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Erfindergemeinschaft Uropep GBR v. Eli Lilly And Co.

United States District Court, E.D. Texas, Marshall Division

April 13, 2017

ERFINDERGEMEINSCHAFT UROPEP GbR, Plaintiff,
v.
ELI LILLY AND COMPANY, Defendant.

          MEMORANDUM OPINION AND ORDER

          WILLIAM C. BRYSON UNITED STATES CIRCUIT JUDGE.

         Before the Court is Plaintiff UroPep's Motion to Strike Previously Undisclosed Prior Art and a Non-Prior Art Reference from Lilly's Second Amended Invalidity Contentions, Dkt. No. 253; an objection by plaintiff Erfindergemeinschaft UroPep GbR (“UroPep”) to the admissibility of trial exhibits related to some of the prior art references that are the subject of the previous motion, see Dkt. No. 268, at 7; and an objection by UroPep to the admissibility, as substantive evidence, of two exhibits related to the prosecution of patent application serial no. 11/545, 173, see Dkt. No. 268, at 13-15. The Court received briefing on the motion and held a hearing on April 11, 2017, on the motion and objections. The motion is GRANTED, and the objections are SUSTAINED.

         I. Motion to Strike

         UroPep has moved the Court to prohibit the defendant, Eli Lilly and Company (“Lilly”), from introducing or otherwise using at trial two references that Lilly recently disclosed in its second amended invalidity contentions. The first reference is a translated Chinese publication, which Lilly identifies as Prostate Hypertrophy, Clinical Curative Effect Observation of 34 in Benign Hyperplasia, 7-89:7, Shanghai Journal of Chinese Medicine and Medicinals. Dkt. No. 256-5; Dkt. No. 271-14. Lilly refers to that publication as the “Shanghai reference.” The second reference consists of two applications, a Patent Cooperation Treaty (“PCT”) application, WO 98/49166, Dkt. No. 253-2, and an earlier application filed in the United Kingdom to which the PCT application claims partial priority, Dkt. No. 256-1. Lilly refers to those two applications collectively as “the Bunnage applications.”

         Lilly proposes to use the Shanghai reference in support of its anticipation argument. It offers the Bunnage applications not as prior art, but as relevant evidence of “simultaneous invention, ” an objective consideration that bears on the issue of obviousness. UroPep objects to the admission or other use of the Shanghai reference on the ground that it was not timely disclosed as a prior art reference. UroPep objects to the admission or other use of the Bunnage applications on the grounds that Lilly did not timely disclose a theory of simultaneous invention in support of its obviousness defense and that, although the PCT application was disclosed early in the proceedings, neither of the Bunnage applications was addressed in any of Lilly's expert reports.

         A. The Shanghai reference

         The Shanghai reference was not included in Lilly's original invalidity contentions. The Shanghai reference is cited in another reference on which Lilly relies for its anticipation argument, a 1994 book authored by C.S. Cheung and K. Deaton entitled “TCM Management Benign Prostate Hyperplasia-Long Bi (Prostatism).” That reference is known as the Cheung reference.

         In its second amended invalidity contentions, submitted on March 16, 2017, Lilly asserted that the Shanghai reference is independently invalidating prior art, apart from Cheung. UroPep objects to that use of the reference on the ground that it was not disclosed until a month before trial, in violation of the Local Patent Rules and without justification.

         Lilly contends that the late disclosure is justified because Lilly had no reason to rely on the Shanghai reference until recently. In UroPep's response to Lilly's motion for summary judgment of anticipation, Dkt. No. 187 (filed on January 31, 2017), UroPep argued that the Cheung reference did not qualify as a printed publication. Lilly states that it was surprised by that argument and that it now seeks to use the Shanghai reference to buttress its anticipation defense in light of UroPep's challenge to the Cheung reference. Because the “printed publication” argument arose only at the time of the summary judgment proceedings, Lilly argues that it should not be barred from relying on the Shanghai reference, even though the reference was not disclosed in Lilly's original invalidity contentions.

         That argument is not persuasive. First, while it is true that the printed publication argument was raised only in response to Lilly's motion for summary judgment of anticipation, Lilly should not have been caught entirely unawares by UroPep's printed publication defense to Lilly's reliance on the Cheung reference as anticipating prior art. Given the obscurity of the Cheung reference, it is not surprising that UroPep would raise an issue as to whether the Cheung publication was sufficiently in the public domain to qualify as prior art.[1] Second, and as explained in more detail below, the Shanghai reference, which predates Cheung, is not relevant to the question of whether Cheung qualifies as a printed publication.

         The Court holds that Lilly's notice of its intent to use the Shanghai reference was untimely and that Lilly's untimeliness was not justified by UroPep's opposition, in the summary judgment proceedings, to the use of Cheung as an anticipating reference. Nothing prevented Lilly from citing both Cheung and the Shanghai reference in its original invalidity contentions. In light of Lilly's failure to make a timely disclosure of the Shanghai reference as invalidating prior art, the Court will not permit Lilly to use the Shanghai reference for that purpose at trial.

         Lilly makes a second argument that the Shanghai reference should at minimum be allowed as rebuttal evidence. That argument fares no better than the first. The Shanghai reference would not rebut UroPep's argument that Cheung is not a qualifying printed publication, because the fact that Cheung cited the Shanghai article says nothing about whether the Cheung reference was publicly available as of the critical date of the UroPep patent, U.S. Patent No. 8, 791, 124 (“the '124 patent”). In addition, it is unclear how the Shanghai reference would bolster the scientific reliability of the Cheung reference, at least absent further evidence that the Shanghai publication and the study reported therein is more reliable than the Cheung reference. In fact, Lilly suggests that the study reported in the Cheung reference is simply taken from the Shanghai reference. Lilly Response, Dkt. No. 256, at 6-7 (Shanghai reference “describes a study that Dr. Cheung discussed in the ‘Cheung reference, ' which was the focus of Lilly's prior motion for summary judgment”). The cited Shanghai reference would therefore seem to be of very little value as rebuttal evidence.

         On the other hand, permitting the use of the Shanghai reference for any purpose would create the risk that the jury would use that reference for the improper purpose of finding that the Shanghai reference was itself an anticipating reference, regardless of any value it might have in helping the jury evaluate the Cheung reference. Indeed, Lilly explains that it planned to use the Shanghai reference in rebuttal and not as prior art, but wished “to put UroPep on notice that, if appropriate and reasonably supported, Lilly may make a motion to conform the pleadings to the proof at trial.” Defendant Eli Lilly and Company's Response in Opposition [to] Plaintiff Erfindergemeinschaft UroPep GbR's Motion to Strike (“Lilly Response”), Dkt. No. 256, at 7. That is, Lilly seeks to reserve the right to use the Shanghai reference as invalidating prior art by itself, independent from Cheung, once introduced in rebuttal.

         Beyond that, contrary to Lilly's contention, it would be highly prejudicial to UroPep for Lilly to be allowed to use the Shanghai reference after having raised it for the first time only a few weeks before trial and after the close of discovery. The reference is a Chinese publication; determining the extent to which the publication is disseminated would require some effort on UroPep's part, as would determining whether the contents of the publication read on UroPep's patent. Lilly's only argument on the issue of prejudice is that the Shanghai ...


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