By Kevin E. Noonan --
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 Amneal's response to Teva's arguments in its Opening Brief.
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") having these representative claims:
8,132,712:
1. A dose counter for a metered-dose inhaler, the counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator, the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery; a pawl to prevent reverse rotation of the rotary gear; and a display coupled to the rotary gear, the display having a visible array of incrementing integers on a surface thereof indexable by a single integer in response to each step of the step-wise rotary motion of the rotary gear; wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear, the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear.
18. The use of a dose counter for preventing miscounting in a metered dose inhaler, the dose counter comprising: an actuator; a rotary gear; a driver for driving the rotary gear in a step-wise fashion in response to displacement of the actuator, the rotary gear comprising a wheel mounted on a spindle which wheel having a plurality of ratchet teeth around its periphery; a pawl to prevent reverse rotation of the rotary gear; and a display coupled to the rotary gear, the display having a visible array of incrementing integers on a surface thereof indexable by a single integer in response to each step of the step-wise rotary motion of the rotary gear; wherein the pawl comprises at least two ratchet teeth each for engaging with the ratchet teeth of the wheel to prevent reverse rotation of the rotary gear, the at least two ratchet teeth being radially spaced such that one of the at least two ratchet teeth of the pawl engages with the ratchet teeth of the wheel following each step of the step-wise rotary motion of the rotary gear.
9,463,289:
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.
9,808,587:
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,
wherein the canister housing has a longitudinal axis X which passes through the center of the central outlet port, and
wherein the first inner wall canister support formation, the actuation member, and the central outlet port lie in a common plane coincident with the longitudinal axis X such that the first inner wall canister support formation protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister relative to the main body of the inhaler.
10,561,808:
1. A dose counter for an inhaler, the dose counter having a counter display arranged to indicate dosage information, a drive system arranged to move the counter display incrementally in a first direction from a first station to a second station in response to actuation input, wherein a regulator is provided which is arranged to act upon the counter display at the first station to regulate motion of the counter display at the first station to incremental movements.
11,395,889:
1. An incremental dose counter for a metered dose inhaler having a body arranged to retain a canister for movement of the canister relative thereto, the incremental dose counter having a main body, an actuator arranged to be driven and to drive an incremental output member in a count direction in response to canister motion, the actuator being configured to restrict motion of the output member in a direction opposite to the count direction, such that the actuator acts as an anti-back drive member when the actuator is in a non-depressed position, and wherein the incremental dose counter further comprises a second anti-back member configured to restrict motion of the output member in a direction opposite to the count direction when the actuator is disengaged from the output member by a bump surface.
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) argues that the District Court made the right decision (and to be fair also 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 emphasizes (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 contends 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 states 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 argues that, to overcome these infirmities Teva and its amici (actually only two of seven amicus briefs filed) "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). Teva does indeed argue in its opening brief that the claims of its asserted patents read on its ProAir inhalation device, but that this is analogous to claims for excipients or generic claims that do not recite the species identified as the active pharmaceutical ingredient. Where Amneal identifies the principle distinction between the parties' positions is in the definition of the term "drug product," as will be set forth herein. Further, Amneal disputes 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.
Amneal's brief identifies the legal issue in the appeal as being the proper construction of that portion of the statute that sets forth what must be disclosed in any patent listed in the Orange Book (21 U.S.C. § 355(b)(1)(A)(viii)):
(viii) 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
(II) claims a method of using such drug for which approval is sought or has been granted in the application.
