Opinion
1:20-cv-400-GHW
07-29-2024
MEMORANDUM OPINION & ORDER
GREGORY H. WOODS UNITED STATES DISTRICT JUDGE
The Court refers the reader to the ruling on the motions for summary judgment, filed contemporaneously with this opinion, for a comprehensive overview of the background of this case. In short, Plaintiff Novartis Pharma AG (“Novartis”) and Defendant Incyte Corporation (“Incyte”) partnered to commercialize a valuable drug compound. Under the parties' Agreement, Incyte sells this drug in the United States as “Jakafi,” and Novartis sells it elsewhere as “Jakavi.” The parties agreed to pay one another royalties based on sales of the drug in their respective domains. A dispute arose when Incyte halved its royalty payments to Novartis on U.S. sales of Jakafi in 2019, based on Incyte's interpretation of Section 8.3(c) of the parties' Agreement. Novartis argues that invocation of Section 8.3(c)'s Stepdown Provision in 2019 was improper; Incyte argues that it was not.
Capitalized terms herein take on the meanings prescribed in the Court's summary judgment opinion.
The parties have each proffered two experts to assist in understanding the parties' intent in entering into the agreement, and specifically Section 8.3(c), the agreement's royalty duration provision. This opinion addresses the motions to exclude the proposed opinions, testimony, and reports of the parties' four designated expert witnesses: Novartis's Dr. Linda Pullan and Larry Tedesco, and Incyte's Peter Lankau and Dr. Mohan Rao. For the reasons that follow, each of the four motions to exclude is granted in part and denied in part.
I. PROCEDURAL HISTORY
Novartis filed its complaint on January 15, 2020, asserting that Incyte had breached the parties' contract, and seeking a declaratory judgment requiring repayment of the royalties that Novartis believes have been overdue from the 2019 calendar year “moving forward until either of the two contingencies for Step Down invocation have been satisfied.” Dkt. No. 1 (“Compl.”) ¶ 7. The contractual provision at issue-setting the duration of the parties' royalty payments-is Section 8.3(c) of the parties' November 24, 2009 Collaboration and License Agreement. See Ex. 1 (the “Agreement”).
Section 8.3(c) reads in full:
Royalties payable under this Section 8.3 shall be paid by the applicable Party on a Licensed Product-byLicensed Product and country-by-country basis from the date of First Commercial Sale of each Licensed Product with respect to which royalty payments are due for a period which is the longer of: (i) the last to expire of any Valid Claim of Licensed Patent Rights Covering such Licensed Product in such country; (ii) ten (10) years following the date of First Commercial Sale in such country; and (iii) the expiration of Regulatory Exclusivity for such Licensed Product in such country (each such term with respect to a Licensed Product and a country, a “Royalty Term”).
Notwithstanding the foregoing, in the event that either (A) the Royalty Term continues solely due to clause (ii) (i.e. in a specific country the Licensed Product is neither Covered by a Valid Claim of Licensed Patent Rights nor is such Licensed Product subject to Regulatory Exclusivity) or (B) Generic Competition exists with respect to a Licensed Product in a country with respect to a royalty-reporting period, then the royalty rates in such country for such Licensed Product (for such royalty-reporting period, if applicable) will be reduced to fifty percent (50%) of the applicable rate in Section 8.3(a) or 8.3(b), based on the weighted average annual royalty rate in the Novartis Territory or the Incyte Territory, as the case may be, beginning on January 1st of the Calendar Year following the first Calendar Year in which there exists a situation described in (A) or (B) of this sentence in the applicable country.Agreement § 8.3(c) (emphasis added and line break added for clarity). The cross-motions for summary judgment debate the meaning of this provision, specifically the meaning of the underscored words above: “Licensed Patent Rights” and “Covering.” The second sentence of the provision represents the “Stepdown Provision” that Incyte argues it properly invoked in 2019, which Novartis disputes.
On April 20, 2020, Incyte moved to dismiss Novartis's complaint. See Dkt. No. 32. On February 18, 2021, the Court ruled on the motion to dismiss. Dkt. Nos. 50, 52 (the “MTD Ruling”). In the MTD Ruling, the Court concluded that (1) “Incyte's ‘Regulatory Exclusivity' over Jakafi has expired,” id. at 14; and (2) “the ‘relevant' ‘Licensed Patent Rights' are not unambiguously limited to Novartis Patent Rights,” id. at 19. Thus, “[b]ecause clause (i) of Section 8.3(c) of the Agreement suggests more than one meaning,” the Court concluded that “that provision of the Agreement is ambiguous, and Incyte's motion to dismiss must be denied.” Id. at 24.
The MTD Ruling was corrected on February 22, 2021, see Dkt. No. 52, to “correct[] a single typographical error [that] does not substantively modify the opinion,” see Dkt. No. 51.
On October 21, 2022, the parties filed cross-motions for summary judgment, Dkt. Nos. 175, 176, and moved to exclude the proposed expert testimony of four designated experts: Novartis's Dr. Pullan and Mr. Tedesco, and Incyte's Mr. Lankau and Dr. Rao, Dkt. Nos. 157, 160, 167, 170.
The briefing on the motion to exclude the proposed testimony of Novartis's designated expert, Dr. Pullan, appears at Dkt. Nos. 161 (“Pullan Mem.”), 382 (“Pullan Opp'n”), and 278 (“Pullan Reply”). It is accompanied by declarations at Dkt. Nos. 162, 383. The briefing on Mr. Tedesco, also designated by Novartis as an expert, appears at Dkt. Nos. 388 (“Tedesco Mem.”), 384 (“Tedesco Opp'n”), and 280 (“Tedesco Reply”). It is accompanied by declarations at Dkt. Nos. 187, 385. As for Incyte's designated experts, the briefing to exclude the testimony of Mr. Lankau appears at Dkt. Nos. 374 (“Lankau Mem.”), 249 (“Lankau Opp'n”), and 377 (“Lankau Reply”). It is accompanied by declarations at Dkt. Nos. 375, 250. Last, the briefing pertaining to Dr. Rao, another Incyte-designated expert, appears at Dkt. Nos. 378 (“Rao Mem.”), 245 (“Rao Opp'n”), and 380 (“Rao Reply”). It is accompanied by declarations at Dkt. Nos. 379, 246, 381.
II. LEGAL STANDARD
A. Admissibility of Expert Testimony
Federal Rule of Evidence 702, which governs the admissibility of expert testimony, provides the following:
A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.Fed. R. Evid. 702.
In Daubert v. Merrell Dow Pharm's, Inc., 509 U.S. 579 (1993), the Supreme Court explained that Rule 702 requires district courts to act as gatekeepers-ensuring that expert testimony “both rests on a reliable foundation and is relevant to the task at hand.” Id. at 597. As such, the Court must make “a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.” Id. at 592-93. In short, the Court must “make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999).
1. Qualification as Expert
“Rule 702 requires a trial court to make an initial determination as to whether the proposed witness qualifies as an expert.” Baker v. Urban Outfitters, Inc., 254 F.Supp.2d 346, 352-53 (S.D.N.Y. 2003). “Courts within the Second Circuit ‘have liberally construed expert qualification requirements' when determining if a witness can be considered an expert.” Cary Oil Co. v. MG Refin. & Mktg., Inc., 2003 WL 1878246, at *1 (S.D.N.Y. Apr. 11, 2003) (quoting TC Sys. Inc. v. Town of Colonie, 213 F.Supp.2d 171, 174 (N.D.N.Y. 2002)); accord Plew v. Ltd. Brands, Inc., 2012 WL 379933, at *4 (S.D.N.Y. Feb. 6, 2012). “To determine whether a witness qualifies as an expert, the court must first ascertain whether the proffered expert has the educational background or training in a relevant field.” Crown Cork & Seal Co., Inc. Master Ret. Tr. v. Credit Suisse First Boston Corp., 2013 WL 978980, at *2 (S.D.N.Y. Mar. 12, 2013) (citation and internal quotation marks omitted). “Any one of the qualities listed in Rule 702-knowledge, skill, experience, training, or education-may be sufficient to qualify a witness as an expert.” Id. (citing Tiffany (N.J.) Inc. v. eBay, Inc., 576 F.Supp.2d 457, 458 (S.D.N.Y. 2007)).
Even if a proposed expert lacks formal training in a given area, she may still have “practical experience” or “specialized knowledge” qualifying her to give opinion testimony under Rule 702. See McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1043 (2d Cir. 1995) (quoting Fed.R.Evid. 702) (internal quotation marks omitted). But “[i]f the witness is relying solely or primarily on experience, then [she] must explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts.” Pension Comm. of Univ. of Montreal Pension Plan v. Banc of Am. Sec., LLC, 691 F.Supp.2d 448, 473 n.148 (S.D.N.Y. 2010) (quoting Fed.R.Evid. 702 Advisory Committee's Note). Where a witness's “expertise is too general or too deficient,” the Court “may properly conclude that [she is] insufficiently qualified.” Stagl v. Delta Air Lines, Inc., 117 F.3d 76, 81 (2d Cir. 1997).
A court must then “compare the area in which the witness has superior knowledge, education, experience, or skill with the subject matter of the proffered testimony.” United States v. Tin Yat Chin, 371 F.3d 31, 40 (2d Cir. 2004) (citing United States v. Diallo, 40 F.3d 32, 34 (2d Cir. 1994)). “The expert's testimony must be related to those issues or subjects within his or her area of expertise.” Crown Cork, 2013 WL 978980, at *2 (citing Malletier v. Dooney & Bourke, Inc., 525 F.Supp.2d 558, 642 (S.D.N.Y. 2007)). “If the expert has educational and experiential qualifications in a general field closely related to the subject matter in question, the court will not exclude the testimony solely on the ground that the witness lacks expertise in the specialized areas that are directly pertinent.” In re Zyprexa Prods. Liab. Litig., 489 F.Supp.2d 230, 282 (E.D.N.Y. 2007) (citing Stagl, 117 F.3d at 80). “Thus, an expert ‘should not be required to satisfy an overly narrow test of his own qualifications,' and the court's focus should be on ‘whether the expert's knowledge of the subject is such that his opinion will likely assist the trier of fact in arriving at the truth.'” Crown Cork, 2013 WL 978980, at *2 (quoting Johnson & Johnson Vision Care, Inc. v. CIBA Vision Corp., 2006 WL 2128785, at *5 (S.D.N.Y. July 28, 2006)). “Assertions that the witness lacks particular educational or other experiential background, ‘go to the weight, not the admissibility, of [the] testimony.'” Zyprexa Prods., 489 F.Supp.2d at 282 (quoting McCullock, 61 F.3d at 1044).
2. Expert Testimony Must Assist the Trier of Fact
To be admissible, a district court must conclude that proposed testimony will assist the trier of fact. In re Rezulin Prods. Liab. Litig., 309 F.Supp.2d 531, 540 (S.D.N.Y. 2004). “Testimony is properly characterized as ‘expert' only if it concerns matters that the average juror is not capable of understanding on his or her own.” United States v. Mejia, 545 F.3d 179, 194 (2d Cir. 2008); see also United States v. Amuso, 21 F.3d 1251, 1263 (2d Cir. 1994) (“A district court may commit manifest error by admitting expert testimony where the evidence impermissibly mirrors the testimony offered by fact witnesses, or the subject matter of the expert's testimony is not beyond the ken of the average juror.”).
“Weighing whether the expert testimony assists the trier of fact goes primarily to relevance.” Faulkner v. Arista Recs. LLC, 46 F.Supp.3d 365, 375 (S.D.N.Y. 2014) (citing Daubert, 509 U.S. at 591). Relevance can be expressed as a question of “fit”-“whether expert testimony proffered in the case is sufficiently tied to the facts of the case that it will aid the jury in resolving a factual dispute.” Daubert, 509 U.S. at 591 (quoting United States v. Downing, 753 F.2d 1224, 1242 (3d Cir. 1985) (internal quotation marks omitted)). Expert testimony is not helpful if it “usurp[s] either the role of the trial judge in instructing the jury as to the applicable law or the role of the jury in applying that law to the facts before it.” United States v. Duncan, 42 F.3d 97, 101 (2d Cir. 1994) (quoting United States v. Bilzerian, 926 F.2d 1285, 1294 (2d Cir. 1991)). Expert testimony that is “directed solely to lay matters which a jury is capable of understanding and deciding without the expert's help” should not be admitted. United States v. Mulder, 273 F.3d 91, 101 (2d Cir. 2001) (quoting United States v. Castillo, 924 F.2d 1227, 1232 (2d Cir. 1991)).
