Teva Pharmaceuticals International GmbH et al v. Eli Lilly and Company
Judge Allison D. Burroughs: REDACTED MEMORANDUM AND ORDER entered. Teva's motion for sanctions, [ECF No. 143 ], is DENIED, Lilly's motion to exclude, [ECF No. 181 ], is DENIED, and Lilly's motion to amend, [ECF No. 175 ], is GRANTED. SO ORDERED. (McManus, Caetlin)
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UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
INTERNATIONAL GMBH and
ELI LILLY AND COMPANY,
Civil Action No. 18-cv-12029-ADB
MEMORANDUM AND ORDER
In this patent infringement suit, Teva Pharmaceuticals International GmbH and Teva
Pharmaceuticals USA, Inc. (collectively, “Teva”) allege that Eli Lilly and Company’s (“Lilly”)
product Emgality, with the active ingredient galcanezumab, has infringed Teva’s patents,
including U.S. Patent Nos. 8,586,045 (the “’045 Patent”); 9,884,907 (the “’907 Patent”); and
9,884,908 (the “’908 Patent”) (collectively, the “patents-in-suit”). [ECF No. 1]. The patents-insuit are related to a treatment for migraines that is marketed under the brand name Ajovy. [Id.
Currently before the Court are Teva’s motion for sanctions, [ECF No. 143], Lilly’s
motion to exclude Teva’s rebuttal expert Dr. Geoffrey Hale, [ECF No. 181], and Lilly’s motion
to amend its answer, [ECF No. 175]. For the reasons set forth below, (1) the motion for
sanctions is DENIED; (2) the motion to exclude Dr. Hale is DENIED but Dr. Hale is ORDERED
not to disclose any of Lilly’s confidential information or work product to Teva; and (3) Lilly’s
motion to amend its answer is GRANTED.
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TEVA’S MOTION FOR SANCTIONS
On August 18, 2021, Teva moved to impose sanctions on Lilly pursuant to Federal Rule
of Civil Procedure 37(b), arguing that sanctions are warranted because Lilly did not apply the
proper search terms when collecting documents in violation of the Court’s March 8, 2021 Order
(the “March 8 Order”). [ECF No. 143].
The March 8 Order resolved a discovery dispute that Teva raised in a letter filed with the
Court. In its letter, Teva asked the Court to compel Lilly to run the following two searches:
1. galca* OR gmab OR 2951742 OR L2951742 OR Y2951742 OR LY2951742
OR LLY2951742 OR LSN2951742 OR [any internal project o[r] code names
used by Lilly]
2. CGRP* AND ((Jan w/2 Benschop* OR [email address of Jan Benschop]) OR
(Barrett w/2 Allan* OR [email address of Allan Barrett]) OR (Mark w/2
Chambers* OR [email address of Mark Chambers]) OR (Ryan w/2 Darling OR
[email address of Ryan Darling]) OR (Donald w/2 Gehlert* OR (Kalpana w/2
Merchant* OR [email address of Kalpana Merchant]) OR (Armen w/2
Shanafelt* OR [email address of Armen Shanafelt]))
[ECF No. 99-4 at 1 (emphasis added)]. The March 8 Order, in relevant part, states that
[t]he parties have submitted several discovery disputes for the Court’s
consideration via letter/requests . . . . Lilly is ordered to perform a search using
the phrase “galca,” as described in Teva’s letter/request. [ECF No. 99]. As
Teva notes, this is not a product name (Emgality) but is the name of the active
ingredient antibody in that product and is therefore highly relevant to this litigation
despite the relative burden that running the search may impose on Lilly. As to the
second search string that Teva discussed in its letter/request, Lilly represents that it
has already agreed to run it, so that issue is moot. [ECF No. 103 at 1].
[ECF No. 104 (emphasis added)].
