Addressing various evidentiary issues, US Court of Appeals for the Federal Circuit Judge Bryson (sitting by designation on the US District Court for the Eastern District of Texas) addressed a number of pre-trial motions, including granting a motion to preclude references to a patent’s “presumption of validity” because that the phrase might be confusing to the jury in light of the court’s instructions on the burden of proof for invalidity. Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., Case No. 2:15-CV-1202-WCB (ED Tex., Mar. 13, 2017; Mar. 17, 2017) (Bryson, J).

UroPep alleged that Eli Lilly’s sale of Cialis infringed UroPep’s method patent covering treatment of benign prostatic hyperplasia (BPH). Leading up to trial, the district court issued a number of orders related to the admissibility of evidence and expert testimony. Among them, the district court granted Eli Lilly’s motion to prevent UroPep from referencing the “presumption of validity” of a patent because that phrase might confuse the jury by requiring it to consider both the presumption and the overall burden of proof that accompanies a validity challenge. At the very least, the Court would be required to give an additional jury instruction to explain the “presumption of validity.” The district court ultimately determined that use of the phrase “presumption of validity” would not add to the jury’s understanding of the burden of proof on validity issues, and thus excluded its use.

In the same order, the Court granted UroPep’s motion to preclude Eli Lilly from offering evidence that UroPep was improperly taking advantage of the patent system. UroPep had sought to add specific claims to cover Cialis’s treatment of BPH only after the US Food and Drug Administration approved Cialis for that purpose. Eli Lilly intended to elicit testimony that UroPep’s application was therefore “opportunistic.” The Court agreed that Eli Lilly should not be able to offer such evidence, explaining that a patentee is permitted to seek claims that specifically cover a product already on the market. Moreover, any evidence that UroPep’s application was improper or untimely was inadmissible because Eli Lilly was not alleging inequitable conduct or unclean hands.

In a separate order, the Court addressed Eli Lilly’s motions to exclude testimony of UroPep’s experts. First, Eli Lilly argued that UroPep’s infringement expert (Dr. Sliwinski, a urologist with experience prescribing Cialis) should be prevented from testifying about the nature of Eli Lilly’s promotional material for Cialis and from estimating the number of Cialis prescriptions he has written for BPH. The Court agreed with Eli Lilly that Dr. Sliwinski was not a marketing expert and therefore could not testify about the overall impact of the marketing materials for Cialis. Because Dr. Sliwinski had personally received marketing materials, however, he was able to testify as to his personal experience and the impact those marketing materials had on his practice as a fact witness. Similarly, Dr. Sliwinski was permitted to estimate his practice of prescribing Cialis for BPH as a fact witness—not an expert.

Eli Lilly also sought to exclude testimony from UroPep’s damages expert, arguing that the expert’s damages calculation referenced and utilized profits from Cialis that were non-infringing. According to Eli Lilly, UroPep’s expert first calculated the total profits from Cialis prior to 2011 (when it was approved for the treatment of BPH), then calculated incremental profits due only to the treatment of BPH by analyzing additional profits made after 2011. Finally, the expert subtracted profits from 2011 to 2014, which were made before Eli Lilly had knowledge of the patent and were therefore non-infringing. Eli Lilly argued that the non-infringing profits were unrelated to reasonable royalty damages and were prejudicial as they would only serve to improperly influence the jury to think that UroPep’s damages model was reasonable. The Court rejected Eli Lilly’s argument, finding that reference to these non-infringing profits was admissible because it was a necessary step in UroPep’s damages calculation.