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In re Loestrin 24 FE Antitrust Litigation

United States District Court, D. Rhode Island

December 17, 2019




         With trial fast approaching, Defendants seek summary disposition of this case. The Court disagrees that issues presented may be disposed of summarily - although some issues are fairly close calls - and therefore denies Defendants' motion for summary judgment, ECF No. 842. The reasons are explained below.

         The Court also, for the reasons set forth below, denies the pending cross-motions for summary judgment on market power, ECF Nos. 496, 569. And finally, related to all motions for summary judgment, the Court resolves in this order several of the pending Daubert motions.

         I. Background

         Warner Chilcott launched Loestrin 24 (“Loestrin”), an oral contraceptive, in 2006 after the Food and Drug Administration (“FDA”) approved its New Drug Application (“NDA”); Warner Chilcott then listed its new drug in the FDA's Orange Book as covered by U.S. Patent No. 5, 552, 394 (“´394 patent”). See Pls.' Statement of Disputed Facts (“PSOF”) ¶¶ 1, 48-51, ECF No. 979. The company sold Loestrin until 2013, when it discontinued its manufacture and switched to making the drug Minastrin 24 (“Minastrin”) under a new NDA. See id. ¶¶ 2-3, 192. Minastrin had the same active ingredients and dosing schedule, but Warner Chilcott added labeling informing customers that the pills could be chewed and added spearmint to the inactive pills to distinguish it from Loestrin. See id. ¶¶ 2, 192.

         An AB-rated generic version of Loestrin was not marketed until 2014, despite attempts by three separate companies to introduce one sooner. Id. ¶¶ 52, 58, 62, 110. Pursuant to the protocol envisioned by the Hatch-Waxman Act, Warner Chilcott sued all three for infringing the ´394 patent. Id. ¶¶ 52, 58, 62. These suits ended in settlements in which Warner Chilcott allegedly compensated the generic manufacturers to refrain from entry until a specific date, six months before the ´394 patent expired. See id. ¶¶ 52-53, 58, 60, 62, 65. Since the first generic entered in 2014, six additional Loestrin generics have come to market, as have multiple Minastrin generics. Id. ¶¶ 110, 209, 212.

         Plaintiffs' case - detailed in this Court's most recent motion-to-dismiss decision, with which the Court assumes familiarity - is simply that generics should have been available for them to purchase earlier. See In re Loestrin 24 Fe Antitrust Litig., 261 F.Supp.3d 307, 324-25 (D.R.I. 2017) (“Loestrin II”). And indeed they would have been but for Defendants' allegedly anticompetitive conduct, including: protecting Loestrin with a patent Warner Chilcott knew was invalid; filing sham patent infringement lawsuits against prospective generic entrants; settling those suits to split monopoly profits; and formulating a new drug (Minastrin) only to limit generic substitution. Id.

         II. Discussion

         The Court has before it three motions for summary judgment, and the standard necessary to resolve these motions is well established. Summary judgment is appropriate when “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56. The nonmovant defeats a summary-judgment motion by marshaling evidence that would allow a jury to decide a material fact in its favor. Theriault v. Genesis HealthCare LLC, 890 F.3d 342, 348 (1st Cir. 2018). Although given the benefit of all reasonable inferences, nonmovants may not rely on “conclusory allegations, improbable inferences, and unsupported speculation.” Mulloy v. Acushnet Co., 460 F.3d 141, 145 (1st Cir. 2006) (citation omitted). Where appropriate, in a case like this one, “the plaintiffs must present a ‘genuinely disputed issue of material fact' as to the elements of the rule of reason analysis; only then will the case go to a jury.” In re Namenda Direct Purchaser Antitrust Litig., 331 F.Supp.3d 152, 198 (S.D.N.Y. 2018) (“Namenda I”) (quoting In re Wellbutrin XL Antitrust Litig., 133 F.Supp.3d 734, 754 (E.D. Pa. 2015), aff'd sub nom. In re Wellbutrin XL Antitrust Litig. Indirect Purchaser Class, 868 F.3d 132 (3d Cir. 2017), judgment entered sub nom. In re Wellbutrin XL Antitrust Litig., No. 15 Civ. 2875, 2017 WL 3529114 (3d Cir. Aug. 9, 2017) (“Wellbutrin XL I”)).

         Here, there are many Daubert motions standing between the Court and the evidence it may consider in deciding these motions. These need to be resolved in order to consider (or not) the proffered expert opinions in support of, and in opposition to, summary judgment. See Namenda I, 331 F.Supp.3d at 168 (“If the expert testimony is excluded as inadmissible, the court must make the summary judgment determination without that evidence.”) (citation omitted).

         In its role as gatekeeper, the Court “may exercise wide discretion to admit or exclude such testimony consistent with its obligation to ensure that the jury receives only relevant and reliable expert evidence.” Alifax Holding SpA v. Alcor Sci. Inc., 387 F.Supp.3d 170, 173 (D.R.I. 2019). Rule 702 of the Federal Rules of Evidence provides that a qualified witness may testify if “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; [] the testimony is based on sufficient facts or data; [] the testimony is the product of reliable principles and methods; [] and the expert has reliably applied the principles and methods to the facts of the case.” Fed. R. Evid. 702.

