The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering Teva to delist five Orange Book-listed patents, in Teva Pharms. Inc. v. Amneal Pharms. LLC. This post concerns Teva's Reply brief answering Amneal's Responsive brief to Teva's Opening Brief on appeal.
To recap, the issues arose in litigation over Amneal's ANDA directed to its generic version of Teva's ProAir® HFA (albuterol sulfate) Inhalation Aerosol product. In this litigation, Teva asserted five Orange Book-listed patents: 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") (representative claims for these patents can be found here).
The District Court granted Amneal's motion on the pleadings (asserted in its counterclaims as required by statute) that these patents were improperly listed in the Orange Book as not being directed to an FDA-approved drug nor method of using such a drug for treating a disease or disorder and granted an injunction compelling Teva to delist these patents. Teva appealed, the Federal Circuit entering a stay on the order to delist during pendency of the appeal.
On appeal Teva made two arguments: the first is based on a legal and technical definition of how the term "drug product" is defined in the statute, and the second is whether the District Court erred procedurally, including whether claim construction was required to properly determine the first question.
Amneal's Responsive Brief
In its responsive brief, Amneal (unsurprisingly) argued that the District Court made the right decision (and to be fair has the easier argument, in view of the intrinsic tug of the argument that Orange Book-listed patents should, at a minimum, recite the drug product itself, in this case albuterol sulfate). In its argument, Amneal emphasized (literally) that FDA's definition of a "drug product" recites "a finished dosage form . . . that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients," citing 21 C.F.R. § 314.3 (emphasis added) (in contrast to Teva, Amneal cites the FDA rules rather than the statutory language). Amneal contended that "the drug substance" is albuterol sulfate per se and not the combination of the drug and the inhaler that is the subject matter of the claims destined to be delisted if the District Court decision is affirmed. As Amneal stated in its argument, "[i]t is undisputed, however, that the Asserted Patent claims do not recite, identify or refer to the drug substance—albuterol sulfate—as a part of the claimed inventions" (at least not expressly). Amneal argued that, to overcome these infirmities, Teva and its amici (actually only two of seven) "seek in effect to rewrite the Listing Statute" by changing the plain meaning of the term "claims" therein to mean "reads on any part of" (which is an abbreviated but not entirely unfair characterization). Where Amneal identified the principle distinction between the parties' positions was in the definition of the term "drug product." Further, Amneal disputed the need for claim construction because "even if the claims were construed as Teva proposes, the Asserted Patents still would not qualify for listing in the Orange Book" as they do not recite albuterol sulfate as an affirmative limitation therein.
Teva's Reply Brief
In Teva's Reply to Amneal initially the brief notes that FDA approved it ProAir HFA as a drug, that the inhaler component is the dosage form, and patents claiming dosage forms must be listed under 21 U.S.C. § 321(g)(1)(D). And this listing does precisely what the Hatch-Waxman regime intended: notifying generic drug applicants of the patents that can be asserted in ANDA litigation (i.e., it provides the intended statutory benefit to them). Teva continues by reasserting the consequences of affirming the District Court, including delisting "any genus patent, any patent that claims some but not all components of a drug product, and any patent that claims one but not all of the active ingredients in a drug product" (emphasis in brief).
Teva further reiterates its positions in its Opening Brief: that the statutory term "claim" should be interpreted to mean "read on" rather than "recite" (clearly a broader construction that resolves Teva's issue regarding the absence of the NDA-approved drug, albuterol sulfate, from the claims of the asserted patents); in this regard, Teva relies on the same precedent (and arguments) asserted in its Opening Brief. Teva rebuts Amneal's arguments regarding the definiteness requirement in the statute (35 U.S.C. § 112(b)) as not requiring express recitation of the NDA-approved drug but rather (citing the statutory language) that the claim "inform, with reasonable certainty, those skilled in the art about the scope of the invention," citing Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014). This requirement would not be necessary, Teva contends,"if the entire scope of a patent were explicitly recited in detail in the claims." Properly understood, what the statute entails is providing notice of the boundaries of the right to exclude and to define limits," Teva argues, citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1348 (Fed. Cir. 2010) (en banc).
As applied to the Listing Statute, Teva asserts Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, 60 F.4th 1373, 1379 (Fed. Cir. 2023), for the principle that claims must be construed based on "not just 'the words of the claims themselves'" but also "the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art," citing Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc) (citation omitted). Teva, in making this argument, seeks (it appears) to refute Amneal's more straightforward argument that the absence of any recitation of the NDA-approved drug in the asserted claims is dispositive. "'Claim language, standing alone' is not the correct standard of law and is contrary to uniform precedent" Teva asserts, quoting Nature Simulation Sys. Inc. v. Autodesk, Inc., 50 F.4th 1358, 1364 (Fed. Cir. 2022). "Claim language," Teva asserts, "is a boundary, not a laundry list" and "[a] genus claim unambiguously encompasses every species in the genus without mentioning any one of them." This is where Teva asserts Amneal errs in its responsive brief.