The parties now disagree about which internal project or code names Lilly needed to
include in its search to comply with the March 8 Order. Teva argues that the terms
are “internal project o[r] code names used by Lilly” and therefore Lilly
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Under Rule 37(b)(2),
[i]f a party or a party’s officer, director, or managing agent—or a witness
designated under Rule 30(b)(6) or 31(a)(4)—fails to obey an order to provide or
permit discovery, including an order under Rule 26(f), 35, or 37(a), the court where
the action is pending may issue further just orders.
Fed. R. Civ. P. 37(b)(2)(A). These “just orders” include various sanctions, such as dismissal of
claims and defenses or accepting factual inferences in favor of the moving party. Id. “The
imposition of sanctions under Rule 37(b) is left to the discretion of the trial court.” Patel v. 7Eleven, Inc., No. 17-cv-11414, 2020 WL 6940124, at *2 (D. Mass. June 24, 2020) (citing Ruiz v.
Principal Fin. Grp., No. 12-cv-40069, 2014 WL 257429, at *5 (D. Mass. Jan. 22, 2014)). Rule
37(b), however, “contemplate[s] a threshold determination by the court that the offending party
has failed to comply with a court order. . . .” Ortiz-Lopez v. Sociedad Espanola de Auxilio
Mutuo Y Beneficiencia de Puerto Rico, 248 F.3d 29, 33 (1st Cir. 2001). Accordingly, the Court
must first determine if Lilly ignored its obligations under the March 8 Order.
Teva argues that the March 8 Order required Lilly to search for
because the Order directed Lilly to perform a search “as described in Teva’s
letter/request,” and the search that Teva proposed in its letter clearly considered
to be internal project or code names. [ECF No. 144 at 13–14]. Though Teva
argues that the Court adopted its interpretation of “internal project o[r] code names,” such a
conclusion is not supported by the record. The parties’ briefing on disputes concerning Search
Term No. 1 focused on whether the term “galca*” would lead to relevant discovery and the
burden it would impose on Lilly. [ECF No. 99-4 at 3 (Teva’s letter stating that “[t]he only
dispute as to Search Term No. 1 is whether to include the name of the active ingredient in Lilly’s
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infringing Emgality® product, as set forth below. Specifically, the parties dispute whether Lilly
should have to search for “galca*,” which would encompass “galcanezumab” and variations
thereof.”); ECF No. 103 at 2 (“Lilly had already agreed to independently run each of the above
terms, except for ‘galca*’. . . .”)]. The briefing did not squarely address the meaning of the term
“internal project o[r] code names used by Lilly” as used in Search Term No. 1. In fact, the only
discussion of the term “internal project o[r] code names” as used in Search Term No. 1 was
Teva’s statement, in a footnote, that documents “indicate” that
were project names used by Lilly. [ECF No. 99-4 at 3 n.3]. 1 Thus, the March 8 Order
responded to the dispute that was briefed and presented to the Court (i.e., whether Lilly must
search the term “galca*”), but did not incorporate arguments put forth by Teva that were
unrelated to that issue.
Accordingly, the Court never clearly adopted the position that Teva advanced in its
footnote (i.e., that
are internal project or code names used by
Lilly), and without a clear finding on the definition of that term, it cannot be said that Lilly
disregarded the Court’s order. Therefore, because there was no violation of a Court order, there
are no grounds for imposing any sanctions and Teva’s motion is DENIED.
LILLY’S MOTION TO EXCLUDE
Pursuant to the amended Scheduling Order in this case, the parties exchanged opening
expert reports on September 16, 2021. [ECF No. 128 at 3 (proposed amended schedule); ECF
Although Teva’s briefing on Search Term No. 2 argued that internal Lilly documents
“refer[red] to the development project that led to galcanezumab as
[ECF No. 99-4 at 5], the dispute over Search Term No. 2 was moot, and the Court
therefore did not determine the relevance of the terms
context, [ECF No. 104 (Court’s order stating “[a]s to [Search Term No. 2] that Teva discussed in
its letter/request, Lilly represents that it has already agreed to run it, so that issue is moot.”)].
