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Almirall LLC v. Taro Pharmaceutical Industries Ltd.

United States District Court, D. Delaware

January 24, 2019

ALMIRALL LLC, Plaintiff,


          Joseph F. Bataillon Senior United States District Judge.

         This matter is before the Court on the parties' motions in limine, (D.I. 133-1, Ex. 13 and D.I. 133-2, Ex. 14). This case arises out of the Hatch-Waxman Act, 21 U.S.C. § 355 and 35 U.S.C. § 271(e). Defendant Taro Pharmaceutical Industries, LTD, a manufacturer of generic drugs, is seeking the approval of the United States Food and Drug Administration (“FDA”) to sell a generic version of plaintiff Almirall LLC's (“Almirall”) Aczone® 7.5% (dapsone) Gel product (“Aczone®”). On or around February 13, 2017, TARO submitted an abbreviated new drug application (“ANDA”) No. 210191 to the FDA.[1] Almirall alleges approval of the application would induce infringement of U.S. Patent No. 9, 517, 219 (“the '219 patent”) under the doctrine of equivalents and attempts to block approval of Taro's product by the FDA. ACZONE® was approved for marketing by the FDA in Allergan's New Drug Application ("NDA") No. 207154. Almirall is Allergan's successor in interest. ACZONE® Gel, 7.5% contains dapsone as its active pharmaceutical ingredient ("API"). Almirall alleges infringement of Claims 1, 2, 4, and 5 of the ʼ219 Patent under the doctrine of equivalents pursuant to 35 U.S.C. § 271(b) and (c). Specifically, Almirall alleges Taro's product includes a polymeric viscosity builder, or PVB, [2] equivalent to Sepineo P 600, the PVB used in Aczone®. Taro contends that its ANDA described product does not infringe the asserted claims of the ‘219 patent, and counterclaims for a declaratory judgment that the asserted claims are invalid. The '219 patent is a method patent. The matter is set for trial on February 4, 2019.

         A. Almirall LLC's (“Almirall”) Motion in Limine (D.I. 133, Ex. 13)

         1. Plaintiff's Motion in Limine No. 1 to Preclude Testimony of Dr. Amiji Outside the Scope of His Expert Report

         a. Parties' Positions

         Almirall moves to preclude Taro from eliciting expert opinion testimony from Dr. Amiji that is outside the scope of his expert report. Specifically, Almirall contends Dr. Amiji should not be allowed to testify regarding the amendment of claim 1 of U.S. Patent Application No. 14/082, 955 (“the '955 application”). The '955 application is “parent application” to which the asserted '219 patent claims priority. Almirall contends that in his report, Dr. Amiji's opinion of prosecution estoppel relies exclusively on prosecution events relating to original claim 14, and also asserts that Taro now refers to the amendment of original claim 1 of the '955 application in its statement of uncontested facts. Id. at 279. Almirall acknowledges, however, that Dr. Amiji recited the prosecution history of the '955 application in a background section of his report, including events related to original claim 1. It argues that it has not had opportunity to respond to Dr. Amiji's opinions that rely on claim 1 prosecution history as the basis for prosecution history estoppel, nor to probe those opinions in deposition. It contends it would be prejudiced by presentation of his opinion as to claim 1 for the first time at trial.

         Taro responds that, contrary to Almirall's assertion, Dr. Amiji explicitly referred to amendment of original claim 1 of the '955 application with a narrowing amendment to overcome a rejection over prior art compositions containing Carbomer. Further, it argues that even if Dr. Amiji did not expressly rely on the amendment to claim 1 in reaching his conclusion that Almirall's equivalents theory is barred by prosecution history estoppel, his anticipated testimony regarding the narrowing amendment to original claim 1 would be a permissible elaboration on the opinions set out in his expert report. Taro also contends that Almirall had sufficient notice of Dr. Amiji's anticipated testimony regarding the amendment to original claim 1 and its presumptive impact on Almirall's doctrine of equivalents theory by virtue of Dr. Amiji's references to the amendment of claim 1 in his report and Taro's motion for leave to file a motion for summary judgment, which espoused the same theory.[3] It also argues that Almirall's expert, Dr. Majella Lane, had an opportunity to attempt to rebut the presumption of prosecution history estoppel in her Reply Report and Almirall also had an opportunity to seek deposition testimony from Dr. Amiji regarding the amendment but chose not to do so. Taro contends that Almirall's failure to address the amendment in its expert reports or at deposition should not preclude Taro from eliciting expert opinion testimony from Dr. Amiji on the issue.

