Yeda Research and Development Co., Ltd. v. Abbott Gmbh & Co. Kg ( 2013 )

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
__________________________________
)
YEDA RESEARCH AND )
DEVELOPMENT CO., LTD., )
)
Plaintiff, )
)
v. ) Civil Action No. 10-1836 (RMC)
)
ABBOTT GMBH & CO. KG, ) UNDER SEAL
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)
Defendant. )
_________________________________ )
OPINION
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
1
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. App’x 524 (Fed. Cir. 2009) (dismissing
Yeda’s appeal for lack of jurisdiction); Abbott GmbH & Co., KG v. Yeda Research & Dev. Co.,
415 F. App’x 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.
2
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
3
Technically, the patent applications discussed here were filed by groups of scientists and
companies owned the rights in the patents. At the time the patent applications were filed,
predecessor companies owned the rights in the patent applications. Because none of these facts
is in dispute, for the sake of efficiency, the Court will refer to the patent applications and patents
as having been filed by or granted to “Yeda” or “Abbott.”
4
Yeda’s predecessor in interest filed two additional applications in Israel (91229 on August 6,
1989 and 94039 on April 6, 1990).
4
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
5
35 U.S.C. § 146 provides, in relevant part, that “[a]ny party to an interference dissatisfied with
the decision of the [Board] on the interference, may have remedy by civil action. . . . Such suit
may be instituted against the party in interest as shown by the records of the [USPTO] at the time
of the decision complained of, but any party in interest may become a party to the action.
. . . Judgment of the court in favor of the right of an applicant to a patent shall authorize the
Director to issue such patent on the filing in the [USPTO] of a certified copy of the judgment and
on compliance with the requirements of law.” “District court review of an interference
proceeding under Section 146 is an equitable remedy of long standing,” and a Section 146 action
is “an authorized phase of the interference proceeding” before the USPTO. Abbott GMBH &
Co., KG v. Centocor Ortho Biotech, Inc., 870 F. Supp. 2d 206, 212–13 (D. Mass. 2012) (quoting
Gen. Instrument Corp. v. Scientific–Atlanta, Inc., 995 F.2d 209, 214 (Fed. Cir. 1993) & Vas-
Cath, Inc. v. Curators of the Univ. of Mo., 473 F.3d 1376, 1382 (Fed. Cir. 2007)).
6
Yeda takes the position that in the first case, “the sufficiency of the 072 [A]pplication was not
at issue” because “the 089 [A]pplication disclosed more complete and correct N-terminal amino-
acid sequence information than the 072 [A]pplication, and Abbott obtained that information only
5
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. App’x 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
by using materials and methods that that [sic] it did not use in connection with the 072
[A]pplication.” Yeda 1st Opp. at 5.
6
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
7
“The specification shall contain a written description of the invention, and of the manner and
process of making and using it, in such full, clear, concise, and exact terms as to enable any
person skilled in the art to which it pertains, or with which it is most nearly connected, to make
and use the same, and shall set forth the best mode contemplated by the inventor of carrying out
his invention.” 35 U.S.C. § 112, ¶ 1 (as effective through Sept. 15, 2012).
8
See In re Wallach, 378 F.3d 1330, 1334–35 (Fed. Cir. 2004) (“Whether Appellants were in
possession of the protein says nothing about whether they were in possession of the protein’s
amino acid sequence. . . . Until Appellants obtained the complete amino acid sequence of TBP-
II, they had no more than a wish to know the identity of the DNA encoding it.”); see also
Goeddel v. Sugano, 617 F.3d 1350, 1356–57 (Fed. Cir. 2010) (reversing Board determination in
interference proceeding that foreign patent application for protein satisfied 35 U.S.C. § 112, ¶ 1
because the application insufficiently described the process for producing the subject matter of
the patent).
7
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
9
Beyond acknowledging at oral argument that the European patent proceedings essentially
involved the same priority dispute as the United States proceedings, neither party has been more
specific about the nature of the European proceedings.
8
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]
10
Specifically, Abbott repeated Example 2 of the 072 Application, which is also Example 2 of
the 089 Application and the 915 Patent. Bradshaw Decl. ¶¶ 38–39; Engelmann Decl. ¶ 7.
Example 2 “describes the isolation of protein from urine collected from patients with a fever in
excess of 38 degrees °C.” Bradshaw Decl. ¶ 38. Yeda contests Abbott’s description of the tests,
but that disagreement is immaterial to the discovery dispute.
9
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
10
remain confidential, unless that foreign law is contrary to the public policy of [the] forum.”
Astra, 208 F.R.D. at 98 (citations and internal quotation marks omitted, alterations in original).
B. Discovery Generally
Parties are permitted to obtain discovery “regarding any nonprivileged matter that
is relevant to any party’s claim or defense,” and, “[f]or good cause, the court may order
discovery of any matter relevant to the subject matter involved in the action.” Fed. R. Civ. P.
26(b)(1). Discovery can be limited by court order if (1) “the discovery sought is unreasonably
cumulative or duplicative, or can be obtained from some other source that is more convenient,
less burdensome, or less expensive,” (2) “the party seeking discovery has had ample opportunity
to obtain the information by discovery in the action,” or (3) “the burden or expense of the
proposed discovery outweighs its likely benefit.” Fed. R. Civ. P. 26(b)(2)(C).
C. Required Disclosures for Testifying Experts—Rule 26(a)(2)(B)
Pursuant to Fed. R. Civ. P. 26(a)(2)(B), when an expert witness is “retained or
specially employed to provide expert testimony in the case,” the expert witness must prepare a
report for disclosure to the adverse party that includes, inter alia, “a complete statement of all
opinions the witness will express and the basis and reasons for them” and “the facts or data
considered by the witness in forming them.” The phrase “facts or data” is a change from the pre-
2010 rule, which referred to “data or other information.” See Fed. R. Civ. P. 26 advisory
committee’s note to 2010 amendments (“2010 Ad. Comm. note”) (stating that the 2010
amendment is intended to “limit the expert report to facts or data (rather than ‘data or other
information,’ as in the current rule) considered by the witness”). The Advisory Committee
clarified the intent of the change:
The refocus of disclosure on ‘facts or data’ is meant to limit
disclosure to material of a factual nature by excluding theories or
mental impressions of counsel. At the same time, the intention is
13
that ‘facts or data’ be interpreted broadly to require disclosure of
any material considered by the expert, from whatever source, that
contains factual ingredients. The disclosure obligation extends to
any facts or data ‘considered’ by the expert in forming the opinions
to be expressed, not only those relied upon by the expert.