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No. 129 (Court’s order adopting proposed amended schedule)]. The next day, September 17,
2021, Teva disclosed Dr. Geoffrey Hale as a rebuttal expert. [ECF No. 183-6 at 1]. Lilly
objected to Teva’s disclosure because Dr. Hale has previously performed work for Lilly relating
to antibody development, [ECF No. 183-7 at 1], and has now moved to exclude Dr. Hale as an
expert. [ECF No. 181].
Dr. Hale is an expert in the field of antibody development, which includes the
humanization of antibodies. [ECF No. 192-1 ¶ 1]. Currently he is the CEO of mAbsolve, the
managing director of Bioarchitech, and a freelance scientist and consultant. [Id.]. Over the last
decade, as a freelance consultant, he has consulted for approximately forty-five companies on
more than sixty projects that all related to antibody development, including antibody
humanization. [Id. ¶ 2]. In 2012 and then again in 2018, Dr. Hale consulted for Lilly in the area
The March 2012 Engagement
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On October 12, 2021, Lilly filed its motion to exclude Dr. Hale as an expert in this
litigation based on his prior work for Lilly. [ECF No. 181]. In the alternative, Lilly requests that
the Court prohibit Dr. Hale from disclosing Lilly’s confidential material and protected work
product pursuant to his signed engagement letters. [ECF No. 182-1 at 19]. Teva opposed the
motion on October 19, 2021, [ECF No. 190-1], and Lilly replied on October 25, 2021, [ECF No.
“Although courts are generally reluctant to disqualify expert witnesses, federal courts
have inherent authority to disqualify experts if necessary to preserve public confidence in the
fairness and integrity of the judicial system.” Palomar Med. Techs., Inc. v. Tria Beauty, Inc.,
No. 09-cv-11081, 2012 WL 517532, at *2 (D. Mass. Feb. 15, 2012) (quoting Lacroix v. Bic
Corp., 339 F. Supp. 2d 196, 199 (D. Mass. 2004) (internal quotation marks omitted)). When
analyzing a motion to disqualify, “[t]he court must determine whether, (1) it was objectively
reasonable for the moving party to believe that it had a confidential relationship with the expert;
and (2) whether the moving party disclosed confidential information to the expert that is relevant
to the current litigation.” Lacroix, 339 F. Supp. 2d at 199–200 (emphasis added). “Confidential
information essentially is information ‘of either particular significance or [that] which can be
readily identified as either attorney work product or within the scope of the attorney-client
privilege.’” Id. at 200–01 (quoting Hewlett–Packard Co. v. EMC Corp., 330 F. Supp. 2d 1087,
1094 (N.D. Cal. 2004)) (alteration in original). Confidential information could include
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discussion of the party’s “strategy in the litigation, the kinds of experts [the party]
expected to retain, [the party’s] view of the strengths and weaknesses of each side,
the role of each of the [party’s] experts to be hired and anticipated defenses.”
Id. at 201 (quoting Hewlett–Packard, 330 F. Supp. 2d at 1094; Mayer v. Dell, 139 F.R.D. 1, 4
(D.D.C. 1991)) (alterations in original). The party seeking disqualification bears the burden of
demonstrating that a confidential relationship existed and relevant confidential information was
disclosed. Palomar Med. Techs., Inc., 2012 WL 517532, at *2.
Lilly contends that Dr. Hale must be disqualified because it had a confidential
relationship with him and during the course of that relationship provided him with privileged and
confidential information that is relevant to this litigation. [ECF No. 182-1 at 13–17].
First, the Court agrees, and Teva does not dispute, [ECF No. 190-1 at 17], that Lilly and
Dr. Hale entered into a confidential relationship. In the 2012 and 2017 engagements,
Lilly “reasonably . . . expect[ed] that any communications would be
maintained in confidence.” Lacroix, 339 F. Supp. 2d at 200 (quoting Hewlett-Packard, 330 F.
