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.
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 makes 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. That first question is the more difficult one, to the extent to which Teva must convince the Court that the 1st Circuit erred in the Lantus decision and the District Court erred in interpreting the 2nd Circuit's decision in the Takeda case, both of which were decided consistently with the decision against Teva by the District Court.
With regard to its statutory construction argument, Teva maintains that not only did it comply with the listing statute but that it was compelled by the statute to do so. "A drug product patent must be listed in the Orange Book for a specific NDA (i.e., a brand-name product) if the patent 'claims the drug for which the applicant submitted the application'" under 21 U.S.C. § 355(b)(1)(A)(viii)(I) according to Teva's brief. This argument can only be persuasive should "the drug for which the applicant submitted the application" be interpreted to encompass per se the inhaler device (and related administration-related accoutrement and not need to include express recitation of the drug administered thereby). That interpretation further depends on the Federal Circuit being persuaded that the drug itself is impliedly contained in the claims to the "drug product," as interpreted by Teva, analogously to recitations of either genus claims to particular classes of drugs or more broadly to formulation claims reciting excipients and the like. Teva argues that accepting the arguments by Amneal (and their supportive amici) would greatly reduce the number of Orange Book-listed patents in ways that would harm the careful "balance'" struck under the Hatch-Waxman framework in disclosing to generic competitors (and the public) what patents could be asserted against ANDA-seeking drugmakers under 35 U.S.C. § 271(e)(2).
According to Teva, the District Court erred in what it means to claim a drug product, focusing not on that is recited in the claim but what generic drug product would be adjudged to be infringed. In the context of Orange Book listing, Teva argues that under the statute, that definition "includes not just an 'article' that treats an illness or affects the body's functioning, but also any 'component' of such an 'article'" under 21 U.S.C. § 321(g)(1)(B)-(D). This is because "FDA's rulemaking expressly contemplates that patents claiming a 'dosage form' will be listed in the Orange Book and identifies 'metered aerosols' like those at issue here as one example of a 'dosage form.'"
The brief relies on this definition of the term "drug" in the statute:
(A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; 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).
21 U.S.C. § 321(g)(1) (italics emphasizing the portion of the statute expressly relied upon by Teva). This definition is both "express" and "expansive," Teva argues, and applies to the listing statute as well, according to the brief. Teva acknowledges that mere packaging cannot be listed but contends that its inhalers are part of the approved "finished dosage form" of the approved product and therefore the asserted patents to such inhalers et al. were properly listed. Inclusion of subsection (D) above "ensures that the term 'drug' will reach the entirety (any 'component') of any drug product (any 'article[]' used to treat disease)," Teva argues.
Relying on FDA regulations (68 Fed. Reg. 36,676, 36,680 (June 18, 2003)), the brief asserts that metered aerosols are "expressly categorized" as a dosage form, wherein 'drug delivery systems used and approved in combination with a drug'—a category that includes 'metered dose inhalers'—are distinguishable from the type of 'packaging and containers' that are not properly listed in the Orange Book," Teva citing Orange Book, Appendix C, at C- 1 (44th ed. 2024) in support for this argument. Moreover, Teva argues that "FDA classifies MDIs [metered dose inhalers] like ProAir as "single-entity combination products," meaning a drug and a device "combined or mixed and produced as a single entity," wherein "[c]ombination products 'constitute a combination of a drug, device, or biological product'" under 21 U.S.C. § 353(g)(1)(A)" that are "regulated either as a drug or a device" under 21 U.S.C. § 353(g)(1). Regarding MDIs, Teva argues that FDA has classified them as "drug-device combination products for which 'the primary mode of action . . . is attributable to the drug component,'" citing FDA guidance from 1993 (which states that "an aerosol delivery device will be considered a drug product . . . when the primary purpose of the device is delivering or aiding in the delivery of a drug and the device is distributed with the drug"). (This determination also applies to dose counters according to the brief.). In this way Teva contends the Court must treat the inhaler as it would an excipient or other component of a drug formulation covered under the statute and relevant FDA regulations because that is how FDA approved the combination.
The District Court, in Teva's telling, erred in ruling that the asserted claims must be delisted because none of those claims expressly recited the active ingredient of the drug product, albuterol sulfate, and did so without claim construction (despite the decision depending on whether the drug was claimed in any of the asserted claims). The brief also asserts that the District Court apparently vacillated "between stating that the claims must recite the active ingredient and stating that the claims must recite the full product itself," finally resting on the purported need for the claims to recite expressly albuterol sulfate. But Teva asserts another interpretation of the District Court's holding would require a properly Orange Book-listed patent would need to "recite every aspect of a drug (active ingredients, inactive ingredients, excipients, etc.)" which would permit listing only of "claim[s] with limitations explicitly directed to every part of the drug product [that] would satisfy the opinion," which would be "a dramatic narrowing of the scope of the Listing Statute and contrary to established law, citing in this regard Cadence Pharms. Inc. v. Exela PharmSci Inc., 780 F.3d 1364, 1369 (Fed. Cir. 2015), as an example.
