Case 1:18-cv-12029-ADB Document 535 Filed 10/17/22 Page 1 of 20
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MASSACHUSETTS
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`Civil Action No. 18-cv-12029-ADB
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`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and TEVA
`PHARMACEUTICALS USA, INC.,
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`Plaintiffs,
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`v.
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`ELI LILLY AND COMPANY,
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`Defendant.
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`MEMORANDUM AND ORDER ON MOTIONS IN LIMINE
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`BURROUGHS, D.J.
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`Currently before the Court are several motions in limine (“MIL”) filed by Plaintiffs Teva
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`Pharmaceuticals International GmbH and Teva Pharmaceuticals USA, Inc. (collectively,
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`“Teva”), [ECF No. 481 (omnibus motion)], and Defendant Eli Lilly and Company (“Lilly”),
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`[ECF Nos. 472, 474, 476, 477, 478, 479, and 480]. Having considered all of the submissions
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`filed in connection with these motions, and having heard oral argument regarding Lilly’s MIL
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`No. 2 regarding Bergerot, the Court makes the following determinations with respect to the
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`motions.
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`I.
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`DISCUSSION
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`The Court assumes the parties’ familiarity with the underlying facts and allegations in
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`this case. In sum, Teva brings this case alleging that Lilly has infringed three patents1 (the
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`“Patents-in-Suit”) that relate to the treatment of headaches. Lilly disputes this and contends that
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`1 U.S. Patent Nos. 8,586,045 (the “’045 patent”); 9,884,907 (the “’907 patent”); and 9,884,908
`(the “’908 patent”).
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`Case 1:18-cv-12029-ADB Document 535 Filed 10/17/22 Page 2 of 20
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`the Patents-in-Suit are unenforceable because they are invalid and because Teva engaged in
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`inequitable conduct or has unclean hands. The Court ruled on the parties’ cross-motions for
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`summary judgment, [ECF No. 513], and the case is now ready for trial.
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`A.
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`Teva’s MIL No. 1: Motion to Preclude Lilly From Arguing and Introducing
`Post-Filing Date Evidence to Support Its Enablement and Written
`Description Defenses
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`Teva moves to preclude Lilly from offering opinions or arguments in support of its
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`invalidity defenses that rely on evidence that post-dates the filing date of the Patents-in-Suit,
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`arguing that such evidence is irrelevant and unfairly prejudicial. [ECF No. 483 at 10]. Teva
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`argues that the evidence is irrelevant because compliance with the written description and
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`enablement requirements is judged based on the state of the art as of the filing date of the
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`patents. [Id. at 11 (citations omitted)].
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`Although Teva is correct that written description and enablement are judged based on the
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`state of the art as of the filing date, see Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336,
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`1351 (Fed. Cir. 2010) (“[T]he description must ‘clearly allow persons of ordinary skill in the art
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`to recognize that [the inventor] invented what is claimed.’ In other words, the test for sufficiency
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`is whether the disclosure of the application relied upon reasonably conveys to those skilled in the
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`art that the inventor had possession of the claimed subject matter as of the filing date.”) (second
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`alteration in original) (internal citations omitted); Ajinomoto Co. v. Archer-Daniels-Midland Co.,
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`228 F.3d 1338, 1345 (Fed. Cir. 2000) (“Enablement is determined from the viewpoint of persons
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`of skill in the field of the invention at the time the patent application was filed.”), this does not
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`mean that all evidence that post-dates the filing date is irrelevant. With respect to the written
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`description inquiry, the Federal Circuit has held that in the context of functionally defined genus
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`claims, such as those at issue here, “post-priority-date evidence of a particular species can
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`reasonably bear on whether a patent fails to disclose a representative number of species falling
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`2
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`Case 1:18-cv-12029-ADB Document 535 Filed 10/17/22 Page 3 of 20
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`within the scope of the genus or structural features common to the members of the genus so that
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`one of skill in the art can visualize or recognize the members of the genus.” Amgen Inc. v.
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`Sanofi, 872 F.3d 1367, 1374 (Fed. Cir. 2017) (internal quotation marks and citation omitted). As
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`for enablement, the Federal Circuit has held that “post-priority-date evidence showing that [the
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`patent owner] engaged in lengthy and potentially undue experimentation to enable the full scope
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`of the claims” “could have been relevant to determining if the claims were enabled as of the
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`priority date and should not [be] excluded simply because [the evidence] post-date[s] the claims’
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`priority date.” Id. at 1375.