2010 Ad. Comm. note (emphasis added); see also Allstate Ins. Co. v. Electrolux Home Prods.,
Inc., 840 F. Supp. 2d 1072, 1077–78 (N.D. Ill. 2012) (observing that Rule 26(a)(2)(B) “was
amended in 2010 to . . . [make] clear that disclosure of theories or mental impressions of counsel
is not required”); Fialkowski v. Perry, Civ. No. 11-5139, 2012 WL 2527020, at *4 (E.D. Pa. June
29, 2012) (“[T]he purpose of amending Rule 26 in 2010 was to limit disclosure to materials of a
factual nature and to protect against disclosure of counsel’s work product.”).
As discussed in additional detail below, the 2010 amendment to Rule 26(a)(2)(B)
was accompanied by several other changes to the expert discovery rules governing privilege.
The 2010 amendment was, in essence, an effort to reign in courts that had held that the
disclosure requirement of Rule 26(a)(2)(B) trumped all claims of privilege, such as Regional
Airport Authority of Louisville v. LFG, LLC, 460 F.3d 697, 717 (6th Cir. 2006) (adopting the
“overwhelming majority” approach that “Rule 26 creates a bright-line rule mandating disclosure
of all documents, including attorney opinion work product, given to testifying experts.”). The
bright-line rule is no longer valid; attorneys’ “theories or mental impressions” are protected, but
everything else is fair game. See Fialkowski, 2012 WL 2527020, at *3 (“[R]equired disclosures
under Rule 26(a)(2)(B) [after the 2010 amendment] still include ‘any information furnished to a
testifying expert that such an expert generates, reviews, reflects upon, reads, and or uses in
connection with the formulation of his opinions . . . .’” (quoting Synthes Spine Co., L.P. v.
Walden, 232 F.R.D. 460, 463 (E.D. Pa. 2005)); accord Sara Lee Corp. v. Kraft Foods, Inc., 273
F.R.D. 416, 419 (N.D. Ill. 2011) (discussing intent of 2010 amendment).
14
Because the word “considered” is unchanged, cases interpreting its meaning
remain valid. “For Rule 26 purposes, a testifying expert has ‘considered’ data or information if
the expert has read or reviewed the privileged materials before or in connection with formulating
his or her opinion.” In re Commercial Money Ctr., Inc., Equip. Lease Litig., 248 F.R.D. 532,
537 (N.D. Ohio 2008) (internal citation and quotation marks omitted). “Courts have declined to
adopt a definition that would necessitate an inquiry into the ‘subjective mental processes’ of the
testifying expert,” and “[m]aterials reviewed or generated by an expert must be disclosed,
regardless of whether the expert actually relies on the material as a basis for his or her opinions.”
Id. (internal citations, quotation marks, and modifications omitted). “Thus, experts have been
deemed to have considered materials even when they have testified, under oath, that they did not
consider the materials in forming their opinions.” Id.D. Work Product Doctrine
The work product doctrine has been developed by courts, including extensively in
the D.C. Circuit, and is also codified in part in the Federal Rules of Civil Procedure. Both
standards are set forth here.
1. D.C. Circuit Case Law
“The party who seeks work product doctrine protection is responsible for
establishing applicability of the protection and that there has not been a waiver.” United States
ex rel. Westrick v. Second Chance Body Armor, Inc., 288 F.R.D. 222, 225 (D.D.C. 2012) (citing
U.S. Airline Pilots Ass’n v. Pension Benefit Guar. Corp., 274 F.R.D. 28, 31 (D.D.C. 2011)). The
work product privilege “applies to material ‘obtained or prepared by an adversary’s counsel’ in
the course of his legal duties, provided that the work was done ‘with an eye toward litigation.’”
In re Sealed Case, 676 F.2d 793, 809 (D.C. Cir. 1982) (quoting Hickman v. Taylor, 329 U.S.
495, 511 (1947)). “Work product protection is not absolute but rather is a qualified immunity.”
15
Westrick, 288 F.R.D. at 226; see also United States v. Nobles, 422 U.S. 225, 239 (1975) (“Like
other qualified privileges, [the work-product privilege] may be waived.”). “In reviewing
documents claimed to be protected by the work-product privilege, the court must determine
‘whether, in light of the nature of the document or the factual situation in a particular case, the
document can fairly be said to have been prepared or obtained because of the prospect of
litigation.’” F.T.C. v. Boehringer Ingelheim Pharms., Inc., 286 F.R.D. 101, 107 (D.D.C. 2012)
(quoting Banks v. Office of Senate Sergeant–At–Arms, 228 F.R.D. 24, 26 (D.D.C. 2005)); see
also United States v. Deloitte LLP, 610 F.3d 129, 137 (D.C. Cir. 2010) (applying the same
standard).
Under Hickman, work product is subject to two different levels of protection: “To
the extent that work product contains relevant, nonprivileged facts, the Hickman doctrine merely
shifts the standard presumption in favor of discovery and requires the party seeking discovery to
show ‘adequate reasons’ why the work product should be subject to discovery. However, to the
extent that work product reveals the opinions, judgments, and thought processes of counsel, it
receives some higher level of protection, and a party seeking discovery must show extraordinary
justification.” In re Sealed Case, 676 F.2d at 809–10. In Boehringer Ingelheim
Pharmaceuticals, another judge of this Court recently summarized the two standards as follows:
If a party can show that the documents were developed because of
ongoing litigation, they are not discoverable absent the requesting
party’s showing that their need for the documents is substantial and
that they are unable to obtain the substantial equivalent of the
materials by other means without suffering “undue hardship.”
Dir., Office of Thrift Supervision v. Vinson & Elkins, LLP, 124
F.3d 1304, 1307 (D.C. Cir. 1997). Even when the requesting party
can meet this burden, only “factual” work product will be
disclosed; “opinion” work product, which reveals the mental
processes or impressions of an attorney or his or her agents, will
still receive the utmost protection. Upjohn Co. v. United States,
449 U.S. 383, 400 (1981); Dir., Office of Thrift Supervision, 124
16
F.3d at 1307 (“Opinion work product ... is virtually
undiscoverable.”).
286 F.R.D. at 107–08; see also United States v. Clemens, 793 F. Supp. 2d 236, 244 (D.D.C.
2011) (same). “The ‘difficult matter’ of deciding what ‘degree of selection is necessary to
transform facts into opinions’ has yet to be resolved by the District of Columbia Circuit.”
