Order Granting Takeda's Motion to Strike, Takeda Pharmaceutical Co. LTD., et al., v. TWi Pharmaceuticals, Inc., Case No. 13-cv-02420-LHK (Judge Lucy H. Koh)
The Northern District Patent Local Rules are specifically designed to narrow the scope of complex litigation early in the case; they are not designed to "punish" a party. More than a year after serving its initial invalidity contentions and after moving to amend its contentions twice, TWi attempted to backdoor additional invalidity theories through its expert reports. Unsurprisingly, Takeda filed a motion to strike. Judge Koh granted the motion, rejecting TWi's argument that it was being "punished" for complying with case narrowing orders.
First, Takeda moved to strike the expert's opinion that PCT Publication No. WO 00/09092 ("Dietrich") anticipated the asserted claims of U.S. Patent No. 8,461,187 ("the '187 patent"). Takeda argued that TWi could not have its expert opine that Dietrich was both a 102 and 103 reference, when TWi's previous invalidity contentions only alleged Dietrich "render[s] obvious all the asserted claims" and did not explicitly state Dietrich "anticipated" the asserted claims. In its opposition, TWi argued that it implicitly disclosed that Dietrich must be anticipatory, because it had alleged that Dietrich alone rendered the claims invalid in its contentions. Judge Koh disagreed, because anticipation and obviousness are distinct legal theories and a single reference can also render a claim obvious. This was further supported by TWi's failure to provide a citation to Dietrich for a limitation of Claim 1, suggesting that there was nothing purely anticipatory in Dietrich for that limitation. Judge Koh thus struck the anticipation theory because "the Invalidity Contentions did not disclose where Dietrich teaches each limitation of the asserted claims."
Next, Takeda moved to strike the expert's opinion that presented an additional non-enablement theory of invalidity for U.S. Patent No. 8,173,158 ("the '158 patent") pursuant to 35 U.S.C. §112 ¶1. The patent claimed a method of treatment that could be administered under "fasted or fed conditions," which Judge Koh construed to mean "without regard to food." TWi's new expert non-enablement theory contended that the patent did not enable a treatment that could be administered "without regard to food" and therefore required undue experimentation. TWi argued this new theory was actually a part of a bioequivalence theory that it did disclose in its invalidity contentions. Judge Koh again disagreed. She found that the bioequivalency theory1 only asserted "a failure to adequately enable bioequivalencey with statistical significance," which did not touch on the formulation of a treatment administered with or without food. Furthermore, TWi's contentions did not even mention that one of ordinary skill would require "undue experimentation" to practice the claims "without regard to food" based on the disclosures of the '158 patent specification.
Judge Koh did note that TWi was not prevented from relying on an example in Dietrich that was not specifically cited in its contentions, because the example was not "divorced" form the cited portions of Dietrich. And, an 11 page long reference was not burdensome for Takeda to review in its entirety.
Finally, Judge Koh did not need to consider the prejudice to the parties, because TWi failed to show diligence in amending its contentions. TWi possessed the whole Dietrich reference when it first filed its initial invalidity contentions. Similarly, the new non-enablement theory could have been alleged based solely on the '158 patent's specification. Nevertheless, Judge Koh concluded that Takeda would be prejudiced by admitting these theories at this late stage in litigation.
The Patent Local Rules are in place for a reason—to focus complex litigation early in the case. A party cannot skate around these early notice requirements, and must ensure it explicitly states all possible theories that the evidence it has supports. Non-compliance or partial-compliance can and will result in harsh penalties – no punishment intended.
Footnotes
1.TWi's bioequivalence theory in its invalidity contentions asserted the following: Claim 9 in the '158 patent recites the limitation "wherein the administration of the composition to a human subject in a fed state is bioequivalent to administration of the composition to a human subject in a fasted state." Claims 10 and 11, which both depend from Claim 9, recite bioequivalence is established with a 90% Confidence Interval between 0.80 and 1.25. However, the '158 patent's specification included Confidence Interval values outside of the 0.80-1.25 range. Therefore, the claims were not enabled.
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