Amneal's interpretation of this portion of the statute is that it requires any patent listed to be one wherein "there [would] be a reasonable basis to assert that the patent would be infringed by the unauthorized manufacture, use, or sale of the NDA drug" (emphasis added). The brief sets forth the history of this portion of the statute insofar as it was changed in 2021, purportedly due to an appreciation (evinced by a House committee report) of "the proliferation of device patents submitted under the auspices of the Listing Statute for drug device combination products, including, most commonly, inhalers," which delayed generic entry by an average of 3.4 years. Relevant to the issue before the Court, Amneal cites the definition of "drug product" in FDA regulations (but not the statute) to require the presence of the drug substance, citing 21 C.F.R. § 314.3: "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 (emphasis in brief)." The statute, on the other hand, defines the term "drug" broadly (according to Amneal) at 21 U.S.C. § 321(g)(1):
(A) articles recognized in [certain compendia]; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).
and defines "device" at 21 U.S.C. § 321(h)(1) as:
[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is — (A) recognized in [certain compendia], (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
As interpreted by the D.C. Circuit, "FDCA prohibits the FDA from treating a device as if it were a 'drug,'" citing Genus Medical Techs. LLC v. United States, 994 F.3d 631, 644 (D.C. Cir. 2021), "even though [Amneal concedes] the term 'drug' is so broadly defined that it linguistically could include a device." Amneal points out that the District Court held, consistent with the decision by the Second Circuit's decision in United Food v. Takeda Pharm. Co. Ltd., 11 F.4th 118, 134 (2d Cir. 2021), that "the Listing Statute required a drug product patent to claim not just any 'drug,' but specifically 'the drug for which the applicant submitted the application,'" nor did any of the asserted claims to inhaler devices qualify under the statute as a "finished dosage form."
Regarding the requirements for qualifying as a drug product Amneal's brief identifies three:
• "First, it must be a 'patent for which a claim of infringement could reasonably be asserted [against unauthorized] manufacture, use or sale' of the NDA product. 21 U.S.C. § 355(b)(1)(A)(viii). In other words, it must be infringed by the NDA product.
• "Second, the patent must be a 'drug product' patent, which simply means that it must claim a drug product. 21 U.S.C. § 355(b)(1)(A)(viii)(I) [although this seems to beg the question here].
• "Third, the patent must 'claim[] the drug for which the applicant submitted the application.""
Amneal argues that the second and third requirements act in tandem to require that the patents claim not just any drug product but the approved drug product itself. Under this interpretation, the Orange Book-listed claims must recite the drug product (here, albuterol sulfate) and as they undisputedly do not the Court should affirm the judgment of the District Court and lift the stay of the injunction compelling Teva to delist these patents.
Amneal argues that Teva's interpretation of these statutory provisions is erroneous, by being contrary to how the term "claims" is interpreted, inter alia, in Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756, 758-59 (Fed. Cir. 1997), and Graver Tank & Mfg. Co., Inc. v. Linde Air Prods. Co., 339 U.S. 605 (1950). Further, Amneal argues that this interpretation would render superfluous the requirement that the patent "claims the drug," contrary to statutory interpretation precedent citing Facebook, Inc. v. Windy City Innovations, LLC, 973 F.3d 1321, 1336 (Fed. Cir. 2020), and Arlington Cent. Sch. Dist. Bd. of Educ. v. Murphy, 548 U.S. 291, 299 n.1 (2006) in support for this argument. Also, Amneal argues, this overbroad reading of the statute would permit listing of patents for "any type of component, regardless of its nature." While conceding that "adjacent" provisions of the NDA statute permits "NDA applicants to submit information and samples of all components of the NDA drug" in Amneal's view what is permitted to be listed in the Orange Book is more narrow (it "does not broadly permit listing of any kind component patents" (emphasis in brief)). What is permitted is listing patents of only one kind, those that claim "a drug substance (active ingredient)" under 21 U.S.C. §355(b)(1)(A)(viii)(I), and Amneal argues that "this implies that patents on other kinds of drug components are not authorized," citing Syngenta Crop Protection, LLC v. Willowood, LLC, 944 F.3d 1344, 1361 (Fed. Cir. 2019) (emphasis added). Amneal objects to Teva's "plug[ging]" the "component" aspect of the definition of the term "drug" into the statute, due to the specificity of the statutory language for "the drug for which the applicant submitted the application." Citing Genus Medical Techs. again Amneal further argues that "the FDCA prohibits the FDA from treating a device as if it were a drug" and thus ("by extension") the statute should prohibit FDA from listing patents that claim only devices from being listed as if they claimed a drug.
