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Noven Pharmaceuticals, Inc. v. Amneal Pharmaceuticals LLC

United States District Court, D. Delaware

October 24, 2019




         At Wilmington this 24th day of October, 2019:

         Having reviewed the proposed final pretrial order ("PTO") (D.I. 169-71) submitted by Plaintiff Noven Pharmaceuticals, Inc. ("Noven" or "Plaintiff") and Defendant Amneal Pharmaceuticals L.L.C. ("Amneal" or "Defendant"), IT IS HEREBY ORDERED that:

         1. Plaintiffs motion in limine ("MIL") number 1, to preclude Dr. Alekha K. Dash from testifying regarding noninfringement of U.S. Patent No. 9, 833, 419 ("the '419 patent"), is DENIED. It does not appear to the Court that Dr. Dash intends to improperly compare the Amneal ANDA Product to prior art Vivelle-Dot®. Nor is there anything improper about one basis of Dr. Dash's opinion being confidential documents to which a POSA would not have access; non-public information may appropriately be the basis for an illustration that provides additional support for an opinion grounded in public information. Noven's arguments are best understood as being directed to the weight to be accorded to Dr. Dash's testimony, not its admissibility. Finally, the Court is not (yet) persuaded that Amneal's non-infringement position depends on an untimely request for claim construction. The testimony of Dr. Dash may be helpful to the Court, as finder of fact, in understanding and applying the plain and ordinary meaning of the coat weight term, or alternatively may provide the basis for what the Court might ultimately determine is an obligation to further construe disputed claim terms. See generally Pressure Prods. Med. Supplies, Inc. v. Greatbatch Ltd., 599 F.3d 1308, 1315-16 (Fed. Cir. 2010) (recognizing that Court "may engage in a rolling claim construction, in which [it] revisits and alters its interpretation of the claim terms as its understanding of the technology evolves").

         2. Plaintiffs MIL number 2, to preclude Dr. M. Laurentius Marais from offering his statistical probability analysis in support of Defendant's anticipation theory, is DENIED. Dr. Marais's statistical analysis is sufficiently reliable to be helpful to the Court as a trier of fact in determining whether Defendant has met its burden in proving that Vivelle-Dot®, sold pre-critical date, met all disputed claim limitations. See 35 U.S.C. § 102(b). The Court agrees with Amneal that "Noven's motion merely describes fact issues to be resolved at trial through weighing of evidence and credibility determinations." (PTO Ex. 12 Ans. Br. at 3)

         3. Plaintiffs MIL number 3, to preclude portions of Dr. M. Laurentius Marais's anticipated testimony relating to non-prior art products, is DENIED. The Court agrees with Amneal: "fluxes achieved by post-critical date Vivelle-Dot® (or flux achieved by samples taken from Vivelle-Dot® lots that were not sold) can be representative of fluxes achieved by Vivelle-Dot® sold before the critical date." (PTO Ex. 13 Ans. Br. at 1) The Court further agrees with Amneal that Noven's motion presents issues that "go[] to weight, not admissibility." (Id.) There appears to be a genuine dispute of material fact on the representativeness issue and both parties will have the opportunity to present their competing evidence on this dispute at trial.

         4. Defendant's MIL number 1, to exclude Plaintiffs "claim of infringement under the doctrine of equivalents ["DOE"] due to prosecution history estoppel ["PHE"]," is DENIED. Amneal's motion appears to be an unauthorized motion for summary judgment. Regardless of how the motion is characterized, the Court will benefit from hearing the parties' evidence on DOE so that it can make any necessary factfinding in the event the Court concludes PHE does not apply or the Court decides to reach the DOE issue in the alternative (even if PHE does apply). (See PTO Ex. 14 Ans. Br. at 1) ("The parties should brief the issue of PHE post-trial, and the Court should hear the DOE analysis so that if it determines PHE does not apply, it can decide infringement under the DOE.") The parties are both permitted to argue and brief their positions on the applicability (or not) of PHE. See also Noven Pharmaceuticals, Inc. v. Actavis Lab. UT, Inc., C.A. No. 15-249-LPS D.I. 252 at 35-45 (D. Del. Dec. 28, 2017) (deciding PHE applied to bar DOE theory of infringement in connection with related patent after trial).

         5. Defendant's MIL number 2, to exclude Noven's expert witness Dr. Richard Guy from testifying about a publication by van der Bijl (1998) that was not cited in his expert reports, is DENIED. Application of the Pennypack factors supports this conclusion. Although Plaintiff produced the publication after Dr. Guy's expert reports were served, there is no indication that Plaintiff acted willfully or flagrantly disregarded any Court Order. Instead, Dr. Guy identified and reviewed the 1998 publication during preparation for his September 11, 2019 deposition, and provided testimony about it during redirect examination in that deposition, providing Defendant with notice of his opinion on the import of the publication. While there is some prejudice to Defendant, it is not substantial, for reasons including: (i) van der Bijl 1998 is only five pages long and was cited in another reference that was disclosed in Dr. Guy's expert reports; (ii) Amneal's expert had more than a week to consider the new reference and the opportunity to provide his opinion on it at his deposition (had he wished to do so); and (iii) van der Bijl 1998 is not the basis for any new opinion but rather is cited by Dr. Guy only in the nature of reasonable elaboration of previously-disclosed opinion, consistent with proper rebuttal. Although the new reference does not appear to be crucially-important evidence, the Court's admission of it does not threaten to disrupt the trial and is warranted under the totality of circumstances.

         6. Plaintiffs Motion for Clarification (D.I. 147) of the Court's July 25, 2019 discovery order (D.I. 144) is GRANTED. Noven is not required to stipulate with respect to Novartis's belatedly produced third-party documents. The parties shall execute a stipulation consistent with this clarification and the July 25 order no later than the first day of trial.

         7. With respect to other issues raised in the PTO:

a. The parties are permitted and encouraged to make opening statements and closing arguments, although they are not required to do either, and they will not be permitted to make a closing argument if they have already used all of their allocated trial time. (See PTO at p. 10)
b. The parties need not list exhibits they may offer at trial to be used solely for impeachment or cross-examination. (See PTO ¶¶ 43, 44, 46, 48)
c. The parties need not serve one another with non-demonstrative exhibits, nor make available for inspection any physical exhibits, when such exhibits are to be used solely for impeachment or cross-examination. (See PTO ¶¶ 49, 57)
d. The parties are directed to raise the issue of post-trial briefing with the Court at the conclusion of ...

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