Teva asserts that the statute requires that its claims must, under 21 U.S.C. § 355(b)(1)(A)(viii), claim "the drug for which the applicant submitted the application" and the test for whether this is the case is if the accused product would infringe the asserted claims ("The scope of what a patent 'claims' is effectively coterminous with the products that infringe a patent."). "Critically," the brief asserts (and this is the crux of whether Teva will be successful before the Federal Circuit), a "patent need not read on the entirety of a product to 'claim[]' the product," citing SunTiger, Inc. v. Sci Rsch. Funding Grp., 189 F.3d 1327, 1336 (Fed. Cir. 1999)("[i]f a claim reads merely on a part of an accused device, that is enough for infringement"), "[n]or, in the case of pharmaceuticals, must a patent recite the active ingredient by name in order to claim the drug" (basing this assertion on generic claims "whose active ingredient is one species within the genus," citing In re Omeprazole Patent Litig., 536 F.3d 1361, 1365-66 (Fed. Cir. 2008), and Indivior Inc. v. Dr. Reddy's Lab'ys, S.A., 930 F.3d 1325, 1349-50 (Fed. Cir. 2019)). Thus, Teva argues that the Federal Circuit has held that a patent that "'claims the drug for which the applicant submitted the application'—and therefore 'must be listed'— if it contains a product claim that reads on the drug that is the subject of the NDA,'" citing Apotex, Inc. v. Thompson, 347 F.3d 1335, 1343-44 (Fed. Cir. 2003). And under 21 U.S.C. § 321(g)(1)(D), that would include the claims Teva asserted before the District Court (because the term "drug" "covers the entirety of the drug product and any component thereof—not just the active ingredient"). This is because, Teva argues, the FDA-approved "drug product" is the ProAir HFA (the device in combination with albuterol sulfate) -- and "[t]he statutory scheme treats combination products like ProAir HFA as drug products where—as is the case with ProAir HFA—the product's 'primary mode of action' is that of a drug" under 21 U.S.C. § 353(g)(1)(D)(i).
The two "out-of-circuit" cases the District Court relied upon for its contrary determination -- United Food & Commercial Workers Local 1776 v. Takeda Pharmaceutical Co., 11 F.4th 118 (2d Cir. 2021), and In re Lantus Direct Purchaser Antitrust Litigation, 950 F.3d 1 (1st Cir. 2020) – either actually supported Teva's position (Takeda) or were wrongly decided (Lantus), the brief asserts. In the former case the court used an "infringement-type [judicial] analysis," which Teva argues was required but not performed by the district court. And the latter case (as did the District Court here) equated "claims" for a drug with "mention[ing]," the drug in the claims, which is Teva's basis for asserting error. The brief also notes that these were both antitrust cases, not patent cases, and as such did not address patent-specific issues important in this case. In Takeda, according to Teva, the Second Circuit adopted the approach Teva espoused, that "a patent claims any product that falls within the bounds of the claim—a determination that must be made through an infringement-type analysis." And that case was directed to a combination product, with the Second Circuit holding that a patent on only one component of the combination did not "read on" the approved drug comprising the combination. Regarding Lantus, which held that "if a patent 'do[es] not mention the drug for which the sNDA was submitted, the patent does not "claim the drug" under the Listing Statute,'" the District Court also did not perform claim construction. Moreover, Teva's brief contends "Lantus's reasoning is inapplicable by its own terms to Teva's claims directed to the entire inhaler product [because the] patent at issue in Lantus did 'not include a claim for an injector pen more broadly,' but rather 'mention[ed] that the drive mechanism is intended for use in a "drug delivery device"'" and in that case the listed claim, despite claiming "a device intended for use as an injector pen [did] not claim any injector pen" (rather it claimed merely a component part of the injector pen). In this case, "three of the Asserted Patents plainly claim the entire inhaler . . . and thus claim the equivalent of the injector pen—precisely what the court in Lantus thought was missing."
At a minimum, Teva argues, the District Court's decision was error because it was decided on the pleadings and not properly supported by claim construction, because the listing question is one of patent law needing "ordinary claim construction principles" to be applied in making a determination whether an accused infringing product infringes (and there is more to this analysis than "whether a claim name-checks the active ingredient or the drug" according to the brief). The brief cites several Federal Circuit decisions and those from other circuit courts, including Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, 60 F.4th 1373 (Fed. Cir. 2023); Biogen Int'l GmbH v. Mylan Pharms. Inc., 18 F.4th 1333, 1336 (Fed. Cir. 2021); Teva Pharmaceuticals USA, Inc. v. Leavitt, 548 F.3d 103 (D.C. Cir. 2008); Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1080 (D.C. Cir. 2001), for the primacy of this principle. Teva argues that the asserted claims in fact contain terms that encompass the active drug -- albuterol sulfate -- including "[a]n inhaler for metered dose inhalation" recited in the '289 and '587 patents; "medicament canister" recited in the '289, 587, and '712 patents; "an inhaler" recited in the '808 patent; "a metered dose inhaler" recited in the '889 and '712 patents; and "cannister" recited in the '889 patent.
These errors by the District Court require the Federal Circuit to vacate the judgment and remand for further consideration, Teva argues. Further Teva asserts that this would pose no burden on the District Court, which is construing claims in these patents during the litigation that has proceeded on other grounds not affected by the order to delist. And doing so would help clarify circumstances like this under the Hatch-Waxman framework, Teva argues, which is beneficial because it "facilitate[s] a scheme that allows the parties to obtain patent certainty before the launch of a drug, thereby supporting the development of both brand and generic medicines" (emphasis in brief); without doing so the consequence of the District Court's decision will result in "significant uncertainty and risk" because "many more infringement disputes would be resolved only after launch of a generic product, including preliminary injunction proceedings, a post-launch jury trial, and an award of money damages."
Teva concludes these arguments by imploring the Federal Circuit not to "disrupt" the balance struck by Congress that "[a]ll drug product patents must be listed in the Orange Book for every drug they claim, for as long as a claim of infringement can reasonably be made under those patents," and that "[t]raditional Paragraph IV invalidity and noninfringement challenges to those listed patents provide an expeditious pathway toward patent certainty." It must be said that the highest burden towards that end will be the ineluctable lure of the more simple-minded concept that claims not reciting the drug product should not be Orange Book listed, regardless of the nuances found in Teva's explication of the statute and FDA ruled implementing its provisions. The arguments against such statutory interpretations, by Amneal and almost all the amici, will be set forth in later posts.