3. Expert Testimony Must Be Reliable
In assessing reliability, courts should consider “the indicia of reliability identified in Rule 702, namely, (1) that the testimony is grounded on sufficient facts or data; (2) that the testimony is the product of reliable principles and methods; and (3) that the witness has applied the principles and methods reliably to the facts of the case.” Amorgianos v. Nat'l R.R. Passenger Corp., 303 F.3d 256, 265 (2d Cir. 2002) (citing Fed.R.Evid. 702).
“Under Daubert, factors relevant to determining reliability include ‘the theory's testability, the extent to which it ‘has been subjected to peer review and publication,' the extent to which a technique is subject to ‘standards controlling the technique's operation,' the ‘known or potential rate of error,' and the ‘degree of acceptance' within the ‘relevant scientific community.'” Restivo v. Hessemann, 846 F.3d 547, 575-76 (2d Cir. 2017) (quoting United States v. Romano, 794 F.3d 317, 330 (2d Cir. 2015)). Daubert set forth a non-exhaustive list of factors that district courts may consider in gauging the reliability of scientific testimony, which include: (1) whether the theory has been tested; (2) whether the theory has been subjected to peer review and publication; (3) the known or potential rate of error and whether standards and controls exist and have been maintained with respect to the technique; and (4) the general acceptance of the methodology in the scientific community. Daubert, 509 U.S. at 593-95. “Whether some or all of these factors apply in a particular case depends on the facts, the expert's particular expertise, and the subject of his testimony.” In re Fosamax Products Liab. Litig., 645 F.Supp.2d 164, 173 (S.D.N.Y. 2009) (citing Kumho Tire, 526 U.S. at 138).
When evaluating the reliability of an expert's testimony, the court must “undertake a rigorous examination of the facts on which the expert relies, the method by which the expert draws an opinion from those facts, and how the expert applies the facts and methods to the case at hand.” Id. at 267. If the expert's testimony does not rest on traditional scientific methods, the court may permit testimony “where a proposed expert witness bases her testimony on practical experience rather than scientific analysis.” Davis v. Carroll, 937 F.Supp.2d 390, 412 (S.D.N.Y. 2013). “[T]he reliability inquiry may . . . focus upon personal knowledge and experience of the expert.” Id.
“In undertaking this flexible inquiry, the district court must focus on the principles and methodology employed by the expert, without regard to the conclusions the expert has reached or the district court's belief as to the correctness of those conclusions.” Amorgianos, 303 F.3d at 266. But as the Supreme Court has explained, “conclusions and methodology are not entirely distinct from one another,” and a district court is not required to “admit opinion evidence that is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997) (citation omitted). “Thus, when an expert opinion is based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Amorgianos, 303 F.3d at 266. On the other hand, “[w]here an expert's methodology overcomes the hurdle of being based on a reliable process, remaining controversies as to the expert's methods and conclusions generally bear on the weight and credibility-but not admissibility-of the testimony.” Royal & Sun All. Ins. PLC v. UPS Supply Chain Sols., Inc., 2011 WL 3874878, at *2 (S.D.N.Y. Aug. 31, 2011) (citation omitted).
In light of the liberal admissibility standards of the Federal Rules of Evidence, exclusion of expert testimony is warranted only when the district court finds “serious flaws in reasoning or methodology.” In re Fosamax Prods. Liab. Litig., 645 F.Supp.2d 164, 173 (S.D.N.Y. 2009) (citing Amorgianos, 303 F.3d at 267). Otherwise, if an expert's testimony falls within “the range where experts might reasonably differ,” the duty of determining the weight and sufficiency of the evidence on which the expert relied lies with the jury, rather than the trial court. Kumho Tire, 526 U.S. at 153. “Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.” Daubert, 509 U.S. at 596 (citation omitted). “[T]he proponent of expert testimony has the burden of establishing by a preponderance of the evidence that the admissibility requirements under Rule 702 are satisfied.” United States v. Williams, 506 F.3d 151, 160 (2d Cir. 2007) (citing Daubert, 509 U.S. at 593 n.10).
If, at the end of the court's evaluation of these factors, “‘some, but not all, of an expert's opinions . . . meet the criteria' of Rule 702 of the Federal Rules of Evidence, then ‘a court may exclude portions of an expert report while admitting other portions.'” Royal Park Invs. SA/NV v. U.S. Bank Nat'l Ass'n, 324 F.Supp.3d 387, 394 (S.D.N.Y. 2018) (quoting Carpenters Pension Tr. Fund of St. Louis v. Barclays PLC, 310 F.R.D. 69, 76 (S.D.N.Y. 2015)).
Testimony that is admissible under Rule 702 may be excluded under Federal Rule of Evidence 403 if the court finds that “the probative value of the evidence is substantially outweighed by a danger of . . . unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.” Fed.R.Evid. 403. Expert testimony is particularly susceptible to these dangers, “given to the unique weight such evidence may have in a jury's deliberations.” Nimely v. City of New York, 414 F.3d 381, 397 (2d Cir. 2005). “Expert evidence can be both powerful and quite misleading because of the difficulty in evaluating it. Because of this risk, the judge in weighing possible prejudice against probative force under Rule 403 . . . exercises more control over experts than lay witnesses.” Daubert, 509 U.S. at 595 (quotations omitted).
III. DISCUSSION
The motions to exclude raise common questions of what is, and is not, appropriate for experts to opine on in assisting the factfinder with questions of contract interpretation. As a general matter-and with the caveats explained below-expert opinions discussing (a) what is (or is not) consistent with (or typical of) industry customs and practice, (b) terms of art used in the industry, or (c) the financial models may reliably assist the trier of fact. See, e.g., Iacobelli Const., Inc. v. Cnty. of Monroe, 32 F.3d 19, 25 (2d Cir. 1994) (stating that the district court erred in failing to consider expert affidavits that “described industry practices and customs, defined terms of art used in the industry, explained the approach by which reasonably prudent contractors would interpret the contract documents, and enumerated the conclusions such reasonably prudent contractors would reach”). In contrast-and again, with the caveats explained below-expert opinions discussing (a) the parties' actual state of mind, or speculative inferences regarding what a particular party did or “would have” done had they, as a factual matter, intended a particular result, (b) the meaning of the contract's words per se (in other words, rote contractual interpretation exclusively rooted in, for example, mere dictionary definitions or a provision's grammatical structure), (c) credibility determinations, or (d) other contracts unrelated to this dispute, are generally inadmissible.
Whether any particular opinion is admissible at trial will be resolved at trial. The general rules of decision stated here are intended only to provide guidance and clarity on what follows; they should not be read as a blanket guarantee that any particular statement or piece of evidence that arguably falls into one of these categories will therefore automatically be admissible at trial.
See, e.g., Orlander v. Staples, Inc., 802 F.3d 289, 294 (2d Cir. 2015) (“Whether or not a writing is ambiguous is a question of law to be resolved by the courts.” (quoting W.W.W. Assocs., Inc. v. Giancontieri, 77 N.Y.2d 157, 162 (1990)); Nimely, 414 F.3d at 398 (“[E]xpert opinions that constitute evaluations of witness credibility, even when such evaluations are rooted in scientific or technical expertise, are inadmissible under Rule 702.”); In re Rezulin Prod. Liab. Litig., 309 F.Supp.2d 531, 546 (S.D.N.Y. 2004) (“[T]he opinions of these [expert] witnesses on the intent, motives or states of mind of [the litigants or otherwise] have no basis in any relevant body of knowledge or expertise.”).
Looking ahead, the Court also notes that the question on which the experts will be opining at trial is not whether the language of Section 8.3(c) is ambiguous or not, nor is the question what the text “actually says.” The Court holds in its contemporaneously filed summary judgment ruling-as it must, given that ambiguity is a question of law for the Court, see Orlander v. Staples, Inc., 802 F.3d 289, 294 (2d Cir. 2015)-that the term “Licensed Patent Rights,” as used in Section 8.3(c)(i) of the Agreement, is ambiguous. Further, for the reasons explained in that opinion, the Court holds that a genuine dispute of material fact exists regarding the parties' intended meaning of Section 8.3(c). The question that will remain for the jury is what the intent of the parties was, in 2009, when they drafted this provision. Any expert testimony opining solely on the first step of the inquiry-the ambiguity question-may not be presented to the jury, both because that was a question for the Court, and because the Court resolves it in its contemporaneously filed decision.
As discussed in greater depth in the Court's summary judgment opinion, this should not be misconstrued as suggesting that the Court does not at all consider the expert witnesses' opinions and reports in its summary judgment ruling. First, as discussed in that opinion, the Court considers the admissible opinions in its analysis of whether “the extrinsic evidence illuminating the parties' intended meaning of the contract is ‘so one-sided that no reasonable person could decide to the contrary.'” New York Marine & Gen. Ins. Co. v. Lafarge N. Am., Inc., 599 F.3d 102, 115 (2d Cir. 2010 (quoting Compagnie Financiere de CIC et de L'Union Europeenne v. Merrill Lynch, Pierce, Fenner & Smith, Inc., 232 F.3d 153, 158 (2d Cir. 2000)). Second, as noted in footnote 140 of the summary judgment opinion, the Court's citation to the experts in its discussion of ambiguity vis-a-vis the term “Covering” is done merely to underscore that it is “cognizant of the customs, practices, usages and terminology as generally understood in the particular trade or business.” See Orchard Hill Master Fund Ltd. v. SBA Commc'ns Corp., 830 F.3d 152, 156-57 (2d Cir. 2016) (“A contract is ambiguous under New York law if its terms could suggest more than one meaning when viewed objectively by a reasonably intelligent person who has examined the context of the entire integrated agreement and who is cognizant of the customs, practices, usages and terminology as generally understood in the particular trade or business.” (quoting Chesapeake Energy Corp., 773 F.3d at 114)).
With those introductory comments in mind, the Court turns to each motion to exclude. The Court first discusses the two designated experts on pharmaceutical industry customs and practices (Incyte's Mr. Lankau and Novartis's Dr. Pullan), followed by the two experts on economic and financial analysis (Incyte's Dr. Rao and Novartis's Mr. Tedesco).
A. Motion to Exclude Peter Lankau's Opinions & Testimony
For the reasons that follow, the motion to exclude the opinions and testimony of Mr. Lankau is granted in part and denied in part.
1. Background
Incyte's designated witness, Mr. Lankau, has over “40 years of experience in the pharmaceutical industry” and “expertise in commercial activities including sales, marketing, business development, portfolio management, clinical development, research and development, product manufacture, and commercial launch preparations.” Ex. 247 (“Lankau Rpt.”) ¶ 2; see also id., Appendix A (“Lankau's Curriculum Vitae”). In addition, since 2014 Mr. Lankau has been “a Principal at Lankau Consulting LLC, an advisory and consulting firm that provides strategic expertise and guidance to management and boards of directors for pharmaceutical and biotechnology firms.” Lankau Rpt. ¶ 1. He previously served as Endo Pharmaceuticals, Inc's Chief Executive Officer and Chief Operating Officer. Id. ¶ 3. In this role, he has taken part in “negotiat[ing] the in-licensing and out-licensing of 16 clinical development programs or commercial products from U.S. and global partners,” id.; and he has “served as a board member for multiple pharmaceutical companies, including branded and generic drug makers,” id. ¶ 5.
Mr. Lankau was retained by Incyte's counsel “to apply [his] knowledge and expertise in negotiating licensing agreements in the pharmaceutical industry to analyze the terms of the [Agreement] between Incyte and Novartis from a commercial perspective and based on industry norms.” Id. ¶ 16. And he was “asked to offer [his] opinions regarding the customs and practices pertaining to the negotiation, application, and interpretation of royalty provisions in licensing agreements for pharmaceutical products, and to apply [his] understanding of industry practices to the Agreement.” Id. Mr. Lankau summarizes his opinions in his opening report as follows:
• There are no “Licensed Patent Rights,” as that term is defined and used in the Agreement, relating to Incyte's commercialization of Jakafi ® in the United States.
• Jakafi ® is not “Covered,” as that term is defined in the Agreement, by any Patent Rights in the United States.