         Experts, of course, do not have “carte blanche” to express any opinion, no matter its limitations or lawfulness. Ruiz-Troche v. Pepsi Cola of Puerto Rico Bottling Co., 161 F.3d 77, 80 (1st Cir. 1998). The Supreme Court has interpreted Rule 702 to direct “the trial judge to evaluate an expert's proposed testimony for both reliability and relevance prior to admitting it.” Id. (citing Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589-95 (1993)). This “flexible inquiry into the overall reliability of a proffered expert's methodology” involves review of such factors as “the verifiability of the expert's theory or technique, the error rate inherent therein, whether the theory or technique has been published and/or subjected to peer review, and its level of acceptance within the scientific community.” Id. at 81. Put simply, the expert's opinion and testimony should “impart[] ‘scientific knowledge' rather than guesswork.” Id. (quoting Daubert, 509 U.S. at 592). The Court will rule on the relevant Daubert motions as necessary to decide the summary judgment motions.

         With these guideposts in mind, the Court first turns to the threshold issue of market power, then moves on to the merits issues, and finally state law and damages issues.

         A. Market Power Summary Judgment[1]

         Market power is a hotly contested, threshold issue. See Flovac, Inc. v. Airvac, Inc., 817 F.3d 849, 853 (1st Cir. 2016). Plaintiffs' Sherman Act claims require them to show Defendants possessed market power, “meaning the power to control prices or exclude competition.” E. Food Servs., Inc. v. Pontifical Catholic Univ. Servs. Ass'n, Inc., 357 F.3d 1, 5 (1st Cir. 2004); United States v. E. I. du Pont de Nemours & Co., 351 U.S. 377, 391 (1956); see also 15 U.S.C. §§ 1-2. Section 2 requires a greater degree of market power - referred to as monopoly power - than Section 1. Eastman Kodak Co. v. Image Tech. Servs., Inc., 504 U.S. 451, 481 (1992).

         To be frank, the law and economics of market power is a confusing mess. See Louis Kaplow, Why (Ever) Define Markets?, 124 Harv. L. Rev. 437, 440 (2010) (“Defects [of the market definition/market share paradigm] have been identified by courts, enforcement agencies, and both legal and economic commentators. No one believes that the market definition process is flawless or that market power inferences drawn from market shares are uniformly reliable, or even nearly so.”). And when applied in the pharmaceutical context, it really shows its warts. But this much we know: Market power and monopoly power can be established by the same kind of evidence, either direct or indirect. Direct evidence of market power includes proof such as supracompetitive prices or reduced output. Ohio v. Am. Express Co., 138 S.Ct. 2274, 2283-85 (2018) (Section 1) (“Direct evidence of anticompetitive effects [is] proof of . . . reduced output, increased prices, or decreased quality in the relevant market.” (citation omitted)).[2]Proof of market power can also come indirectly by defining a market and determining the defendant's share of that market. Coastal Fuels of P.R. v. Caribbean Petroleum Corp., 79 F.3d 182, 197 (1st Cir. 1996); Flovac, 817 F.3d at 853-54.

         Case law suggests that when direct evidence is dispositive, indirect evidence is unnecessary. F.T.C. v. Ind. Fed'n of Dentists, 476 U.S. 447, 460-61 (1986); In re Nexium (Esomeprazole) Antitrust Litig., 968 F.Supp.2d 367, 388 n.19 (D. Mass. 2013) (“Nexium I”) (“Where direct evidence of market power is available . . . a plaintiff need not attempt to define the relevant market.”). This is because “inquiries into market definition and market power . . . [are] but a surrogate for detrimental effects” on competition. Ind. Fed'n of Dentists, 476 U.S. at 460-61 (citation omitted); Coastal Fuels, 79 F.3d at 197 (“[F]inding the relevant market and its structure is not a goal in itself but a surrogate of market power[.]”) (citation omitted); In re Aggrenox Antitrust Litig., 94 F.Supp.3d 224, 246 (D. Conn. 2015) (“Aggrenox I”) (“[W]hen direct evidence is available that a party profitably charges supracompetitive prices, the existence of market power can be established from that fact alone.”). But where direct and indirect evidence are instructive, and neither dispositive, the factfinder should evaluate both.[3]

         In the specialized field of pharmaceutical antitrust reverse payment cases, the Supreme Court's seminal holding, F.T.C. v. Actavis, Inc., tells us that “where a reverse payment threatens to work unjustified anticompetitive harm the patentee likely possesses the power to bring that harm about in practice.” Actavis, 570 U.S. 136, 157 (2013); see also In re Aggrenox Antitrust Litig. (“Aggrenox II”), 199 F.Supp.3d 662, 666 (D. Conn. 2016) (“a large reverse payment is . . . a strong indicator of market power”); id. (“[a] large reverse payment is itself suggestive of market power”). And, to evaluate whether a reverse payment is an unreasonable restraint prohibited by Section I, it must be tested by the rule of reason. See Actavis, 570 U.S. at 156.

         The rule of reason has been equated with “an inquiry into market power and market structure” intended to assess the actual effect of the restraint. Copperweld Corp. v. Indep. Tube Corp., 467 U.S. 752, 768 (1984). It requires the factfinder to “weigh[] all of the circumstances of a case in deciding whether a restrictive practice should be prohibited as imposing an unreasonable restraint on competition.” Leegin Creative Leather Prods. v. PSKS, Inc., 551 U.S. 884, 885 (2007) (quoting Cont'l T. V., Inc. v. GTE Sylvania Inc., 433 U.S. 36, 49 (1977)). These circumstances include “specific information about the relevant business”; “the restraint's history, nature, and effect”; and “[w]hether the businesses involved have market power.” Id. at 885-86. To that end, “[i]n its design and function the rule distinguishes between restraints with anticompetitive effect that are harmful to the consumer and restraints stimulating competition that are in the consumer's best interest.” Id. at 886.