Supp. 2d at 1093).
Second, Lilly asserts that Dr. Hale received confidential and privileged information in his
prior engagements that is relevant to the issues he would opine on in this case.
Dr. Hale’s receipt
of privileged or confidential information during his prior consultancies does not merit
disqualification. The facts here are similar to those in LaCroix v. Bic Corp., 339 F. Supp. 2d 196
(D. Mass. 2004). In LaCroix, the plaintiff, after being injured by a lighter explosion, sued the
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See CreAgri, Inc. v. Pinnaclife
Inc., No. 11-cv-06635, 2013 WL 6700395, at *6 (N.D. Cal. Dec. 18, 2013) (finding that
discussions of topics that “have no relation to the patents-in-suit or this litigation” are not
evidence of confidential information); H. Lundbeck A/S v. Apotex Inc., No. 18-cv-0088, 2020
WL 1285834, at *2 (D. Del. Mar. 18, 2020) (noting that even accepting that the expert received
confidential and privileged information during previous engagements, the court was “not
persuaded that the information [the expert] received in decade-old litigations involving different
drugs would require his disqualification” and “nothing in the record suggests that [the expert]
was privy to any privileged information other than the trial strategy used” in the previous cases);
Chamberlain Grp., Inc. v. Interlogix, Inc., No. 01-cv-6157, 2002 WL 653893, at *4 (N.D. Ill.
Apr. 19, 2002) (“[A]n expert’s exposure to trial strategy in an unrelated and different action is
insufficient to warrant the extreme sanction of disqualification.”).
Accordingly, Lilly’s motion to exclude Dr. Hale is DENIED. Although Dr. Hale may
continue to serve as an expert,
Dr. Hale is ORDERED not to disclose any
confidential information or work product
LILLY’S MOTION TO AMEND ITS ANSWER
Lilly moves to amend its answer to add factual allegations and assert additional
counterclaims and affirmative defenses based on inequitable conduct in connection with the
’045, ’907 and ’908 patents. [ECF No. 176-4 at 6; ECF No. 176-6 at ¶¶ 187–307]. 4 Lilly
When citing to Lilly’s proposed amended answer, all citations are to the paragraphs in the
amended counterclaims section.
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1417, 1419 (11th Cir. 1998); see also O’Connell v. Hyatt Hotels of P.R., 357 F.3d 152, 155–56
(1st Cir. 2004) (citing Sosa with approval).
“Rule 16(b)’s ‘good cause’ standard emphasizes the diligence of the party seeking the
amendment.” O’Connell, 357 F.3d at 155. Under this inquiry, “[p]rejudice to the opposing party
remains relevant but is not the dominant criterion.” Id. Rather, “‘[i]ndifference’ by the moving
party” may preclude leave to amend “irrespective of prejudice because such conduct is
incompatible with the showing of diligence necessary to establish good cause.” Id. (citation
omitted). “Particularly disfavored are motions to amend whose timing prejudices the opposing
party by ‘requiring a re-opening of discovery with additional costs, a significant postponement of
trial, and a likely major alteration in trial tactics and strategy . . . .’” Steir v. Girl Scouts of the
USA, 383 F.3d 7, 12 (1st Cir. 2004) (quoting Acosta-Mestre v. Hilton Int’l of P.R., Inc., 156
F.3d 49, 52 (1st Cir. 1998)). “As a case progresses, . . . the burden on a plaintiff seeking to
amend a [pleading] becomes more exacting.” Id.
In addition to good cause, futility presents another potential bar to amendment. In the
context of a motion to amend, “futility means that the complaint, as amended, would fail to state
a claim upon which relief could be granted.” O’Leary v. N.H. Boring, Inc., 323 F.R.D. 122, 126
(D. Mass. 2018) (citing Glassman v. Computervision Corp., 90 F.3d 617, 623 (1st Cir. 1996)).