• The Agreement is drafted to incentivize Novartis to contribute to the new therapeutic uses and commercialization of the drugs to improve its financial position, by rewarding Novartis with a prolonged royalty under Section 8.3(c)(i) if, but only if, Novartis contributes U.S. patent rights (either its own patents or Joint IP patents) to the collaboration.Id. ¶ 19.
Novartis moves to exclude the opinions, reports, and testimony of Mr. Lankau pursuant to Federal Rules of Evidence 104, 403, and 702. See Lankau Mem. In sum, Novartis argues that Mr. Lankau's opinions are (1) “improper legal opinion” to the extent that he interprets the text of the Agreement; (2) “improper and unreliable” insofar as he opines on the intent, motive, or state of mind had by the parties in forming the Agreement; (3) “inconsistent” inasmuch as he opines on pharmaceutical licensing custom and practice; (4) “improper legal opinion, unreliable, irrelevant, and . . . confus[ing]” to the jury, for his opinions regarding other agreements involving the parties; and (5) inappropriate to the extent that Mr. Lankau opines on witness credibility determinations, recites the facts, or mischaracterizes Dr. Pullan's opinions. See Lankau Mem. at 11-25.
2. Qualifications as an Expert Witness
Novartis does not challenge Mr. Lankau's qualifications as an expert. Regardless, the Court has considered Mr. Lankau's qualifications as part of its gatekeeping function and determines that he is qualified to testify as an expert.
3. The Disputed Opinions' Reliability and Helpfulness
As is explained in greater detail below, the following types of Mr. Lankau's opinions are inadmissible: opinions on (a) the meaning of the text of the Agreement per se-for example, by reference to dictionary definitions, the provision's grammatical structure, or any traditionally legal canons of construction, (b) any unfounded speculations regarding the factual motive, intent, or state of mind of either or both parties, (c) how to interpret 21 other contracts unrelated to this dispute, (d) mere recitations of the facts themselves, or (5) credibility determinations regarding any other witnesses.
a. Textual Interpretation Per Se
Any of Mr. Lankau's (or any other expert's) purely text-based interpretations of Section 8.3(c) of the Agreement are inadmissible. “Under New York law, ‘the initial interpretation of a contract is a matter of law for the court to decide.'” See Int'l Multifoods Corp. v. Com. Union Ins. Co., 309 F.3d 76, 83 (2d Cir. 2002) (quoting K. Bell & Assocs., Inc. v. Lloyd's Underwriters, 97 F.3d 632, 637 (2d Cir. 1996)). Expert witnesses may not render “legal opinions as to the meaning of the contract terms at issue,” as the “[c]onstruction (of a contract) is always a matter of law for the Court.” See Marx & Co. v. Diners' Club Inc., 550 F.2d 505, 510 (2d Cir. 1977) (internal quotation marks and citations omitted, second alteration in original); see also id. (“The question of interpretation of the contract is for the jury and the question of legal effect is for the judge. In neither case do we permit expert testimony.” (internal quotation marks and citation omitted)); Sigmon for Hindin v. Goldman Sachs Mortg. Co., No. 1:12-CV-3367 (ALC), 2018 WL 1517189, at *4 n.4 (S.D.N.Y. Mar. 26, 2018), aff'd sub nom., 800 Fed.Appx. 25 (2d Cir. 2020) (summary order) (“[I]t is well-settled that contract interpretation is not a proper subject of expert testimony.”); Kidder, Peabody & Co. v. IAG Int'l Acceptance Grp. N.V., 14 F.Supp.2d 391, 404 (S.D.N.Y. 1988) (excluding expert report where the expert “would inevitably have to discuss his construction of the contract and the parties' obligations thereunder,” as such “testimony would usurp the role of the jury”); Securities and Exchange Commission v. Gruss, 245 F.Supp.3d 527, 594 (S.D.N.Y. 2017) (excluding expert opinion where expert offered a conclusory opinion on whether a contract was violated).
Many of Mr. Lankau's opinions impermissibly employ standard methods of legal contractual interpretation to opine on whether the text itself is ambiguous and what the text itself, based on textual analysis alone, says. These include Mr. Lankau's interpretations of the text itself based on: the provision's overall structure, see, e.g., Lankau Rpt. ¶¶ 94, 100, 118; or where (if at all) particular terms are used elsewhere in the Agreement, Id. ¶¶ 98, 101; the “grammatical structure” of the provision, Id. ¶¶ 99, 119-20; “the common English meaning of”' particular words in it, Id. ¶ 100, “the words themselves,” see id. ¶¶ 112-13, and the words' definitions according to dictionaries, Id. ¶ 99 n.133; as well as the surplusage canon, id. ¶¶ 103, 107, and the whole-text canon, Id. ¶ 134.
Cf. Rush Indus., Inc. v. Garnier LLC, 309 Fed.Appx. 431, 432 (2d Cir. 2009) (summary order) (deeming inadmissible expert testimony that “consists almost entirely of discussion and application of legal standards”).
These opinions are inadmissible. First, the Court decides whether the text itself is ambiguous. See Orlander, 802 F.3d at 294 (“Whether or not a writing is ambiguous is a question of law to be resolved by the courts.” (quoting W.W.W. Assocs., Inc. v. Giancontieri, 77 N.Y.2d 157, 162 (1990)); see also Pearlman v. Cablevision Sys. Corp., 2015 WL 8481879, at *8-10 (E.D.N.Y. Dec. 8, 2015) (excluding an expert's opinions which “veer[ed] away from custom and practice and assert[ed] the legal conclusion”); see also Marx & Co., 550 F.2d at 509-10 (holding that expert testimony should have been excluded where the expert's “testimony did not concern only the customary practices of a trade or business” but instead addressed “legal standards”); Sigmon for Hindin, 2018 WL 1517189, at *4 n.4; Gruss, 245 F.Supp.3d at 594. The Court-not Mr. Lankau-resolves the ambiguity issue in its concurrent ruling on the parties' motions for summary judgment.
Second, opinions regarding the “common English meaning[s]” of particular words, or the grammatical structure of a given provision-which are “based solely on common tools of contract interpretation”-are improper subjects of expert testimony insofar as these matters are “equally accessible to the jury.” Red Hawk, LLC v. Colorforms Brand LLC, 638 F.Supp.3d 375, 383 (S.D.N.Y. 2022). In other words, testimony that looks exclusively to the text of the Agreement in order to elucidate the parties' intentions when drafting it is directed “to lay matters which a jury is capable of understanding and deciding without the expert's help.” Andrews v. Metro N. Commuter R. Co., 882 F.2d 705, 708 (2d Cir. 1989); see also Red Hawk, 638 F.Supp. at 383 (stating that purely text-based testimony like this “would not be helpful to the jury” insofar as this testimony “fail[s] to offer ‘specialized knowledge, not possessed by the jury ....'” (quoting United States v. Carson, 702 F.2d 351, 369 (2d Cir. 1983)).
The cases cited in Incyte's opposition regarding Mr. Lankau's purely text-based opinions regarding particular words of the contract are inapposite. For example, ECD Investor Group v. Credit Suisse International involves an expert interpreting a term of art, “hedging,” which is industry jargon. See No. 14-CV-8486 (VM)(SN), 2017 WL 3841872, at *17 (S.D.N.Y. Sept. 1, 2017). ECD is unlike the situation presented here, where the parties do not contend that “Licensed Patent Rights” is a term of art with a widely accepted meaning within the pharmaceutical industry. See, e.g., Pullan Mem. at 16 (Incyte conceding that “the disputed Agreement provisions and definitions are not undefined industry terms of art” (emphasis in original)). Nor is Alto v. Sun Pharmaceutical Industries, Inc. apposite. See No. 1:19-CV-09758-GHW, 2021 WL 4803582, at *9-12 (S.D.N.Y. Oct. 13, 2021), judgment entered, No. 19 CIVIL 9758 (GHW), 2021 WL 4805430 (S.D.N.Y. Oct. 14, 2021). Alto involves an expert offering “his view regarding the industry standard of conduct with respect to . . . commercial decisions,” opinions which were “founded in an ascertainable methodology and . . . useful to the finder of fact.” Id. There, the Court permitted only the expert's opinions that “help[ed] the trier of fact understand how a person in the industry evaluates the decisions confronted by Defendant” at the time. Id. at *12. Here, Mr. Lankau's purported principles and methodology undergirding his textual opinions are classic tools of contractual interpretation-not anything “beyond the ken of the average juror.” See Amuso, 21 F.3d at 1263. Last, Iacobelli Construction, Inc. v. County of Monroe, 32 F.3d 19, 25 (2d Cir. 1994) is inapposite. The Iacobelli Court accepted expert affidavits as evidence of construction site conditions to show the extent to which the actual site conditions differed from those hypothetically described in the construction contract. The Second Circuit did not assert a blanket rule in Iacobelli that “endorse[s] industry expert testimony” so long as it “explain[s] the approach by which reasonably prudent [industry members] would interpret the contract documents,” as Incyte's opposition incorrectly asserts. See Lankau Opp'n at 6 (quoting Iacobelli, 32 F.3d at 25). Again, the “approach” Mr. Lankau takes for this subset of opinions-looking to basic dictionary definitions and the grammatical structure of particular provisions-“is not beyond the ken of the average juror.” See Amuso, 21 F.3d at 1263.
Couching these opinions as based in “custom and practice” does not render them admissible, as the admissibility of expert testimony is not governed by magic words. See Luizzi v. Pro Transp., Inc., No. 02 CV 5388 CLP, 2011 WL 1655567, at *3 (E.D.N.Y. May 2, 2011) (excluding expert testimony despite “attempts to cloak the testimony as being about industry customs”). “[W]hen an expert opinion is based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Amorgianos, 303 F.3d at 266. These opinions are inadmissible insofar as they seek to opine on either matters for the Court (namely, whether the contract is ambiguous on its face) or matters that are simply not helpful for the jury (whether the text of the Agreement itself, by its plain language, shines light on the parties' intent at the time). Because expert testimony cannot “usurp either the role of the trial judge in instructing the jury as to the applicable law or the role of the jury in applying that law to the facts before it,” this testimony is excluded. See Duncan, 42 F.3d at 101 (quoting Bilzerian, 926 F.2d at 1294).
For example, Mr. Lankau describes some of these purely text-based opinions as views that “a person having knowledge of and experience with business norms and expectations in the pharmaceutical industry” would have. See, e.g., Lankau Rpt. ¶ 99; see also id. ¶ 121 (similar). “If the witness is relying solely or primarily on experience, then [he] must explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts.” Pension Comm., 691 F.Supp.2d at 473 n.148 (quoting Fed.R.Evid. 702 Advisory Committee's Note). Incyte has not established that Mr. Lankau has “superior knowledge, education, experience, or skill,” see Tin Yat Chin, 371 F.3d at 40, in examining “grammatical structure[s]” and “common English phrase[s],” Lankau Rpt. ¶ 99, just by virtue of his background in the pharmaceutical industry.
b. Motive, Intent, State of Mind
Nor may Mr. Lankau testify as to the intent, motive, or state of mind that either or both parties had when negotiating and entering into the Agreement. “Inferences about the intent or motive of parties or others lie outside the bounds of expert testimony,” as “[t]he question of intent is a classic jury question and not one for the experts.” In re Rezulin Prod. Liab. Litig., 309 F.Supp.2d 531, 546 (S.D.N.Y. 2004) (internal quotation marks and citation omitted); see also In re Rezulin Prod. Liab. Litig., 309 F.Supp.2d 531, 546 (S.D.N.Y. 2004) (“[T]he opinions of these [expert] witnesses on the intent, motives or states of mind of corporations, regulatory agencies and others have no basis in any relevant body of knowledge or expertise.”). Factual testimony as to what individuals “did, or what they said to each other” “must come from the trial testimony of the individuals concerned” and not the expert. Kidder, Peabody & Co. v. IAG Int'l Acceptance Grp., N.V., 14 F.Supp.2d 391, 398 (S.D.N.Y. 1998).
