By Kevin E. Noonan —

The Federal Circuit continued its recent willingness to affirm findings of infringement under the doctrine of equivalents (see, e.g., "Eli Lilly & Co. v. Hospira, Inc. (Fed. Cir. 2019)"), in Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC.

The case came to the Court after ANDA litigation over Galderma's low dose formulations of doxycycline for treating acne or rosacea.  Galderma asserted two sets of patents:  the Chang patents (U.S. Patent Nos. 8,206,740; 8,394,405; and 8,470,364) and the Ashley II patents (U.S. Patent Nos. 8,603,506 and 9,241,946).  Claim 1 of the '740 patent was set forth in the Court's opinion as representative:

1.  An oral pharmaceutical composition of doxycycline, which at a once-daily dosage will give steady state blood levels of doxycycline of a minimum of 0.1 μg/ml and a maximum of 1.0 μg/ml, the composition consisting of (i) an immediate release (IR) portion comprising 30 mg doxycycline; (ii) a delayed release (DR) portion comprising 10 mg doxycycline; and optionally, (iii) one or more pharmaceutically acceptable excipients.

The specification expressly defined the immediate-release component of the pharmaceutical composition as "a dosage form that is intended to release substantially all of the active ingredient on administration with no enhanced, delayed or extended release effect."  In contrast, the delayed release component was not strictly defined.

Relevant to the issues on appeal was Amneal's inter partes review proceeding against the '740 and '405 patents, and the arguments the patent owner made regarding claim construction.  Specifically, the patent owner argued that the DR portion of the pharmaceutical composition "requires no substantial release from the [DR] portion until some time other than promptly after administration – and in particular, until after the DR portion passes through the acidic stomach and sections of the GI tract below pH 4.5" (emphases in opinion).  The patent owner also argued that prior art "secondary loading" portion was "intentionally designed to be 'leaky' in the stomach," but that "the Chang '740 patent expressly stated that for the 'DR portion' described and claimed therein, 'there is no substantial release of doxycycline in the acidic stomach environment of approximately below pH 4.5.'"  Thus the distinction the patent owner attempted to draw between its claimed invention and the prior art was that the '740 patent had essentially no release of the delayed release component in stomach, while the prior art had some stomach release (characterized as being "leaky").

The Board disagreed; applying the broadest reasonable interpretation standard, the Board construed the claims to mean that the DR component of the claimed pharmaceutical composition "is not limited to formulations requiring that there be no substantial release in the stomach" and "[t]he portion of the '740 patent specification upon which [Patent Owner] relies to support its narrower construction addresses properties of 'enteric coated pellets,' not a delayed-release component" and hence did not provide a basis for distinguishing the claims.  The Board based its construction on the rubric that it would have be improper to read limitations reciting a narrow embodiment in construing a claim term that is read more broadly elsewhere in the specification.  As set forth in the Federal Circuit's opinion, "the Board construed 'delayed release' to mean 'release of a drug at a time other than immediately following oral administration'" and that the cited art did not disclose a delayed release formulation as the term was construed.

In the ensuing ANDA litigation, the District Court held that Amneal's generic product infringed under the doctrine of equivalents, construing the "delayed release" limitation as the Board had in the IPR.  Under this construction, the Court held that Amneal's proposed generic version of Galderma's delayed release doxycycline pharmaceutical formulation contained the "equivalent" of the DR formulation in Galderma's claimed formulation and hence would infringe.

Regarding the asserted Ashley II patents, the representative claim considered by the Federal Circuit was claim 15 of the '946 patent:

15.  A method for treating papules and pustules of rosacea in a human in need thereof, the method comprising administering orally to said human doxycycline, or a pharmaceutically acceptable salt thereof, in an amount of 40 mg per day, wherein the amount results in no reduction of skin micro-flora during a six-month treatment, without ad-ministering a bisphosphonate compound.

The District Court construed the phrase "wherein the amount results in no reduction of skin microflora during a six-month treatment" to mean "wherein the amount results in no reduction of skin microflora vis-à-vis a placebo control during a six-month treatment, with microbiological sampling at base-line and month six."  Under this construction, the Court also found that the use of Amneal's generic version of Galderma's delayed release doxycycline formulation would be infringed under the doctrine of equivalents.

The Federal Circuit affirmed the District Court's decision regarding infringement under the doctrine of equivalents of the asserted Chang patents and reversed as to doctrine of equivalents infringement of the Ashley II patents, in an opinion by Judge Moore joined by Judges Lourie and Stoll.  And the Court found infringement under the DOE.  Regarding the Chang patents, Amneal asserted argument-based estoppel, amendment-based estoppel, and claim vitiation, based on patent owner's arguments and representations in the IPR.