         The question, in the end, is whether Warner Chilcott was in a position with Loestrin to inflict anticompetitive harm, that is, whether it had sufficient “market power”. Having the benefit of trenchant briefing and argument, and concluding that genuine issues of material fact are an insurmountable hurdle to the answer, the Court denies the pending cross-motions, ECF Nos. 496, 569, and will submit this matter to the jury.

         First, the definition of the market at issue is a question of fact. See In re Impax Labs., Inc., No. 9373, 2019 WL 1552939, at *25 (F.T.C. Mar. 28, 2019) (“To establish market power, a plaintiff typically first defines the relevant antitrust market”); see also Flovac, 817 F.3d at 853 (“The definition of the relevant market is ordinarily a question of fact[.]”); Loestrin II, 261 F.Supp.3d at 326 (“Defendants concede, as they must, that courts generally treat this fact-intensive issue as one to be decided on a motion for summary judgment (if no genuine issue of material fact exists) or at trial.”). Plaintiffs and Defendants disagree about the products that make up the market capable of constraining Warner Chilcott's profit margins and price to a competitive level. Defendants are adamant that the oral contraceptive market is an unusually crowded one with over one hundred available hormonal contraceptives: Defendants say the consequent competition could not possibly allow a single brand to gain market power of any concern, and adding one more competitor - generic or otherwise - would be just a drop in the bucket. Plaintiffs predictably oppose this characterization, urging the Court instead to rule as a matter of law that this is a single-product market. And Plaintiffs have some support for their position because Actavis recognizes that “a branded drug and its generic equivalents could - and, in the reverse payment context, often would - together constitute an antitrust-relevant market.” Impax, 2019 WL 1552939, at *25 (citing Actavis, 570 U.S. at 157).

         The practical reality is that the pharmaceutical market is rife with idiosyncrasies. And while several courts in comparable cases have held that the relevant market was a single-product market, market power looks different from one case to the next. See Am. Express, 138 S.Ct. at 2285 (“[C]ourts should ‘combin[e]' different products or services into ‘a single market' when ‘that combination reflects commercial realities.'” (quoting United States v. Grinnell Corp., 384 U.S. 563, 572 (1966)); compare Mylan Pharm. Inc. v. Warner Chilcott Pub. Ltd. Co., 838 F.3d 421, 436 (3d Cir. 2016) (“Doryx”) (affirming district court decision that relevant market was broad, consisting of all oral tetracyclines prescribed to treat acne) with Nexium I, 968 F.Supp.2d at 389 (holding the branded drug and its generic to be a plausible relevant market). Facing the record evidence (documentary, testimonial, and expert) before the Court which, among other things, includes wildly variant estimates of price cost margins (depending on which costs are included, the time frame of the comparisons, and the relevant comparators); differing descriptions of the relevant market - from hundreds of hormonal contraceptives to a single molecule based market; and the highly disputed nature and value of the claimed reverse payments, which may be strong evidence of market power (along with, potentially, the other anticompetitive conduct alleged), the Court is left with the firm view that granting summary judgment for either party would encroach on the function of the jury.[4]

         In reaching this conclusion, and with trial just around the bend, the Court rules on several market power Daubert motions as follows. As to physician prescribing practices, Defendants' Motion to Exclude Certain Opinions and Testimony of Dr. Richard J. Derman, ECF No. 781, and Defendants' Motion to Exclude Certain Opinions and Testimony of Michael Thomas, M.D., ECF No. 640, are GRANTED IN PART AND DENIED IN PART. First, Dr. Derman may not testify as to what all physicians do or consider in making prescribing decisions. He may, however, testify to his own prescribing decision-making process and knowledge, as well as that of his colleagues or other doctors with whom he has personal experience. See Bartlett v. Mut. Pharm. Co., Inc., 742 F.Supp.2d 182, 195 (D.N.H. 2010) (“Indeed, most courts have prohibited experts from testifying ‘about what all doctors generally consider in making prescription decisions' or about ‘what doctors generally think' . . . .” (citations omitted)). For example, Dr. Derman would be free to provide a counter-opinion to that of Dr. Darney that speaks to how he “and other clinicians with whom [he] worked and interacted during [his] career” prescribe oral contraceptives. See Darney Report ¶ 28, ECF No. 654-2. He may also provide an opinion that he and Defendants' experts agree as to certain topics, and any disagreement on that score may be addressed by Defendants on cross-examination. Second, Dr. Derman may provide his opinion that, for some patients, “there may be one [combination oral contraceptive] which is more appropriate than any other[.]” See Derman Report ¶ 17, ECF No. 782-2. Third, Dr. Derman may not - without more - speculate that other experts' opinions may be due to reimbursement constraints unique to California. See id. ¶ 20.

         With respect to Dr. Thomas, and consistent with the discussion between counsel and the Court at the September 12, 2019 Daubert hearing, Plaintiffs agree that Dr. Thomas's testimony on prescribing practices, behavior, and knowledge will be limited to his own experience, and that Dr. Thomas will not be permitted to testify as to what all physicians do or if it is common for physicians to do something. Dr. Thomas may testify from his own experience. The same applies regarding any opinions he may offer relating to the impact of cost on patient behavior. Dr. Thomas may similarly opine on his experience regarding the interchangeability of contraceptives but may not more generally opine on how all doctors view this issue.