Several of Mr. Lankau's opinions fall into this category. See, e.g., Lankau Rpt. ¶ 96 n.132 (stating that his opinion on how to interpret “Licensed Patent Rights” “was shared by Incyte employees during the negotiations”); Id. ¶ 113 n.143 (asserting the same); Id. ¶ 109 (opining on how the parties actually “drafted” the Agreement); Id. ¶ 137 (opining that “Section 9.3(a)(v) only makes sense if the parties expected Novartis to develop its own IP that provided value to Incyte” (emphasis added)); Id. ¶ 139 (opining on what the parties actually “negotiated”); Ex. 299 (“Lankau Rebuttal Rpt.”) ¶ 18 (opining that “had the parties wanted to draft the definition of ‘Covering' to include the patent owner-Incyte-they clearly knew how and could have done so”); Id. ¶ 21 (opining on what the parties “agreed” to do in the Agreement and how they “chose . . . to draft Section 8.3(c)”); id. ¶ 25 (describing what “would have been simpler” to do “[i]f the parties had intended” a particular construction of the contract).
Mr. Lankau, an expert recently retained by Incyte's counsel for purposes of this litigation,does not possess any personal knowledge of what Novartis or Incyte employees were thinking during the negotiations and drafting process. Any speculations he may have regarding the “real motive” the parties had in entering into the Agreement-what they factually “did” do, or affirmatively “would have done” had they in fact intended a particular result-are improper. See Rezulin Prod. Liab., 309 F.Supp.2d at 546 (“[P]laintiffs' experts propose improperly to assume the role of advocates for the plaintiffs' case by arguing as to the intent or motives underlying the conduct [of the parties].”); Highland Cap. Mgmt., L.P. v. Schneider, 379 F.Supp.2d 461, 469 (S.D.N.Y. 2005) (excluding as inadmissible proposed expert testimony “as to the state of mind and knowledge possessed by defendants” as improperly “supplant[ing] . . . the role of the jury [in] interpreting the evidence” (internal quotation marks and citations omitted)).
See Ex. 268 (“Lankau Dep. Tr.”) at 49:12-52:12 (Mr. Lankau testifying that he spoke to “one individual that [he] kn[e]w was involved in the negotiations in 2009” at Incyte, namely Mr. Hoppenot, that he did not “believe [he] spoke to anyone at Novartis” regarding the negotiations, and that he recalls being retained in “July of 2021” by Incyte's counsel).
Notwithstanding the inadmissibility of Mr. Lankau's testimony on factual issues like a party's actual intent, “[i]t is of course common for testimony regarding the ‘customs and practices' in a particular industry to be the subject of expert testimony.” Reach Music Pub., Inc. v. Warner Chappell Music, Inc., 988 F.Supp.2d 395, 403 (S.D.N.Y. 2013). Moreover, where a contract is ambiguous, “testimony regarding standard industry practice is admissible ‘to enable the jury to evaluate the conduct of the parties against the standards of the ordinary practice in the industry.'” Red Hawk, 638 F.Supp. at 381 (quoting Marx & Co., Inc. v. Diners' Club, Inc., 550 F.2d 505, 509 (2d Cir. 1977), and citing AU New Haven, LLC v. YKK Corp., No. 15-CV-3411, 2019 WL 1254763, at *4 (S.D.N.Y. Mar. 19, 2019)) (emphasis added). Thus, to the extent that Mr. Lankau (or any other expert) opines on what is consistent with or typical of industry practices or customs, such opinions may reliably assist the trier of fact. For example, Mr. Lankau may opine on the customary “business norms and expectations in the pharmaceutical industry,” on the overall processes of negotiating collaborations in the pharmaceutical industry, or on whether a particular provision or interpretation of Section 8.3(c) is consistent with what parties in the industry might typically do when negotiating collaborations like the Novartis-Incyte arrangement.
Novartis argues that these opinions should be excluded in part because Mr. Lankau additionally testified that “there[s] no such thing in the pharmaceutical industry in terms of norms or customs. It's a variety.” See Lankau Dep. at 60:23-25. But he did not testify that there are literally zero customs in the industry, as Novartis's brief misleadingly suggests. Rather, Mr. Lankau stated:
So the customs in the industry are - I'm going to call them variable. If you have seen one agreement, you've seen one agreement. They are all different. And so there's a range of variability that exists .... [T]he customs in the industry are quite broad.....They are not [a] narrow range.....And . . . within that range, there are many different kinds of agreements..... And all through the entire negotiation process of fine-tuning those expectations[, you] hopefully develop a win/win relationship. Those are the norms, those are the customs,
those are the practices that exist within the industry..... [C]ustoms means the overall ordinary approach to an agreement, and the practice is how you get there..... [A] norm is an ordinary course of action that companies would typically take to approach these licensing arrangements and the practices [are] . . . sort of the steps in how you get there.Id. 61:9-25-67:1-3. That Mr. Lankau testified to there being a “range” of customs in the industry, which may ultimately manifest in idiosyncratic ways specific to one agreement, does not mean that no customs, norms, or practices exist in the industry at all. While this argument may be fertile grounds for Novartis's counsel's cross-examination, the Court will not exclude his customs and practice testimony entirely on this basis.
See, e.g., Lankau Rpt. ¶ 138 (opining that “it would be highly unusual for a party that has out-licensed its rights to pay a royalty on its own IP, especially where to the party that has in-licensed the rights where the in-licensing party has not contributed intellectual property that serves to protect that market exclusivity”); Lankau Dep. 61:9-25-67:1-3 (describing the “customs in the industry”).
And he may permissibly opine on what someone in the industry might customarily assume prior to entering into a collaborative pharmaceutical licensing agreement, with the necessary caveat that the parties, of course, may have diverged from any prevailing “industry custom” in any particular agreement. See, e.g., Pension Comm. of Univ. of Montreal Pension Plan v. Banc of Am. Sec., LLC, 691 F.Supp.2d 448, 467 (S.D.N.Y. 2010) (holding that “[a]lthough some of [an expert's] deposition testimony walks a fine line between opining on what investors would customarily assume and what Plaintiffs actually did assume, so long as [the expert] refrains from opining on the actual state of mind of the Plaintiffs, his opinions on these matters are admissible”); United States Commodity Futures Trading Comm'n v. Wilson, No. 13 CIV. 7884 (AT), 2016 WL 7229056, at *8 (S.D.N.Y. Sept. 30, 2016) (“Experts are not permitted to testify to an actor's state of mind, but an expert can testify to whether a given practice is consistent with a given state of mind.”).
Both Incyte's designated expert, Mr. Lankau, and Novartis's designated expert, Dr. Pullan, agree that, notwithstanding any background industry customs and practices, each agreement is ultimately bespoke. See, e.g., Ex. 1060 (“Pullan Dep.”) 33:5-18; Id. 37:7-19; Id. 230:4-7; Lankau Rebuttal Rpt. ¶¶ 12, 24; Lankau Dep. 60:19-62:18; Id. 173:25-174:9. The meaning of Section 8.3(c) here is the ultimate issue for the factfinder to decide, although the experts may provide “specialized knowledge,” such as the context an industry insider may bring to a pharmaceutical collaboration and licensing deal, to “help the trier of fact . . . understand the evidence [and] determine a fact in issue.” See Fed.R.Evid. 702; Scott v. Chipotle Mexican Grill, Inc., 315 F.R.D. 33, 45 (S.D.N.Y. 2016) (“An expert also may offer commentary on documents in evidence if the expert's testimony relates to the ‘context in which [documents] were created, defining any complex or specialized terminology, or drawing inferences that would not be apparent without the benefit of experience or specialized knowledge.'”).
Some of Mr. Lankau's opinions toe this line. See, e.g., Lankau Rpt. ¶ 109 (“Typically, where parties intend to pool the IP (e.g., here in the Licensed Patent Rights definition), they use the type of language reflected in Section 7.3 rather than including the directional phrases ‘with respect to,' ‘in each case,' and ‘as applicable' that are used in the definition of Licensed Patent Rights.”) & n.136 (“If ‘Licensed Patent Rights' was really a pooling of the Parties' IP, the Parties would have used ‘Licensed Patent Rights' in place of ‘Joint IP, Incyte IP or any Novartis IP' in Section 7.3.”); id. ¶¶ 137-38; Id. ¶ 139 (describing one interpretation as “more consistent with industry norms and what would have been the Incyte/Novartis teams' general expectations as they negotiated the Agreement in 2009”); Lankau Rebuttal Rpt. ¶ 74-76 (opining on what Novartis's incentives “would be,” Id. ¶ 74, that “Novartis [was] clearly incentivized to obtain additional patent protection,” id. ¶ 75, and opining on what the parties “view[ed]” in terms of “the possibility of Novartis obtaining relevant patents,” Id. ¶ 76).
Mr. Lankau may opine on what, in his view, is customary within the industry, or consistent with industry customs or practices-though any opinion that opines on what the parties actually intended, said, or did in negotiating and drafting the Agreement is inadmissible. See, e.g., NIC Holding Corp. v. Lukoil Pan Americas, LLC, No. 05CIV9372LAKFM, 2007 WL 1467424, at *4 (S.D.N.Y. May 16, 2007) (holding that an expert may testify, first, regarding whether a particular clause “is . . . commonly employed in the . . . industry” and, second, that parties to a particular kind of contract “typically employ language other than that found in the [contract at issue] to manifest their intent”). His testimony on industry customs and practices generally is reliable given Mr. Lankau's extensive experience negotiating licensing agreements over his 40 years in the pharmaceutical industry. See Amorgianos, 303 F.3d at 265; see also Davis, 937 F.Supp.2d at 412 (“[T]he reliability inquiry may . . . focus upon personal knowledge and experience of the expert.”). It is then for the parties' counsel, and not their designated experts, to argue any inferences about the parties' intent from Mr. Lankau's (or any other expert's) testimony on what is typical, usual, or consistent with a given practice or custom in the industry. See Rezulin Prod. Liab., 309 F.Supp.2d at 546 (“[P]laintiffs' experts propose improperly to assume the role of advocates for the plaintiffs' case by arguing as to the intent or motives underlying the conduct [of the parties].”).
Any “remaining controversies as to the expert's methods and conclusions generally bear on the weight and credibility-but not admissibility-of the testimony.” Royal & Sun All. Ins., 2011 WL 3874878, at *2.
c. 21 Other Contracts
To the extent that Mr. Lankau purports to directly interpret or explain 21 other contracts involving either Incyte or Novartis, any opinions proffered about those 21 contracts themselves are excluded. These opinions are excluded both because they attempt to offer legal conclusions regarding the underlying contracts, which is improper and usurps the role of the Court, and because Mr. Lankau lacks personal knowledge regarding the intent or context surrounding these contracts' formation and implementation. Simply put, he is not a fact witness. See Amuso, 21 F.3d at 1263 (“A district court may commit manifest error by admitting expert testimony where the evidence impermissibly mirrors the testimony offered by fact witnesses ....”). Thus, he cannot testify to what Incyte intended or did regarding those other contracts. Incyte also fails to establish that these other agreements are sufficiently analogous to the Agreement or in any way probative as to the meaning of Section 8.3(c). Any expert testimony regarding them does not “rest[] on a reliable foundation [nor] is relevant to the task at hand.” See Daubert, 509 U.S. at 597. And even if the 21 other contracts were themselves properly considered, Mr. Lankau is not an expert on Incyte's or Novartis's licensing practices and would be the improper voice for any commentary as to what is the “typical” practice of Incyte or Novartis. Again, he is a designated expert witness-not a factual one.
See, e.g., Ex. 268 (“Lankau Dep.”) at 49:12-52:2 (noting that Mr. Lankau had not communicated with anyone at Incyte or Novartis involved in the negotiations in the Agreement, with the exception of one brief discussion with Mr. Hoppenot, on whose comments Mr. Lankau did not rely in preparing his opinions in his reports); Id. at 88:2-9 (stating that Mr. Lankau has “not had any relationship with Incyte prior to” being engaged by their counsel for this litigation); at 185:2-9 (same).
d. Factual or Credibility Testimony
Last, experts may not offer credibility determinations of other witnesses, as “expert opinions that constitute evaluations of witness credibility, even when such evaluations are rooted in scientific or technical expertise, are inadmissible under Rule 702.” Nimely, 414 F.3d at 398; see also id. (“It is a well-recognized principle of our trial system that ‘determining the weight and credibility of [a witness's] testimony . . . belongs to the jury ....'” (citations omitted)). Nor are expert witnesses the proper voice for purely fact-based testimony. See, e.g., Amuso, 21 F.3d at 1263. Because these matters are not appropriate for Mr. Lankau to opine on, these opinions are inadmissible.