Clemens, 793 F. Supp. 2d at 245 (citing Dir., Office of Thrift Supervision, 124 F.3d at 1308).
2. Federal Rules of Civil Procedure
“Ordinarily, a party may not discover documents and tangible things that are
prepared in anticipation of litigation or for trial by or for another party or its representative
(including the other party’s . . . consultant . . . ).” Fed. R. Civ. P. 26(b)(3)(A). A party can
overcome the general rule protecting work product when the requested materials are (1)
“otherwise discoverable under Rule 26(b)(1)” and (2) “the party shows that it has substantial
need for the materials to prepare its case and cannot, without undue hardship, obtain their
substantial equivalent by other means.” Id. The Advisory Committee anticipated that the
substantial need/undue hardship showing would only be met in the “rare case.” 2010 Ad.
Comm. note. In evaluating whether there is a substantial need, courts have considered factors
including: “(1) [the] importance of the materials to the party seeking them for case preparation;
(2) the difficulty the party will have obtaining them by other means; and (3) the likelihood that
the party, even if he obtains the information by independent means, will not have the substantial
equivalent of the documents he seeks.” MeadWestvaco Corp. v. Rexam PLC, No.
1:10cv511(GBL/TRJ), 2011 WL 2938456, at *4 (E.D. Va. July 18, 2011).
17
The Federal Rules now contain express protection for communications between
attorneys and testifying expert witnesses, subject to three exceptions.11 Drafts of testifying
expert reports are protected from disclosure under Rule 26(b)(4)(B), and Rule 26(b)(4)(C) now
makes clear that Rule 26(b)(3) (governing work product generally) also protects
“communications between the party’s attorney and any witness required to provide a report
under Rule 26(a)(2)(B) . . . except to the extent that the communications: (i) relate to
compensation for the expert’s study or testimony; (ii) identify facts or data that the party’s
attorney provided and that the expert considered in forming the opinions to be expressed; or (iii)
identify assumptions that the party’s attorney provided and that the expert relied on in forming
the opinions to be expressed.”
Rule 26(b)(4)(C) was added in 2010 “to provide work-product protection for
attorney-expert communications regardless of the form of the communications, whether oral,
written, electronic, or otherwise” and “to protect counsel’s work product and ensure that lawyers
may interact with retained experts without fear of exposing those communications to searching
discovery.” 2010 Ad. Comm. note. “The protection is limited to communications between an
expert witness required to provide a report under Rule 26(a)(2)(B) and the attorney for the party
on whose behalf the witness will be testifying. . . . The rule does not exclude protection under
other doctrines, such as privilege or independent development of the work-product doctrine” Id.However, the Advisory Committee added that the addition of Rule 26(b)(4)(C) does “not impede
discovery about the opinions to be offered by the expert or the development, foundation, or basis
of those opinions.” Id. It further stated:
11
As discussed above, the 2010 Amendments respond to the post-1993 view, adopted by many
courts, that Rule 26 “authorize[s] discovery of all communications between counsel and expert
witnesses and all draft reports.” 2010 Ad. Comm. note. In practice, though, “routine discovery
into attorney-expert communications and draft reports . . . had undesirable effects.” Id.18
For example, the expert’s testing of material involved in litigation,
and notes of any such testing, would not be exempted from
discovery by this rule. Similarly, inquiry about communications
the expert had with anyone other than the party’s counsel about the
opinions expressed is unaffected by the rule. Counsel are also free
to question expert witnesses about alternative analyses, testing
methods, or approaches to the issues on which they are testifying,
whether or not the expert considered them in forming the opinions
expressed.
Id. (emphasis added).
E. Non-testifying Expert (i.e., Consultant) Protection
Non-testifying experts receive protection under two parts of amended Rule 26.
First, there is the general statement in Rule 26(b)(3)(A) that “[o]rdinarily, a party may not
discover documents and tangible things that are prepared in anticipation of litigation or for trial
by or for another party or its representative (including the other party’s . . . consultant . . . ).”
Fed. R. Civ. P. 26(b)(3)(A). As stated above, this general rule is subject to an exception in cases
where the proponent shows “substantial need” and when the requested materials or their
“substantial equivalent” cannot be obtained “without undue hardship.” Id.Rule 26(b)(4)(D) (former Rule 26(b)(4)(B)12) expressly addresses the case of non-
testifying experts and sets an “even higher barrier” for discovery of their work product. Sara
Lee, 273 F.R.D. at 419. Rule 26(b)(4)(D) states: “Ordinarily, a party may not, by interrogatories
or deposition, discover facts known or opinions held by an expert who has been retained or
specially employed by another party in anticipation of litigation or to prepare for trial and who is
not expected to be called as a witness at trial.” As relevant here, discovery of such facts or
opinions is appropriate “on showing exceptional circumstances under which it is impracticable
12
The 2010 amendments to Rule 26 did not modify present Rule 26(b)(4)(D) in any substantive
way. See 8A Charles Alan Wright & Arthur R. Miller, Federal Practice & Procedure § 2032
(3d ed. & Supp.).
19
for the party to obtain facts or opinions on the same subject by other means.” Fed. R. Civ. P.
26(b)(4)(D)(ii). There are “four commonly stated policy considerations” for this rule: “(1) the
interest in allowing counsel to obtain the expert advice they need in order [to] properly evaluate
and present their clients’ positions without fear . . . ; (2) the view that each side should prepare its
own case at its own expense; (3) the concern that it would be unfair to the expert to compel its
testimony and also the concern that experts might become unwilling to serve as consultants if
they suspected their testimony would be compelled; and (4) the risk of prejudice to the party who
retained the expert as a result of the mere fact of retention.” Westrick, 288 F.R.D. at 227–28
(quoting Long Term Capital Holdings, L.P. v. United States, No. 01–CV–1290 (JBA), 2003 WL
21269586, at *2 (D. Conn. May 6, 2003)).
