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Yeda Research and Development Co., Ltd. v. Abbott Gmbh & Co. Kg

United States District Court, District Circuit

June 7, 2013

YEDA RESEARCH AND DEVELOPMENT CO., LTD., Plaintiff,
v.
ABBOTT GMBH & CO. KG, Defendant.

OPINION

ROSEMARY M. COLLYER, District Judge.

The parties in this patent case dispute which was the first to purify and isolate a protein called TBP-II. Working independently in two different countries, Yeda and Abbott filed patent applications just nine days apart in 1989. Twenty-four years later, litigation continues over which has priority to the United States patent for the protein, with each party having won and lost battles along the way. Abbott was granted the U.S. patent in 2000. However, Yeda succeeded in invalidating Abbott's patent in administrative proceedings before the United States Patent and Trademark Office in 2000. Another judge of this Court vacated that ruling, found for Abbott, and sent the case back to the Patent and Trademark Office. Abbott prevailed on remand in 2010, and the case returned to this Court with Yeda as plaintiff. The parties recently finished discovery.

As a final precursor to briefing on summary judgment, scheduled for this summer, Abbott has asked the Court to compel Yeda to produce materials that, according to Abbott, Yeda should have turned over in discovery. Abbott's request can be broken generally into two categories: (1) documents related to 2003 experiments, attended by Yeda representatives, that Abbott conducted to replicate the 1989 experiments that led to Abbott's original German patent application, and (2) the royalty agreement that Dr. Engelmann (one of Yeda's inventors and Yeda's testifying expert) has with other Yeda inventors. The former category presents potentially complex legal issues implicating Dr. Engelmann's multiple roles over the long history of this case; the latter category is a much simpler debate. The Court heard oral argument on June 5, 2013, and, for the reasons set forth below, Abbott's motion to compel will be granted as to its request for documents related to the 2003 experiments and denied as to its effort to obtain the royalty agreement.

I. BACKGROUND

The facts of this case and its procedural history are set forth in detail in prior opinions of this Court and the United States Court of Appeals for the Federal Circuit. See Abbott GmbH & Co., KG v. Yeda Research & Dev. Co. (" Abbott I "), Civ. No. 00-1720 (RMU), Memo. Op. (D.D.C. filed June 13, 2005) (denying Yeda's motion for summary judgment); Abbott GmbH & Co., KG v. Yeda Research & Dev. Co. (" Abbott II "), 516 F.Supp.2d 1 (D.D.C. 2007) (construing U.S. Patent 5, 344, 915 ("915 Patent, " sometimes referred to as the "LeMaire patent")); Abbott GmbH & Co., KG v. Yeda Research & Dev. Co. (" Abbott III "), 576 F.Supp.2d 44 (D.D.C. 2008) (granting Abbott's motion for summary judgment); Abbott GmbH & Co., KG v. Yeda Research & Dev. Co. (" Abbott IV "), 333 F.Appx. 524 (Fed. Cir. 2009) (dismissing Yeda's appeal for lack of jurisdiction); Abbott GmbH & Co., KG v. Yeda Research & Dev. Co., 415 F.Appx. 257 (Fed. Cir. 2011) (dismissing Yeda's second appeal for lack of jurisdiction). The background of the case is repeated here only as necessary to resolve Abbott's motion to compel.

A. Parties' Competing Patent Claims and Procedural History

Plaintiff Yeda Research & Development Co., Ltd. ("Yeda") is an Israeli company; Abbott GmbH & Co. KG ("Abbott") is a German subsidiary of Abbott Laboratories, Inc., which is based in Illinois. Comps. [Dkt. 1] ¶¶ 3, 6-7.

At issue in this case is the parties' dispute as to which was the first to isolate, purify, and identify a proteins[1] called Tumor Necrosis Factor Binding Protein-II ("TBP-II"). TBP-II "is isolated from the urine of individuals with a fever and from the ascites fluid of individuals with ovarian carcinomas." Abbott III, 576 F.Supp.2d at 46. TBP-II "binds to, and thereby neutralizes, potentially harmful polypeptides." Id. at 45. The record does not reveal how the discovery of TBP-II has been significant medically, [REDACTED] See Yeda Br. Supp. Opp. Abbott Mot. Compel ("Yeda 1st Opp.") [Dkt. 54], Ex. J [Dkt. 58-1] (Engelmann April 15, 2013 Dep.) at 14; [REDACTED] Under patent law then in effect, [2] the "first person to conceive the invention is the first inventor, ... provided that when the first to conceive the invention is the last to reduce it to practice, the person who was first to conceive must have exercised reasonable diligence to his own actual or constructive reduction to practice, from a time prior to conception by the other.'"