         Moreover, after careful consideration of the pertinent briefing and underlying expert reports and rebuttal materials, the Court DENIES the Daubert motions filed to preclude the opinions and testimony of Defendants' and Plaintiffs' economic experts. Accordingly, the Court DENIES Defendants' Motions to Exclude the Opinions and Testimony of Plaintiffs' Expert Dr. Christopher F. Baum and Certain Opinions of Dr. Meredith Rosenthal, ECF No. 646, and Plaintiffs' Motion to Exclude the Expert Testimony of Dr. Sumanth Addanki, ECF No. 711. See In re Solodyn (Minocycline Hydrochloride) Antitrust Litig., No. 14-md-2503, 2018 WL 563144, at *7, 9, 10 n.17 (D. Mass. Jan. 25, 2018) (“Solodyn I”) (rejecting Daubert challenges to Drs. Baum's, Rosenthal's, and Addanki's opinions and testimony).

         B. Summary Judgment

         Having determined that the jury will decide the issue of market power, the Court turns to Defendants' motion for summary judgment on the merits and the accompanying Daubert motions.[5]

         1. Plaintiffs' But-For World

         Defendants' first line of attack is a whopper. They assert that Plaintiffs cannot establish a viable but-for world for their Walker Process claim, because if the patent was procured by fraud and therefore invalid, there would have been no patented product and no one would have been injured in the but-for world. No. patent, no product; no product, no purchases; no purchases, no damages, Defendants say. Voila! The problem is this argument has no basis in law and would nullify antitrust liability in any case involving Walker Process fraud alongside another antitrust violation. It is untenable[6] and ignores the reality of the anticompetitive conduct as alleged.

         2. Walker Process Fraud

         That settled, Defendants next claim broadly that Plaintiffs fail to identify a triable issue with respect to Walker Process fraud, a claim that centers on whether the ´394 patent was procured by fraud. Under a Walker Process fraud theory, antitrust liability is imposed on those who enforce a patent they know to be procured by knowing and willful fraud on the U.S. Patent and Trademark Office (“PTO”).[7] See Walker Process Equip., Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172, 179 (1965) (Harlan, J., concurring). For the Court to enter judgment for Defendants on Plaintiffs' Walker Process fraud claim now, Defendants must show there is no genuine dispute as to any material fact, even when all reasonable inferences are drawn in Plaintiffs' favor. See Fed.R.Civ.P. 56; see also Exergen Corp. v. Kaz USA, Inc., 120 F.Supp.3d 1, 6 (D. Mass. 2015).

         In Walker Process fraud, “it is the enforcement of a patent procured by fraud that may give rise to a Sherman Act claim; mere procurement without more does not ‘affect the welfare of the consumer and cannot in itself violate the antitrust laws.'” Loestrin II, 261 F.Supp.3d at 339 (quoting FMC Corp. v. Manitowoc Co., 835 F.2d 1411, 1418 & n.16 (Fed. Cir. 1987)). Walker Process fraud is only actionable against those associated with the filing and prosecution of a patent application who owe a duty of candor and good faith to the PTO. See 37 C.F.R. § 1.56(c); see also Avid Identification Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967, 973 (Fed. Cir. 2010) (analyzing inequitable conduct). This includes (1) “[e]ach inventor named in the application”; (2) “[e]ach attorney or agent who prepares or prosecutes the application”; and (3) “[e]very other person who is substantively involved in the preparation or prosecution of the application and who is associated with the inventor, the applicant, an assignee, or anyone to whom there is an obligation to assign the application.” Id.

         To succeed, then, “the plaintiff must show that the defendant procured the relevant patent by knowing and willful fraud on the PTO or (in the case of an assignee) that the defendant maintained and enforced the patent with knowledge of the fraudulent manner in which it was obtained.” Ritz Camera & Image, LLC v. SanDisk Corp., 700 F.3d 503, 506 (Fed. Cir. 2012) (recognizing that “invalidity of the patent [is] not sufficient; a showing of intentional fraud in its procurement [is] required.”). In addition, Plaintiffs must also show “all the other elements necessary to establish a Sherman Act monopolization claim.” TransWeb, LLC v. 3M Innovative Properties Co., 812 F.3d 1295, 1306 (Fed. Cir. 2016). Thus, here, apart from monopoly power, there are two required showings: first, that the patent was procured by knowing and willful fraud; and second, knowing of the fraud, Warner Chilcott enforced it anyway. See id.

         Fraudulent procurement requires evidence of (1) a misrepresentation or omission made to the PTO (2) material to the patent's issuance, (3) made with intent to deceive the PTO. Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1070-71 (Fed. Cir. 1998). “But-for” materiality is required, meaning that “the patent would not have issued but for the misrepresentation or omission.”[8] Id. at 1071; see also Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1291 (Fed. Cir. 2011). Intent to deceive must be “the single most reasonable inference able to be drawn from the evidence.”[9] Therasense, 649 F.3d at 1290 (quoting Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1366 (Fed. Cir. 2008)).

