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Takeda Pharmaceutical Co., Ltd. v. TWI Pharmaceuticals, Inc.

United States District Court, N.D. California, San Jose Division

March 17, 2015

TAKEDA PHARMACEUTICAL CO., LTD., et al., Plaintiffs,


LUCY H. KOH, District Judge.

Plaintiffs Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceuticals America, Inc. (collectively, "Takeda") move to strike portions of the Opening Expert Report of Dr. Edmund J. Elder, Jr., the Reply Expert Report of Dr. Edmund J. Elder, Jr., the Opening Expert Report of Dr. Michael Mayersohn, and the Reply Expert Report of Dr. Michael Mayersohn, related to opinions regarding invalidity that were allegedly not disclosed in the Invalidity Contentions served by Defendant TWi Pharmaceuticals, Inc. ("TWi"). ECF No. 139 ("Mot."). The Court finds this matter suitable for decision on the papers pursuant to Civil Local Rule 7-1(b), and hereby VACATES the hearing set for March 19, 2015, at 1:30 p.m. For the reasons explained below, the Court GRANTS Takeda's Motion to Strike.


This case involves patent infringement claims by Takeda against TWi. TWi filed an Abbreviated New Drug Application ("ANDA") under the Hatch-Waxman Act for generic forms of the branded drug Dexilant®. Takeda asserts that TWi's ANDA infringes claims 1, 2, 5, 6, 7, 11, and 16 of U.S. Patent No. 8, 461, 187 (the "187 Patent") and claims 1, 2, 3, and 6 of U.S. Patent No. 8, 173, 158 (the "158 Patent"). See generally Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 1282-86 (Fed. Cir. 2008) (explaining ANDA procedures and patent infringement claims under the Hatch-Waxman Act); ECF No. 129 (Dec. 10, 2014 Case Mgmt. Order) at 2 (listing asserted claims).

A. TWi's Invalidity Contentions

Pursuant to Patent Local Rule 3-3, TWi served its Invalidity Contentions on November 4, 2013. ECF No. 140-1 (Takahashi Decl. Ex. A) ("Invalidity Contentions"). TWi listed PCT Publication No. WO 00/09092 ("Dietrich") as a reference that "anticipate[s] and/or make[s] obvious the asserted claims of the 02bc187 Patent." Invalidity Contentions at 5-6; see also ECF No. 140-6 (Takahashi Decl. Ex. F) (Dietrich). TWi then included an extended discussion of Dietrich, concluding that "Each of the asserted claims 1-2, 5-8, and 10-17 of the 02bc187 Patent are invalid as obvious in view of Akiyama I, Muir, Beckert I, Lundberg I, Cherukuri, Percel, Dietrich, Louie-Helm, Lenaerts, and/or Odidi, alone or in combination, and further in view of the admitted prior art recited in the 02bc187 Patent specification." Invalidity Contentions at 58. TWi did not provide a citation to Dietrich for the limitation "wherein each of the first and second doses comprise a sufficient amount of the PPI to raise plasma levels of the PPI to a threshold concentration of at least 100 ng/ml" found in Claim 1 of the 187 Patent. Id. at B-3; see also id. at 76-79 (not disclosing where Dietrich teaches the 100 ng/ml limitation). TWi also failed to identify Dietrich in conjunction with asserted dependent claims 5 and 16. Id. at B-4 (claim 5) and B-8 (claim 16).

TWi contended further that claims 1-11 of the 158 Patent were invalid under 35 U.S.C. § 112, ¶ 1 (2006 ed.), [1] for failure to satisfy the enablement requirement. Invalidity Contentions at 98. TWi's Invalidity Contentions included three arguments: (1) the 158 Patent failed to adequately enable the limitations in claims 10 and 11 that "bioequivalency is established with a 90% Confidence Interval between 0.80 and 1.25"; (2) the 158 Patent failed to adequately enable treatment of a "patient" because the 158 Patent only described the treatment of healthy subjects; and (3) the 158 Patent does not enable a composition that can be administered "regardless of whether the patient is under fasted or fed conditions" measured by intragastric pH. Id. at 98-101.

After serving the Invalidity Contentions, TWi moved to amend its contentions twice. On June 4, 2014, TWi moved to amend its Invalidity Contentions with regard to the 158 Patent. ECF No. 77. Magistrate Judge Grewal denied the motion, finding that TWi had not been diligent in seeking to amend its contentions. ECF No. 98 at 6-7. On October 30, 2014, TWi moved a second time to amend, this time asserting anticipation by an alleged offer for sale. ECF No. 118. Judge Grewal granted the motion to amend. ECF No. 128. Neither amendment is at issue in the instant Motion.

