Opinion ID: 4519341
Heading Depth: 3
Heading Rank: 1

Heading: An oral pharmaceutical composition of doxycy-

Text: cline, 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 compo- sition consisting of (i) an immediate release (IR) portion comprising 30 mg doxycycline; (ii) a de- layed release (DR) portion comprising 10 mg doxycycline; and optionally, (iii) one or more pharmaceutically acceptable excipients. “Immediate release” or IR is defined by the ’740 patent 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.” ’740 patent at 4:5–8. “Delayed release” or DR is not expressly defined. In June 2013, Amneal filed a petition for inter partes review of the Chang ’740 and ’405 patents, which the Board instituted in December 2013. During the inter partes review, Patent Owner 1 sought to distinguish the claimed DR portion from the prior-art secondary loading portion of 1 The inter partes review proceedings were between Amneal Pharmaceuticals, LLC and Supernus Pharmaceuticals, Inc., the previous assignee of the Chang patents. The proceedings as to the ’740 and ’405 patents were consolidated. We refer to the ’740 proceeding throughout. Case: 19-1021 Document: 90 Page: 4 Filed: 03/25/2020 4 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC slow-release pellets that begin dissolving in the stomach as disclosed in U.S. Patent No. 5,348,748 (Sheth). It argued that “‘a DR portion’ as claimed in the Chang ’740 patent requires no substantial release from the 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.” J.A. 2560 (emphasis in original); see also J.A. 16958–61, J.A. 2749. It further argued that Sheth’s “secondary loading” portion was “intentionally designed to be ‘leaky’ in the stomach,” but that “the Chang ’740 patent expressly states 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.’” J.A. 16957–58 (emphasis in original). Patent Owner argued that “the approach taught by Sheth is substantially different from the claimed IR/DR formulations of the Chang ’740 patent, and in fact would teach away from the claimed formulations of the Chang ’740 patent.” J.A. 16953 ¶ 170 (emphasis in original); J.A. 2189 at 53:22–24 (Sheth “shows a substantial portion is dissolving in the acidic environment of the stomach. The point is that’s not delayed release.”). The Board rejected Patent Owner’s argument and instead agreed with Amneal “that the broadest reasonable construction of ‘delayed release,’ in light of the specification of the ’740 patent, is not limited to formulations requiring that there be no substantial release in the stomach.” J.A. 17023. It stated that “[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.” Id. Because the ’740 patent discloses formats other than enteric coated pellets as being delayed-release components, the Board would “not read the limitations of an embodiment, even a preferred embodiment, into the construction of a Case: 19-1021 Document: 90 Page: 5 Filed: 03/25/2020 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC 5 claim term that is plainly used elsewhere in the specification more broadly.” Id. (citing In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)). After reviewing “other evidence of how the term is understood and used by persons of ordinary skill in the art,” the Board construed “delayed release” to mean “release of a drug at a time other than immediately following oral administration.” J.A. 17024. The Board ultimately found that Sheth did not disclose a “delayed release” format under the proper construction. J.A. 17029. Galderma sued Amneal in March 2016, alleging, inter alia, infringement of the Chang Patents. Like the Board, the district court construed “delayed release” or “DR” as “release of a drug at a time other than immediately following oral administration.” Based on this construction, the district court found, after a bench trial, that Amneal’s product contained the equivalent of the claimed 10 mg DR portion and entered judgment of infringement against Amneal. Amneal appeals this judgment, arguing that Galderma is precluded from asserting infringement under the doctrine of equivalents due to argument-based estoppel, amendment-based estoppel, and claim vitiation. Alternatively, it argues its product does not infringe the Chang Patents under the doctrine of equivalents. We first address the parties’ arguments with respect to argument-based estoppel. We conclude that the district court did not err in concluding that Galderma “did not disclaim particular DR formulations.” J.A. 70. Amneal argues that Patent Owner’s arguments during the ’740 inter partes review proceedings clearly and unmistakably surrendered subject matter and therefore preclude a finding that Amneal’s products infringe the Chang patents under the doctrine of equivalents. Based on Patent Owner’s statements, Amneal argues that competitors would interpret a DR portion as not encompassing a drug that begins dissolving or “leaking” in the stomach. Galderma argues that Amneal has not shown any statements Case: 19-1021 Document: 90 Page: 6 Filed: 03/25/2020 6 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC that, when considered within the context of the complete inter partes review record, amount to a “clear and unmistakable surrender.” We have held 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.” Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353, 1361–62 (Fed. Cir. 2017). Prosecution disclaimer “promotes the public notice function of the intrinsic evidence and protects the public’s reliance on definitive statements made during prosecution.” Id. at 1360 (citing Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1324 (Fed. Cir. 2003)). The doctrine is rooted in the understanding that “[c]ompetitors are entitled to rely on those representations when determining a course of lawful conduct, such as launching a new product or designing-around a patented invention.” Id. (citing Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713 F.3d 1090, 1095 (Fed. Cir. 2013)). Statements by the patent owner are not considered in a vacuum; rather, the skilled artisan would look at the record as a whole in assessing claim scope. See Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 867 (Fed. Cir. 1993) (“The prosecution history must be examined as a whole in determining whether estoppel applies.”). There is no doubt that the Board rejected the Patent Owner’s attempt to limit the meaning of delayed release. See J.A. 17023 (“[W]e agree with Amneal that the broadest reasonable construction of ‘delayed release,’ in light of the specification of the ’740 patent, is not limited to formulations requiring that there be no substantial release in the stomach.”). Because the Board rejected the Patent Owner’s arguments regarding the meaning of delayed release, 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 Case: 19-1021 Document: 90 Page: 7 Filed: 03/25/2020 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC 7 no substantial release in the stomach. While clear and limiting statements made by the patent owner can give rise to disclaimer, they do not in this case where those statements were clearly and expressly rejected by the Patent Office. Because the record makes clear to a skilled artisan that Patent Owner’s arguments were rejected, those arguments do not impact claim scope. Accordingly, we see no error in the district court’s conclusion that Galderma was not precluded by these statements from asserting the doctrine of equivalents. 