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`Therefore, because evidence that post-dates the filing date is not categorically irrelevant
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`to the issues of written description and enablement, Teva’s motion is DENIED.
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`B.
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`Teva’s MIL No. 2: Motion to Preclude Lilly From Arguing and
`Introducing Evidence That FDA-Required Studies Are Relevant to
`Lilly’s Written Description and Enablement Arguments
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`Teva next moves to prevent Lilly from introducing, with respect to the written description
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`and enablement inquiries, three categories of evidence related to testing performed for regulatory
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`purposes in connection with FDA approval. [ECF No. 483 at 16]. The evidence pertains to (1)
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`the timeline relating to Lilly’s Phase II and Phase III clinical trials and the amount of effort
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`involved in conducting those trials, (2) the Phase III results for Emgality (Lilly’s galcanezumab)
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`and Ajovy (Teva’s fremanezumab) for the treatment of episodic cluster headaches, and (3) the
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`assertion by Lilly’s experts that testing in “non-human primates” was “required” to comply with
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`the written description and enablement inquiries. [Id.].
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`35 U.S.C. § 112 states that a patent specification “shall contain a written description of
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`the invention[,]” the test for which is “an objective inquiry into the four corners of the
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`specification from the perspective of a [POSA].” Ariad, 598 F.3d at 1351. “A specification
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`adequately describes an invention when it ‘reasonably conveys to those skilled in the art that the
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`Case 1:18-cv-12029-ADB Document 535 Filed 10/17/22 Page 4 of 20
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`inventor had possession of the claimed subject matter as of the filing date.’” Juno Therapeutics,
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`Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1335 (Fed. Cir. 2021) (quoting Ariad, 598 F.3d at
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`1351). The enablement requirement, for its part, demands that the specification “teach the public
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`how to practice the full scope of the claimed invention.” McRO, Inc. v. Bandai Namco Games
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`Am., Inc., 959 F.3d 1091, 1099–100 (Fed. Cir. 2020) (internal quotation marks omitted) (quoting
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`AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244 (Fed. Cir. 2003)). Further, “[t]o prove that a
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`claim is invalid for lack of enablement, a challenger must show by clear and convincing evidence
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`that a person of ordinary skill in the art would not be able to practice the claimed invention
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`without ‘undue experimentation.’” Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080, 1084
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`(Fed. Cir. 2021) (quoting Alcon Rsch. Ltd. v. Barr Lab’ys, Inc., 745 F.3d 1180, 1188 (Fed. Cir.
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`2014)). “Whether undue experimentation is needed is not a single, simple factual determination,
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`but rather is a conclusion reached by weighing many factual considerations.” In re Wands, 858
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`F.2d 731, 737 (Fed. Cir. 1988).
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`1.
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` The timeline related to Lilly’s Phase II and Phase III clinical trials and the
`effort involved in conducting such trials.
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`Teva argues that Lilly should not be permitted to introduce evidence related to its Phase
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`II or Phase III clinical trials to support its invalidity defenses because those trials are part of the
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`FDA’s process for evaluating the safety and efficacy of new drugs, which, according to Teva, is
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`irrelevant to these defenses. [ECF No. 483 at 17]. Lilly argues in response that Teva has
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`confused what is required for patentability with relevance. [ECF No. 501 at 19]. In Lilly’s view,
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`the clinical trials are relevant to both invalidity defenses because they bear on when persons
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`skilled in the art would have believed it was possible to treat headache using an anti-CGRP
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`antagonist antibody. [Id.].
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`Following the same line of reasoning discussed in the Court’s order on Teva’s MIL No.
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`1, the Court finds that evidence of Lilly’s clinical trials is relevant to the enablement inquiry
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`because it may offer insight into the extent of experimentation necessary to practice the claimed
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`methods. In contrast, the Court does not see how Lilly’s later clinical trials are relevant to the
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`issue of written description. As an en banc panel of the Federal Circuit has held, the test to
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`determine if the written description requirement is met involves “an objective inquiry into the
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`four corners of the specification from the perspective of a [POSA].” Ariad, 598 F.3d at 1351.
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`Evidence of later clinical trials are thus outside of the proper scope of the written description
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`inquiry. Therefore, Lilly may introduce evidence of its Phase II and Phase III clinical trials in
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`the context of enablement but may not use the same evidence with respect to written description
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`unless it can show relevance beyond what is currently before the Court. The Court will give
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`limiting instructions as warranted.