Thus, the motion to exclude the opinions and testimony of Mr. Lankau is granted in part and denied in part.
B. Motion to Exclude Dr. Linda Pullan's Testimony
The motion to exclude the opinions and testimony of Dr. Pullan is likewise granted in part and denied in part as discussed below.
1. Background
Novartis's designated expert witness, Dr. Pullan, has “approximately 40 years' experience in the pharmaceutical industry, with about 28 years in business development and licensing and pursuing and negotiating licensing transactions on behalf of pharmaceutical companies.” See Ex. 48 (“Pullan Rpt.”) at 1; Id., Ex. B (“Pullan's Curriculum Vitae”). After receiving her Ph.D. in biochemistry, Dr. Pullan spent a decade working in “drug discovery”-related research and thereafter “switched . . . to licensing, with a role in identifying deal opportunities, evaluating them, and negotiating licensing deals.” Pullan Rpt. at 1. She served as “director of oncology and hematology licensing for about eight years” at Amgen, and then served as VP of Business Development at Kosan Biosciences. Id. Dr. Pullan's current role consists of consulting on business development and licensing at Pullan Consulting, where she has “worked on approximately 100 signed deals . . . and many more term sheets as advisor or negotiator.” Id. at 1-2. She has “lectured or taught on all aspects of partnering” regarding “licensing deals in the pharmaceutical industry,” too. Id. at 2.
Novartis designed Dr. Pullan as an expert, and her expert report opines on “custom and practice with respect to pharmaceutical business development and licensing deals,” including “the purpose of business development and licensing [(‘BD&L')] deals,” Id. at 3, purportedly typical “financial terms for a BD&L deal,” Id. at 4, and the “process of diligencing, negotiating, and finalizing a BD&L deal,” Id. at 5. Dr. Pullan summarizes her opinions in her opening report as follows: (1) “As used in the Agreement between Novartis and Incyte, based on my experience and industry custom and practice, ‘Licensed Patent Rights' encompasses all patent rights, irrespective of which party to the Agreement obtained or owns the applicable patent(s),” Id. at 7; (2) “[b]ased on [her] experience and industry custom and practice, it makes commercial sense for ‘Licensed Patent Rights' to encompass all patent rights, independent of which party to the collaboration is the patent holder, in determining the duration of the reverse royalty term,” Id. at 19; and (3) “[b]oth parties' financial modeling and valuation analyses with respect to the reverse royalty are consistent with an understanding that the reverse royalty would be paid for well more than ten years,” Id. at 23.
This is because, in Dr. Pullan's view, (A) “[t]he duration of a royalty stream in a pharmaceutical licensing agreement is typically tied to loss of market exclusivity, including patent protection; as such, if the duration of the reverse royalty was going to somehow deviate from the norm, that would have been clearly reflected in the parties' Agreement, but no such deviation is clearly identified. To the contrary, the technical terms and structure of the Agreement reflect that the duration of the reverse royalty being paid by Incyte (just as the duration of the regular royalty being paid by Novartis) takes into consideration all possible avenues of exclusivity protecting the product from market competition by third parties,” Id.; (B) “[t]he shorthand, terms of art, and other language used by the parties in communications between each other and in internal communications discussing the royalties reflect a commercial understanding that each party's royalties would be paid at the full negotiated royalty rates until the loss of market exclusivity in the applicable country, consistent with industry custom and practice, and thus support my opinion,” Id. at 10; (C) “[t]he final, agreed-upon term sheet reflects that the duration of the royalty stream going in each direction would be calculated in the same manner; there is no limitation or contingency with respect to patent rights when calculating the duration of the reverse royalty to be paid by Incyte. Moreover, it would be expected that any attempt by Incyte to shorten or condition the duration of the reverse royalty following the final term sheet and in the contract drafting stage would have been the subject of extensive discussion, which did not occur,” Id. at 13; and (D) “[b]oth the Agreement's structure and technical language as to patents and the practical improbability of Novartis obtaining new and additional U.S. patents to assist Incyte in its commercialization of Jakafi further support my opinion,” Id. at 18.
This is because (A) “[c]ollaborators like Novartis and Incyte are to share in the upside of their commercialization efforts of a drug, and here Novartis provided many contributions which ultimately benefited the development and commercialization of Jakafi in the U.S.,” Id. at 19; (B) “[t]here is no commercially rational basis to limit ‘Licensed Patent Rights' to exclude Incyte's patents protecting Jakafi in the U.S.,” Id. at 20; (C) “[a]ny suggestion that Novartis achieved ‘payback' and thus has sufficiently obtained an appropriate return on its investment is inconsistent with commercial realities,” Id. at 22; and (D) “[t]he ongoing and increasing commercial success of Jakafi in the U.S., as Incyte continues to maintain market exclusivity given the patent protections, further supports my opinion,” Id. at 23.
Incyte moves to exclude certain opinions and testimony of Dr. Pullan pursuant to Federal Rule of Evidence 702 and Daubert. See Pullan Mem. In sum, Incyte argues that (1) Dr. Pullan's opinions are “unsupported” and “irrelevant” “ipse dixit,” not “‘based on sufficient facts or data' as Rule 702(b) requires,” Pullan Mem. at 2, 5; (2) her “methodology is unreliable because her opinions . . . are not tethered to the words of the [A]greement,” Id. at 9; and (3) her “opinions regarding financial models should be excluded for the same reasons as Mr. Tedesco's opinions” and because “they are not based on ‘sufficient facts or data,'” Id. at 3, 17.
2. Qualifications as an Expert Witness
Incyte prudently declines to challenge Dr. Pullan's qualifications as an expert. Given the Court's gatekeeping function, the Court has considered Dr. Pullan's qualifications and determines that she is amply qualified.
3. The Disputed Opinions' Reliability and Helpfulness
Insofar as Dr. Pullan opines on (1) the meaning of the text of the Agreement per se, (2) any unfounded speculations regarding the factual motive, intent, or state of mind of either or both parties, either in entering into the Agreement or in creating the financial models, or (3) mere recitations of the facts themselves, the motion to exclude the proposed testimony is granted.
As with Mr. Lankau's opinions, any of Dr. Pullan's speculative opinions regarding the actual motive, intent, or state of mind of either or both of the parties in negotiating and entering into the Agreement are excluded, as are any opinions regarding what Novartis or Incyte did in fact agree to, or any opinions that purely interpret the text of the Agreement (e.g., by analyzing its structure alone). The same reasons discussed above, in ruling on the motion to exclude Mr. Lankau's opinions, apply with equal force to Dr. Pullan's opinions that fall into the same inadmissible categories.
For example, it is improper for Dr. Pullan to opine on what the parties intended vis-a-vis their construction of the term “Licensed Patent Rights.” See Pullan Rpt. at 10; Id. at 16 (opining on what does or does not “reflect an intentional substantive change” by the parties in the provision throughout the drafting process); Id. at 17 (opining on what the parties “intended” in terms of “whose patents would be considered for purposes of calculating the royalty term”).
For example, her opinion that “‘Licensed Patent Rights' encompasses all patent rights, irrespective of which party to the Agreement obtained or owns the applicable patent(s),” Pullan Rpt. at 7, is improper as it opines on the meaning of the text per se.
But again, Dr. Pullan's (or Mr. Lankau's) opinions regarding what is typical of, ordinary in, or consistent with the customs and practices of the pharmaceutical industry may be admissible. See Reach Music, 988 F.Supp.2d at 403; Red Hawk, 638 F.Supp.3d at 381. For example, Dr. Pullan's testimony may be helpful to the factfinder to the extent that it reliably provides context on (1) what is typical of a term sheet negotiation process, (2) patent protection issues and the meaning of a “territorial split”-style agreement, or (3) how reverse royalties are typically structured in complex collaborative licensing deals in the pharmaceutical industry. Her testimony may be helpful to the factfinder by reliably assisting in understanding relevant industry customs and practice, as well as any terms of art used by the parties in their internal and external communications. See Pension Comm., 691 F.Supp.2d at 467.
For example, Dr. Pullan may opine on what she believes “makes commercial sense” “[b]ased on [her] experience and industry custom and practice,” Pullan Rpt. at 19; and she may opine on whether the parties' financial models “are consistent with” any particular understanding, Id. at 23.
For example, the meaning and concept of a “reverse royalty” itself is an industry term of art, a permissible subject of expert testimony. See, e.g., ECD Investor Group, 2017 WL 3841872, at *17; In re AXA Equitable Life Ins. Co. COI Litig., 595 F.Supp.3d 196, 254 (S.D.N.Y. 2022), on reconsideration on other grounds, No. 16-CV-740 (JMF), 2022 WL 3018104 (S.D.N.Y. July 29, 2022) (accepting the testimony of two expert witnesses, “both of whom have substantial industry expertise,” as “plainly relevant to the question of how [a term utilized in the contract] is customarily used in the industry”). That said, purely text-based interpretations of other terms, like “Licensed Patent Rights,” which are not industry terms of art, are not appropriate subjects for expert testimony. See, e.g., Red Hawk, 638 F.Supp.3d at 383 (holding that “while ‘Products' is not a highly technical or scientific term, expert testimony regarding industry usage of the term, and terms like ‘Net Sales,' is relevant as it may help the trier of fact resolve the ambiguity surrounding the meaning of the term ‘Products' as it is used in the Royalty Agreement”).
Incyte is incorrect in stating that Dr. Pullan's opinions “ignore the actual words of the Agreement,” Pullan Mem. at 4, and that she “offers nothing to substantiate her opinions beyond her say-so,” Id. at 6. First, the fact that Dr. Pullan does not (at least for the most part) provide pure “textual analysis”-which Incyte frames as a problem with her testimony, see Pullan Mem. at 14-is in fact proper for the reasons explained above. Namely, questions of contractual ambiguity are for the Court, and references to the text alone-without more-is not “beyond the ken of the average juror.” See Amuso, 21 F.3d at 1263. Incyte unpersuasively argues that Dr. Pullan's “opinions are not relevant or helpful” because she does not look to dictionary definitions and other traditional principles of contract interpretation to interpret the Agreement. As discussed above, such an exercise would be improper as it usurps the roles of the Court and-later-the jury. See Red Hawk, 638 F.Supp.3d at 383. And Dr. Pullan clearly does reference the Agreement repeatedly in her report; Incyte's argument that she “ignores” its contents is entirely specious. See generally Pullan Rpt.
Second, Incyte's argument that Dr. Pullan provides nothing beyond ipse dixit to support her opinions mischaracterizes the record. Incyte is correct in observing that “a court cannot permit experts to ‘offer credentials rather than analysis,'” see LinkCo, Inc. v. Fujitsu Ltd., No. 00 CIV. 7242 (SAS), 2002 WL 1585551, at *4 (S.D.N.Y. July 16, 2002); Pullan Reply at 2, but that is not what Dr. Pullan has done. Dr. Pullan repeatedly cites to her “extensive experience” and background in explaining her opinions, and she ties that experience to observations of what she considers typical in the industry-just as Mr. Lankau cites to his own experience as supportive of his views of what is “typical” in the industry. See, e.g., Pullan Rpt. at 6-8 (explaining what is customary in the industry and why); Id. at 10 (same); Id. at 11 (describing what she “ha[s] seen” in other territorial split contracts and basing her opinion in part on “other agreements [she has] reviewed” in the industry); Id. at 17 (citing her own experience “[h]aving gone through multiple rounds of term sheet negotiations to work out the core financial deal terms”). This suffices to show that Dr. Pullan's “testimony is the product of reliable principles and methods” and that she “has applied the principles and methods reliably to the facts of the case.” See Amorgianos, 303 F.3d at 265; SR Int'l Bus. Ins. Co. v. World Trade Ctr. Properties, LLC, 467 F.3d 107, 133 (2d Cir. 2006) (upholding a district court's ruling to permit expert testimony where the expert's methodology was challenged, and finding that he was qualified based on his “31 years of experience in the insurance industry,” where the expert “testified that . . . he was familiar with practices in the industry” and adequately “explained that through [his] experiences [in the industry], he was able to identify” practices within it). To the extent that Incyte alleges any “gaps or inconsistencies in the reasoning leading to [the expert's] opinion in this case, . . . such arguments go to the weight of the evidence, not to its admissibility.” Campbell ex rel. Campbell v. Metro. Prop. & Cas. Ins. Co., 239 F.3d 179, 186 (2d Cir. 2001) (citing, inter alia, Daubert, 509 U.S. at 595).