Teva first argues that its asserted patents "claim" a drug so long as it claims a component of the FDA-approved drug product. Citing Apotex, Teva argues that "[t]he listing decision thus requires what amounts to a finding of patent infringement [literal infringement, Teva specifies], except that the 'accused product' is the drug that is the subject of the NDA." Amneal doesn't address this, Teva asserts, and thus its attempts to "make something of the modest distinctions between the scope of a claim and the scope of infringement fall flat." This conclusion is supported, Teva asserts, by Teva Pharms. USA, Inc. v. Leavitt, 548 F.3d 103, 106 (D.C. Cir. 2008), and In re Actos End-Payor Antitrust Litig., 417 F. Supp. 3d 352, 369 (S.D.N.Y. Sept. 30, 2019). Teva rebuts Amneal's attempts to distinguish Apotex, construing the language of the statute to support its interpretation (and rebutting Amneal's dismissal of Apotex as dicta because that court's decision was directed to interpreting the Listing Statute to determine whether the case raised a substantial question of patent law for jurisdictional purposes). Teva also asserts the Jazz Pharma case as supporting its interpretation of the Apotex decision.
On somewhat less firm grounds, Teva argues that a patent that claims a component of an NDA drug claims "the drug" based on the express definition of the term "drug" under 21 U.S.C. § 321(g)(D). After distinguishing Amneal's (and the FTC's) analogy to construing claims to car brakes to encompass the car itself, Teva argues that "the term 'drug' is expressly defined to include its components" unlike the hypothetical car. Teva also addresses the distinctions raised by Amneal regarding statutory language to "drugs" and "drug substance" patents and conflicts between them (as well as Congress's amendments to the statute to include as listable drug substance as well as drug patents, citing Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 586 U.S. 123, 131-32 (2019). (Indeed, Teva argues that some of these statutory changes were motivated by "a unique requirement to list patents claiming polymorphs" and, accordingly, "not all drug substance patents will also qualify as drug product patents." Teva states that (incorrectly) Amneal argues that "a patent on a component, including a drug substance, cannot be a 'drug product patent'" where according to Teva's interpretation of the statute "FDA recognizes that there is." Teva further argues that there is no "incongruity" between there being a broad definition of the term "drug" and the phrase "claims the drug for which the applicant submitted the application" in the statute because (in Teva's interpretation) this merely ensures that an applicant cannot list patents that claim "a" drug but claims the NDA-approved drug product. But this interpretation "does not rule out patents on the components that are submitted to FDA" which, Teva argues, is the situation here.
Teva also insists that FDA approved its ProAir HFA product as a drug, not a device. If Amneal (or its supportive amici) believe this is not the proper policy then this is an issue for Congress not the courts, Teva argues, because the statute mandates that FDA treat combination products as drugs "in their entirety" (under a single application whenever appropriate" under 21 U.S.C. § 353(g)(1)(B)). Contrary to Amneal's argument, Teva asserts that "FDA does not regulate 'the device part' of a combination product as a device on its own [but r]ather, a combination product in its entirety is regulated either as a drug or as a device, and the statutory scheme expressly contemplates that the device parts will sometimes be regulated as drug under 21 U.S.C. § 353(g)(1). (Indeed, Teva maintains that Congress amended the statute in 1990 to "remove the exclusion of devices and their counterparts to 'facilitate the regulation of combination products,' as drugs," citing Genus Medical Technologies LLC v. FDA, 994 F.3d 631, 644 (D.C. Cir. 2021), and the Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 16(b), 104 Stat. 4511, 4526 (Nov. 28, 1990).
Teva also disputes Amneal's arguments that its interpretation of the Listing Statute renders come provisions to be surplusage. With regard to the statutory phrase "claims the drug" Teva argues that FDA has excluded "[p]atents claiming packaging, patents claiming metabolites, and patents claiming intermediates." These patents may indeed raise infringement liability under the infringement clause of the Listing Statute but they cannot raise liability under the "claims the drug" clause, citing Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756, 759 & n.2 (Fed. Cir. 1997), for patents claiming metabolites, for example. Nor should the Court find persuasive Amneal's arguments regarding other changes in the statute under the Orange Book Transparency Act of 2020, Pub. L. No. 116-290, 134 Stat. 4889 (2021), codified at 21 C.F.R. § 314.53(b)(1) because, Teva argues, "both the text and the legislative history refute the notion that Congress sought to change listing practices in the significant way Amneal hypothesizes." Regarding Congress's motivations and directions to the GAO related to this statutory change, Teva disputes Amneal's implications that Congress intended to prevent device patents from being Orange Book listed. Instead, Teva contends Congress was trying to determine the number of patents claiming the device-drug combination and those claiming the device per se (a heavily nuanced argument that comes perilously close to mimicking Amneal's contentions). Nevertheless, "[c]urrent regulation and practice is to list precisely the types of patents Amneal complains are at issue here," Teva argues, and (turnabout being fair play) Teva notes that "[u]ntil recently, Amneal itself recognized as much with respect to its patents on epinephrine injection products—which likewise did not mention the active ingredient."