         To this end, Plaintiffs carry the “burden to show ‘no less than clear, convincing proof of intentional fraud involving affirmative dishonesty.'” Tyco Healthcare Grp. LP v. Mut. Pharm. Co., Inc., 762 F.3d 1338, 1350 (Fed. Cir. 2014) (quoting C.R. Bard, Inc. v. M3 Sys., Inc., 157 F.3d 1340, 1364 (Fed. Cir. 1998)). “Because direct evidence of deceptive intent is rare, a district court may infer intent from indirect and circumstantial evidence.” Therasense, 649 F.3d at 1290. That said, “the evidence ‘must be sufficient to require a finding of deceitful intent in the light of all the circumstances.'” Id. (quoting Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 873 (Fed. Cir. 1988) (emphasis in original)). Thus, “when there are multiple reasonable inferences that may be drawn, intent to deceive cannot be found.” Id. at 1290-91. The question here is whether Plaintiffs have proffered clear and convincing evidence that could support a jury determination of an intent to deceive by the applicant, and that this is the single most reasonable inference the jury could draw from the evidence. Id. at 1290.

         Defendants argue Plaintiffs cannot meet this high evidentiary bar for any of the three factual bases that form their Walker Process fraud claim. Those bases are: (1) the so-called “Molloy Article”; (2) the 30-Woman Study (“the Study”); and (3) the Loestrin 1/20 Fe (“Loestrin 1/20”) Reference. To address each of these in detail, and to understand just what Plaintiffs would offer to the jury to meet their burden, it is necessary to first resolve Defendants' motion to exclude certain opinions and testimony from Plaintiffs' patent experts: Mr. Lentz, Mr. Doll, and Dr. Jewell.

         a. Defendants' Motion to Exclude Certain Opinions and Testimony of Edward Lentz, John Doll, and Nicholas Jewell, ECF No. 890

         Defendants move to exclude these expert opinions on multiple grounds. First, Defendants argue that Mr. Lentz is not qualified to opine that Watson had a 90% likelihood of success in Warner Chilcott's litigation against it. They emphasize that Mr. Lentz has never worked as a patent litigator, and instead served only as general counsel of GlaxoSmithKline. But other courts have permitted similar expert opinions on likelihood of success. See, e.g., Namenda I, 331 F.Supp.3d at 188. While Defendants distinguish these cases, the Court finds them persuasive. Defendants may address any perceived shortcomings of Mr. Lentz's qualifications and his opinion on cross-examination.[10]

         Next, Defendants argue that Mr. Lentz improperly opines about materiality, the significance of prior art references, and technical patent issues; opinions that may only come from a person of ordinary skill in the art (“POSA”), which Mr. Lentz is not. Defendants make the same arguments related to Mr. Doll, alleging he discusses similar technical matters, as well as the materiality of references.

         It is true that only a POSA may opine on these technical patent law issues. See Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362 (Fed. Cir. 2008). But these experts clearly do not do so. Mr. Lentz's opinions are “directed to how a patent attorney in the field would have evaluated the prosecution of the ´394 patent and what advice and opinions a patent attorney would have given to his or her client regarding that prosecution and the related litigation.” Pls.' Opp'n to Defs.' Mot. To Exclude Lentz, Doll, and Jewell 7, ECF No. 1024. And Mr. Doll offers his conclusions in the context of evaluating the ´394 patent's prosecution history. Each expert relies on the references themselves (or another expert) for his opinions. Thus, so long as Mr. Lentz and Mr. Doll only evaluate these issues from their respective perspectives, and do not offer legal conclusions on technical patent issues, their opinions are allowed.[11] See Namenda I, 331 F.Supp.3d at 187 (recognizing that it is the perspective from which the expert opines that is significant); see also Solodyn I, 2018 WL 563144, at *17-18 (finding Mr. Doll qualified to offer an opinion as to what a reasonable patent officer would find material in a patent application and relevant PTO policies and procedures, but not for legal conclusions).

         Third, Defendants argue Dr. Jewell impermissibly offers opinions outside his statistical expertise in opining on the clinical significance and relevance of the 30-Woman Study, the primate study, and the Phase III Clinical Trial. Dr. Jewell is qualified as a biostatistician, sure - but without expertise as a clinician, Defendants say he cannot testify about whether the results of any study would be relevant or significant. The Court is satisfied that he is qualified to opine on the statistical merits of the studies (but not their clinical significance).

         Defendants next posit that Dr. Jewell's analysis of breakthrough bleeding from the 30-Woman Study data should be excluded as unreliable and irrelevant where Dr. Jewell is not qualified to manipulate and analyze data about bleeding days from a human study using definitions from a primate study.[12] The Court is again satisfied that Dr. Jewell is qualified to offer these opinions; Defendants' concerns are best addressed on cross-examination.

         Lastly, Defendants argue that Dr. Jewell, Mr. Lentz, and Mr. Doll improperly opine on intent and/or state of mind. At oral argument, Plaintiffs assured the Court their experts will not express such opinions, and instead will only reference documents from which a jury could find facts that may support a jury determination on intent to deceive. If any expert attempts to opine on intent and state of mind, legal conclusions, or speculates about the patent examiner's state of the mind, those opinions will be excluded and appropriate corrective instructions will be given to the jury.[13] See Solodyn I, 2018 WL 563144, at *18 n.25. Further, neither side will be permitted to offer cumulative opinions.[14] For these reasons, Defendants' Motion to Exclude Certain Opinions and Testimony of Edward Lentz, John Doll, and Nicholas Jewell, ECF No. 890, is GRANTED IN PART AND DENIED IN PART. The motion is DENIED except to the extent, as discussed above, that these experts opine on intent and/or state of mind, legal conclusions, offer cumulative opinions, or speculate about the patent examiner's state of mind.