For example, should this case advance to trial, Incyte may question Dr. Pullan on cross-examination regarding her relevant experiences in the industry. Incyte's argument that Dr. Pullan must cite to a specific document in another licensing arrangement, or a specific singular experience in support of her conclusions regarding what she has found to be customary in the industry as a whole, see Pullan Reply at 3-4-testimony that is rooted in the four decades that Dr. Pullan has spent as an industry insider, see Pullan Rpt. at 1-is unavailing. Incyte cites no caselaw that supports this novel proposition, which contravenes the purpose of industry custom and practice testimony-namely, testifying to “the standards of the ordinary practice in the industry,” and not to a singular example of what may have happened in one or two other, unrelated instances. See Red Hawk, 638 F.Supp.3d at 381.
Last, Incyte's argument that Dr. Pullan's opinions regarding the financial models should be excluded because they are not “based on ‘[]sufficient facts or data'” fails to move the Court. See Pullan Mem. at 17. Incyte's argument is, in essence, that the financial models “are not designed to make any prediction of when Incyte's royalty would step down or end” and that, as a result, it is improper for Dr. Pullan (or Mr. Tedesco) to rely on them. Though framed as a Rule 702 problem, Incyte's argument principally takes issue with the admissibility of the financial models themselves. See Pullan Reply at 9 (acknowledging that the “problem” Incyte sees with respect to the financial model testimony “lies with the evidence itself [i.e., the models], not the experts or their methods”).
Incyte argues that the financial models should not be considered because they are not “relevant,” but the “standard of relevance established by the Federal Rules of Evidence is not high.” United States v. Southland Corp., 760 F.2d 1366, 1375 (2d Cir. 1985). If the evidence has “any tendency to make a fact more or less probable than it would be without the evidence” and “the fact is of consequence in determining the action,” it is relevant. Fed.R.Evid. 401. Nonetheless, under Rule 403, relevant evidence may be excluded if “its probative value is substantially outweighed by a danger of one or more of the following: unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.” Fed R. Evid. 403. The Second Circuit has instructed that “[d]istrict courts have broad discretion to balance probative value against possible prejudice” under Rule 403. United States v. Bermudez, 529 F.3d 158, 161 (2d Cir. 2008) (citation omitted). Because virtually all evidence is prejudicial to one party or another, to justify exclusion under Rule 403 the prejudice must be unfair. See Fed.R.Evid. 403; Weinstein's Federal Evidence § 403.04[1][a] (2019) (collecting cases). “The unfairness contemplated involves some adverse effect beyond tending to prove a fact or issue that justifies admission.” Costantino v. David M. Herzog, M.D., P.C., 203 F.3d 164, 174-75 (2d Cir. 2000). Further, as the Advisory Committee Notes to Rule 403 explain, “‘[u]nfair prejudice' within its context means an undue tendency to suggest decision on an improper basis, commonly, though not necessarily, an emotional one.” Fed.R.Evid. 403, Advisory Committee Notes (1972).
Here, the financial models are clearly relevant to the parties' intent in drafting Section 8.3(c). The models drafted by the parties in the course of deal evaluation are probative of the parties' understandings of the royalty term, and whether the models meaningfully speak to the duration of that term is a question for the factfinder. It may be, as Incyte posits, that the models do not speak at all to the issue of duration because they do not expressly model invocation of Section 8.3(c)'s 50% stepdown provision in any given year. The factfinder may also reasonably conclude, as Novartis posits, that the models speak to the issue of the reverse royalty's duration because they do not expressly model invocation of the 50% Stepdown Provision-that is to say, perhaps the parties expected that the 50% stepdown would not be invoked within the course of any given modeling period. And as the Court observes in its summary judgment ruling, “choices between conflicting versions of the events are matters for the jury, not for the court on summary judgment.” Jeffreys v. City of New York, 426 F.3d 549, 553 (2d Cir. 2005) (citation omitted). It is for the jury, not the Court, to choose among inferences to be drawn from the disputed material facts of what the parties' respective pre- and post-Agreement financial models show. See id.
Because the Court finds that the financial models are relevant, and not outweighed by the risk of unfair prejudice pursuant to Rule 403 balancing, the Court does not deem the financial models (and related communications described above) categorically inadmissible on that basis. Nor does the Court deem inadmissible Mr. Tedesco's, Dr. Pullan's, or (for that matter) Dr. Rao's testimony to the extent that it is based in part on these financial models, or seeks to explain what they show and how such financial models may typically factor into the deal valuation process of a pharmaceutical collaboration. Expert testimony on the financial models is relevant: it “is sufficiently tied to the facts of the case that it will aid the jury in resolving a factual dispute.” Daubert, 509 U.S. at 591 (internal quotation marks and citation omitted).
Nor will the Court categorically bar Dr. Pullan's testimony concerning the models merely because her review of Mr. Tedesco's report was among the factors on which she based her opinion. Simply referencing another expert's report does not itself “amount to improper bolstering.” See, e.g., Medisim Ltd. v. BestMed LLC, 861 F.Supp.2d 158, 169 (S.D.N.Y. 2012), on reconsideration in part, No. 10 CIV. 2463 SAS, 2012 WL 1450420 (S.D.N.Y. Apr. 23, 2012) (concluding the same).
For these reasons, the motion to exclude the opinions and testimony of Dr. Pullan is granted in part and denied in part, as described above.
C. Motion to Exclude Larry Tedesco's Opinions & Testimony
Moreover, the motion to exclude the opinions and testimony of Mr. Tedesco is granted in part and denied in part.
1. Background
Novartis's second designated expert witness, Mr. Tedesco, describes himself as “an expert in intellectual property valuation, damages, licensing, and transactions.” Ex. 243 (“Tedesco Rpt.”) ¶ 1. He has over 20 years of experience “as an IP owner, manager, and consultant for corporations, financial institutions, government agencies, and law firms performing asset valuation, litigation support, IP management, and forensic investigations,” and he has “negotiated and/or served as an advisor in over 200 IP-related transactions as an owner of IP and on behalf of companies and inventors.” Id. ¶ 2; see also id., Appendix B (“Tedesco's Curriculum Vitae”). In this work, he has “reviewed and analyzed more than 1000 license agreements.” Tedesco Rpt. ¶ 3. He currently serves as Managing Director of Berkeley Research Group, Id. ¶ 6, as an intellectual property advisor to a regenerative biotechnology company, and as President and Chief Intellectual Property Officer to a biomedical device company, Ex. 1293 (“Tedesco Rebuttal Rpt.”) ¶¶ 1-2; see also id., Appendix A (“Tedesco's Updated Curriculum Vitae”).
Mr. Tedesco was retained by Novartis's counsel “as an independent expert in economic modeling analysis relating to, in particular, royalty streams.” Tedesco Rpt. ¶ 15. He was “asked to review and assess the financial modeling and related materials produced by Goldman Sachs [(‘GS')] on Incyte's behalf before the Agreement was signed, as well as deposition testimony relating to certain pre-Agreement financial modeling issues,” in addition to “certain internal modeling performed by Incyte after the Agreement was signed.” Id. In his opening report, Mr. Tedesco summarizes his opinions on the GS-generated pre-Agreement models as follows:
• The GS Models consistently incorporated the concept of Incyte paying Novartis a Reverse Royalty on U.S. sales of Jakafi, starting from the first term sheet that Novartis sent to Incyte on April 22, 2009 ....
• None of the GS Models forecasted a cessation of payment of Reverse Royalties to Novartis prior to the end of the duration of U.S. Jakafi sales being forecasted to be made by Incyte, which often included the period through 2030. Nor do they reflect any contingency involving Novartis obtaining a hypothetical patent in the future after the closing of the transaction subject of the Agreement in 2009.
• The GS Models do not contain or reflect the assumption that Incyte will only pay
ten years' worth of Reverse Royalties unless a contingency is achieved .... In fact,
there is nothing in any of the GS Models that pre-date or post-date the final term sheet suggesting that a contingency must be achieved in order for Novartis to receive a Reverse Royalty for more than 10 years. To the contrary, the GS Models do not reflect any limitation being imposed on, or scenario testing with respect to, the Reverse Royalty. They reflect that paying a Reverse Royalty well past ten years, and for nearly two decades, was the most likely projected outcome.
• The GS Models reflect a decrease in sales in the U.S. starting several years before patent expiration and a corresponding decrease in the amount of forecasted Reverse Royalty payments being made to Novartis. This contemplated decline in sales is also reflected in the GS Models as to other bidders looking to partner with Incyte . . ., and so this decline cannot be something attributed to Novartis, but rather, must be attributed to something within/associated with Incyte .... I conclude that this reduction in anticipated sales relates to the loss of market exclusivity, likely due to patent expiration.....
• The GS Models do not reflect a (i) 50% reduction to the Reverse Royalty being paid by Incyte to Novartis or (ii) the invocation of the 50% reduction/“step down” provision in Section 8.3(c) of the Agreement for any period during which Jakafi is being sold in the U.S. by Incyte.
• The GS Models do not contain or reflect the assumption that Incyte will be able to reduce the amount of Reverse Royalties owed by 50% in or around 2019.Id. ¶ 19. And Mr. Tedesco summarizes his opinions as to Incyte's internal, post-Agreement models as follows:
• The Incyte Models calculate a Reverse Royalty to be paid by Incyte ....
• The Incyte Models do not contain or reflect an assumption that Novartis “may” obtain a patent in the U.S. and license it to Incyte, nor do they contain or reflect an assumption that any contingency was considered ....
• The Incyte Models are modeling a “base case” scenario in which the payment of Reverse Royalties . . . was the most likely outcome.
• The Net Present Value calculation reached by Incyte to value the Reverse Royalty at [a given rate] includes an assumption that Incyte will be making such royalty payments to Novartis .... Put differently, Incyte's own valuation analysis assumes a durational period of the Reverse Royalty that is well past ten years ....
• The internal Incyte Models prepared after the Agreement was signed in 2009 consistently reflect expected Reverse Royalty payments flowing from Incyte to Novartis until [a particular date, provisionally redacted] and do not reflect that Incyte
expected a 50% reduction in payments to Novartis in Q4 2018 or Q1 2019, or for a cessation of Reverse Royalty payments in Q4 2021 or Q1 2022, unless a contingency (such as Novartis obtaining a U.S. Patent) occurred.
• The Incyte Models do not contain or reflect an assumption of a forthcoming 50% reduction in Reverse Royalties in late 2018 or early 2019.Id. ¶ 20.
Incyte moves to exclude certain opinions and testimony of Mr. Tedesco pursuant to Federal Rule of Evidence 702 and Daubert. See Tedesco Mem. In sum, Incyte argues that (1) Mr. Tedesco's opinions “are not based on sufficient facts because the [financial] models [on which he opines] are not evidence of the parties' expectations of the royalty duration;” (2) his “‘opinions' are a mere parroting of factual content, not expert analysis;” and (3) his “opinions that the models support Novartis's interpretation are inadmissible because he disavows knowledge of the parties' legal positions.” See Tedesco Mem. at 8-17.
2. Qualifications as an Expert Witness
As with Dr. Pullan, Incyte does not challenge Mr. Tedesco's qualifications as an expert. Nonetheless, as part of its gatekeeping function, the Court has considered Mr. Tedesco's qualifications and determines that he is qualified to testify as an expert.
3. The Disputed Opinions' Reliability and Helpfulness
Any of Mr. Tedesco's unfounded speculations regarding the factual motive, intent, or state of mind of either or both parties, in entering into the Agreement or creating the financial models, are inadmissible. But again, testimony that instead opines on what is typical of or ordinary in the industry with respect to modeling assumptions or interpreting financial models may assist the factfinder.
Incyte's principal issue with Mr. Tedesco's opinions and testimony concerns his reliance on a series of financial models, which Incyte argues are “irrelevant to the parties' expectations on the duration of Incyte's royalty payments.” Tedesco Mem. at 8. For the reasons discussed above in the ruling on the motion to exclude the opinions and testimony of Dr. Pullan, it is not categorically impermissible for Mr. Tedesco to testify about the financial models themselves; but he cannot testify regarding what any party actually intended, as a matter of fact, in creating the models.