Teva devotes a separate section to its arguments that the asserted patents are properly drug product patents. This basis for affirming the District Court asserted by Amneal in its responsive brief was not part of the court's legal reasoning below, Teva states (terming it "an afterthought"). Regardless, Teva argues that the argument "cannot be reconciled with the text of either the Delisting Statute or the Listing Statute" (emphasis in brief), inter alia, because "Congress did not provide for delisting patents on the basis that it does not claim a drug product," citing 21 U.S.C. § 355(j)(5)(C)(ii)(I) (and Teva argues the patents ordered to be delisted did claim a drug product by virtue of being combination patents). (Teva takes the opportunity to disparage the lack of legal reasoning, in its view, the FTC mustered in supporting Amneal's arguments in this regard, explicated in a detailed footnote.) This portion of Teva's argument reaches the important difference between the parties (and amici): while agreeing that a "drug product" is a "finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients" under 21 C.F.R. § 314, does this definition include mechanical devices used to administer the drug? Teva's answer is expansive: a patent claims a drug product "if it reads on one or more components of a drug," in this case "whether albuterol sulfate, the propellant, the inhaler device, or the entire inhaler, with its constituent parts." Amneal contends that whatever else is claimed it must include the drug substance itself: "because a drug product contains a drug substance, it insists that every drug product patent must expressly recite a drug substance (i.e., active ingredient)." Teva's argument is bound up with the definitions and legal strictures of the relevant statutes ("the relevant regulation defines a 'drug product' as 'contain[ing] a drug substance, generally, but not necessarily, in association with one or more other ingredients," citing 21 C.F.R. § 314.3(b) (emphasis in brief)). In contrast, Amneal's position is a simple and straightforward one: how can a patent claim a drug product if the claims do not recite the drug substance itself?
Teva also disputes whether its asserted patents are "formulation or composition" patents. Teva claims they are, relying on FDA rules having "expressly recognized" that metered aerosols can be listed as "finished dosage forms." Teva cannot rely on FDA definitions for the term "composition" (Teva's brief concedes there isn't one) and falls back on patent law definitions of "compositions of matter" as "all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders, or solids," citing In re Nuijten, 500 F.3d 1346, 1357 (Fed. Cir. 2007), and Jazz Pharms. This language indicates that "composition patents" include patents on "composition articles" which easily (for Teva) includes "multiple physical components," citing, of all things, Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013). Importantly here Teva argues that this use of the term is consistent with how the FDCA statute and FDA regulations use the term "component" with regard to drug products. And Teva points out that what Amneal (and the FTC) define as a composition (i.e., "a mixture of active and inactive ingredients") is more properly termed a formulation, citing HZNP Meds. LLC v. Actavis Lab'ys UT, Inc., 940 F.3d 680, 683 (Fed. Cir. 2019), for this distinction (supported in a footnote by reference to the Hatch-Waxman letter, cited by Amneal, to the effect that "a formulation patent as a subcategory of composition patents" at https://www.fda.gov/media/149035/download?attachment.)
The brief then addresses Teva's assertion that at a minimum claim construction is required, which the District Court pointedly did not perform. Teva maintains its position that "a patent can claim an active ingredient without naming it," citing genus claims as an example (emphasis in brief). Again here Teva takes the opportunity to denigrate the FTC's position (reminding the reader that it is "an agency with no specialized patent knowledge") that "limitations cannot be imported into the claims" (emphasis in brief), stating that claim construction is needed to ascertain properly whether the limitation is present in the claim in the first place.
Finally, Teva restates its contentions that following Amneal's arguments will "destabilize the Hatch-Waxman regime" because the line drawn to balance the rights of branded drugmakers and their generic counterparts is one for Congress, not the courts to set down, citing PDS Consultants, Inc. v. United States, 907 F.3d 1345, 1360 (Fed. Cir. 2018). Here, Congress had drawn the line, Teva argues, so that its patents are properly listed. The brief calls "deeply flawed" arguments by Amneal and certain amici that permitting patents like the ones at issue here to be Orange Book-listed "stifles generic competition." One reason is, Teva maintains, that "FDA typically takes more than 30 months to review an ANDA, meaning that the [statutory 30-month stay] does not actually delay approval" (although to be fair it cannot be said that the ANDA litigation process under §271(e)(2) accelerates approval, either). Teva argues that this case illustrates that the current situation does not prevent generic competition because "[m]ultiple generic versions of ProAir HFA are already on the market; the first [being] approved in 2020" and Teva itself is marketing an authorized generic version of its branded ProAir HFA inhaler. Teva extols the benefits of the Hatch-Waxman regime and its "highly ordered process" in contrast to "chaotic, hurried, and risky preliminary-injunction proceedings" arising from § 271(a) litigation proceedings. Lost will be the notice provisions provided by Orange Book listing Teva asserts, an outcome warned against by the Association for Accessible Medicines in a comment to FDA stating that "[i]nformation on those device-related patents that 'read on' the approved drug product and that is subsequently listed in the Orange Book would be beneficial to the generic drug industry by allowing the normal pre-approval patent resolution to take place . . . ."
The views of several amici will be discussed in future posts.
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