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` 2. Phase III results for Emgality and Ajovy for treating episodic cluster
`headache.
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`For the same reasons discussed above, evidence regarding Phase III results for Emgality
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`and Ajovy may be referenced in the context of enablement but not with regard to written
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`description unless there is a showing of relevance at trial.
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` 3. Assertion by Lilly’s experts that testing in “non-human primates” is
`“required” to comply with the written description and enablement
`inquiries.
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`The parties appear to agree that Lilly may not suggest to the jury that testing on non-
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`human primates is required to meet Section 112’s written description and enablement
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`requirements. The Court concurs. Nevertheless, Lilly may, subject to proper objections, argue
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`that the absence of such data supports its invalidity arguments.
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`Accordingly, Teva’s MIL No. 2 is GRANTED in part and DENIED in part with leave to
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`renew at trial if warranted.
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`C.
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` Teva’s MIL No. 3: Motion to Preclude Lilly From Using and Introducing
`As Evidence Expert Depositions and Declarations From Witnesses That Are
`Not Testifying In This Case
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`In this motion, Teva seeks to prohibit Lilly from introducing deposition testimony and
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`declarations by experts that Teva relied upon in the inter partes review (“IPR”) proceedings
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`regarding the Patents-in-Suit. Granting Teva’s request would be improper. To begin, statements
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`by Teva’s experts in the IPR proceedings—whether in the form of deposition testimony or
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`declarations—are admissible if Lilly’s experts relied on those statements in forming their
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`opinions. Fed. R. Evid. 703. The Court also agrees with Lilly that statements by these experts
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`fall under Fed. R. Evid. 801(d)(2)(C)’s exception to hearsay because they were made by people
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`whom Teva “authorized to make a statement on the subject[.]” Accordingly, Teva’s MIL No. 3
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`is DENIED with leave to renew at trial if warranted.
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`D.
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`Teva’s MIL No. 4: Motion to Preclude Lilly From Arguing and Introducing
`Evidence Regarding Statements Concerning Unrelated Patents
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`Teva seeks to stop Lilly from introducing (1) a statement by Teva’s counsel that
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`described the specification in the Patents-in-Suit as “scant and mostly irrelevant” when talking
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`about dosing fremanezumab in connection with a different invention and (2) prior statements by
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`one of Teva’s experts, Dr. Ravetch. The statement by Teva’s counsel was made during the
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`prosecution of a different patent, the ’705 Application, that related to the “recommended dose”
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`of fremanezumab. In contrast, the Patents-in-Suit claim only the treatment of headache with an
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`“effective amount” of an anti-CGRP antibody. And, as Teva correctly notes, later inventive
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`work, such as the identification of a recommended dose, “does not alone show nonenablement.”
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`CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1340 (Fed. Cir. 2003). While the statement
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`by Teva’s counsel may have a modicum of relevance to the invalidity inquiries, the Court finds
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`that the relevance of this statement—made in the context of a separate invention that claimed
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`something above and beyond what was claimed in the Patents-in-Suit—is far outweighed by the
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`risk it will confuse and prejudice the jury. The Court thus GRANTS to the motion to the extent
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`it seeks to include the statement by Teva’s counsel.
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`Lilly, however, is free to use Dr. Ravetch’s prior sworn testimony during cross-
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`examination to impeach his credibility, and accordingly the motion is DENIED to the extent it
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`sought to exclude said testimony. If Teva believes the line of questioning lacks relevance or is
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`otherwise objectionable, it may raise those issues at trial.
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`E.
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`Teva’s MIL No. 5: Motion to Preclude Lilly from Introducing As Evidence
`Lilly’s Patent Covering the Use of Emgality
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`Teva also moves to bar the introduction of Lilly’s patents related to Emgality
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`(galcanezumab). [ECF No. 483 at 23]. The motion is DENIED with leave to renew at trial.
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`Beyond the doctrine of equivalents, the patents, at a minimum, are relevant to Lilly’s written
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`description defense and whether there was willful infringement. Any potential confusion—the
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`risk of which the Court views as minimal—can be appropriately addressed by a limiting
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`instruction to the jury.
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`F.