“If leave to amend is sought before discovery is complete and neither party has moved for
summary judgment, the accuracy of the ‘futility’ label is gauged by reference to the liberal
criteria of Federal Rule of Civil Procedure 12(b)(6).” Hatch v. Dep’t for Children, Youth &
Their Families, 274 F.3d 12, 19 (1st Cir. 2001). Under this standard, an amendment will not be
deemed futile unless it fails to support a “plausible entitlement to relief.” Rodríguez-Ortiz v.
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Margo Caribe, Inc., 490 F.3d 92, 95 (1st Cir. 2007) (quoting Bell Atl. Corp. v. Twombly, 550
U.S. 544, 559 (2007)).
Under the original scheduling order, the deadline for amendments to the pleadings was
March 22, 2021. [ECF No. 46]. Because the amended scheduling orders extending the
discovery deadlines made no reference to a new deadline for amended pleadings, all amendments
to pleadings should have been filed by March 22, 2021. Given the untimeliness of the motion to
amend, the Court reviews the request under Rule 16(b)’s “good cause” standard, which is based
on diligence and prejudice to the non-moving parties, and also considers the futility of the
Lilly maintains that it was diligent in seeking leave to amend its answer because it was
Teva’s February 26, 2021 document production that first “suggested” that
and it was not until August 2021, during the depositions of the named
inventors, that the “full factual information supporting Lilly’s new grounds of unenforceability
due to inequitable conduct was fully revealed.” [ECF No. 176-4 at 11–16, 19–21].
The key discovery Lilly needed to develop its potential inequitable conduct claim related
to the early development of the patents-in-suit by the named inventors. [ECF No. 176-4 at 11,
13–14, 19]. On March 8, 2021, Lilly wrote to Teva regarding the small number of early
development documents produced to date. [ECF No. 177-13 at 2–3]. On April 6, 2021, Teva
notified Lilly that, as of April 2, 2021, it had produced all relevant, non-privileged early
development documents in its control. [ECF No. 177-14 at 2–3]. Teva also explained that “[i]f
Lilly remains unsatisfied with the volume and/or type of
documents Teva has
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delay in producing them contributed to Lilly’s delay in learning of a potential inequitable
conduct defense. Thus, the Court cannot conclude that Lilly’s late discovery of a potential
inequitable conduct defense was attributable solely to its own lack of diligence or evidence of
Accordingly, the Court focuses on whether Lilly’s decision to move to amend in October
2021 was diligent accepting that it first learned of a potential claim in February 2021.
Fundamentally, the Court agrees that given the heightened pleading standard for inequitable
conduct claims, see Section III.C.2 infra, it was reasonable for Lilly to further develop its claim
through deposition testimony before moving to amend. Although there was an eight-month
delay in filing the motion, there was only a few-week delay between Teva’s confirmation that it
would not be producing any additional early development or named inventor documents and
Lilly serving third-party discovery. This short delay does not manifest indifference. Third-party
depositions, document productions, and privilege logs were not completed until September 28,
2021, and the motion to amend was filed approximately a week later. Again, this relatively brief
delay between the completion of third-party discovery and the filing of the motion to amend is
not evidence of a lack of diligence. In sum, the Court credits Lilly’s assertion that it did not
know enough about any alleged inequitable conduct until after discovery progressed and finds
the delay in bringing this motion to be the result of a slow discovery process rather than bad faith
or indifference. See Penobscot Nation v. Mills, No. 12-cv-00254, 2014 WL 442429, at *3 (D.
Me. Feb. 4, 2014) (“Defendant’s request to amend does not reflect delay, rather it reflects the
developing factual record related to this litigation.”).
While Rule 16(b)’s “good cause” standard “focuses on the diligence (or lack thereof) of
the moving party more than it does on any prejudice to the party-opponent,” Somascan, Inc. v.