Amneal argues that the plain meaning of the Listing Statute does not authorize listing of "any drug product" (emphasis in brief) but only if the patent "claims the [NDA] drug" under 21 U.S.C. § 355(b)(1)(A)(viii)(I) and further that this interpretation is supported by the legislative history (which indicates "congressional intent to curtail the listing of device component patents specifically"). This interpretation, Amneal argues, is also consistent with FDA's definition of a "drug product," the inclusion of which in the Listing Statute necessarily contains the NDA-approved drug product itself. (Amneal points out that in other contexts Teva itself argued that "drug product patents must require the presence of the active ingredient to qualify for listing in the Orange Book," citing Warner Chilcott (US), LLC v. Teva Pharms. USA, Inc., No. 18-1241 (Fed. Cir. 2018)). If a "drug product" requires the presence of an approved drug substance in the product, Amneal argues that a "drug product patent" must also do so (emphasis in brief), and if a drug product patent must also claim the FDA-approved drug, "at a minimum" such a patent "must . . . require the presence of the particular drug substance in the NDA product."
Taken together none of the asserted patents meet these requirements, Amneal asserts.
Turning to Teva's arguments, Amneal asserts they are "both erroneous and problematic" for four reasons: they "stray from controlling black letter patent law" under 35 U.S.C. § 112 and erroneously equating "claiming with being infringed"(emphasis in brief); the interpretation would make superfluous the "claiming the drug" requirement; Teva's arguments "ignore[] FDA's definition of 'drug product'"; and "would open up the Orange Book to patents on any aspect of the NDA product or any component that happens to be found in the NDA product." So doing would be contrary to the existence of the "powerful exclusionary rights bestowed on Orange Book patents" (naming an automatic preliminary injunction, i.e., the 30-month stay, and automatic permanent injunction for the prevailing NDA holder). Amneal also mentions that requiring Orange Book-listed patents to recite the approved drug product "provides a clear rule that will allow stakeholders to more confidently order their affairs when it comes to the listing of patents in the Orange Book" (elsewhere calling this a "commonsense notion").
Specifically, Amneal argues that the claims in an Orange Book-listed patent must recite the NDA-approved drug, not merely by infringed by the accused generic product as Teva contends, if only because Federal Circuit precedent, Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756, 758-59 (Fed. Cir. 1997), has acknowledged the statutory requirement that the patent "particularly pointing out and distinctly claiming the subject matter which the inventor . . . regards as the invention" under 35 U.S.C. § 112(b). Amneal makes a simple and straightforward argument, that because "the words of the claim do the claiming," citing Corning Glass Works v. Sumimoto Elec. U.S.A., Inc., 868 F.2d 1251, 1258 (Fed. Cir. 1989) (emphasis in brief), the absence of those words (specifically, of the NDA-approved drug substance, albuterol sulfate) precludes Teva from properly Orange Book listing the asserted claims. Once again, Amneal asserts the legislative history of amendments to the Listing Statute to illustrate Congress's concerns, including a direction to the General Accounting Office "to submit data on claims in listed patents 'that claim a device that is used for the delivery of the drug, but do not claim such device in combination with an active ingredient or formulation of a drug,'" Orange Book Transparency Act of 2020, Pub. L. No. 116-290, 134 Stat. 4889, 4892 (Jan. 5, 2021). This history, Amneal argues, also forms the basis for the Court to narrowly construe the Listing Statute, because it "demonstrates [that] these requirements were introduced expressly to preclude Orange Book listing of the very type of device patents at issue here." This "plain meaning" interpretative analysis is supported by the Takeda case from the Second Circuit and In re Lantus Direct Purchaser Antitrust Litig., 950 F.3d 1, 7-8 (1st Cir. 2020), relied upon by the District Court, Amneal argues. Amneal also cites a 1997 Guidance from FDA "explaining" that "a drug product patent must explicitly 'refer to' the NDA product," where Amneal contends "refer to" be interpreted to mean "recite in the claims" of such a patent. Teva's arguments that "being infringed" is equivalent to "claiming" is contrary to Federal Circuit precedent, Amneal argues, including Hoechst, and is not supported by the Apotex case, relied upon by Teva. In that case, Amneal argues, the Court merely held that infringement is a necessary, but not sufficient condition (emphasis in brief), and in any case Amneal contends, statements relied upon by Teva are merely dicta (because they were directed to whether the Federal Circuit had jurisdiction). Amneal similarly dismisses the relevance of Envirotech Corp. v. Al George, Inc., 730 F.2d 753, 759 (Fed. Cir. 1984), and Teva's proffered interpretation of Takeda.