B. TWi's Expert Reports

TWi served its opening expert reports on December 4, 2014. See ECF No. 140-2 (Takahashi Decl. Ex. B) ("Elder Opening Report"); ECF No. 140-3 (Takahashi Decl. Ex. C) ("Mayersohn Opening Report").

Dr. Elder's report expresses his opinion that the asserted claims of the 187 Patent are anticipated by Dietrich in paragraphs 17, 52, and 74-86 of his opening report and paragraphs 7-26 of his reply report. See Elder Opening Report; ECF No. 140-4 (Takahashi Decl. Ex. D) ("Elder Reply Report"). Dr. Mayersohn also expresses his opinion that the asserted claims of the 187 Patent are anticipated by Dietrich in paragraphs 31, 66, and 95-107 of his opening report. See Mayersohn Opening Report.

Drs. Elder and Mayersohn also opine that the 158 Patent is invalid for lack of enablement because undue experimentation would be required for one of ordinary skill to make and use a formulation that can be taken without regard to meals as required by claim 1 of the 158 patent. Elder Opening Report ¶¶ 17, 116, 129-49; Elder Reply Report ¶¶ 27-41; Mayersohn Opening Report ¶¶ 31, 141-48; ECF No. 140-5 (Takahashi Decl. Ex. E) ("Mayersohn Reply Report") ¶¶ 25-29.

After receiving TWi's opening report, Takeda contacted TWi and requested that "TWi agree in writing to withdraw and to otherwise not further pursue these new invalidity theories." ECF No. 140-7 (Takahashi Decl. Ex. G) (Dec. 10, 2014 Letter to TWi). Takeda's letter identified both the anticipation and enablement theories Takeda now moves to strike. Id. That same day, the Court held a case management conference and Takeda raised the possibility of filing a motion to strike. ECF No. 140-8 (Takahashi Decl. Ex. H) (Dec. 10, 2014 Hr'g Tr.) at 62:3-12. The Court required the parties to meet and confer before filing the motion to strike, id. at 64:4-7, which Takeda and TWi did, but the parties did not reach a resolution. ECF No. 140 (Takahashi Decl.) ¶ 10.


"The local patent rules in the Northern District of California... require[e] both the plaintiff and the defendant in patent cases to provide early notice of their infringement and invalidity contentions, and to proceed with diligence in amending those contentions when new information comes to light in the course of discovery." O2 Micro Int'l Ltd. v. Monolithic Power Sys., Inc., 467 F.3d 1355, 1365-66 (Fed. Cir. 2006). "For invalidity claims, the Patent Local Rules achieve this objective by requiring the party asserting invalidity to serve contentions early in the case disclosing: (1) the identity of each item of prior art that allegedly anticipates each asserted claim or renders it obvious, Patent L. R. 3-3(a); (2) whether each of those items of prior art anticipates each asserted claim or renders it obvious, Patent L. R. 3-3(b); (3) a chart identifying where specifically in each alleged item of prior art each limitation of each asserted claim is found, Patent L. R. 3-3(c); and [(4)] any grounds of invalidity based on 35 U.S.C. § 101, indefiniteness under 35 U.S.C. § 112(2) or enablement or written description under 35 U.S.C. § 112(1) of any of the asserted claims, Patent L. R. 3-3(d)." Largan Precision Co., Ltd. v. Genius Elec. Optical Co., No. 13-CV-02502-JD, 2014 WL 6882275, at *1 (N.D. Cal. Dec. 5, 2014).

"Any invalidity theories not disclosed pursuant to Local Rule 3-3 are barred... from presentation at trial (whether through expert opinion testimony or otherwise)." Mediatek Inc. v. Freescale Semiconductor, Inc., No. 11-CV-5341-YGR, 2014 WL 690161, at *1 (N.D. Cal. Feb. 21, 2014) (citing Avago Techs. Gen. IP PTE Ltd. v. Elan Microelectronics Corp., No. 04-CV-05385-JW (HRL), 2007 WL 2103896, at *1 (N.D. Cal. July 20, 2007)). A "party may not use an expert report to introduce new infringement theories, new infringing instrumentalities, new invalidity theories, or new prior art references not disclosed in the parties' infringement ...

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