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`Teva’s MIL No. 6: Motion to Preclude Lilly from Arguing Or Suggesting
`That Teva Is Asserting DOE In This Case Because Of Concerns Of Validity
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`Teva contends that Lilly should be precluded from arguing that Teva is asserting
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`infringement under the doctrine of equivalents because Teva doubts the validity of its asserted
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`claims. [ECF No. 483 at 27]. Lilly responds that it “should be permitted to present this
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`[argument] to the jury if Teva opens the door by telling the jury that the patents-in-suit are
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`presumed valid.” [ECF No. 501-1 at 29]. Because Lilly’s motion to preclude Teva from
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`referring to the “presumption of validity,” [ECF No. 476], is GRANTED, this motion is
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`DENIED as moot with leave to renew if warranted.
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`G.
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`Teva’s MIL No. 7: Motion to Preclude Lilly From Referencing Inequitable
`Conduct Allegations, Including Any Facts Solely Related To Equitable
`Defenses
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`Teva moves to bar Lilly from introducing any evidence or making any arguments
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`regarding Lilly’s inequitable conduct and unclean hands defenses, and specifically requests that
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`Lilly be precluded from referring to alleged decisions by the named inventors of the Patents-in-
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`Suit to withhold any scientific references from the United States Patent & Trademark Office
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`(“PTO”), the process by which these references would have been disclosed to the PTO, or
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`disparaging the named inventors of the Patents-in-Suit. Teva further asks that Lilly be prevented
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`from offering any opinions regarding the materiality of the allegedly withheld scientific
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`references or the intent of the named inventors. [ECF No. 483 at 28]. This motion is DENIED
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`with leave to renew at trial. To begin, Lilly states that it “does not plan to present evidence to the
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`jury relating to the intent of Drs. Zeller and Pons or the ‘materiality’ of the references per se.”
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`[ECF No. 501-1 at 30]. Lilly further “agrees that no evidence related to its inequitable conduct
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`Counterclaims XIX-XX on correction of priority of the patents-in-suit will be shown to the jury.”
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`[Id. n.13]. Thus, it appears that the parties understand that there are proper and improper uses for
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`evidence that is related to Lilly’s inequitable conduct defenses, and because such evidence may
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`be relevant to other issues to be decided by the jury, it would be improper for the Court to
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`preemptively bar the introduction of any evidence that pertains to alleged inequitable conduct.
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`H.
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`Teva’s MIL No. 8: Motion to Preclude Lilly From Arguing Or Introducing
`Evidence That It Had A Subjective Good Faith Belief That Teva’s Patents
`Were Invalid or Not Infringed
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`Teva contends that Lilly should be prevented from introducing argument or evidence that
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`Lilly and its principals had a subjective good faith belief in the company’s defenses, namely
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`Case 1:18-cv-12029-ADB Document 535 Filed 10/17/22 Page 9 of 20
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`invalidity and non infringement. [ECF No. 483 at 29]. Teva’s view is that any subjective belief
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`that Lilly, or its principals, had regarding its defenses was the product of receiving advice from
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`counsel and, therefore, Lilly was required to disclose summaries of the legal advice within 28
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`day of the Court’s claim construction ruling pursuant to Local Rule 16.6(f). [Id. at 30]. Lilly
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`counters that it “has never stated that its subjective, good faith belief was based on [advice of
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`counsel]” and points to other evidence, including its IPR petitions and the alleged structural and
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`functional differences between galcanezumab and fremanezumab, as the basis for its good faith
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`subjective belief. [ECF No. 501-1 at 32]. Based on the briefing on this motion, it appears there
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`may be evidence apart from advice received from counsel that supports Lilly’s belief in its
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`defenses, and thus the Court will not categorically preclude Lilly from introducing evidence
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`supporting its beliefs absent an inquiry into whether that particular piece of evidence was related
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`to advice of counsel. The Court, however, warns Lilly that use of its IPR petitions or other IPR
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`materials may open the door to inquiries by Teva concerning the advice of counsel with this
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`determination to be made at trial with a more complete record and some context. Teva’s motion
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`is therefore DENIED with leave to renew at trial as warranted.
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`I.
