Takeda Pharm. Co., Ltd. v. TWi Pharms., Inc.

Case Name: Takeda Pharm. Co., Ltd. v. TWi Pharms., Inc., Civ. No. 13-CV-02420-LHK, 2015 U.S. Dist. LEXIS 32948 (N.D. Cal. Mar. 17, 2015) (Koh, J.) 

Drug Product and Patent(s)-in-Suit: Dexilant^® (dexlansoprazole); U.S. Pats. Nos. 8,461,187 (“the ’187 patent”) and 8,173,158 (“the ’158 patent”) 

Nature of the Case and Issue(s) Presented: The issue here concerns whether TWi’s invalidity contentions provided sufficient detail in order for it to survive a motion to strike portions of TWi’s expert reports. Pursuant to N.D. Cal. L. Pat. R. 3-3, TWi served its invalidity contentions on Nov. 4, 2013. TWi alleged that prior art known as the Dietrich reference anticipated and/or made obvious the asserted claims of the ’187 patent.  But 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” in claim 1 of the ’187 patent. TWi also failed to identify Dietrich in conjunction with asserted dependent claims 5 and 16.  TWi contended further that claims 1-11 of the ’158 patent were invalid under 35 U.S.C. § 112 ¶ 1 for failure to satisfy the enablement requirement.  TWi’s invalidity contentions concerning the ’158 patent included three arguments: (1) it 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) it failed to adequately enable treatment of a “patient” because the ’158 patent only described the treatment of healthy subjects; and (3) it did not enable a composition that can be administered “regardless of whether the patient is under fasted or fed conditions” measured by intragastric pH.

TWi’s experts expressed opinions in their reports that the asserted claims of the ’187 patent were anticipated by Dietrich. TWi’s experts also opined that the ’158 patent was 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. After service of TWi’s expert reports, Takeda contacted TWi and requested that TWi withdraw its new invalidity defenses based on anticipation and enablement. The parties met and conferred on the issue, but could not reach a resolution. Takeda filed the pending motion to strike, which the court granted.

Why Takeda Prevailed:  Takeda’s motion specifically related to two theories that it alleged TWi had included for the first time in its expert reports: (i) anticipation of the ’187 patent by Dietrich; and (ii) invalidity of the ’158 patent based on non-enablement.

TWi responded to argument (i) by noting that its invalidity contentions clearly stated that Dietrich “render[s] obvious all the asserted claims 1-2, 5-8, 10-17, alone in light of the knowledge of a person of ordinary skill in the art.” According to TWi, its citation to a single reference indicated an intent to claim that the reference anticipated the asserted claims.  The court was unpersuaded, finding that a single prior art reference, coupled with the knowledge of a skilled artisan, can still render a claim obvious.  Therefore, the court rejected TWi’s argument. Additionally, TWi was forced to concede that it did not include the above limitation as taught by Dietrich in its contentions. The court concluded that TWi failed to list where each element of the asserted claims appeared in the Dietrich reference, and also that Dietrich was anticipatory art. The court granted Takeda’s motion to strike as it pertained to the Dietrich reference.

Next, the court addressed Takeda’s argument (ii). Claim 1 of the ’158 patent claims a method of treatment comprising “administering to a patient suffering from heartburn, acid reflux or gastroesophageal reflux, regardless of whether the patient is under fasted or fed conditions, a therapeutically effective amount of the pharmaceutical composition.” TWi argued that the ’158 patent did not enable one of ordinary skill in the art to formulate a composition that could be administered without regard to food. Specifically, TWi alleged that because a person of skill would have to select a trial-and-error formulation and possibly expend upwards of $1 million per test to determine whether the limitation was met, the claim was not enabled. Takeda argued that while TWi did disclose three theories of non-enablement in its invalidity contentions, this was not one of them. The court agreed, finding that TWi’s invalidity contentions failed to address the issue of formulations. Additionally, the court noted that TWi’s invalidity contentions failed to even address the issue of undue experimentation.

Lastly, the court considered Takeda’s argument that because TWi was not diligent in seeking to add these new defenses, Takeda was not required to show that it was prejudiced by the late additions. The court agreed, finding that TWi failed to establish diligence. The court concluded that TWi was not diligent in disclosing its anticipation defense because it possessed the Dietrich reference and could have included an anticipation theory at the time TWi served its invalidity contentions. Furthermore, TWi was not diligent with respect to its non-enablement defense because the theory would have been apparent from reading the face of the ’158 patent.