This is because (1) in Incyte's view, the models “do not speak to the disputed question in this case” since they “are not designed to predict, simulate, or otherwise model the duration of Incyte's royalty,” and (2) at least some of the models “are purely internal, financial analyses that, because they were never shared between the parties, do not evidence any mutual intent of Incyte and Novartis . . ., nor can they support any inference or analysis leading to expert testimony on such intent.” Id.
Incyte next argues that Mr. Tedesco's opinions are “a mere parroting of factual content,” Tedesco Mem. at 14, as Incyte wrongly asserts that he “did not examine or analyze why the models showed what they did in any way, shape, or form,” Id. at 15 (emphasis in original). This is a mischaracterization of Mr. Tedesco's opinions. Mr. Tedesco synthesized the economic models' inputs and outputs into streamlined findings, illustrated via demonstratives that summarize and interpret the data in a format more easily understandable to the factfinder. See Tedesco Rpt., Appendix C (collecting the demonstratives); Tedesco Rebuttal Rpt., Appendix C (same, displaying the parties' royalty payments and financial projections). This method is sufficiently reliable, and Mr. Tedesco may testify to his understanding of what the models empirically show. See, e.g., Louis Vuitton Malletier S.A. v. Sunny Merch. Corp., 97 F.Supp.3d 485, 504 (S.D.N.Y. 2015) (holding that an expert's spreadsheets that streamline voluminous data are admissible); Capri Sun GmbH v. Am. Beverage Corp., 595 F.Supp.3d 83, 133 (S.D.N.Y. 2022), motion to certify appeal denied, No. 19CIV1422PAEVF, 2022 WL 3137131 (S.D.N.Y. Aug. 5, 2022) (“[I]t is well-established that ‘[e]xpert testimony is . . . admissible where it ‘synthesizes' or ‘summarizes' data in a manner that ‘streamline[s] the presentation of that data to the jury, saving the jury time and avoiding unnecessary confusion.'” (citations omitted)).
Incyte also reiterates the same argument it made to exclude Dr. Pullan's opinions, citing caselaw that “a court cannot permit experts to ‘offer credentials rather than analysis.'” See LinkCo, Inc., 2002 WL 1585551, at *4; Tedesco Reply at 2; Pullan Reply at 2. But again, that is a mischaracterization of the record: Mr. Tedesco undertook an extensive review and analysis of a series of complicated financial models as described above.
While fact witnesses' testimony on the financial models is critical to understanding the parties' intent and, as discussed above, Mr. Tedesco and Dr. Pullan (and Dr. Rao) cannot opine on what Novartis and Incyte actually intended at the time, their testimony may be helpful to the factfinder in understanding the data, assumptions (and what an “assumption” is in a financial model), and mathematical processes underlying these highly sophisticated financial models. See, e.g., Scott v. Chipotle Mexican Grill, Inc., 315 F.R.D. 33, 45 (S.D.N.Y. 2016) (“Expert testimony is . . . admissible where it ‘synthesizes' or ‘summarizes' data in a manner that ‘streamline[s] the presentation of that data to the jury, ....' .... [But] experts may not offer opinions regarding the intent or motive of parties as part of their analysis.” (citations omitted)). In addition to “unit[ing] large and varied types of data to support a conclusion grounded in a field in which he has genuine expertise,” Mr. Tedesco “has usefully ‘draw[n] inferences that would not be apparent without the benefit of experience or specialized knowledge.'” Capri Sun, 596 F.Supp.3d at 134 (citations omitted). That said, these inferences may not include ones regarding the parties' actual intentions, as that is an argument for counsel to make. See Rezulin Prod. Liab., 309 F.Supp.2d at 546.
Novartis agrees, noting in its opposition that “Mr. Tedesco does not intend to testify about the parties' intent, understanding, or knowledge in 2009; he has no personal knowledge to do so and that would be for the fact witnesses to discuss in any event.” Tedesco Opp'n at 22. This is correct.
Incyte unpersuasively asserts that “anyone with a rudimentary understanding of how to read a chart or spreadsheet would see” that “the models do not show a reduction or cessation of Incyte's royalty payments,” arguing that the fact witnesses who prepared the models “are . . . better equipped to speak to the models at issue and the intent behind preparation of those models.” See Tedesco Mem. at 16-17. Incyte is correct that only the fact witnesses may opine on the actual intent of the parties in preparing the models. But an average layperson would surely benefit from the experts' efforts to parse and interpret the myriad complex, data-driven, and voluminous financial models prepared by Goldman Sachs and other highly educated professionals in this specialized field.These insights, which “would be by no means obvious to a lay juror,” when “communicated by a professional drawing on genuine expertise, do not usurp the role of the jury.” See Capri Sun, 596 F.Supp.3d at 134.
Even Incyte's counsel appears to recognize this, dedicating a seven-line footnote in their brief to explaining what “fixed values” and “hard-coded inputs” in an Excel spreadsheet are. See Tedesco Mem. at 4 n.5. Incyte also repeatedly refers to “[t]he formulas embedded in the Excel spreadsheets,” which, notably, the factfinder does not have in native format and could surely benefit from the assistance of an expert in understanding. See, e.g., Tedesco Reply at 3.
In addition, Mr. Tedesco's reliable opinions may assist the factfinder in understanding the industry customs and practices applicable to financial modeling and valuation analyses, such as “scenario financial analysis;” these opinions may provide probative context for the factfinder in viewing the financial models at issue (which, of course, Incyte's own experts may then rebut). See, e.g., Scott, 315 F.R.D. at 45 (“An expert also may offer commentary on documents in evidence if the expert's testimony relates to the ‘context in which [documents] were created, defining any complex or specialized terminology, or drawing inferences that would not be apparent without the benefit of experience or specialized knowledge.'” (citation omitted)). Relatedly, the parties' financial and economic experts may helpfully opine on what an “assumption” in a model is, how empirical assumptions can be incorporated into cell-level formulas, how to read a given input or output in a spreadsheet's calculations, and what the presence or absence of certain information in financial models pertaining to complex deal valuation may reflect, from the perspective of an industry professional.
Last, Incyte argues that some of Mr. Tedesco's opinions should be excluded because “he disavows any understanding of the parties' competing interpretations of Section 8.3(c)(i).” Tedesco Mem. at 17. In support, Incyte cites deposition testimony wherein Mr. Tedesco stated that he does not “have a legal interpretation of [the parties'] positions,” while recognizing that “there's a dispute over the step-down that was invoked in 2019 and the cessation of the royalties that were paid.” See id. at 18 (quoting Ex. 284(“Tedesco Dep.”) 175:14-176:4) (internal quotation marks omitted); see also id. n.14.
This argument is specious: Mr. Tedesco clearly understood the heart of the dispute well enough to opine on the meaning of Section 8.3(c). See, e.g., Tedesco Dep. 176:10-176:17 (clarifying that Mr. Tedesco does not know the parties' “legal interpretation” of the provision, while understanding the parties' general positions that Incyte “felt their interpretation of that section enabled them to cut the royalties by 50 percent in 2019 and stop paying royalties in . . . 2021” (emphasis added)). Mr. Tedesco need not understand the precise ins and outs of either side's legal theory of the case to be qualified as a financial expert. Indeed, it would be improper for an expert like Mr. Tedesco to usurp the roles of the factfinder and the Court by opining on legal issues in the case. And again, should this case go to trial, any objections to the weight of the expert's testimony may be challenged on cross-examination. See, e.g., Reach Music Pubc., 988 F.Supp.2d at 405; R.F.M.A.S., Inc. v. So, 748 F.Supp.2d 244, 252 (S.D.N.Y. 2010) (“To the extent that a party questions the weight of the evidence upon which the other party's expert relied or the conclusions generated from the expert's assessment of that evidence, it may present those challenges through cross-examination of the expert.”).
See, e.g., MPM Silicones, LLC v. Union Carbide Corp., No. 111CV1542BKSATB, 2016 WL 11604974, at *4 (N.D.N.Y. July 7, 2016) (correctly observing that an expert “need not be qualified as an expert on legal interpretation,” as that task is one “for the Court”).
This may include, for example, questioning Mr. Tedesco's reliance on financial models that were themselves originally created by someone else (be it Incyte, Novartis, or Goldman Sachs). See, e.g., Gussack Realty Co. v. Xerox Corp., 224 F.3d 85, 94 (2d Cir. 2000) (noting that “an expert may rely on data that she did not personally collect”); Rinaldi v. SCA La Goutte, D'Or, No. 16-CV-1901 (VSB), 2021 WL 4553850, at *5 (S.D.N.Y. Sept. 30, 2021) (stating that a party may cross-examine another's expert on “her reliance on [a third party's] projections” while deeming the testimony admissible); cf. Lickteig v. Cerberus Cap. Mgmt., L.P., 589 F.Supp.3d 302, 332-33 (S.D.N.Y. 2022) (permitting the defendants to “attack the credibility of their own financial projections if they so choose” at trial “as a matter of weight,” rather than ruling out the experts' opinions as inadmissible).
D. Motion to Exclude Dr. Mohan Rao's Opinions & Testimony
Finally, the motion to exclude the opinions and testimony of Dr. Rao is granted in part and denied in part.
1. Background
Incyte's second designated expert witness, Dr. Rao, is a Ph.D.-holding economist specializing in intellectual property and antitrust. Ex. 265 (“Rao Rpt.”) ¶ 1. He is currently the Chief Executive Officer of Epsilon Economics and the Chief Executive Officer of Expression Therapeutics Inc. (“ETI”), a biotechnology company. Id.; see also id., Tab 1 (“Rao's Curriculum Vitae”). He has “taught courses in finance, statistics, game theory, and competition policy,” as well as “advanced courses on intellectual property valuation and transactions - with an emphasis on pharmaceuticals - at the Licensing Executives Society (LES), the leading professional organization for IP valuation and licensing.” Rao Rpt. ¶ 3. He has written academically on econometrics and intellectual property valuation in licensing transactions. Id. In addition, Dr. Rao serves on the boards of Epsilon Xi, Expression Therapeutics, the Children's Hospital of Chicago, and the Stanley Manne Children's Research Institute. Id. ¶ 4. He is a member of a variety of academic and professional associations, including the American Economic Association and the American Society of Gene and Cell Therapy. Id. ¶ 6.
Dr. Rao was retained by Incyte's counsel “to assess certain economic issues” pertaining to the dispute over Section 8.3(c). Id. ¶ 8. In conducting his analysis, he “reviewed various documents produced in this litigation, pleadings, depositions, economic and financial information, and publicly available information,” and he interviewed “key executives at Incyte with knowledge of the . . . Agreement.” Id. ¶ 9. Dr. Rao summarizes his opinions in his opening report as follows:
• Typical licensing practice is to structure royalties such that payments flow to the IP owner, and the term of royalty payments is linked to the duration of the IP rights licensed to the royalty-paying party. Novartis's proposed interpretation of Section
8.3(c) is not consistent with this typical practice.
• Incyte's interpretation of Section 8.3(c) is consistent with the economic principles of licensing and follows the practice of structuring royalties to flow to the IP owner.
• Neither Incyte's nor Novartis's pre-negotiation financial modeling provide insight into either party's interpretation of Section 8.3(c) of the Agreement.
• The Agreement confers significant value to Novartis under Incyte's interpretation of Section 8.3(c), both prospectively as Novartis forecasted at the time of the 2009 negotiation, and based on the actual performance of the JAK and c-MET Programs.Id. ¶ 10.
Novartis moves to exclude the opinions, testimony, exhibits, and “supporting papers” of Dr. Rao pursuant to Federal Rules of Evidence 104, 403, and 702. See Rao Mem. In sum, Novartis argues that Dr. Rao's opinions should be excluded in their totality because he is not qualified to make them; and that even if he was, (1) his “opinions concerning purported intent, expectations, assumptions, or state of mind had by either of the parties should be excluded as improper;” (2) his “witness credibility determinations and factual narratives . . . are not appropriate;” (3) his “licensing opinions . . . are irrelevant, will not assist the trier of fact, and rely on unreliable methodology;” (4) his opinions regarding “Incyte's practice” “are unreliable and speculative;” (5) his opinions regarding the financial models “are speculative, usurp the role of the factfinder, and ignore key evidence;” and (6) his “value opinions . . . are improper, speculative, unreliable, and likely to cause jury confusion.” See Rao Mem. at 7-21.