When invoking the “exceptional circumstances” exception to discover a non-
testifying expert’s work product, “the burden on the moving party is to show [exceptional]
circumstances such that it cannot get any facts or opinions on the subject in which it is
interested.” 8A Charles Alan Wright & Arthur R. Miller, Federal Practice & Procedure
(“FPP”) § 2032 (3d ed. & Supp.). The “exceptional circumstances” burden is high. See Lowery
v. Circuit City Stores, Inc., 158 F.3d 742, 765 (4th Cir. 1998) (affirming finding that exceptional
circumstances were not shown when proponent of discovery was “able to obtain sufficient
information by other means,” the consulting expert from whom discovery was sought “submitted
a detailed expert report,” the proponent had its own experts that were able to challenge the
consulting expert’s analysis, and the proponent was able to “thoroughly examine” the consulting
expert during his deposition), judgment vacated on other grounds, 527 U.S. 1031 (1999); see
also Doe v. District of Columbia, 231 F.R.D. 27, 41 (D.D.C. 2005) (no exceptional
circumstances existed when proponent had “other means” to obtain discovery because proponent
20
had access to consulting expert’s report and underlying materials and could depose expert).
However, the burden is not so high as to be insurmountable, and “cases allowing discovery often
involve information about since-destroyed materials or situations in which the expert might also
be viewed as a fact witness regarding matters at issue.” FPP § 2032; see, e.g., Braun v. Lorillard
Inc., 84 F.3d 230, 236 (7th Cir. 1996) (affirming grant of motion to compel because the
defendant “could not conduct its own tests on tissues that had been destroyed in the course of the
plaintiff’s tests” and “[t]he only way the defense could find out whether there were crocidolite
asbestos fibers in the tissues that the plaintiff’s experts had tested was to get the test results”).
Courts have also found that “[e]xceptional circumstances ‘may exist when a non-testifying
expert’s report is used by a testifying expert as the basis for an expert opinion, or where there is
evidence of substantial collaborative work between a testifying expert and a non-testifying
expert.’” Westrick, 288 F.R.D. at 228 (quoting Long Term Capital Holdings, 2003 WL
21269586, at *2).
F. Dual-Hat Experts
This case presents the issue of “whether, and to what extent, the work-product
privilege applies when an expert alternately dons and doffs the ‘privileged hat’ of a litigation
consultant and the ‘non-privileged hat’ of the testifying witness. In other words, does a litigant
forfeit the privilege that would otherwise attach to a litigation consultant’s work when he offers
that expert as a testifying witness?” SEC v. Reyes, No. C06-04435 CRB, 2007 WL 963422, at *1
(N.D. Cal. Mar. 30, 2007); Monsanto Co. v. Aventis Cropscience, N.V., 214 F.R.D. 545, 546
(E.D. Mo. 2002) (“[T]he overwhelming majority of courts have taken the language of Rule 26 to
mean that providing otherwise protected materials to a testifying expert who considers them in
forming an expert opinion generally waives the protection, whether the expert actually relies on
21
the information or not.”). The Reyes court summarized the approach of courts prior to the 2010
amendments to Rule 26 as follows:
Every court to address this “multiple hats” problem has concluded
that an expert’s proponent still may assert a privilege over such
materials, but only over those materials generated or considered
uniquely in the expert’s role as consultant. B.C.F. Oil Refining,
Inc. v. Consol. Edison Co. of New York, 171 F.R.D. 57, 61–62
(S.D.N.Y. 1997); Grace A. Detwiler Trust v. Offenbecher, 124
F.R.D. 545, 546 (S.D.N.Y. 1989); Beverage Mktg. Corp. v. Ogilvy
& Mather Direct Response, Inc., 563 F. Supp. 1013, 1015
(S.D.N.Y. 1983); see also Messier v. Southbury Training Sch., No.
3:94–CV–1706, 1998 WL 422858, at *1–2 (D. Conn. June 29,
1988) (unpublished opinion).
These courts have further concluded that the scope of the privilege
must be narrowly construed against the expert’s proponent, lest the
privilege interfere with the goal of the disclosure requirements,
which is to allow an adversary “to expose whatever weaknesses,
unreliabilities, or biases might infect the opinions of testifying
experts called by [an] adverse party.” [United States v.] City of
Torrance, 163 F.R.D. 590, 593 (C.D. Cal. 1995). Thus,
“documents having no relation to the expert’s role as [a witness]
need not be produced but . . . any ambiguity as to the role played
by the expert when reviewing or generating documents should be
resolved in favor of the party seeking discovery.” B.C.F. Oil
Refining, Inc., 171 F.R.D. at 62; see also Offenbecher, 124 F.R.D.
at 546 (noting that documents “would become discoverable” to the
extent that “the delineation between [the expert’s] roles . . .
become[s] blurred”); Beverage Marketing, 563 F. Supp. at 1014(noting that the privileged and non-privileged status of
“consultant” and “witness” materials can be maintained only “if
this delineation [is] clearly made”).
Reyes, 2007 WL 963422, at *1–2. In dual-hat expert cases, the term “considered” in Rule
26(a)(2)(B) should be construed expansively in favor of the party seeking discovery, and “the
courts should order disclosure when there is at least an ambiguity as to whether the materials
informed the expert’s opinion. In most instances, if the subject matter directly relates to the
opinion in the expert report, there will be at least an ambiguity as to whether the materials
informed the expert’s opinion.” Monsanto, 214 F.R.D. at 547.
22
Because the 2010 amendments were intended (as relevant here) to limit discovery
only with regards to certain types of attorney work product, the same approach remains valid
after the amendments. That is, courts should apply the “broader discovery for testifying experts
. . . to everything except ‘materials generated or considered uniquely in the expert’s role as
consultant,” being sure to avoid compelling production of any of the materials now expressly
protected by Rule 26. See Sara Lee, 273 F.R.D. at 419–20 (quoting Reyes, 2007 WL 963422, at
*2). At least one court has applied the exact same standards set forth in Reyes to a dual-hat
expert after the 2010 amendments. See Sara Lee, 273 F.R.D. at 419–20.
G. Dual-Hat Expert Cases Cited by the Parties
In their briefs, the parties discuss the applicability of five dual-hat expert cases: In
re Commercial Money Center, Inc. Equipment Lease Litigation, 248 F.R.D. 532 (N.D. Ohio
2008); Monsanto Co. v. Aventis Cropscience, 214 F.R.D. 545 (E.D. Mo. 2002); Fialkowski v.
Perry, Civ. No. 11-5139, 2012 WL 2527020 (E.D. Pa. June 29, 2012); Employees Committed for
Justice v. Eastman Kodak Co., 251 F.R.D. 101, 105 (W.D.N.Y. 2008); and Sara Lee Corp. v.
Kraft Foods, Inc., 273 F.R.D. 416, 419 (N.D. Ill. 2011). These cases provide a useful illustration
of how courts apply the dual-hat expert rules and are summarized here.