         b. Law

         Although the motion in limine is an important tool available to the trial judge to ensure the expeditious and evenhanded management of the trial proceedings, performing a gatekeeping function and sharpening the focus for later trial proceedings, some evidentiary submissions, cannot be evaluated accurately or sufficiently by the trial judge in such a procedural environment. Jonasson v. Lutheran Child and Family Servs., 115 F.3d 436, 440 (7th Cir. 1997). A motion in limine is appropriate for “evidentiary submissions that clearly ought not be presented to the jury because they clearly would be inadmissible for any purpose.” Id. In other instances, it is necessary to defer ruling until during trial, when the trial judge can better estimate the impact of the evidence. Id.

         Moreover, trial courts should be more reluctant to exclude evidence in a bench trial than a jury trial. See First Am. State Bank v. Cont'l Ins. Co., 897 F.2d 319, 328 (8th Cir. 1990); Builders Steel Co. v. Comm'r, 179 F.2d 377, 379 (8th Cir. 1950). In bench trials, evidence should be admitted and then sifted when the district court makes its findings of fact and conclusions of law. Fields Eng'g & Equip., Inc. v. Cargill, Inc., 651 F.2d 589, 594 (8th Cir. 1981). In a nonjury case, the trial court is presumed to consider only the competent evidence. First Am. State Bank, 897 F.2d at 328. Where the court has assumed the role of fact-finder in a bench trial, ''the better course'' is to ''hear the testimony, and continue to sustain objections when appropriate.'' Easley v. Anheuser-Busch, Inc., 758 F.2d 251, 258 (8th Cir. 1985).

         “Evidentiary rulings made by a trial court during motions in limine are preliminary and may change depending on what actually happens at trial.” Walzer v. St. Joseph State Hosp., 231 F.3d 1108, 1113 (8th Cir. 2000); see also Leonard v. Stemtech Health Scis., Inc., 981 F.Supp.2d 273, 276 (D. Del. 2013) (noting that evidentiary rulings, especially those that encompass broad classes of evidence, should generally be deferred until trial to allow for the resolution of questions of foundation, relevancy, and potential prejudice in proper context).

         The Federal Rules of Civil Procedure require a testifying expert to prepare and sign a written report containing, inter alia, “a complete statement of all opinions the witness will express and the basis and reasons for them . . . at the times and in the sequence that the court orders.” Fed.R.Civ.P. 26(a)(2)(B)(i) & (a)(2)(D). Rule 26 also imposes a duty to “supplement or correct [an expert report] . . . in a timely manner if the party learns that in some material respect the disclosure or response is incomplete or incorrect, and if the additional or corrective information has not otherwise been made known to the other parties during the discovery process or in writing.” Fed.R.Civ.P. 26(e)(1)(A). “If a party fails to provide information or identify a witness [in the manner required by the Court under Rule 26], the party is not allowed to use that information or witness . . . at a trial, unless the failure was substantially justified or is harmless.” Fed.R.Civ.P. 37(c)(1); see W.L. Gore & Assocs., Inc. v. C.R. Bard, Inc., No. CV 11-515- LPS-CJB, 2015 WL 12806484, at *3 (D. Del. Sept. 25, 2015). Although the Federal Rules clearly contemplate the exclusion of untimely or improper expert disclosures (and the concomitant exclusion of expert testimony), the Third Circuit cautions that because “[t]he exclusion of critical evidence is an extreme sanction, ” it should not be imposed where an untimely or improper expert disclosure amounts to only a “slight deviation from pre-trial notice requirements” or occasions only “slight prejudice” to the movant. In re Paoli R.R. Litig., 35 F.3d 717, 791-92 (3d Cir. 1994) (internal quotation marks and citations omitted).

