to claim something, a patent must particularly point out and distinctly claim what it purports to be the invention.” Id. at 38 (citing 35 U.S.C. § 112(b)).
Coming full circle, the court then explained why this failure to claim “the drug” disqualifies Teva’s patents from eligibility for Orange Book listing—“the FDA does not approve a medical product as a drug with reference to some vague active ingredient in the abstract.” Id. Instead, the FDA “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.” Id. (citing 21 U.S.C. § 355(b), (d)).
The court emphasized that it would reject Teva’s Orange Book listing of the patents even if it were to accept Teva’s proposed claim construction because “[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.” Id. The court therefore held that “[a]s 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.” Id. For that reason, the court affirmed the district court’s ruling that Teva improperly listed its inhaler patents in the Orange Book.
Critique and Concluding Remarks
The Federal Circuit’s decision in Teva v. Amneal will undoubtedly serve as a guide to future Orange Book listing decisions, particularly for patents to combination products involving both drug and device components. The court's ultimate holding—that patents claiming device components alone, without claiming the active ingredient, do not satisfy the statutory criteria for Orange Book listing—adheres closely to the statutory text and the intent behind the OBTA and broader patent listing rules. However, the path to this holding raises concerns about the clarity and future implications of the court’s reasoning and analysis.
The court’s concluding analysis, centered on the specific language of the patents’ claims, strongly suggests that the outcome may have been different if Teva’s patents had explicitly claimed the inhaler in combination with its active ingredient, albuterol sulfate. This claim-focused analysis aligns with the OBTA’s statutory criteria, which permit Orange Book listing of patents that claim “the drug.” The fact that the patents’ claims might extend beyond the active ingredient itself to other mechanical components of the inhaler would likely not disqualify the patents from Orange Book listing.
Nonetheless, the court’s broader analysis—distinguishing between “claiming” and “infringing” and analyzing distinctions between drug and device components—arguably went beyond what was necessary to resolve this case. The district court’s ruling could have been affirmed through a straightforward analysis of the patent claims, demonstrating that none expressly claimed the active ingredient in the approved drug. By engaging with these potentially extraneous issues, the court risks complicating future application of Orange Book listing criteria, especially for combination products.
As innovation in drug delivery progresses, these complications may create unnecessary barriers to the Orange Book listing of patents to device-dependent drug formulations. The court acknowledged that Teva’s ProAir® HFA inhaler, as a combination product, literally met the FDCA’s broad definition of “a drug,” yet it treated the mechanical components as devices for Orange Book purposes. This approach, while factually grounded, diverges from long-standing practice allowing Orange Book listing of patents to simpler mechanically delivered drug products—encapsulated drug products.
At a high level, a gelatin capsule is a two-component device that facilitates drug delivery to the gut. As a “component” of the formulated drug product, the capsule fits neatly within the FDCA’s definition of “a drug.” And there has been no historical resistance to Orange Book listing of patents that claim capsules filled with inactive and active drug ingredients. Arguably, Teva’s inhaler components perform a similar function by facilitating drug delivery to the bronchial cavities. The design and function of future patented drug delivery mechanisms is yet unknown, as well as how the court’s decision in this case will affect future eligibility of those patents for Orange Book listing.
Viewed in this light, the court’s extended analysis of “drug” versus “device” components of an approved drug product may thus introduce unnecessary inconsistencies and complications in future evaluations of Orange Book listing eligibility for device-dependent drug patents. In hindsight, the court’s focus on the patents’ claim language alone could have sufficed to produce the same outcome, while avoiding this unnecessary confusion and preserving clarity for combination products. While the Federal Circuit’s ruling preserved adherence to statutory requirements, its expansive reasoning may muddy Orange Book listing determinations for similar patents and potentially complicate future innovation in drug-device integration.
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