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Ortho-Mcneil Pharmaceutical Inc. v. Barr Laboratories

June 29, 2006


The opinion of the court was delivered by: Hughes, U.S.M.J.


This matter having come before the Court upon Motion by Plaintiffs Ortho-McNeil Pharmaceutical, Inc. and Johnson & Johnson Pharmaceutical Research & Development, LLC ("Plaintiffs") to Preclude Trial Testimony of Dr. James A. Simon on "New Opinions Not Contained in His Expert Reports," [Docket Entry #51], returnable June 5, 2006. Defendant Barr Laboratories, Inc. ("Defendant") submitted opposition to the Motion claiming that a fair reading of Dr. Simon's report included the opinions expressed in his deposition testimony and, beyond that, there is no prejudice to Plaintiff if such testimony is allowed. The Court considered the submissions of the parties and conducted oral argument on June 5, 2006. For the reasons set forth below, Plaintiff's Motion to Preclude Trial Testimony of Dr. James A. Simon is denied.


On October 1, 2003, Plaintiffs filed a Complaint against Defendant alleging willful infringement of United States Patent No. 6,214,815 ("the '815 patent") pursuant to 35 U.S.C. § 271(e)(2) and 21 U.S.C. § 355 [Docket Entry #1]. On October 14, 2003, Defendant filed its answer and counterclaim stating that "Claims 1, 2, 3, and 4 of the '815 patent are invalid for failure to satisfy the provisions of one or more of sections 101, 102, 103, 112, and/or 116 of Title 35 of the United States Code." [Docket Entry #3]. After numerous adjustments to the Scheduling Order, the Court set the deadline for initial expert reports for June 22, 2005 [Docket Entry #39]. Pursuant to this schedule, both parties served initial expert reports. Defendant included in its reports those of James A. Simon, M.D. and Sarah L. Berga, M.D., both of whom opined that the invention claimed in the '815 patent was invalid because it was anticipated or rendered obvious to the person of ordinary skill in the art by two prior art patents, United States Patent No. 4,616,006 ("the '006 patent") and United States Patent No. 4,628,051 ("the '051 patent").*fn1 These reports were nearly identical. On November 22, 2005, Defendant filed the Rebuttal Expert Report of James A. Simon, M.D., which asserted similar opinions as his previous report.

Depositions began shortly thereafter, and on December 20, 2005, Plaintiffs deposed Dr. Simon. During examination, Dr. Simon was unable to point to a reference in a direct paragraph or page in his report that would have suggested the '815 patent to a person of ordinary skill in the art, although he continually insisted that his report, in its entirety, supported his opinion. Simon Dep. 238:13-242:12, Dec. 20, 2005. Defendant continually objected to Plaintiffs' questioning on the record during the deposition. The next day, Defendant sent a letter to Plaintiff to follow up on the deposition and to inform Plaintiff that Dr. Simon's testimony about knowledge of a person of ordinary skill in the art would be included in the trial. See Letter from G. Pfadenhauer to J. Elikan, (Dec. 21, 2005), Exh. H. Plaintiff's response created the initial dispute over the proper interpretation of Dr. Simon's report. See Letterfrom J. Elikan to G.

Pfadenhauer (Dec. 21, 2005). The following day, Defendant's counsel questioned Dr. Simon, at which time he testified that a person of ordinary skill in the art would have known the facts stated in his report on the '006 and '051 patents and been motivated to create the claimed invention. Simon Dep. 462:19 - 466:21, Dec. 22, 2005.

One week before Dr. Berga's deposition, Defendant served a Supplemental Expert Report on her behalf, which contained the theory of motivation identical to that advanced by Dr. Simon during his deposition testimony. (Supplemental Expert Report of Sarah L. Berga, M.D. ¶ 2). Defendant submitted the report stating that it did so in order to prevent further confusion about the theory. Plaintiff immediately objected. In a hearing on January 24, 2006, this Court denied Plaintiff's request to preclude Dr. Berga from testifying to opinions not expressed in her initial expert report but permitted a supplemental rebuttal report. In the telephone hearing, the Court also said it was not inclined to allow Dr. Simon to submit a supplemental report because he had already been deposed. Defendant advised the Court that it did not intend to submit a similar report for Dr. Simon because it believed that his opinion was properly contained in his report.

As permitted by the Court, Plaintiffs filed the present Motion, [Docket Entry # 51], to Preclude Trial Testimony of Dr. James A. Simon on New Opinions Not Contained in His Expert Reports. Plaintiffs claim that (1) allowing such testimony would "irremediably prejudice" their case, (2) the decision to withhold the testimony was willful, and (3) Defendant would not be prejudiced by precluding the proposed testimony.


With this Motion, Plaintiffs seek to preclude Defendant from using the part of Dr. Simon's testimony which refers to his motivation theory. They claim that Dr. Simon's testimony violates Federal Rule of Civil Procedure 26(a)(2)(B) because his report does not specifically state the opinion he put forth in the testimony. Plaintiffs further argue that even if the opinion could be inferred from the entirety of Dr. Simon's report, In re Roufett, 149 F.3d 1350 (Fed. Cir. 1998), requires heightened specificity when making claims of motivation. Thus, if the expert is required to state particular principles in his or her report that are known to a person of ordinary skill in the art, a theory of obviousness may be derived if that person of ordinary skill could have been motivated to create the patent in question from the known principles in the report.

The present case, however, can be distinguished from Roufett for two reasons. First, in Roufett, the plaintiffs were appealing a rejection of their patent application in the Federal Circuit. Roufett, 149 F.3d at 1356. The substantive issue of the matter required that the court use Federal Circuit law. The present Motion is procedural in nature and therefore, Third Circuit law controls. Second, because Roufett was an appeal, discovery was complete and redeposition of an expert would have been impractical at that stage of the proceeding. In the present Motion, discovery is ongoing and therefore, redeposing Dr. Simon would not delay or hinder the case. In addition, no trial date has been set.

Nonetheless, Plaintiffs contend that even under a Third Circuitanalysis, see Meyers v. Pennypack Woods Home Ownership Association, 559 F.2d 894 (3d Cir. 1977), Plaintiffs would suffer prejudice if Dr. Simon's testimony was not excluded and that Defendant would not suffer prejudice because Dr. Berga would testify to the same theory as Dr. Simon. This court finds that Plaintiffs will not in fact be prejudiced by the inclusion of Dr. Simon's testimony and that if, conversely, his testimony was excluded, Defendant would be unfairly disadvantaged.

A. Full Disclosure - FED.R.CIV.P. 26(a)(2)(B)

Plaintiffs claim that there is good cause to preclude part of Dr. Simon's testimony because he included an opinion that he did not expressly include in his expert report. According to FED. R. CIV. P. 26(a)(2)(B), the expert report must contain "a complete statement of all opinions to be expressed and the basis and reasons therefore." In this case, Plaintiffs argue that Dr. Simon did not include his theory of motivation within his report. Defendant, however, claims that Dr. Simon's entire report comprises his theory of motivation. ...

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