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`Teva’s MIL No. 9: Motion to Preclude Lilly From Relying On Testimony
`From Witnesses Not Disclosed On Initial Disclosures
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`Teva asks the Court to stop five of Lilly’s fact witnesses (Ryan Darling, Ryan Pettibone,
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`Kathryn Ramseyer, Cory Rotterman, and Laura Steele) from testifying at trial primarily because
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`Lilly did not identify any of the witnesses in its Fed. R. Civ. P. 26(a)(1)(A) disclosures. Teva
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`claims that Lilly’s failure to properly disclose these individuals reflects its “complete disregard”
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`for its disclosure obligations. This contention, however, ignores the express language of Rule
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`26(e), which states that a party must supplement its Rule 26(a) disclosures only “if the additional
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`or corrective information has not otherwise been made known to the other parties during the
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`discovery process . . . .” Fed. R. Civ. P. 26(e)(1)(A). Each of the five witnesses that Teva asks
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`be barred from testifying were deposed by Teva during the course of discovery. See [ECF No.
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`483 at 34]. Given that Lilly designated four of the five witnesses as Fed. R. Civ. P. 30(b)(6)
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`corporate designees and that Teva deposed each of them, its nondisclosure argument fails.
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`Accordingly, the motion is DENIED.
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`J.
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`Teva’s MIL No. 10: Motion to Preclude Lilly From Disparaging Generic
`Drugs, Generic Drug Manufacturers, or Teva
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`In this multi-part motion, Plaintiff asks the Court to preclude Lilly from advancing a wide
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`variety of arguments, statements, and evidence, including: (1) Teva’s involvement in a
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`Department of Justice (“DOJ”) antitrust investigation and opioid litigation; (2) Teva’s respect, or
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`lack thereof, for patent rights; (3) references to Teva as an Israeli business or derogatory
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`statements regarding Israel or Israeli businesses; (4) Teva’s alleged lack of experience working
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`with pharmacy benefit managers (“PBMs”); (5) Teva’s sale of opioids; and (6) Teva’s
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`discontinuation of Zecuity. [ECF No. 483 at 35–39].
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`Teva asks the Court to stop Lilly from introducing any evidence or referring to other
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`proceedings involving Teva that are unrelated to the Patents-in-Suit, including but not limited to
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`a Department of Justice antitrust investigation and opioid litigation. [ECF No. 483 at 35]. Teva
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`argues that these other matters are irrelevant to the substantive issues in this case and that such
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`evidence is likely to confuse and mislead the jury. [Id. at 35–36]. Lilly responds that the opioid
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`litigations and DOJ antitrust investigations are “relevant to the damage calculations [in this case]
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`and Teva’s pursuit of damages from Lilly[,]” because they bear on “Teva’s negotiating power
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`during the hypothetical negotiation for the reasonable royalty analysis . . . .” [ECF No. 501-1 at
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`39]. While the DOJ investigation and the opioid litigation may have some minimal relevance to
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`the hypothetical negotiation, that limited relevance is substantially outweighed by the risk of
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`Case 1:18-cv-12029-ADB Document 535 Filed 10/17/22 Page 11 of 20
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`confusion and prejudice, especially in light of media coverage of the ongoing opioid epidemic.
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`Therefore, Teva’s motion is GRANTED to the extent it seeks to preclude evidence related to the
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`DOJ antitrust investigation or Teva’s involvement in opioid litigation.
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`Teva’s motion is further GRANTED to the extent it seeks to preclude (1) Lilly from
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`introducing evidence or argument related to Teva’s sales of opioids and/or opioid abuse and (2)
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`evidence related to removal of Zecuity from the market because any relevance of either category
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`of evidence is similarly substantially outweighed by its danger to confuse and prejudice the jury.
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`To the extent Teva’s motion seeks to preclude Lilly from arguing that Teva does not
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`respect patent rights, it is DENIED as moot because Lilly does not intend to advance such
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`arguments at trial.
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`Teva also seeks to bar Lilly from “referring to Teva as an Israeli business and [] making
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`derogatory statements regarding Israel or Israeli businesses.” [ECF No. 483 at 37]. This aspect
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`of the motion is DENIED as moot based on Lilly’s statement that it does not intend to make such
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`statements. The Court will allow incidental references to the fact that Teva, or its witness, is
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`based in Israel but cautions against any suggestion that this is relevant to the merits of this
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`dispute.
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`Finally, Lilly may introduce evidence regarding the extent of Teva’s experience working
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`with pharmacy benefit managers to the extent relevant to a hypothetical negotiation but is
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`cautioned to limit its reliance on the fact that Teva’s business involves generics.
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`Accordingly, Teva’s MIL No. 10 is GRANTED in part and DENIED in part.
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`K.