Hyatt v. Boone, 146 F.3d 1348, 1351 (Fed. Cir. 1998) (quoting version of 35 U.S.C. § 102(g) prior to 2011 amendment; other citations omitted).

The parties, [3] working independently, submitted their first patent applications for TBP-II in foreign countries just nine days apart. Abbott filed application P39 15 072 on May 9, 1989 ("072 Application") in Germany, while Yeda filed application No. 90, 339 ("339 Application") on May 18, 1989, in Israel.[4] Compl. ¶¶ 8, 12. Abbott filed an additional application in Germany, P39 22 089 ("089 Application") on July 15, 1989. On May 4, 1990, Abbott filed an International Patent Application, "claiming the benefit of the filing date of [the 072 Application];" the International Patent Application was eventually designated as a U.S. Patent Application, and the United States Patent and Trademark Office ("USPTO") issued U.S. Patent No. 5, 344, 915 ("915 Patent") to Abbott on September 6, 1994. Id. ¶¶ 8-10; see also Yeda 1st. Opp., Ex. C [Dkt. 54-4] (915 Patent).

Claiming the benefit of the 339 Application, Yeda filed U.S. Patent Application No. 07/930, 443 ("443 Application") on August 19, 1992. Compl. ¶ 12; see also Yeda 1st Opp., Ex. D [Dkt. 54-5] (443 Application). On October 1, 1996, the Board of Patent Appeals and Interferences ("the Board") declared Interference No. 103, 625 ("625 Interference") between Abbott's 915 Patent and Yeda's 443 Application. Compl. ¶ 14; see also Yeda 1st Opp., Ex. A [Dkt. 54-2] (Declaration of 625 Interference). "An interference is an administrative proceeding designed to determine, inter alia, which party was the first to invent a claimed invention and is therefore entitled to a patent." Abbott Mem. Supp. Mot. Compel ("Abbott Mem.") [Dkt. 57] at 1. In the 625 Interference, "Yeda asserted that Abbott is not entitled to the benefit of the filing dates of either the 072 or 089 [A]pplications, because neither... described or enabled a protein satisfying each limitation of the Count, " which is the Board's definition of the "interfering subject matter at issue." Yeda 1st Opp. at 2-3.

In the 625 Interference, Yeda prevailed. The Board invalidated Abbott's 915 Patent and found that Abbott was not entitled to priority based on the 072 and 089 Applications under 35 U.S.C. § 112. See Abbott III, 576 F.Supp.2d at 47. The Board reasoned that the 072 and 089 Applications did not, "as originally filed, " sufficiently describe the TBP-II protein. Id.; see also Yeda 1st Opp., Ex. G [Dkt. 54-8] (First 625 Interference Decision) at 19. Abbott sought review of the Board's decision in this Court under 35 U.S.C. § 146, in case Civil No. 00-1720.[5]

The first district court case was assigned to the Honorable Ricardo Urbina, who has since retired. In 2005, Judge Urbina denied Yeda's motion for summary judgment, rejecting its argument that Abbott's 072 and 089 Applications did not adequately describe the 915 Patent as a matter of law.[6] See Abbott I at *7. Two years later, Judge Urbina issued an opinion construing the 915 Patent, adopting Abbott's proposed construction, and concluding that the "[915] Patent covers only the TBP-II protein, " not its "naturally occurring muteins." See Abbott II, 516 F.Supp.2d at 6. Then, finding the evidence underlying the Board's decision in the 625 Interference "wholly unsupportive, " Judge Urbina found that the Board committed clear error in invalidating the 915 Patent. See Abbott III, 576 F.Supp.2d at 51. Judge Urbina thus granted summary judgment to Abbott and remanded the case to the Board for further proceedings. See Order, Civ. No. 00-1720 (RMU) (D.D.C. Sept. 15, 2008) (ECF no. 117). Yeda appealed to the Federal Circuit, which dismissed the appeal. See Abbott IV, 333 F.Appx. at 525 ("Since the district court remanded the case for the Board to determine priority, the case is not final; the issue of patentability can be reviewed on appeal from a final judgment resolving all issues.").