2 J.A. 70. 3 Contrary to Amneal’s assertion, our decision in American Piledriving does not compel a different result. In that case, we held that a patentee was bound by arguments that it made to an examiner to distinguish prior art. Am. Piledriving Equip., Inc. v. Geoquip, Inc., 637 F.3d 1324, 1336 (Fed. Cir. 2011). We explained that the patentee had 2 Amneal further argues that Patent Owner disa- vowed compositions that exhibit a “substantially constant rate” of release by arguing that their dissolution profiles “cannot be achieved with an IR/DR-only formulation as claimed in the Chang ’740 patent.” See J.A. 2552; J.A. 2545–46, 2553–54, 2562, 16910–12. We agree with Galderma that Amneal did not raise this estoppel argument before the district court. While Amneal did compare its product’s dissolution profile to that of Sheth, it did not argue that Galderma disavowed products exhibiting a “substantially constant rate.” See J.A. 5393–94 (arguing that its later-releasing portion “[a]chieves a different result than DR”) (emphasis in original). The argument is therefore waived. 3 Amneal also argues that the district court erred in determining that Galderma’s doctrine of equivalents argument was not precluded due to the doctrines of amendment-based estoppel and claim vitiation. We see no error in the district court’s decisions as to these doctrines. Case: 19-1021 Document: 90 Page: 8 Filed: 03/25/2020 8 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC “unambiguously argued” a particular construction during reexamination and, “regardless of whether the examiner agreed with American Piledriving’s arguments concerning [the claim term], its statements still inform the proper construction.” Id. American Piledriving is distinguishable for multiple reasons 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. A prosecution history statement may inform the proper construction of a term without rising to the level of a clear and unmistakable disclaimer. See, e.g., Shire Dev., LLC v. Watson Pharm., Inc., 787 F.3d 1359, 1366 (Fed. Cir. 2015) (“Although the prosecution history statements do not rise to the level of unmistakable disavowal, they do inform the claim construction.”). In American Piledriving, the claim language and specification compelled a particular construction and the statements made during prosecution merely served as additional support that “remove[d] all doubt” about the correct construction. See 637 F.3d at 1334–36. Here, in contrast, the claim construction is undisputed and the only question is whether a clear and unmistakable disclaimer bars a finding of infringement under the doctrine of equivalents. 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. Having determined that the district court did not err in considering Galderma’s doctrine of equivalents arguments, we now turn to the merits of the court’s infringement finding. Amneal argues that Patent Owner’s arguments during inter partes review preclude a finding of infringement as its theory contradicts every “substantial” difference it Case: 19-1021 Document: 90 Page: 9 Filed: 03/25/2020 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC 9 identified during inter partes review. For example, Patent Owner argued that (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 SR-containing formulations was “significantly different” from the two-pulse dissolution of the claimed “IR/DR only” formulations. Amneal argues that its product has both. Galderma argues that Amneal’s product is at least equivalent to the claimed invention under the district court’s construction of DR as “release of a drug at a time other than immediately following oral administration.” It argues that Amneal’s product contains a portion of doxycycline that performs substantially the same function, in substantially the same way, to achieve substantially the same result as the DR portion claimed. We review the district court’s fact findings for clear error, and are not free to make a different finding on appeal. 4 See Rolls-Royce Ltd. v. GTE Valeron Corp., 800 F.2d 1101, 1110 (Fed. Cir. 1986) (“This court does not sit to reweigh the evidence presented to the district court, nor will it draw its own inferences, nor make its own fact findings. It will not reverse unless the inferences drawn and facts found by the trial court are on the full record so unsupported as to have been the result of clear error.”). 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 4 The district court considered the importance of the application of the correct burden of proof by the factfinder and concluded that “Galderma has proven infringement by a preponderance of the evidence.” J.A. 75–76 n.8 (“[T]he Court, when sitting as factfinder, is called upon to make a determination based on the evidence presented, applying the appropriate burden of proof, even when there is strong evidence on both sides of the dispute.”). Case: 19-1021 Document: 90 Page: 10 Filed: 03/25/2020 10 GALDERMA LABS., L.P. v. AMNEAL PHARMS. LLC immediately following oral administration.” J.A. 78. The district court found that these portions together satisfy the DR limitation. Id. Because the record evidence supports the district court’s finding, we conclude that the district court did not clearly err in finding infringement under the doctrine of equivalents. Amneal’s product is manufactured by layering doxycycline such that doxycycline releases at various intervals. See J.A. 5619–20 at B-61:1-B-64:5; J.A. 5621 at B-67:7–19; J.A. 5625 at B-83:21–84:11; J.A. 5627 at B-92:8–93:2; J.A. 5642 at B-153–54; J.A. 14524, 14531. Because a portion is prevented from releasing immediately, such later-releasing portion of doxycycline occurs “at a time other than immediately following oral administration.” See J.A. 76 (citing J.A. 41 ¶ 85); see also J.A. 5658– 59 at B-218:6–219:4. Therefore, this later-releasing portion, “in combination with [the DR portion of doxycycline], is insubstantially different from the 10 mg DR portion claimed in Chang.” J.A. 78; see also J.A. 80–81 (concluding that Amneal’s product’s combination “performs the same function in the same way to achieve the same result as the 10 mg DR portion claimed in Chang.”). In view of the evidence, we hold that the district court did not clearly err in finding infringement under the doctrine of equivalents with respect to the Chang Patents.