         b. Plaintiffs' Evidence of Walker Process Fraud[15]

         To set the stage to address the merits of Defendants' Walker Process fraud arguments, it is helpful to recap the cast of characters implicated and their respective alleged misdeeds. Dr. Gary Hodgen, a researcher at the Jones Institute for Reproductive Medicine (“Jones Institute”) at the Eastern Virginia Medical School (“EVMS”), is the named inventor of the ´394 patent, which he assigned to EVMS and EVMS eventually assigned to Warner Lambert. PSOF ¶¶ 10, 11, 39. Edward Meilman - Dr. Hodgen's experienced patent attorney - aided Dr. Hodgen with the patent prosecution that led to the ´394 patent. PSOF ¶¶ 12, 14. Roger Boissonneault, Anthony Bruno, and Carl Reichel worked for Warner Lambert (or one of its subsidiaries) during the patent prosecution and became executives at Warner Chilcott. PSOF ¶ 12. Francis (“Frank”) Tinney similarly worked for Warner Lambert at the relevant time as a patent attorney. Plaintiffs' Additional Statement of Material Undisputed Facts (“ASOF”) ¶ 226, ECF No. 980.

         Warner Chilcott did not own or license the ´394 patent when it was prosecuted; it came to own the patent nine years after it issued.[16] ASOF ¶ 237. Plaintiffs bridge this seemingly significant time gap by claiming that these Warner Chilcott executives - then employed by Warner Lambert - were substantively involved in the patent's prosecution and Warner Chilcott's later acquisition of it, and carried their knowledge of fraudulent conduct with them to Warner Chilcott, which then enforced the patent in spite of that knowledge of fraud.

         Attacking the foundation of Plaintiffs' claims, Defendants say they failed to plead the fraud allegations with particularity, as required by Rule 9(b), against Carl Reichel, Anthony Bruno, and Frank Tinney. See Fed.R.Civ.P. 9(b). “The core purposes of Rule 9(b) are ‘to place the defendants on notice and enable them to prepare meaningful responses,' ‘to preclude the use of a groundless fraud claim as pretext for discovering a wrong,' and ‘to safeguard defendants from frivolous charges [that] might damage their reputation.'” Dumont v. Reily Foods Co., 934 F.3d 35, 39 (1st Cir. 2019) (quoting New England Data Servs., Inc. v. Becher, 829 F.2d 286, 289 (1st Cir. 1987)). Defendants do not argue that they required any further particularity to respond to the complaints. Rather, they claim that Plaintiffs are impermissibly arguing new fraud theories at the summary judgment stage.

         The Court is satisfied that Plaintiffs adequately put Warner Chilcott on notice of these claims. For example, in their Third Amended Consolidated Complaint, the DPPs allege that “Warner Chilcott, through its executives, knew the ´394 patent is [sic] invalid and/or unenforceable[.]” Direct Purchaser Class Pls.' Third Am. Consolidated Class Action Compl. and Jury Demand (“DPP Compl.”) 38, ECF No. 380 (emphasis added). That pleading refers to Mr. Boissonneault specifically and Warner Chilcott generally. See, e.g., id. ¶¶ 143, 144, 147, 152, 153. The EPPs' Second Amended Consolidated Complaint likewise refers to Dr. “Hodgen, counsel, and others substantially involved in its prosecution” collectively as the “applicants”, alleging these people knew about the fraudulent misrepresentations. EPPs' Second Am. Consolidated Class Action Compl. (“EPP Compl.”) ¶¶ 144, 147, ECF No. 165. And like the DPPs, the EPPs' Complaint calls out Mr. Boissonneault specifically and Warner Chilcott generally. Id. ¶¶ 150, 155, 156, 162, 168. The Retailers' respective Amended Complaints proceed in similar fashion, referring to Dr. Hodgen and Mr. Boissonneault, together with Warner Chilcott generally. CVS First Am. Compl. (“CVS Compl.”) ¶¶ 75, 77, ECF No. 177-1; Walgreen First Am. Compl. (“Walgreen Compl.”) ¶¶ 76, 78, ECF No. 176-1. The Retailers also refer to “senior Warner Chilcott executives - including [Mr.] Boissonneault” who “had been executives at Warner [] Lambert when Warner [] Lambert acquired and prosecuted the application that resulted in the ´394 patent[.]” CVS Compl. ¶ 77; Walgreen Compl. ¶ 80.

         Germane here is: “[w]hat constitutes sufficient particularity necessarily depends upon the nature of the case and should always be determined in . . . light of the purpose of the rule to give fair notice to the adverse party and to enable him to prepare his responsive pleading.” Alex & Ani, LLC v. Elite Level Consulting, LLC, 31 F.Supp.3d 365, 371 (D.R.I. 2014) (quoting Women's Dev. Corp. v. City of Central Falls, 764 A.2d 151, 161 (R.I. 2001)). “The circumstances to be stated with particularity under Rule 9(b) generally consist of ‘the who, what, where, and when of the allegedly [misleading] representation.'” Kaufman v. CVS Caremark Corp., 836 F.3d 88, 91 (1st Cir. 2016) (quoting Alt. Sys. Concepts, Inc. v. Synopsys, Inc., 374 F.3d 23, 29 (1st Cir. 2004)). In these pleadings (and at this point in the case), it is clear Warner Chilcott is the “who”, and the alleged fraud was perpetrated through Warner Chilcott's senior executives. See id. Warner Chilcott therefore had fair notice of these allegations.

         i. Molloy Article

         Turning to the substance of Defendants' challenges, the Molloy Article is the logical starting point. The EPPs and the Retailers (but not the DPPs) allege that Dr. Hodgen, himself or through his attorney, intentionally concealed the so-called “Molloy Article”. Loestrin II, 261 F.Supp.3d at 344 (citing B.G. Molloy et al., “Missed Pill” conception: fact or fiction?, 290 Brit. Med. J. 1474, 1475 (1985)). This Article contains the following statement: “To reduce the risk of missed pill conception a 28 day pack containing 23 pills and 5 blanks could be substituted for the current 21 day pack. This would still permit a withdrawal bleed without the risk of significant follicular development.” Id.