On the argument-based estoppel prong of its argument, Amneal relied on patent owner's representations to the Board during the IPR to the effect that infringing formulations should not encompass ones that began dissolving in the stomach.  The Federal Circuit agreed that Galderma's counterargument that the patent owner's arguments in the IPR did not amounted to a "clear and unmistakable surrender" of claim scope as argument by Amneal.  The panel acknowledged that "statements made by a patent owner during an IPR proceeding can be considered during claim construction and relied upon to support a finding of prosecution disclaimer" so long as the statements are "both clear and unmistakable," citing Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353, 1361–62 (Fed. Cir. 2017), and its utility in satisfying the "public notice function" regarding proper claim scope.  But, the opinion states, such statements should not be considered "in a vacuum" and a court need to review prosecution history "as a whole," citing Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 867 (Fed. Cir. 1993).  Here, "the record before the Patent Office clearly put the public on notice that the meaning of delayed release with respect to the Chang Patents is not limited to formulations requiring that there be no substantial release in the stomach."  The patent owner had made assertions, but these putatively limiting statements had been rejected by the PTO, and thus there was no disclaimer.  With regard to this argument, the opinion illustrates nice nuance between the situation (and legal conclusion) in this case and the seemingly contrary outcome in Am. Piledriving Equip., Inc. v. Geoquip, Inc., 637 F.3d 1324, 1336 (Fed. Cir. 2011), where disclaimer was found from statements made in reexamination to distinguish prior art.  While distinguishing the circumstances under which the putatively disclaiming arguments were made in the two cases (including "that the statements were not made during inter partes review, the statements were used to inform claim construction not prosecution history disclaimer and our court did not find that the examiner had clearly and expressly rejected the patentee's proposed construction") the gist of the differences for the Court was that "[a] prosecution history statement may inform the proper construction of a term without rising to the level of a clear and unmistakable disclaimer," citing Shire Dev., LLC v. Watson Pharm., Inc., 787 F.3d 1359, 1366 (Fed. Cir. 2015).  According to the opinion, in American Piledriving, the statements merely confirmed construction based on the specification and prosecution history, while here Amneal attempted to use those statements to rebut undisputed claim construction and raise an estoppel precluding DOE infringement.  "A person of ordinary skill in the art would not read the prosecution history in this case and conclude that the patent owner's claim construction that the Board expressly rejected was a clear and unmistakable surrender," according to the Court and thus the panel declined to do so.

Turning from disclaimer to IPR estoppel, Amneal argued that the District Court's infringement determination was contrary to positions patent owner took in the IPR, specifically:

[T]hat (1) release of the drug in the stomach from "leaky" SR portions was "substantially different" from the claimed DR portion, and (2) "substantially constant release" from [sustained-release] SR-containing formulations was "significantly different" from the two-pulse dissolution of the claimed "IR/DR only" formulations.

On this point, the standard of review on questions of fact, clear error, was dispositive, because Federal Circuit did not find that here:

The district court found that Amneal's product contains a DR portion of doxycycline and a separate portion of doxycycline that is not available for release until a time "other than immediately following oral administration."  . . .  The district court found that these portions together satisfy the DR limitation

Because the panel found that this determination was based on record evidence, there was no reason to overturn the District Court and thus the Federal Circuit affirmed.

With regard to the Ashley II patents, Galderma first argued (after oral argument under Fed. R. App. Proc. 28(j)) that the Court had lost jurisdiction to hear the appeal because Amneal had ceased to pursue its ANDA.  The panel disagreed, stating that this alone does not divest jurisdiction because the action is not moot and a justiciable controversy remains on the basis that the alleged infringing conduct "could reasonably be expected to recur," citing  Friends of the Earth, Inc. v. Laidlaw Envtl. Servs., Inc., 528 U.S. 167, 189 (2000).

On the merits, the panel held that "Galderma did not present particularized testimony and linking argument as to the reduction in skin microflora term."  Stating that the record "wholly lacked the requisite particularized testimony required to find infringement under the doctrine of equivalents," the Federal Circuit reversed the District Court's decision that Amneal's generic version of Galderma's delayed-release doxycycline pharmaceutical formulation would infringe the asserted claims of the Ashley II patents.

Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC (Fed. Cir. 2020)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Moore, and Stoll
Opinion by Circuit Judge Moore