In Commercial Money Center, a district court applied the dual-hat test to
documents requested from a financial consultant who had audited business records and was later
named as a testifying expert, quoting extensively from Reyes and other similar cases. 248 F.R.D.
at 538–42. The court ordered production of the requested documents. Central to its decision was
the failure of the party opposing production to demonstrate that the documents “were reviewed
or generated [by the dual-hat expert] uniquely in his role as consultant” or that the documents
had “no relation to the subject matter of [the expert’s] report.” Id. at 539.
23
In Monsanto, the consultant and testifying expert were two separate people. At
issue in Monsanto was the size of a gene that Monsanto added to its genetically modified corn
product, Mon810 corn. 214 F.R.D at 545–46. A consultant for the defendant, Aventis, tested the
genes in Mon810, and Monsanto argued that Aventis’s testifying expert had considered the
results of the consultant’s tests prior to preparing his expert report. Id. The court found that
Aventis had waived work product immunity because “[t]he subject matter of [the expert’s]
testimony is the characteristics of Mon810 corn in light of the patents-in-suit” and the
consultant’s test “treat[s] the issue of whether or not Mon810 infringed Aventis’s patents.” Id. at
548; see also id. at 549 (noting that the test “focus[ed] on the exact scientific findings that are
central to the legal arguments the parties have advanced”). Noting the expansive definition of
“considered” in Rule 26(a)(2)(B), and given the direct relevance of the consultant’s test results to
the expert’s report, the Monsanto court rejected the argument that Aventis’s expert did not
“consider” the consultant’s report. Id. at 547–58.
Fialkowski is not a dual expert case per se, although its thoughtful analysis of the
effect of the 2010 amendments to Rule 26 is useful. The case involved a breach of contract
claim among former partners of a law firm, and the court ordered production of spreadsheets and
document analyses the plaintiff had prepared to assist her attorney in understanding the law
firm’s financial records. Id. at *4–5. The plaintiff’s expert openly acknowledged that he had
reviewed the plaintiff’s materials, and the court found that the 2010 amendments did not protect
the materials from disclosure because they were not “counsel’s work product.” Id.
In a deceptive advertising case, the Sara Lee court addressed a defense expert
who was “retained to testify about one of Plaintiff’s advertisements and to consult, but not
testify, about another.” 273 F.R.D. at 417. The court determined that the defendant need not
24
produce materials because that clearly “relate[d] solely to [the expert’s] role as consultant, even
taking into account the preference for disclosure when dealing with an expert who wears two
hats,” because the expert’s work as to one advertisement was clearly discrete from his work as to
the other. Id. at 420. Assuming arguendo that the materials did relate to the expert’s role as a
testifying expert under Rule 26(a)(2)(B), the Sara Lee court found that “[n]one of the
communications contain[ed] facts, data, or assumptions that [the expert] could have considered
in assembling his expert report,” and the communications were thus all protected
communications between the attorneys and expert under Rule 26(b)(4)(C). Id. at 420–21. The
proponent did not show “substantial need” for the materials under Rule 26(b)(3)(A) because it
had “examined the data and methods underlying [the] report, deposed [the expert] about the
report, and retained its own expert to rebut the report.” Id. at 421.
Similarly, in Employees Committed for Justice v. Eastman Kodak Co., 251 F.R.D.
101, 105 (W.D.N.Y. 2008), an employment discrimination case, the court found that the dual-hat
expert’s proffered expert testimony, regarding statistical analysis of employee data performed in
2008, was “not sufficiently related to the consultative analyses he conducted in 2003 and 2004 to
require disclosure.”
III. ANALYSIS
Abbott’s requests can be broken into two broad categories: (1) documents related
to the 2003 experiments, and (2) Dr. Engelmann’s royalty agreement with other Yeda inventors.
The Court will address each in turn.
A. 2003 Experiment Materials
Within the category of documents reviewed or prepared by Dr. Engelmann related
to the 2003 experiments, referred to generally as “the 2003 documents,” Abbott seeks five
groups of documents:
25
(1) Dr. Engelmann’s notes relating to the 2003 experiments, (2)
Dr. Engelmann’s report concerning the 2003 experiments; (3) Dr.
Rubenstein’s report relating to the 2003 experiments (which Dr.
Engelmann reviewed); (4) all documents reflecting Dr.
Engelmann’s analysis of the sequencing data from the 2003
experiments; and (5) all documents relating to the experiments that
Dr. Engelmann conducted or participated in involving the
protocols and procedures in Abbott’s patent applications.
Abbott Mem. at 10. Yeda opposes the request in its entirety.
Abbott argues that Rule 26(a)(2)(B) requires Yeda to disclose all of these
materials as “facts or data” considered by Dr. Engelmann in his role as a testifying expert.
Abbott Mem. at 4–5; see also Abbott Reply at 3–4 (arguing that even if Dr. Engelmann were a
consultant under Rule 26(b)(3)(A) in 2003, “his role in this litigation has now changed,” making
the earlier reports “discoverable under Rule 26(a)(2)(B) because they constitute ‘facts or data’
considered by a testifying expert”). Abbott relies heavily on the 2010 Advisory Committee
Notes, especially the observation that an “expert’s testing of material involved in litigation, and
notes of any such testing, would not be exempted from discovery by this rule.” Abbott Mem. at
4–5. Abbott argues that Yeda must disclose these documents because: “(1) Dr. Engelmann
‘considered’ the withheld documents for purposes of Rule 26 disclosure; (2) the withheld
documents consist of ‘factual material’ that does not contain the theories or mental impressions
of counsel; and (3) the withheld documents relate to the subject matter of Dr. Engelmann’s
expert reports.” Id. at 5.
Yeda argues that Abbott’s request should be denied because “(i) the reports fall
squarely within the immunity from discovery provided by the attorney work-product doctrine[ ]
and (ii) Yeda has not waived that immunity by having Dr. Engelmann testify about the
experiments he performed in 1989 (as reflected in Yeda’s 339 Application) and protein
purification and isolation in general.” Yeda 1st Opp. at 1. Yeda argues that the reports are
26
protected by consulting expert immunity under Fed. R. Civ. P. 26(b)(4)(D) because “Dr.