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Philips Med. Sys. Nederland, B.V., 714 F.3d 62, 64 (1st Cir. 2013) (quoting Flores-Silva v.
McClintock-Hernández, 710 F.3d 1, 3 (1st Cir. 2013)), prejudice is still a factor to be considered.
Teva does not argue that it will be prejudiced by Lilly’s proposed amended answer, and Lilly
represents that there would be no prejudice to Teva if the late amendment is allowed because no
further discovery will be needed beyond the contemplated expert discovery and that the case
scheduling order will not need to be altered. [ECF No. 176-4 at 21–22]. In light of these
representations and Teva’s silence on the issue, the Court finds that the amendment will not
unduly prejudice Teva.
Accordingly, there is good cause for Lilly’s late-filed motion to amend.
Even though Lilly was diligent, Teva argues that the amendment is futile because the
proposed amended pleading fails to state an inequitable conduct claim. “Inequitable conduct is
an equitable defense that prevents enforcement of a patent obtained through fraud.” Lexington
Luminance LLC v. Osram Sylvania Inc., 972 F. Supp. 2d 88, 91 (D. Mass. 2013). An
inequitable conduct defense must satisfy the requirements for alleging fraud set forth in Federal
Rule of Civil Procedure 9(b). Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1326–27
(Fed. Cir. 2009). In determining “whether inequitable conduct has been pleaded with
particularity under Rule 9(b),” the law of the Federal Circuit applies. Id. at 1326. “The [Federal
Circuit] [has] tightened the inequitable conduct [pleading] standard to ensure that the defense is
sustained only in egregious circumstances and to discourage parties from using it as a mere
litigation tactic in garden-variety cases.” PetEdge, Inc. v. Fortress Secure Sols., LLC, No. 15-cv11988, 2016 WL 407065, at *3 (D. Mass. Feb. 2, 2016) (quoting Lexington Luminance LLC,
972 F. Supp. 2d at 91) (alterations in original). “A pleading that simply avers the substantive
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elements of inequitable conduct, without setting forth the particularized factual bases for the
allegation, does not satisfy Rule 9(b).” Exergen Corp., 575 F.3d at 1326–27 (citation omitted).
Thus, “in pleading inequitable conduct in patent cases, Rule 9(b) requires identification of the
specific who, what, when, where, and how of the material misrepresentation or omission
committed before the PTO.” Id. at 1327.
Although Rule 9(b) requires particularity, “[m]alice, intent, knowledge, and other
conditions of mind of a person may be averred generally.” Exergen Corp., 575 F.3d at 1327
(quoting Fed. R. Civ. P. 9(b)) (alteration in original). “The relevant ‘conditions of mind’ for
inequitable conduct include: (1) knowledge of the withheld material information or of the falsity
of the material misrepresentation, and (2) [a] specific intent to deceive the PTO.” Id. To satisfy
this standard, the pleading “must include sufficient allegations of underlying facts from which a
court may reasonably infer that a specific individual (1) knew of the withheld material
information or of the falsity of the material misrepresentation, and (2) withheld or
misrepresented this information with a specific intent to deceive the PTO.” Id. at 1328–29.
Teva avers that Lilly’s proposed amended answer is futile because it (1) generally
ascribes conduct to “the Applicants” rather than to any specific person; (2) does not contain facts
sufficient to show that the false or withheld information was material or known to be material;
and (3) ignores that a specific individual has to act with a deliberate intent to deceive. [ECF No.
207-1 at 11–23].
