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Astellas Pharma Inc. v. Actavis Elizabeth LLC

United States District Court, D. Delaware

May 28, 2019

ASTELLAS PHARMA INC., et al, Plaintiffs,
ACTAVIS ELIZABETH LLC, et al, Defendants.



         On April 2, 2019, the parties in these consolidated Hatch-Waxman actions filed a "Motion for Teleconference to Resolve Discovery Dispute" ("Motion") regarding their various requests that: (1) certain material be stricken from the parties' expert reports; and (2) the parties be precluded from raising the stricken subject matter at trial.[1] (D.I. 391) In this Memorandum Order, the Court considers the portion of Defendants Sawai Pharmaceutical Co., Ltd., Sawai USA Inc. (together with Sawai Pharmaceutical Co. Ltd., "Sawai"), Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd.'s (together with Zydus Pharmaceuticals (USA) Inc., "Zydus") (collectively, Defendants") Motion relating to their request to strike Plaintiffs Astellas Pharma Inc., Astellas Ireland Co., Ltd. and Astellas Pharma Global Development, Inc.'s (collectively, "Astellas" or "Plaintiffs") expert opinions on secondary considerations of non- obviousness ("SC").[2] (D.I. 392 at 1-3; D.I. 409 at 1-3) With respect to this issue, [3] the Court has considered the parties' letter briefs, (D.I. 392, 399, 409), and the parties' arguments made during the April 17, 2019 telephonic argument, (D.I. 420 (hereinafter, "Tr.")).[4]


         Federal Rule of Civil Procedure 37(c)(1) provides that "[i]f a party fails to provide information ... as required by Rule 26 [ ](e), the party is not allowed to use that information . . . to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless." In considering whether to exclude evidence relating to an untimely or otherwise improper disclosure, the United States Court of Appeals for the Third Circuit has directed district courts to weigh certain factors, known as "the Pennypack factors": (1) the surprise or prejudice to the moving party; (2) the ability of the moving party to cure any such prejudice; (3) the extent to which allowing the testimony would disrupt the order and efficiency of trial; (4) bad faith or willfulness in failing to comply; and (5) the importance of the testimony sought to be excluded. See Meyers v. Pennypack Woods Home Ownership Ass 'n, 559 F.2d 894, 904-05 (3d Cir. 1977), overruled on other grounds, Goodman v. Lukens Steel Co., Ill. F.2d 113 (3d Cir. 1985); see also Konstantopoulos v. Westvaco Corp., 112 F.3d 710, 719 (3d Cir. 1997). Because "[t]he exclusion of critical evidence is an extreme sanction," the Third Circuit has explained that it should be reserved for circumstances amounting to "willful deception or flagrant disregard of a court order by the proponent of the evidence." In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 791-92 (3d Cir. 1994) (internal quotation marks and citations omitted).


         The present dispute relating to S.C. is a "continuation" of a previous discovery dispute addressed by the Court in October 2018. (D.I. 392 at 1) In connection with that previous discovery dispute, Sawai sought to strike Plaintiffs' Second Supplemental Response to Defendants' Interrogatory No. 14, in which Plaintiffs had belatedly provided, for the first time, meaningful articulations of their contentions regarding SC. (See D.I. 346 at l-3)[5] In an October 24, 2018 Memorandum Order (the "October 2018 Order"), the Court ruled on the dispute as follows:

Plaintiffs' [Third] Supplement[6] is not stricken from the case, and in making its secondary considerations case at trial, Plaintiffs and their experts may rely on any evidence/argument fairly raised in the [Third] Supplement. However, absent further order of the Court, Plaintiffs' reliance on secondary considerations is limited to the content of the [Third] Supplement.

(Id., at 5) The Court further permitted Sawai to take "targeted discovery relating to secondary considerations." (Id.)