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`Teva’s MIL No. 11: Motion to Preclude Lilly From Relying On Non-
`Comparable Licenses
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`Teva asks that the Court preclude Lilly from introducing any evidence regarding patent
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`licensing agreements that it contends “are not comparable or relevant to the hypothetical
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`negotiation in this case. [ECF No. 483 at 40]. Because Lilly has agreed not to use certain of the
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`licenses referenced in Teva’s motion, this motion now concerns only licenses produced at
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`DTX_0314, DTX_0315, and DTX_0316. [ECF No. 501-1 at 43]. Lilly argues that these
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`remaining licenses are relevant to the royalty analysis and thus damages, and points to its
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`expert’s reliance on the documents in preparing his expert report. [Id.]. The Court cannot
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`determine, based on the very limited briefing, whether the licenses, which purportedly
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`“transferred patent rights and other intellectual property rights related to the active ingredient in
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`Ajovy,” [id.], should be excluded. The Court thus DENIES the motion with leave to renew at
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`trial.
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`L.
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`Teva’s MIL No. 12: Motion to Preclude Lilly From Arguing Any Potential
`Impact Of A Jury Verdict In Teva’s Favor On Patients Or Consumers
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`Teva submits that the Court should preclude Lilly from arguing or otherwise suggesting
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`that a jury verdict in Teva’s favor would impact patients or consumers by, among other things,
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`increasing costs or removing a product option from the market. [ECF No. 483 at 41]. In
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`support, Teva argues that such evidence is irrelevant and unfairly prejudicial. Under Federal
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`Rule of Evidence 401 “[e]vidence is relevant if it has any tendency to make a fact more or less
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`probable” and “the fact is of consequence in determining the action.” Fed. R. Evid. 401.
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`Although relevant evidence is admissible, the Court may still exclude it “if its probative value is
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`substantially outweighed by a danger of one or more of the following: unfair prejudice,
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`confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting
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`cumulative evidence.” Fed. R. Evid. 402, 403. The Court agrees that this sort of market
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`evidence has minimal, if any, relevance to the issues to be decided by the jury and that whatever
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`relevance it has is substantially outweighed by the danger of unfair prejudice. Accordingly, the
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`motion is GRANTED.
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`Case 1:18-cv-12029-ADB Document 535 Filed 10/17/22 Page 13 of 20
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`M.
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`Teva’s MIL No. 13: Motion to Preclude Lilly from Taking Positions
`Contrary to Ones taken by Lilly During Inter Partes Review Proceedings
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`Teva appears to raise in this motion the same arguments set forth in its motion for partial
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`summary judgment regarding judicial estoppel, see [ECF No. 314], and Lilly in its opposition
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`incorporates by reference its position on that motion, see [ECF No. 501-1 at 45–46, 46 n.26].
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`For the reasons set forth in the Court’s order denying Teva’s motion for partial summary
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`judgment, see [ECF No. 513 at 16–23], this motion is similarly DENIED with leave to renew at
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`trial if warranted.
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`N.
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`Teva’s MIL No. 14: Motion to Preclude Lilly From Showing Witnesses
`Documents that They are Not Authorized to Access Under the Protective
`Order
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`Teva asks the Court to categorically preclude Lilly from showing witnesses documents
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`during direct or cross examination that the witnesses are not authorized to access or review under
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`the applicable protective order. [ECF No. 483 at 43 (citing ECF No. 381 (protective order))].
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`The Court agrees with Lilly that any general order prohibiting witnesses from reviewing entire
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`documents would be premature and inappropriate as there will be, for example, portions of
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`documents that are subject to the protective order and other portions that are not. The Court will
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`address such issues as they arise at trial. The motion is DENIED.
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`O.