First, Teva is correct that many of Lilly’s allegations in its proposed amended answer do
not refer to a specific individual and instead refer to “Applicants,” which is defined in Count
XIX of the proposed amended answer, as
the applicants, their attorneys, and/or their agents, and/or the person(s) involved in
the preparation and/or prosecution of that patent, including without limitation,
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Labrys Biologics, Inc. (“Labrys”), attorneys at Wilson Sonsini Goodrich & Rosati,
including, Adam J. Cole (patent agent at Wilson Sonsini Goodrich & Rosati), and
Jeffrey C. Giering (former patent attorney at Wilson Sonsini Goodrich & Rosati)
(collectively, “WSGR Counsel”), Teva Pharmaceutical Industries Ltd. (“Teva
Ltd.”), and Teva Pharmaceuticals International GmbH . . . .
[ECF No. 176-6 ¶ 141]. Lilly disputes that this broad definition applies and asserts that when
used in Count XXI, which is the proposed inequitable conduct claim, “Applicants” is separately
defined to refer only to the named inventors, which is a discrete group of six individuals. See
[ECF No. 221-19 at 10–11; ECF No. 176-5 ¶ 246 (stating that “[d]uring prosecution, each of the
named inventors self-identified as and was referred to as ‘Applicant’ or ‘Applicants’ of the ’045
patent.”)]. Lilly fails to mention, however, that its proffered definition of “Applicants” does not
appear until more than fifty paragraphs into Count XXI and after the term “Applicants” had been
used more than twenty times within the counterclaim. [ECF No. 176-5 ¶¶ 187–245]. Thus, its
argument that any reference to “Applicants” should be interpreted to refer only to the named
inventors strains credulity. Further, throughout Count XXI, Lilly separately uses the term
“named inventors,” which shows that when it wanted to refer to this defined group, it used
“named inventors,” not “Applicants.” E.g., [id. ¶¶ 267–68]. Accordingly, because the
allegations that refer generally to “Applicants” encompass many potential individuals and
entities, they do not meet the specificity requirements of Rule 9. See Exergen Corp., 575 F.3d at
1329 (finding that allegations that generally refer to “Exergen, its agents, and/or attorneys” failed
to “identify the ‘who’ of the material omissions and misrepresentation”).
With the references to “Applicants” stripped away, the Court must determine whether the
remaining factual allegations contain “the specific who, what, when, where, and how of the
material misrepresentation or omission committed before the PTO.” Exergen, 575 F.3d at 1327.
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In its briefing, Lilly largely focuses on three specific individuals who made misrepresentations to
and Dr. Giering.
Lilly alleges that these two inventors knew about
did not disclose them. [ECF No. 176-5 ¶¶ 215
disclosed in the November 2006 PCT Application, which led to the patents-in-suit.”); 220 (“At
were involved in drafting the November 2006 PCT
Application . . . containing claims broadly reciting anti-CGRP antagonist antibodies, not limited
by structure or even epitope.” ); 285, 287, 294 (alleging that the named inventors, which
knew about the
were not disclosed)]. Lilly also alleges that
For Dr. Giering, the proposed amended
answer specifically alleges that in June 2013 he submitted an application to the PTO during
prosecution of the ‘045 patent that stated that “any antibody that effectively binds CGRP may
reasonably be expected to have the claimed effect.” [Id. ¶ 260]. The factual allegations relating
to these three individuals are all specific enough to satisfy the heightened pleading standard.
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Also, the three categories of withheld information
) were plainly material. “[T]he materiality required to
establish inequitable conduct is but-for materiality.” Therasense, Inc. v. Becton, Dickinson &
Co., 649 F.3d 1276, 1291 (Fed. Cir. 2011). Information is material if “there is a substantial
likelihood that a reasonable examiner would consider it important in deciding whether to allow
the application to issue as a patent,” Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359, 1364
(Fed. Cir. 2007) (citing 37 C.F.R. § 1.56(a) (1991)), or “it falls within the standards set forth in
PTO Rule 56” which explains that information is material if “it is not cumulative to information
already of record or being made of record in the application, and . . . [i]t refutes, or is
inconsistent with, a position the applicant takes in: (i) [o]pposing an argument of unpatentability
relied on by the [PTO], or (ii) [a]sserting an argument of patentability.” Signify N. Am. Corp. v.