         Now, Defendants assert that Plaintiffs have violated the October 2018 Order by including "new details, evidence, and theories" relating to S.C. (i.e., beyond the content found in Plaintiffs' Third Supplement) in four rebuttal expert reports served in February 2019.[7] (D.I. 392 at 1) Accordingly, Defendants argue that "the entire issue of SC" should be excluded from this case. (Id., at 3 (emphasis omitted)) Alternatively, if the Court finds that S.C. in its entirety should not be excluded, Defendants seek to strike the portions of the rebuttal expert reports that raise new S.C. theories, arguments and evidence beyond the Third Supplement. (Id. at 3 n.l5) Specifically, Defendants list out six SC[8] for which Plaintiffs' experts purportedly included new details, evidence and theories beyond that set out in the Third Supplement. (Id., at 1-2) For each of these, Defendants also cite to the relevant page number(s) of the Third Supplement and the paragraphs of the various expert rebuttal reports purportedly containing new content beyond that found in the Third Supplement. (Id., at 1-2 & nn. 5-10)

         Plaintiffs, for their part, respond that their experts offered opinions on S.C. "consistent with what was fairly raised" in the Third Supplement. (D.I. 399 at 2) Beyond that, they contend that many of the objected-to paragraphs of their experts' reports were not limited to SC, but were "in direct response to Defendants' experts' alleged prima facie obviousness or nonenablement analyses[.]" (Id. at 3) The October 2018 Order did not preclude Plaintiffs' experts from rebutting Defendants' experts' invalidity opinions set out in their opening reports, and Plaintiffs therefore assert that such rebuttal opinions and evidence are proper. (Id.)

         The Court will take up each of the six S.C. highlighted by Defendants in turn.[9]

         A. Teaching Away

         Defendants first assert that Plaintiffs violated the October 2018 Order by including new content in their experts' reports relating to the "supposed 'teaching away' of references other than [Plaintiffs' United States Patent No. 6, 346, 532 Bl (the '"532 patent")] mentioned in the [Third] Supplement[.]" (D.I. 392 at 1 & n.5)[10] The Court does not agree.

         In the Third Supplement, Plaintiffs first take up teaching away with respect to the T17 and '049 patents. For those patents, Plaintiffs assert that had a person of ordinary skill in the art ("POSA") been motivated to develop a mirabegron drug product, the POSA would have been motivated to use the dihydrochloride crystal form of mirabegron disclosed in the '532 patent, not the crystalline free base form of mirabegron recited in the '117 and '049 patents. (D.I. 394, ex. H (hereinafter, "Third Supp.") at 30) In the next paragraph, Plaintiffs argue that:

As to the '474 and '872 Patents, beta-adrenergic receptors were known, for example, to be present in, inter alia, the heart, and stimulation of these receptors in the heart was known to, inter alia, increase heart rate and cardiac contractility; and were known to be present in, inter alia, the smooth muscle of blood vessels and the trachea, and stimulation of these receptors was known to, inter alia, lead to muscle tremors and tachycardia.

(Id.) Plaintiffs do not cite to any materials in support of this statement.

         Turning to the four paragraphs of Dr. Michel's report called out by Defendants, (D.I. 392 at 1 n.5 (citing D.I. 394, ex. C at ¶¶ 190-94)), they discuss how the prior art taught away from the potential use of B3 AR agonists to treat OAB. Dr. Michel contends that a key concern "would have been cardiovascular side effects, most importantly an increased heart rate" as well as muscular tremors, and he cites to various references in support. (D.I. 394, ex. C at ¶¶ 191-94)

         The Court finds that such content was "fairly raised" in the Third Supplement. (See D.I. 399 at 2) When pressed during telephonic argument as to why the objected-to paragraphs of Dr. Michel's report go beyond the content of the Third Supplement, Sawai's counsel noted that Dr. Michel "relies on a bunch of new evidence that was not cited to us." (Tr. at 59) Defendants' understanding of the Third Supplement had been that Plaintiffs were relying therein only on the '532 patent as support for the teaching away argument relating to the '474 and '872 patents. Defendants thus say they were surprised to see the "many articles" referenced in the relevant paragraphs of Dr. Michel's report. (Id. at 61-62) In the Court's view, however, this was not a particularly reasonable assumption. Plaintiffs reference the '532 patent with regard to teaching away in the Third Supplement with respect to different patents (the '117 and '049 patents), and a different issue. Defendants should therefore not have been very surprised to see other references cited in Plaintiffs' experts' reports to support their opinions for teaching away with respect to the '474 and '872 patents.[11] And with respect to the substance of Dr. Michel's report, it does not seem to be asserting new theories or arguments as to why the prior art taught away from the inventions disclosed in the '474 and '872 patents.

         B. ...

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