On remand, the Board found on December 3, 2009 that Abbott was entitled to the priority of the 089 Application. Compl. ¶ 20. On May 26, 2010, the Board granted judgment in the 625 Interference to Abbott, rejecting Yeda's efforts to modify the claims at issue in the Count. Id. ¶ 20; see also Second 625 Interference Decision, Abbott Mem., Ex. B [Dkt. 57]. On September 8, 2010, Yeda filed its Complaint in the Northern District of Illinois seeking review of the second decision of the Board in the 625 Interference; the Northern District of Illinois granted Abbott's motion to transfer the case back to this District, where it was docketed as Civil No. 10-1836, before Judge Urbina. While discovery was under way, the case was reassigned to this Court. In this case, Yeda asserts that "the Board reversibly erred because the 072 [A]pplication failed to provide a written description under 35 U.S.C. § 112, ¶ 1 of a purified and isolated protein that satisfied all the limitations recited in and required by the Count."[7] Yeda's Resp. Abbott's Mem. ("Yeda 2d Opp.") [Dkt. 64] at 4. Yeda contends that the Board erred in concluding that the 072 Application "described the same proteins described in [the] 915 [P]atent'" because the "same proteins' test cannot be reconciled with controlling Federal Circuit law, which requires that, to benefit from an application for filing-date purposes, the application must provide a written description of each and every limitation required by the Count."[8] Id. Yeda also asserts that the 072 Application "did not enable one of ordinary skill in the art, without undue experimentation, to purify, isolate, or identify a protein satisfying all of the limitations recited in and required by the Count, and it also did not disclose the Abbott applicants' best mode." Id. at 5.

Discovery has now closed and the Court has entered a briefing schedule for cross-motions for summary judgment. See Minute Order dated May 28, 2013. Reply briefs are due on September 13, 2013. Id. Prior to the close of discovery, during a telephone conference on May 2, 2013, Abbott advised the Court that the parties had been unable to resolve a dispute about whether Yeda was required to produce to Abbott two categories of documents: (1) "documents written or reviewed by [Yeda's] testifying expert relating to certain experiments conducted in this case;" and (2) "documents relating to the financial benefit that the same testifying expert stands to gain if Yeda prevails." Abbott Mem. at 1. The Court directed the parties to file briefs addressing Abbott's motion to compel and held oral argument on June 5, 2013; the matter is now fully briefed and ripe for decision.

B. Facts Relevant to Instant Disputes

The parties' discovery disputes concern Dr. Hartmut Engelmann, one of the inventors named in Yeda's patent applications. Dr. Engelmann is a cytokine biologist who worked as a post-doctoral fellow at the Weizmann Institute of Sciences in Rehovot, Israel. Yeda 1st Opp., Att. [Dkt. 54-18] (Engelmann Decl.) ¶¶ 5-6. Dr. Engelmann was part of a group of scientists that generated several patent applications and patents, including the applications for the TBT-II protein. Id. Yeda is the entity that "commercializes inventions of the Weizmann Institute." Yeda 1st Opp., Ex. N [Dkt. 58-4] (Engelmann Jan. 16, 2012 Dep.) at 13-14.

1. The 2003 Abbott Experiments

In 2003, Abbott conducted a set of experiments to reenact its original 1989 experiments. The facts of the 2003 experiments are mostly undisputed. Abbott states that it performed the experiments "as part of a parallel European proceeding involving the same patent claims, "[9] Abbott Mem. at 3, although Yeda argues that "Yeda's U.S. counsel reasonably anticipated that Abbott might rely on those experiments" in the original case in this court and Abbott later did so, Yeda 2d Opp. at 5.

There were two stages to the 2003 experiments. The first took place in Ludwigshafen, Germany, and the second took place in Abbott Park, Illinois. During the experiments, "Abbott repeated the protocol set forth in the 072 Application" in order "to demonstrate that the protocol in the 072 Application enabled a skilled artisan to isolate, purify[, ] and identify the same TBP-II protein claimed in the 915 Patent." Abbott Mem. at 3 (citation omitted). Abbott "invited Yeda to designate two witnesses to observe the Abbott scientists." Id. Yeda retained Dr. Engelmann "as a non-testifying expert consultant" to observe the first phase in Germany and retained Dr. Menachem Rubinstein (another of the Yeda inventors) to observe the second phase in the United States. Engelmann Decl. ¶¶ 7, 10. According to Dr. Engelmann, Yeda asked him "to observe the experiments in Germany, record [his] observations and prepare a report summarizing [his] observations and opinions on the results." Id. ¶ 11.