Specifically, Novartis argues that Dr. Rao, an economist, lacks sufficient experience in a relevant field (namely, that of pharmaceutical licensing) and has “zero experience with ‘reverse' royalties akin to the royalty Incyte is obligated to pay Novartis on U.S. sales of Jakafi.” Rao Mem. at 2; accord id. at 8. In addition, Novartis argues that Dr. Rao is unqualified because he “has no personal knowledge of party expectations, considerations, or financial modeling efforts relating to the Agreement in 2009.” Id. at 8.
2. Qualifications as an Expert Witness
Novartis's arguments for disqualification are not entirely without merit. Nonetheless, the Court concludes that Dr. Rao is sufficiently qualified as an expert. Again, expert qualification requirements are “liberally construed.” Cary Oil, 2003 WL 1878246, at *1 (internal quotation marks and citation omitted); see also Fosamax Prods., 645 F.Supp.2d at 173 (“[I]n accordance with the liberal admissibility standards of the Federal Rules of Evidence, only serious flaws in reasoning or methodology will warrant exclusion.”). As a highly trained economist specializing in intellectual property, whose academic and professional research and writing has explored intellectual property valuation in licensing transactions, see Rao Rpt. ¶¶ 1-3, Dr. Rao has the requisite “educational background or training in a relevant field,” Crown Cork, 2013 WL 978980, at *2.
In suggesting that he is only “a professor in economics” and “litigation consultant . . . working for a small gene therapy company,” Novartis mischaracterizes the record. See Rao Mem. at 14. At his deposition, Dr. Rao testified that he has signed a license agreement for intellectual property in the pharmaceutical industry on behalf of ETI, and he has negotiated licensing agreements. See Ex. 276 (“Rao Dep.”) at 50:5-11; see also id. at 51:6-12 (“[W]e have negotiated license agreements to enterprise software .... Those are all license agreements[, in which] I was the negotiator and . . . the signator.”). He has also “assisted pharmaceutical companies in their negotiations on numerous occasions, Id. at 52:11-14, as “part of . . . the financial team, . . . perform[ing] the analysis and advis[ing] the pharmaceutical company” even where he did not negotiate actively on the company's behalf, Id. at 52:18-25. For example, he testified that “pharma[ceutical] companies”-in the course of “either . . . licensing in or licensing out or as part of a merger transaction”-have “engage[d]” his company, Epsilon, “to provide them” with the “input” required to “value[]” intellectual property and recommend “financial terms.” Id. at 53:2-14.
The subject matter of Dr. Rao's proffered testimony “fits” within his expertise. See Tin Yat Chin, 371 F.3d at 40; Crown Cork, 2013 WL 978980, at *2; see also Zyprexa Prods., 489 F.Supp.2d at 282 (“If the expert has educational and experiential qualifications in a general field closely related to the subject matter in question, the court will not exclude the testimony solely on the ground that the witness lacks expertise in the specialized areas that are directly pertinent.”). Dr. Rao need not “satisfy an overly narrow test of his own qualifications;” rather, his “knowledge of the subject is such that his opinion will likely assist the trier of fact in arriving at the truth.” Crown Cork, 2013 WL 978980, at *2 (internal quotation marks and citation omitted). Novartis's qualms with a lack of any particular “experiential background . . . ‘go to the weight, not the admissibility, of [the] testimony.'” Zyprexa Prods., 489 F.Supp.2d at 282 (quoting McCullock, 61 F.3d at 1044).
This case is unlike Hogan v. Novartis Pharmaceuticals Corp., in which the court found that an expert who “ha[d] never worked for a pharmaceutical company” was “unqualified to opine on . . . pharmaceutical companies' internal operating procedures ....” 2011 WL 1533467, at *3-4 (E.D.N.Y. Apr. 24, 2011). Here, Dr. Rao himself is the CEO of a biotechnology company engaging in gene therapy work; he has had more experience than the expert at issue in Hogan.
Should this case proceed to trial, Novartis could, for example, question Dr. Rao on cross regarding the level of his familiarity with “reverse royalties” and pharmaceutical licensing agreements similar to the one at issue in this case.
3. The Disputed Opinions' Reliability and Helpfulness
To the extent that Dr. Rao offers (1) any unfounded, speculative opinions regarding the factual motive, intent, or state of mind of either or both parties in entering into the Agreement or creating the financial models, (2) mere recitations of the facts themselves, or (3) credibility determinations of any witnesses, the motion to exclude the proposed testimony is granted.
For the reasons discussed above, Dr. Rao may not speculate on either parties' state of mind or intent, nor may he proffer any credibility determinations. See, e.g., In re Rezulin Prod. Liab. Litig., 309 F.Supp.2d at 546; Kidder, Peabody & Co., 14 F.Supp.2d at 398; Nimely, 414 F.3d at 398.
Novartis also takes issue with four sets of opinions which they term, respectively, Dr. Rao's “Licensing Opinions,” which concern the “typical licensing practice” with respect to economic considerations of licensing in the pharmaceutical sector; his “Incyte Practice Opinions,” pertaining to what practice is “typical” of Incyte in structuring its own licensing agreements; his “Financial Model Opinions,” which concern the parties' pre- and post-Agreement financial models; and his “Value Opinions,” which opine on the “value to Novartis of entering into the Agreement with Incyte” and whether/when Novartis achieved “payback” on its investment. See Rao Mem. at 2-6. a. The “Licensing Opinions”
Novartis's brief provides several illustrative examples falling into each bucket. See Rao Mem. at 2-6.
As for the so-called “Licensing Opinions,” Novartis first argues that Dr. Rao's opinions “concerning one-way licenses with one-way royalties” are irrelevant because one- and two-way royalty provisions differ. See Rao Mem. at 11-12. But, as discussed above, the standard for relevance “is not high.” Southland Corp., 760 F.2d at 1375. The Court does not find that the probative value of Dr. Rao's one-way license or one-way royalty opinions is “substantially outweighed” by a danger of unfair prejudice, confusing the issues, or otherwise under Rule 403 balancing. The opinions are not categorically inadmissible on that basis. Nor are all of Dr. Rao's licensing opinions excluded as unreliable because Dr. Rao bases some of these opinions in part on 15 other agreements that Incyte entered into. Though this methodology might be reasonably questioned, it falls within “the range where experts might reasonably differ,” and so the duty of determining this evidence's weight and sufficiency lies with the factfinder; it will not be excluded on admissibility grounds. See Kumho Tire, 526 U.S. at 153; see also Daubert, 509 U.S. at 596 (“Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.”).
That being said, Dr. Rao's opinions that concern solely the 15 other agreements that Incyte entered into are inadmissible for the same reasons described above in ruling on the motion to exclude Mr. Lankau's testimony. First, these opinions attempt to offer legal conclusions regarding the underlying contracts, which is improper; and Incyte has not persuasively argued that these other agreements are, in any case, probative to the interpretation of Section 8.3(c) of the Agreement. Second, Dr. Rao (not a factual witness) lacks personal knowledge regarding the intent or context surrounding these other, unrelated contracts; so he cannot testify to what Incyte intended or did with respect to them. And in any case, opinions interpreting these 15 other contracts are excluded on Rule 403 balancing grounds: they risk unfair prejudice and confusing the issues. See Fed.R.Evid. 403; Nimely, 414 F.3d at 397.
In contrast, among the “Licensing Opinions” on which Dr. Rao may testify include his commentary on what “[t]ypical licensing practice” is in terms of structuring royalty payments, see Rao Rpt. ¶ 10, as well as what is “usual” or “unusual” for licensing structuring, Id. ¶ 31, and what is consistent or “not consistent with this typical practice,” Id. ¶ 10.
b. The “Incyte Practice” Opinions
Moreover, Dr. Rao's “Incyte Practice” opinions, which essentially summarize what he has gleaned from these other 15 agreements, are excluded. See id. ¶¶ 34-40 (opining on what Incyte has done in other deals in comparison to the Novartis-Incyte deal). Dr. Rao may not permissibly opine on what Incyte's own “typical practices” are, given that he lacks no personal knowledge of these practices; he is, again, not a factual witness. See, e.g., Amuso, 21 F.3d at 1263 (“A district court may commit manifest error by admitting expert testimony where the evidence impermissibly mirrors the testimony offered by fact witnesses, or the subject matter of the expert's testimony is not beyond the ken of the average juror.”). And as noted above, Dr. Rao may not permissibly opine on a party's intent, state of mind, or actual practice. See Rezulin Prod., 309 F.Supp.2d at 546 (“The question of intent is a classic jury question and not one for the experts.”).
c. The “Value Opinions”
As for the “Value Opinions,” Dr. Rao may testify to his understanding of what the financial models suggest regarding the statistical concept of an “expected value.” This does not, however, mean that Dr. Rao may permissibly opine on what Novartis or Incyte actually “expected” or believed the value of the deal to be. See, e.g., Rao Rpt. ¶¶ 48 (opining on “Novartis's expectations going into the Agreement” and what “Novartis's expectations from the deal” would have been); Id. ¶ 52 (opining on what “Novartis had expected to spend . . . in up-front costs”); Id. ¶ 57 (opining that “the actual performance of JAK/c-MET and Novartis's return on the deal was above Novartis's expectations”). Those opinions are inadmissible because, again, no expert may opine on a party's actual state of mind as a factual matter. And it is the province of counsel to make any inferential leap from any expert opinions on what a model may show (as a mathematical matter) to what that might imply about the parties' intent at the time.
Novartis's briefing misleadingly suggests that an “expected value” is necessarily a subjective opinion, when it is also a term commonly utilized to express an objective mathematical concept. See, e.g., Expected Value, MERRIAM-WEBSTER, https://www.merriam-webster.com/dictionary/expected%20value [https://perma.cc/L7KH-FUWX] (defining “expected value” as “(1) the sum of the values of a random variable with each value multiplied by its probability of occurrence; (2) the integral of the product of a probability density function of a continuous random variable and the random variable itself when taken over all possible values of the variable”); see also Tedesco Rpt. ¶ 28 (defining “the value of an asset” as “a function of the expected net cash flows in the future, the uncertainty associated with those cash flows, and the opportunity cost of investing in that asset”). Mr. Tedesco's comments on “the expected value of the deal” at times appear to conflate the two, but are nonetheless analytically severable. For example, in his opening report, he writes: “An analysis of Novartis's expectations going into the Agreement suggests that the royalties in dispute stemming from the parties' differing interpretations of Section 8.3(c) of the Agreement constitute a relatively small proportion (less than percent) of the expected value of the deal.” Id. ¶ 48 (emphases added). While the first use of “expectations” is improper insofar as it opines on Novartis's actual expectations or subjective state of mind, the second use of “expected value” references the mathematical concept and not any subjective valuation. The latter opinion is not admissible per se, although it is for counsel-and not any expert witness-to argue any inference regarding what either party in particular expected to receive from the deal.
d. The “Financial Model Opinions”
The same analysis discussed above in ruling on the motion to exclude Mr. Tedesco's opinions on the financial models applies to Dr. Rao's opinions about the models: he may “testify to whether a given practice is consistent with a given state of mind,” but not as to what Novartis or Incyte actually had in mind in creating the financial models. See Wilson, 2016 WL 7229056, at *8.
In addition, Dr. Rao's opinions that the factfinder “cannot” examine the financial models to “infer either party's intent,” and his related “opinions” that the factfinder must therefore disregard the models entirely, are inadmissible. See, e.g., Rao Rpt ¶ 10 (opining that neither party's “financial modeling provide[s] insight into either party's interpretation of Section 8.3(c)”); Id. ¶ 41 (opining that “one cannot look to these . . . models to infer either party's intent”); Id. ¶ 42 (opining that Novartis's financial models in fact “did not attempt to predict or forecast when Incyte's royalty obligations would end or step down”); Id. ¶ 45 (opining on what Incyte's models in fact “attempt[ed] to reflect”). Again, experts cannot opine on what either party actually intended or “contemplated” in creating the models, although Dr Rao may provide context on what the financial models show, mathematically or from an economic perspective. See Wilson, 2016 WL 7229056, at *8.
IV. CONCLUSION
For the reasons described above, each of the motions to exclude the proposed expert testimony of Mr. Lankau, Dr. Pullan, Mr. Tedesco, and Dr. Rao is granted in part and denied in part.
The Clerk of Court is directed to terminate the motions pending at Dkt. Nos. 157, 160, 167, and 170.
SO ORDERED.