         Defendants claim that Plaintiffs have marshaled no evidence that Dr. Hodgen or Mr. Meilman deliberately deceived the PTO. The Court agrees. To meet their burden, Plaintiffs must show evidence from which a rational juror could find by clear and convincing evidence that an intent to deceive is the single most reasonable inference. “A mere failure to cite a reference to the PTO will not suffice.” Nobelpharma, 141 F.3d at 1071; see also Dippin' Dots, Inc. v. Mosey, 476 F.3d 1337, 1347 (Fed. Cir. 2007). Rather, “there must be evidence of intent separable from the simple fact of the omission.” Dippin' Dots, 476 F.3d at 1347. This is because an omission “could happen for any number of nonfraudulent reasons - the applicant could have had a good [] faith belief that disclosure was not necessary, or simply have forgotten to make the required disclosure.” Id.

         Attempting to point to evidence of a transgression, Plaintiffs cite a December 31, 1990 letter Dr. Hodgen wrote to Beatrice Allis (of Warner Lambert), copying Mr. Boissonneault, after Warner Lambert asked Dr. Hodgen to comment on the Article. Plaintiffs also cite Dr. Hodgen's notations on an attached research protocol applying the Molloy Article's reasoning. PSOF ¶ 20. The letter does not attach the Molloy Article. Id. The parties dispute various aspects of this correspondence, including whether Dr. Hodgen agreed with the Article's relevant claim and whether the Article taught taking Loestrin 1/20. Id. Plaintiffs cobble together evidence they contend shows that Dr. Hodgen did in fact agree with the Article's relevant suggestion.

         But no matter. Even with all reasonable inferences drawn in Plaintiffs' favor, where there are two or more equally plausible inferences - forgetting and intentionally omitting - Plaintiffs must do more than say “yeah, right”. And here, they have simply failed to identify any evidence - let alone clear and convincing evidence - beyond the omission itself to show a purposeful intent to deceive. See C.R. Bard, Inc., 157 F.3d at 1365 (“Deceptive intent is not inferred simply because information was in existence that was not presented to the examiner[.]”). Even assuming Plaintiffs can show but-for materiality, Plaintiffs' evidence related to intent to deceive falls short and so this issue cannot sustain Plaintiffs' Walker Process fraud claim. The Molloy Article may not be utilized by Plaintiffs.

         ii. 30-Woman Study

         Plaintiffs' reliance on the 30-Woman Study fares better. Plaintiffs claim Dr. Hodgen's failure to disclose this Study amounted to a material omission. The 30-Woman Study “was designed to determine whether Loestrin 1/20 would suppress ovarian activity more efficiently when given for a 25 day regimen as opposed to the normal 21 day cycle of the pill[.]” Defendants' Statement of Undisputed Facts (“DSOF”) ¶ 28, ECF No. 860. Its objective “was to establish that a shorter pill free interval could increase the efficacy of low dose contraceptives while providing a more regular and agreeable bleeding pattern.” Id.

         The standard is the same. Plaintiffs cry foul because Dr. Hodgen referenced an “embargo[]” of the Study's data and agreed to delay publishing the results. PSOF ¶ 34. And while Defendants can point to evidence that shows Dr. Hodgen thought the Study was “predicated from the preclinical primate data” and was thus consistent with the primate study (which was disclosed), this merely reflects a dispute of fact. DSOF ¶¶ 27, 34. The real question is whether the jury could find that intent to deceive is the single most reasonable inference. Therasense, 649 F.3d at 1290. Defendants say not, particularly where Mr. Lentz has admitted that the claim preamble may be interpreted in two ways; these differing interpretations, they say, disprove that reduced incidence of breakthrough bleeding is a claim limitation (if this is not a claim limitation, then omission of the Study would be of no moment).

         This is a close call. Nevertheless, the Court determines that from these facts, a reasonable jury could find by clear and convincing evidence that intent to deceive is the single most reasonable inference from Dr. Hodgen's failure to disclose the 30-Woman Study. See Nobelpharma, 141 F.3d at 1071.