Engelmann has expressed no opinion regarding whether the 072 [A]pplication or 089
[A]pplication describe[ ] or enable[ ] a protein satisfying the limitations required by the Count,
and he will offer no such testimony at trial,” making him a “non-testifying consultant ‘who is not
expected to be called as a witness at trial’ concerning the 2003 experiments.’” Id.Analyzing Abbott’s request requires the Court to address three issues. First,
Abbott asserts that Yeda has not shown ab initio that Dr. Engelmann was ever retained as a
consultant in 2003, much less that he was retained in connection with the United States patent
litigation. The Court rejects this argument. The Court finds that United States law applies and
that there is a potential dual-hat expert problem because Dr. Engelmann served Yeda as a non-
testifying consultant and has been designated as a testifying expert witness. Second, the Court
briefly addresses Yeda’s argument that the documents requested by Abbott are opinion work
product that deserves absolute protection. Third, the ultimate question is: are the documents
detailing Dr. Engelmann’s 2003 experiments relevant to his expert testimony in this case? The
answer to this third question effectively controls the ultimate ruling on Abbott’s discovery
motion.
1. Dr. Engelmann’s Documents Were Prepared “In Anticipation of” United
States Litigation, So United States Law Applies, and the Documents Are
Protected Work Product Unless Yeda Has Waived the Privilege
As a threshold matter, Abbott contends that Yeda has not established “the factual
predicates for either the work product doctrine or the applicability of Rule 26(b)(4)(D)”—i.e.,
that the documents were prepared by (or at the request of) an attorney in anticipation of
litigation. Abbott Reply at 2. Abbott argues that “Yeda fails to provide any documentary
evidence showing that Yeda’s attorneys engaged Dr. Engelmann in 2003 to serve as a consultant
in connection with either the European patent proceeding or the U.S. proceeding in this case.”
27
Id. at 3. As a corollary to this assertion—in an argument admittedly raised for the first time in its
reply brief—Abbott argues that, without a firmer link between the 2003 experiments and this
litigation, U.S. law may not apply to this dispute because some of the 2003 experiments took
place in Europe in the context of the European patent proceedings. Abbott asserts: “[I]f the Yeda
lawyers who engaged Dr. Engelmann in 2003 were non-U.S. lawyers—or if the relevant
‘litigation’ was the European patent proceeding (as opposed to a U.S. proceeding)—the court
would likely not even apply U.S. privilege law to Yeda’s work product claims.” Abbott Reply at
3 (citing Astra Aktiebolag v. Andrx Pharms. Inc., 208 F.R.D. 92, 98 (S.D.N.Y. 2002)).
Yeda responds that, because “the consultants’ reports were prepared by Drs.
Engelmann and Rubenstein at the request of Yeda’s counsel, with an eye toward both the
proceedings in Europe and the first § 146 case before Judge Urbina in this Court,” the work-
product doctrine protection of Fed. R. Civ. P. 26(b)(3)(A) applies. Yeda 1st Opp. at 14. At oral
argument, Yeda’s counsel acknowledged they have no immediate ability to produce a consulting
agreement between Dr. Engelmann and United States lawyers from 2003 because a different law
firm represented Yeda at that time. However, Yeda did produce documentation
contemporaneous with the first district court case supporting its assertions, including e-mail
correspondence among the parties’ counsel discussing logistics for Yeda’s experts to attend the
first phase of the 2003 experiments in Ludwigshafen. See Yeda Documentation, June 5, 2013
Hr’g Ex. 1. In the e-mails sent on January 30, 2003, then-counsel for Yeda wrote: “Our expert’s
name is Dr. Hartmut Engelmann,” and counsel for Abbott acknowledged the e-mail, providing
the address for Abbott’s lab and stating “Dr. Engelmann should ask for Dr. Hillen on arrival.”
Id.
28
The Court thus finds that Dr. Engelmann was retained as a consulting expert in
connection with United States litigation in 2003. As Yeda’s documentation shows, in January
2003, immediately before the experiments in Germany that began on February 2, 2003, United
States attorneys viewed Dr. Engelmann as their consultant in connection with the predecessor to
this case, Abbott v. Yeda, Civil No. 00-1720 (RMU). At that time, the case before Judge Urbina
had been ongoing for almost three years, and it clearly implicated the validity of Abbott’s 089
Application. In the 2003 experiments, Abbott repeated Example 2 of the 072 Application, which
is also Example 2 of the 089 Application and the 915 Patent. See Bradshaw Decl. ¶¶ 38–39,
Engelmann Decl. ¶ 7. The validity of the 915 Patent was also at issue in the first case before
Judge Urbina. See Abbott I at *7, Abbott III, 576 F. Supp. 2d at 51 (finding that the Board
committed clear error in invalidating Abbott’s 915 Patent). Yeda has noted that Abbott used the
2003 experiment results, at least indirectly, in the first district court case. Yeda 2d Opp. at 5.
Thus, the documents that Dr. Engelmann prepared in connection with 2003 experiments (as well
as those connected to Yeda’s subsequent testing) “can fairly be said to have been prepared or
obtained because of the prospect of litigation” that was ongoing in this court. See Boehringer
Ingelheim Pharms., 286 F.R.D. at 107. United States law thus applies. Moreover, unless the
privilege was later waived, documents prepared by Dr. Engelmann as Yeda’s consultant in
connection with the 2003 experiments are protected from discovery by the work product
privilege. See id.; Fed. R. Civ. P. 26(b)(4)(D) (“Ordinarily, a party may not . . . discover facts
known or opinions held by an expert who has been retained or specially employed by another
party in anticipation of litigation or to prepare for trial and who is not expected to be called as a
witness at trial.”); see also Fed. R. Civ. P. 26(b)(3)(A) (protecting from discovery “documents
29
and tangible things that are prepared in anticipation of litigation or for trial by or for another
party or its representative (including the other party’s . . . consultant . . . )”).
2. The Nature of the Work Product Protection Ascribed to the 2003
Documents
In its briefs and at oral argument, Yeda suggested that the 2010 amendments to
Rule 26 require the Court to ascribe absolute protection to the 2003 documents because they
contain “the mental impressions, opinions, and conclusions of Yeda’s consultants, as informed
by Yeda’s lawyers.” Yeda 2d Opp. at 1. Abbott, of course, disagrees. See Abbott Reply at 4
(asserting that “the experimental data and factual observations of two protein chemists” cannot
“reveal the ‘mental impressions of counsel’”). Although this strand of argument is by no means
the bedrock of Yeda’s justification for opposing Abbott’s motion to compel, the Court will
clarify briefly the effect of the 2010 amendments on expert discovery.