         c. Discussion

         Almirall does not challenge the expert's qualifications or methods, its complaint relates to lack of notice of the expert's opinions. For the most part, the Court finds Almirall's arguments appear unavailing-the Court is inclined to believe the evidence should be heard to the extent it is relevant. However, the Court cannot assess the relevance of the proffered testimony in this context. Because this is a bench trial, the Court finds the plaintiff's contentions are less compelling. Let it suffice to say that testimony will be permitted only on a proper showing of relevance, foundation, and compliance with the Federal Rules of Evidence.

         Also, only testimony and opinions properly disclosed in expert reports will be permitted. Almirall's challenges to purportedly undisclosed testimony may be based on an unduly narrow reading of the reports. The Court is inclined to believe that the testimony as it relates to claim 1 of the '219 patent is a natural outgrowth of his testimony on claim 14 of the parent application. It appears that Almirall had notice of the gist of Dr. Amiji's testimony. Accordingly, the Court finds Almirall's motion in limine should be denied, without prejudice to reassertion via a timely objection at trial.

         B. Taro's motions in limine:

         1. Motion in Limine to Exclude Argument, Evidence or Testimony Relying on Plaintiff's Commercial Product to Prove Infringement

         a. Parties' Contentions

         Taro moves to preclude Almirall from presenting evidence arguments or opinions that compare the accused Taro ANDA product to Almirall's NDA No. 207154 and/or its commercial ACZONE Gel, 7.5% to prove infringement. It argues such comparison is contrary to precedent since the language of the asserted patent claims, and not the patent holder's commercial product, to define the inquiry.

         In response, Almirall contends that Federal Circuit case law does not contain such a prohibition and argues that comparisons of Taro's ANDA product and ACZONE Gel 7.5% can be relevant to infringement. Almirall notes that Taro does not dispute that its product, ACZONE gel 7.5%, meets all the limitations of the asserted claims. It also contends that whether certain excipients can form part of the PVB when they are not separately and explicitly recited in the claims is a question of fact.

         b. Law

         When an alleged infringer files abbreviated new drug application (ANDA), the patentee bears burden of showing by preponderance of the evidence that what is to be sold will infringe. 35 U.S.C.A. § 271(e)(2). Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997). Generally, in deciding the issue of infringement, the trier of fact does not compare the defendant's accused product or method to the plaintiff's commercial product or method. Precision Fabrics Grp., Inc. v. Tietex Int'l, Ltd., No. 1:13-CV-645, 2016 WL 6839394, at *14 (M.D. N.C. Nov. 21, 2016) (noting that the Federal Circuit has advised caution in applying the doctrine of equivalents, reminding courts that it is the terms of the claims, and not the products themselves, that are the focus of the inquiry). Rather, the trier of fact compares the defendant's accused product or method to the claims of the patent when deciding infringement. See Mahurkar v. C.R. Bard, Inc., No. 92 C 4803, 1993 WL 259446, at *10 (N.D. Ill. July 6, 1993) (stating that under the doctrine of equivalents, a court considers infringement of a claim and of an equivalent to a limitation of the claim); see also In re Omeprazole Patent Litig., 536 F.3d 1361, 1378 (Fed. Cir. 2008) (noting district court correctly noted that that evidence regarding infringement must compare the claims to the accused product).

         The inquiry under 35 U.S.C. § 271(e)(2) is a standard infringement test and “[t]he only difference . . . is that the allegedly infringing drug has not yet been marketed and therefore the question of infringement must focus on what the ANDA applicant will likely market if its application is approved.” Glaxo Grp. Ltd. v. Ranbaxy Pharm., Inc., 262 F.3d 1333, 1337-38 (Fed. Cir. 2001) (quoting Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d at 1569). Thus, to determine whether an ANDA applicant's proposed product infringes the a patent, the court compares the ANDA described product to the asserted claims as construed. Id. In order to ...

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