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`ECF No. 472: Lilly’s MIL No. 1 Regarding Judicial Estoppel
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`Lilly’s first motion in limine asks the Court to find that Teva is judicially estopped from
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`advancing arguments at trial related to the state of the art with respect to the blood-brain barrier
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`(“BBB”) and associated skepticism about the ability of antibody drugs to treat migraines, which
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`Lilly contends directly contradict positions Teva advanced in the IPRs. Having closely
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`considered the allegedly contradictory statements, Lilly’s motion is DENIED. Lilly’s arguments
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`fail to take into account key differences between this case and the IPR proceedings, including the
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`Case 1:18-cv-12029-ADB Document 535 Filed 10/17/22 Page 14 of 20
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`different legal issues at play, and also misconstrue the record. For example, in the IPR
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`proceedings one of the questions presented to the Patent Trial and Appeals Board (“PTAB”) was
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`the obviousness of the patents, which involved examining the prior art absent and apart from any
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`new information contained in the claimed invention’s specification. In that context, Teva’s
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`experts opined that a POSA, without the benefit of the specification of the Patents-in-Suit, would
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`be skeptical of an anti-CGRP antibody being able to treat migraine. It is not contradictory,
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`however, for Teva’s experts to opine, in the instant proceeding, that a POSA’s skepticism would
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`have been addressed based on the additional information contained in the specification. Lilly’s
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`additional arguments regarding Teva’s allegedly contradictory statements regarding (1) the
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`action site of small-molecule drugs, (2) the closed cranial window assay, and (3) skepticism that
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`remained after the filing of the Patents-in-Suit, fail because they are each premised on
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`misconstructions or mischaracterizations of the record.
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`P.
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`ECF No. 474: Lilly’s MIL No. 2 Regarding Bergerot
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`
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`Lilly moves to preclude Teva from introducing testimony or argument regarding a
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`scientific article referred to as Bergerot, which was published in September 2006 because it was
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`produced late and because Teva did not supplement its interrogatory responses to identify the
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`article as support for the validity of the asserted claims. [ECF No. 475 at 5]. Lilly also argues
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`that Bergerot is not prior art and therefore irrelevant.
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`
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`Whether to admit Bergerot, a scientific journal article that was produced in discovery and
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`relied on during expert depositions, turns largely on whether it qualifies as prior art. In Lilly’s
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`view, it is not because Teva has stated previously that the asserted claims were reduced to
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`practice as of November 14, 2005. [ECF No. 475 at 10 n.3]. Teva, on the other hand, claims
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`Case 1:18-cv-12029-ADB Document 535 Filed 10/17/22 Page 15 of 20
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`that it is prior art because the “effective filing date” for the Patents-in-Suit is November 2, 2006.
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`[ECF No. 504-1 at 7].
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`
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`35 U.S.C. § 102(a)(1) defines prior art as information that was “available to the public
`
`before the effective filing date of the claimed invention.” Relevant here, the Patents-in-Suit
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`“descend from, and claim priority to, two earlier parent patent applications.” [ECF No. 504-1 at
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`7]. The first parent application is U.S. Provisional Application No. 60/736,623, which was filed
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`on November 14, 2005, and the second is U.S. Patent Application No. 12/093,638, which was
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`filed under 35 U.S.C. § 371 as a U.S. national stage entry of International Patent Application No.
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`PCT/IB2006/003181, which, in turn, was filed on November 2, 2006. [Id.]. This procedural
`
`history matters here because the effective filing date of an “application that entered the national
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`stage under 35 U.S.C. § 371 is the international filing date.” Manual of Patent Examining
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`Procedure § 2139.01. Therefore, although the Patents-in-Suit claim priority to the 2005
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`application, their effective filing date is November 2, 2006.
`
`
`
`Adding yet another level of complexity to this analysis, Teva stated in its first
`
`supplemental responses to Lilly’s first set of interrogatories that the Patents-in-Suit were
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`“constructively reduced to practice as of . . . November 14, 2005.” [ECF No. 486-17 at 4].
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`Nevertheless, Lilly has cited no authority for the proposition that the date an invention is
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`constructively reduced to practice can replace the invention’s effective filing date, and the Court
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`is similarly unaware of authority to support that conclusion. Rather, it seems that the “effective
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`filing date” and the date an invention is constructively reduced to practice are distinct, but only
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`the former is relevant to identifying the scope of prior art. See 35 U.S.C. § 102(a)(1); see also
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`Ariad, 598 F.3d at 1351 (“[T]he test for sufficiency is whether the disclosure of the application
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`Case 1:18-cv-12029-ADB Document 535 Filed 10/17/22 Page 16 of 20
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`relied upon reasonably conveys to those skilled in the art that the inventor had possession of the
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`claimed subject matter of the filing date.”) (citation omitted).
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`
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`Therefore, because the Patents-in-Suit effective filing date is November 2, 2006, Bergerot
`
`qualifies as prior art. Lilly’s arguments that the article should be excluded because it was
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`produced just before the close of discovery and because Teva did not supplement its
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`interrogatory responses to identify Bergerot as support for the validity of its asserted claims are
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`also unavailing. The first argument fails because the late production of the article was a result of
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`Lil