It is true, as Yeda observes, that portions of Rule 26 were amended in 2010 with
the goal of slightly reducing the universe of discoverable information with relation to testifying
expert witnesses. But Yeda misunderstands the amendments, which were intended to “exclud[e]
theories or mental impressions of counsel” from discovery, 2010 Ad. Comm. note (emphasis
added), not theories or mental impressions of experts. It was the disclosure of attorney-expert
communications, including attorney work product, that the Advisory Committee was attempting
to arrest. See id.; Fed. R. Civ. P. 26(b)(4)(C) (protecting from disclosure “communications
between the party’s attorney and any witness required to provide a report under Rule
26(a)(2)(B),” subject to three exceptions). The higher standard of protection for which Yeda
argues would be implicated if this case involved only work performed by Dr. Engelmann as a
consulting expert. Then, Dr. Engelmann’s work product would be subject to the showing of
need under case law or the Federal Rules. See Fed. R. Civ. P. 26(b)(3)(A), Fed. R. Civ. P.
30
26(b)(4)(D)(ii). The problem that Yeda must confront is whether it waived the work product
privilege that would otherwise be applicable to Dr. Engelmann’s consulting materials when (and
if) those materials became “facts or data” he “considered” as a testifying expert in this case. This
problem is unchanged by the 2010 amendments to Rule 26.
3. Yeda’s Designation of Dr. Engelmann as a Testifying Expert in this Case
Waives the Work-Product Privilege Under the Dual-Hat Expert Doctrine
Yeda has designated Dr. Engelmann as a testifying expert, making him subject to
disclosure of “a complete statement of all opinions the witness will express and the basis and
reasons for them” and “the facts or data considered by the witness in forming them.” Fed. R.
Civ. P. 26(a)(2)(B). Thus, Dr. Engelmann “alternately dons and doffs the ‘privileged hat’ of a
litigation consultant and the ‘non-privileged hat’ of the testifying witness.” Reyes, 2007 WL
963422, at *1.
Yeda asserts that Dr. Engelmann need not disclose the 2003 documents because
the 2003 experiments are simply irrelevant to the present proceeding before the Court, and the
Court should thus find that the materials retain work product protection because they were
“generated or considered uniquely in the expert’s role as consultant.” See id. (citing B.C.F. Oil
Refining, Inc., 171 F.R.D. at 61–62). Yeda asserts that “there is a clear distinction between Dr.
Engelmann’s previous role as a consultant,” in which he “served as Yeda’s representative at the
2003 experiments and interpreted those experiments for Yeda’s counsel,” “and his current role as
a testifying expert,” in which he explains the 1989 experiments and the lead-up to Yeda’s 443
Application, as well as “multi-step chromatography procedures” generally. Yeda 1st Opp. at 18;
see also Yeda 2d Opp. at 16 (referring to a “clear line of demarcation”). Yeda argues that Dr.
Engelmann was not designated as a testifying expert in the first district court case, “so there is no
ambiguity that the documents were prepared by Drs. Engelmann and Rubenstein in their roles as
31
consultants,” Yeda 2d Opp. at 3. See Reyes, 2007 WL 963422, at *1–2 (“Thus, ‘documents
having no relation to the expert’s role as [a witness] need not be produced . . . .’” (quoting B.C.F.
Oil Refining, Inc., 171 F.R.D. at 62)).
Yeda is correct to the extent that there is a temporal line of demarcation between
the 2003 experiments and these proceedings. The documents at issue were clearly prepared by
Dr. Engelmann in his capacity as a consultant. However, whether time has passed is not the
pertinent inquiry; instead, the question is the extent of the substantive relationship between Dr.
Engelmann’s two expert roles. In so doing, “the scope of the privilege must be narrowly
construed against the expert’s proponent,” Reyes, 2007 WL 963422, at *1–2 (citing City of
Torrance, 163 F.R.D. at 593), and a court “should order disclosure when there is at least an
ambiguity as to whether the materials informed the expert’s opinion,” Monsanto, 214 F.R.D. at
547. The presumption in favor of the party seeking discovery means that “if the subject matter
directly relates to the opinion in the expert report, there will be at least an ambiguity as to
whether the materials informed the expert’s opinion,” and consulting materials should be
disclosed. Id.
Abbott responds that Dr. Engelmann’s expert report “disputes the conclusions of
Abbott’s experts, including their conclusions that (1) the 072 Application discloses the same
TBP-II protein as the 915 Patent[,] and (2) the 072 Application sets forth a reliable and effective
protocol for isolating and purifying novel proteins.” Abbott Mem. at 4. In Abbott’s view, the
2003 documents relate to the subject matter of Dr. Engelmann’s expert testimony even if he does
not expressly address the 2003 experiments because “the sole issue posed in this proceeding” is
whether “the 072 Application enable[s] (and provide[s] an adequate written description of) the
same normal TBP-II protein claimed in the 915 Patent.” Id. at 7–8. Abbott contends that “[t]he
32
entire purpose of Abbott’s 2003 experiments was to demonstrate—in the presence of Yeda’s
own witnesses, including Dr. Engelmann—that the 072 Application enabled a person of ordinary
skill in the art to isolate, purify and identify the same protein claimed in the 915 Patent.” Id. at 8.
Moreover, Abbott argues, “in their expert reports, Abbott’s expert witnesses demonstrate at
length why Abbott’s 2003 experiments support their conclusion that the 072 application enabled
a skilled person to isolate, purify and characterize the same protein claimed in the 915 Patent.”
Id. Essentially, because Dr. Engelmann is criticizing Abbott’s experts’ conclusion that the
protocol set forth in the 072 Application was “effective and reliable” and because the 2003
experiments were “designed to repeat every step in the very [same] protocol,” the “‘facts and
data’ that Dr. Engelmann observed as a witness to Abbott’s 2003 experiments . . . plainly relate
to the subject matter of his expert testimony.” Id.; see also Abbott Reply at 7 (“Dr. Engelmann’s
observations of Abbott’s 2003 experiments—in which Abbott repeated the same protocol that
Dr. Engelmann now criticizes as an expert witness in this case—are plainly relevant to his expert
testimony.”).
Yeda’s argument depends on the premise that, as a testifying expert, “Dr.