During the first stage, in Germany on February 2-11, 2003, one of Abbott's scientists, Andreas Striebinger, performed the protocol in the 072 Application.[10] Engelmann Decl. ¶ 8; Abbott Mot., Ex. I [Dkt. 54-10] (Decl. of Dr. Ralph A. Bradshaw) ¶¶ 39-40. Also present were: Dr. Ralph Bradshaw, who has been designated as Abbott's testifying expert in this case; Dr. Heinz Hillen, one of the Abbott inventors named on the 915 Patent; and Dr. Engelmann, Yeda's representative. Bradshaw Decl. ¶ 40; accord Engelmann Decl. ¶ 8. The first phase yielded two fractions of "essentially homogenous protein, " which Abbott then sent to Abbott Park "for an analysis of the N-terminal amino acid sequence using automated Edman sequencing techniques." Bradshaw Decl. ¶¶ 41, 43. In lay terms, in Germany, Abbott attempted to isolate the TBT-II protein; in the United States, it sought to determine the composition of that protein. During the first stage, Dr. Engelmann took "handwritten notes, " although he "[does not] remember what happened to them." Abbott Mem., Ex. B [Dkt. 60] (Jan. 16, 2012 Engelmann Dep.) at 73.

The second stage of the experiment took place on March 3-5, 2003, in Abbott Park, Illinois. Abbott scientist Dr. Thomas Holzman and his assistant, Sally Dorwin, performed the Edman degradation. Bradshaw Decl. ¶ 44. Also present for the second phase were Dr. Bradshaw for Abbott and Dr. Rubenstein for Yeda. Id.; accord Engelmann Decl. ¶ 10. The parties, predictably, characterize the results of the two phases differently. See Yeda 2d Opp. at 5-6 (arguing, inter alia, that the first phase "did not result in purification or isolation" and that the identification of amino-acid sequences in the second phase took place outside of the presence of Yeda representatives).

Dr. Rubenstein prepared a report for Yeda's counsel that included the data from the second stage of the 2003 experiment. Engelmann Decl. ¶¶ 11-12. In preparing his report for Yeda in 2003, Dr. Engelmann reviewed Dr. Rubenstein's report of the second stage of the experiment, and Dr. Engelmann acknowledged having a document "somewhere" containing his own re-analysis of the data reported by Dr. Rubenstein. Id.; Jan. 16, 2012 Engelmann Dep. at 202-03 ("I did an analysis. Prof Rubenstein's report contained the data, so I could look at the data and re-analyze it."). Dr. Engelmann testified that his final 2003 report was "[s]ome seven or eight pages maybe, " and he acknowledged reviewing the report prior to being deposed in this case. Jan. 16, 2012 Engelmann Dep. at 74. Dr. Engelmann also stated that he "may... have made" a declaration for the European proceedings about the 2003 experiment, but he was not sure. Id. at 74-75.

In "2004 or 2005, " "after the observations of [the Abbott 2003] experiments, " a group from the Weizmann Institute-including Dr. Engelmann-attempted to reproduce the

Abbott 2003 experiments (and, consequently, the protocol from the 072 Application). Id. at 75-77. Dr. Engelmann was unsure whether the Weizmann Institute group undertook these experiments at the request of Yeda's counsel, but he testified: "Eventually it was done at the request of the lawyers, yes." Id. Dr. Engelmann acknowledged that he "did practically hands on work" and "instructed other people of how to perform certain steps." Id. at 77.

Dr. Engelmann was later retained as a testifying expert consultant for Yeda for this case. Engelmann Decl. ¶ 13. His expert report is at Exhibit L of Yeda's First Opposition, Dkt. 54-13, and his rebuttal report is at sealed Exhibit M, Dkt. 58-3. Dr. Bradshaw has been retained as Abbott's testifying expert; his expert report and rebuttal report are together at Exhibit I to Yeda's First Opposition, Dkt. 54-10.

2. The Royalty Agreement

Dr. Engelmann's testimony about the royalty agreement is at pages 154-158 of his January 16, 2012 Deposition. [REDACTED] Id. at 155. [REDACTED] Id. at 156-57. [REDACTED] Id. Yeda 1st Opp., Ex. J [Dkt. 58-1] (April 15, 2013 Engelmann Dep.) at 10. [REDACTED] [REDACTED] Id. at 12-13 [REDACTED] Id. at 107-08.

II. LEGAL STANDARDS

A number of legal standards are applicable to the instant dispute, including: (1) applicable law, (2) general discovery rules, (3) required disclosures for testifying experts, (4) the work product doctrine under case law and the Federal Rules, (5) discovery for non-testifying (consultant) experts, and (6) discovery as to "dual hat" experts-i.e., those who were both ...


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