Reggiani Lighting USA, Inc., No. 18-cv-11098, 2020 WL 1331919, at *5 (S.D.N.Y. Mar. 23,
2020) (quoting Nycomed U.S. Inc. v. Glenmark Generics Ltd., No. 08-cv-05023, 2010 WL
1257803, at *14 (E.D.N.Y. Mar. 26, 2010)). The 2006 PCT Application claims “[a] method for
preventing or treating at least one vasomotor symptom in an individual, comprising
administering to the individual an effective amount of an anti-CGRP antagonist antibody.” [ECF
No. 176-6 ¶ 240]. Evidence that
directly cuts against the recited claim relating to antiCGRP antibodies. Thus, if this information had been disclosed to the PTO, a reasonable
examiner would have considered it important when deciding whether to issue the patent.
Likewise, Lilly alleges that Dr. Giering’s June 2013 statement was made in response to criticism
from the PTO and was ultimately the reason that the ‘045 patent issued. [ECF No. 176-6
Case 1:18-cv-12029-ADB Document 251 Filed 01/11/22 Page 25 of 26
¶¶ 260–63]. This supports the inference that a reasonable examiner would have found it
important to know if the June 2013 statement were true or false.
Finally, the Court finds that the allegations in the proposed amended answer, when
construed in Lilly’s favor, support the reasonable inference that
specific intent and knew the materiality of the withheld information. Lilly alleges that
(8) during patent prosecution
signed declarations stating that they “reviewed and understand the contents . . .
including the claims” of the 2006 PCT Application and acknowledged their duty to disclose to
the PTO “all information known . . . to be material to patentability[,]” [id. ¶¶ 246–477]. Thus,
considered together, the allegations suggest that
understood the significance
of an antibody’s structure (i.e., ability to bind to different CGRP regions), were aware of the
withheld information, had a role in drafting the 2006 PCT Application, and knew about their
duty to disclose the material information, but chose not to do so. As a result, the Court may
reasonably infer that they knew the withheld information was important and their intent was to
deceive the PTO by not disclosing it. Teva argues that many inferences can be drawn from the
Case 1:18-cv-12029-ADB Document 251 Filed 01/11/22 Page 26 of 26
facts other than an intent to deceive. [ECF No. 207-1 at 20–23]. Although Teva’s theory may
prevail at a later stage, Lilly is not required to prove its case at the pleading stage. See Exergen
Corp. 575 F.3d at 1329 n.5 (“In contrast to the pleading stage, to prevail on the merits, the
accused infringer must prove both materiality and intent by clear and convincing evidence.”).
Lilly’s allegations regarding Dr. Giering, however, do not fare as well. The proposed
amended answer contains no allegation that Dr. Giering knew of
made the June 2013 statement, or that he understood the importance of
Accordingly, the Court cannot reasonably infer that he even knew that his statement was false,
let alone that it was material or meant to deceive. Thus, any inequitable conduct on the part of
Dr. Giering is inadequately pled.
In sum, Lilly’s motion to amend its answer is GRANTED, except to the extent that it
premises its inequitable conduct claim on Dr. Giering’s June 2013 statement or makes
allegations generally about the “Applicants.”
Accordingly, for the reasons set forth above, Teva’s motion for sanctions, [ECF No. 143],
and Lilly’s motion to exclude, [ECF No. 181], are DENIED and Lilly’s motion to amend its
answer, [ECF No. 175], is GRANTED, except to the extent that its inequitable conduct claim
relies on Dr. Giering’s June 2013 statement to the PTO or makes allegations generally about the
“Applicants.” Dr. Hale is ORDERED not to disclose any of Lilly’s confidential information or
work product to Teva.
December 20, 2021
/s/ Allison D. Burroughs
ALLISON D. BURROUGHS
U.S. DISTRICT JUDGE
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