Engelmann is in a unique position, having actually performed the experiments disclosed in
Yeda’s patent applications and patents, to explain why what he did in 1989 was not the same as
the protocol reported in the 072 [A]pplication.” Yeda 2d Opp. at 11. Thus, according to Yeda,
the 2003 documents are “irrelevant to Dr. Engelmann’s role in developing his expert opinions in
this case,” which are “directed to his own 1989 experiments and protein purification and
isolation in general.” Yeda 1st Opp. at 18–19. Yeda characterizes the subjects of Dr.
Engelmann’s expert testimony in this litigation as “(1) the 1989 experiments described in Yeda’s
339 [A]pplication and the reasons that he performed those experiments; and (2) complexities
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associated with purifying and identifying novel proteins using multi-step chromatography
protocols.” Id. at 7 (citations omitted).13 “[W]hether the 072 [A]pplication is enabling has no
relation to Dr. Engelmann’s testimony about the experiments he did in 1989 to isolate and purify
TBP-II” or to his “testimony contrasting the 072 protocol with the experiments he performed in
1989,” which is “offered only in response to Abbott’s expert’s opinion that the protocols are the
‘same basic protocol.’” Id. at 19. Yeda thus contends that “Dr. Engelmann does not offer any
opinion about the 089 [A]pplication,” does not offer “any opinion about the 072 [A]pplication,
other than commenting that the protocol he performed (as reported in the 339 [A]pplication)
considerably differed from the protocol reported in the 072 [A]pplication,” and does not offer
“any opinion about the 2003 experiments.” Id. at 9. In Yeda’s view, “[a]ny reference Dr.
Engelmann makes to the 072 [A]pplication protocol is solely in response to the opinions of
Abbott’s experts who suggest that Abbott’s scientists used the same basic protocol Dr.
Engelmann used.” Yeda 2d Opp. at 11.
The Court finds the line of demarcation Yeda has drawn is more illusory than
real. Counsel for Yeda acknowledged at oral argument that, in a nutshell, Dr. Engelmann’s
expert testimony will be that the protocols Yeda performed in 1989 as a prelude to its 339
Application are divergent from the protocols described in Abbott’s 072 Application. Such
testimony is consistent with the theory of Yeda’s case in this § 146 proceeding, which is that the
Board erred in determining that Abbott’s 915 Patent is entitled to priority based on the
sufficiency of the 072 and 089 Applications. See Yeda 2d. Opp. at 4 (arguing that “the Board
13
Specifically, according to Yeda, “[i]n his opening report, Dr. Engelmann provides background
information regarding proteins and protein purification and characterization; background
information regarding cellular receptors, TNF, and TNF-binding proteins; information about the
level of ordinary skill in the art in 1989; and background information concerning Yeda’s 339
[A]pplication.” Yeda 1st Opp. at 7.
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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.”). But the experiments Dr. Engelmann observed and opined about in
2003 are, in fact, part of the very protocol contained in the 072 Application, as Dr. Engelmann
himself acknowledges. See Engelmann Decl. ¶ 7 (“I was asked by Yeda’s counsel to represent
Yeda by observing Abbott scientists attempt to practice the procedure described in Example 2 of
Abbott’s German patent applications [072 and 089] and U.S. Patent No. 5,344,915 [915
Patent].”). Moreover, Dr. Engelmann himself acknowledged reading at least his own 2003
report in preparation for his fact deposition in this case, Jan. 16, 2012 Engelmann Dep. at 74,
further demonstrating that the overlap in subject matter is sufficient to justify granting Abbott’s
motion to compel.
Yeda attempts to cast this case as involving purely legal disagreement with the
standard applied by the Board or merely a question of the sufficiency of Yeda’s own patent
applications, but Yeda cannot escape the trap into which it has fallen by using Dr. Engelmann,
one of its original patent inventors, as both a consultant for the 2003 experiments and as an
expert witness here. Even a man as highly educated as Dr. Engelmann cannot be expected to
draw a mental line in the sand between information gleaned from a behind-the-scenes look at
Abbott’s process in 2003 and information he learned otherwise. It would be impracticable to ask
such a Herculean task of dual-hat experts, or even of experts generally; that is why courts eschew
a subjective standard for whether a testifying expert has “considered” “facts or data,” see In re
Commercial Money Center, 248 F.R.D. at 537, and why courts construe the dual-hat expert rule
in favor of the party seeking discovery, City of Torrance, 163 F.R.D. at 593.
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The Court finds that Yeda waived the work product protection of Dr.
Engelmann’s work as a consultant in this case by designating him as a testifying expert witness.
Accordingly, Abbott’s motion to compel as to the documents related to the 2003 experiment will
be granted with respect to the five groups of documents Abbott seeks, subject to any attorney
work product otherwise protected by amended Rule 26.
B. Royalty Agreement
The Court next turns to Abbott’s motion to compel production of the royalty
agreement between Dr. Engelmann and other Yeda inventors. Abbott argues that, because Dr.
Engelmann “is one of the named inventors in the Yeda patent application” and “will be testifying
as an expert witness,” “the financial benefit that Dr. Engelmann will realize if Yeda were to
prevail in this litigation and commercialize a product based on the TBP-II protein . . . is relevant
to bias and credibility,” and thus the royalty agreements between Dr. Engelmann and Yeda
should be produced. Abbott Mem. at 10. Yeda responds that Abbott’s request should be denied
because “(i) it is wholly irrelevant to any issue in this case (e.g., while Yeda has challenged
Abbott’s patent applications, Abbott has never challenged the sufficiency of Yeda’s 339
Application or any other Yeda application); (ii) it is cumulative to evidence already provided to
Abbott about royalties; and (iii) Abbott has refused to produce any of its own similar
agreements” on relevance grounds. Yeda 1st Opp. at 1. Yeda also notes that the royalty
agreement “is confidential and cannot be disclosed . . . without permission of all parties to the
agreement.” Id.
A court may “limit . . . the extent of discovery otherwise allowed” upon a
determination that the discovery sought is “(i) unreasonably cumulative or duplicative, or can be
obtained from some other source that is more convenient, less burdensome, or less expensive,” if
“(ii) the party seeking discovery has had ample opportunity to obtain the information by
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Dr. Engelmann conducted or participated in involving the
protocols and procedures in Abbott’s patent applications.
A memorializing Order accompanies this Opinion. Because the parties’ briefs
relied in part on materials that were filed under seal, the parties will be directed to prepare a joint
proposed redacted version of this Opinion for approval and subsequent filing on the public
docket.
Date: June 7, 2013 /s/
ROSEMARY M. COLLYER
United States District Judge
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