Amneal further challenges Teva's construction of the Listing Statute as rendering the "claims the drug" requirement to be superfluous and that it is "far more expansive than afforded by a fair reading of the Listing Statute" so as to encompass "any component found in the [approved] NDA product" (emphasis in brief). Amneal challenges Teva's argument that requiring the "NDA drug substance" to be present would render the "drug substance" category superfluous, because the statute contains two categories of patents: "A drug substance patent requires only the drug substance per se, whereas a drug product patent requires both the drug substance and some further aspect(s) of the drug product." And the requirement is not merely for "a" drug but for "the" NDA-approved drug "for which the applicant submitted the application" under 21 U.S.C. § 355(b)(1)(A)(viii)(I), which is also the most unambiguous way of understanding the meaning of the term in the context of the Listing Statute, Amneal argues.
Amneal puts its greatest reliance in this regard on the Genus Medical Techs. LLC case, wherein the Court held that "the FDA is prohibited from regulating as a 'drug' anything that meets the statutory definition of a 'device,' even if that item also meets the definition of a 'drug'" because FDA is prohibited from Orange Book-listing patents that claim only a device, Amneal argues. ("Teva's interpretation cannot be correct, because it would permit precisely what the FDCA prohibits.") Devices are not drug formulation "ingredients" (which can be listed under the category as components of a "formulation" or "composition") in Amneal's view.
Amneal also addresses Teva's attempts to overcome ("decouple") the undisputed absence of any mention of the drug substance, albuterol sulfate, from the asserted claims of the Orange Book-listed patents at issue. Simply put, the proper consequence of this absence is for the Court to recognize that these patents to not "claim" the NDA drug product and thus should be delisted, according to Amneal.
Amneal further argues that its interpretation of the Listing Statute "best aligns" with Hatch-Waxman Act goals regarding the balance between exclusivity for brand drugmaker's NDA-approved drugs (and the "extraordinary" injunctive rights conferred by the statute) and opportunities for generic competition. Adopting Teva's interpretation of the Listing Statute, on the other hand, would permit "patents having nothing to do with the drug development efforts for a given product" to be listed in the Orange Book "as long as the claimed invention, no matter how inconsequential, was found in some part of the NDA product." And Teva (in addition to listing the asserted patents in this litigation in connection with 21 different products) retains the right to assert them against generic drugmakers under other subsections of 35 U.S.C.§ 271, albeit without the extraordinary advantages conferred by 35 U.S.C.§ 271(e)(2).
Finally, in this regard Amneal rebuts Teva's "baseless and hyperbolic" policy arguments (which will be discussed in future posts on the two amicus briefs submitted in support of Teva).
Amneal asserts in a separate section of the brief that the claims of any properly Orange Book-listed claims must recite the presence of the approved drug, albuterol substrate, and further that there is no need for claim construction because, on their face none of the listed patents asserted by Teva satisfy this requirement.
Teva's Reply to Amneal is discussed here.
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