         The analysis does not end there, however; Plaintiffs must also show that Warner Chilcott knew about this fraud. To do so they claim that Warner Lambert employees, who eventually became Warner Chilcott executives, were substantively involved in the patent prosecution.[17], [18] They cite evidence that Mr. Boissonneault, Mr. Reichel, and Mr. Bruno knew of these misrepresentations. They argue that Mr. Boissonneault conceived of the invention with Dr. Hodgen, and was substantively involved in the application, as well as Warner Lambert/Parke-Davis's acquisition of the patent from the Jones Institute. PSOF ¶¶ 12, 39. Defendants contend that Mr. Boissonneault and Dr. Hodgen discussed a different hormonal contraceptive and that Mr. Boissonneault was not involved in the ´394 patent's conception. Defs.' Resp. to Pls.' Additional Statement of Undisputed Facts (“DASOF”) ¶ 223, ECF No. 1054-1. Plaintiffs emphasize that Mr. Boissonneault was alerted when the 30-Woman Study was complete, including that it evidenced no statistically significant difference in cycle control. PSOF ¶ 12. They say Warner Lambert knew internally that the 30-Woman Study revealed “no statistically significant difference in cycle control[.]” Id. ¶¶ 12, 33. Plaintiffs further claim that certain of these executives received drafts of the patent application and that Mr. Bruno directed EVMS to continue preparing it. Id. ¶ 39. These are all issues of fact for the jury. The Court is satisfied that Plaintiffs have submitted enough evidence from which a jury could find that Warner Chilcott enforced the patent with knowledge of this fraud.

         Finally, Plaintiffs must submit evidence from which a reasonable juror could determine that the patent would not have issued but for this fraudulent omission. Nobelpharma, 141 F.3d at 1072. The parties' dispute as to materiality turns on the Study's purpose and whether that purpose is patently significant, and on this the parties disagree. PSOF ¶¶ 33, 34. Defendants claim the Study did not analyze breakthrough bleeding (rather, it analyzed bleeding generally), and thus it is duplicative of the primate study. DSOF ¶¶ 33, 34. Plaintiffs submit that it did analyze breakthrough bleeding and in fact proved inconsistent with the primate study. PSOF ¶ 33, 34.

         To argue that breakthrough bleeding is patently significant, Plaintiffs cite arguments Mr. Meilman made in office actions to the PTO (as well as Dr. Lentz's expert opinions interpreting them) to say that the patent examiner first rejected the patent because she doubted whether the invention actually reduced the incidence of breakthrough bleeding. Id. ¶¶ 37, 38. They say these doubts were eventually overcome by Mr. Meilman's breakthrough bleeding arguments. Id.

         Defendants lean heavily on a favorable Markman claim-construction decision out of the U.S. District Court for the District of New Jersey. In an action like that brought by Warner Chilcott against Watson for patent infringement, Warner Chilcott sued one of Loestrin's generic manufacturers, Mylan Pharmaceuticals Inc. (“Mylan”), alleging infringement of the ´394 patent. Loestrin II, 261 F.Supp.3d at 323. There, the court held that a reduced incidence of breakthrough bleeding is not a claim limitation of the ´394 patent. DSOF ¶¶ 64, 76. But that decision is not conclusive evidence here, and this is a clear fact dispute. PSOF ¶ 64. As such, a reasonable juror could conclude that the patent would not have issued had the PTO examiner known about this Study.

         Separately, the EPPs and the Retailers argue that the 30-Woman Study constituted an “invalidating prior public use” of the invention, rendering the ´394 patent obvious and requiring the Study's disclosure to the PTO. Pls.' Opp'n to Defs.' Mot. for Summ. J. (“Pls.' Opp'n to Summ. J.”) 6, ECF No. 978. They rely on evidence that the Study's subjects were given Loestrin 1/20 labels, commercial blister packs of Loestrin 1/20, were recruited through public advertising, and had no obligation of secrecy. Id. at 7; PSOF ¶¶ 29.

         The invalidating public use doctrine renders unpatentable an invention that was either in public use or on sale “more than one year prior to the date of the application for patent[.]” Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1379 (Fed. Cir. 2005) (citation omitted). A public use bar to patentability “arises where, before the critical date, the invention is in public use and ready for patenting.” Id.; see also Weatherchem Corp. v. J.L. Clark, Inc., 163 F.3d 1326, 1332 (Fed. Cir. 1998). An invention is “ready for patenting” “in at least two ways: by proof of reduction to practice before the critical date; or by proof that prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.” Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67-68 (1998).

         Although close, the Court concludes that Plaintiffs have submitted enough evidence to allow a reasonable jury to find the invention was in public use and ready for patenting one year before the critical date of July 22, 1994. See id. Defendants argue the invention was not ready for patenting more than one year before the critical date because the Study was completed in September 1993, less than one year before July 22, 1994. DSOF ¶¶ 13, 29. But the Study began around four months earlier and nothing precludes the jury from finding that the invention was in public use and ready for patenting at that time. Id. ¶ 29; see Invitrogen, 424 F.3d at 1379. While Defendants cite evidence to support their claim that the Study was an experimental use, [19] which would negate both that the invention was ready for patenting and in public use, this is an issue of fact. Cf. Invitrogen, 424 F.3d at 1380 (holding that the invention was not a public use where the process was used in the inventor's own laboratories). Based on this evidence, a rational juror could conclude that the Study constituted an invalidating public use that should have been disclosed to the PTO. All aspects of this claim, then, may proceed to the jury.

         iii. Loestrin 1/20 Reference

         Plaintiffs' final basis for their Walker Process fraud claim - and probably their most persuasive - is the omission of Loestrin 1/20 as prior art. Plaintiffs argue Dr. Hodgen and Mr. Meilman fraudulently misrepresented the amount of estrogen in other commercially available oral contraceptives, and, had they been truthful that Loestrin 1/20 has less than 30 mcg ethinyl estradiol (“EE”), the patent would not have issued. Pertinently, the ´394 patent specification says the invention “provide[s] a new estrogen-progestin combination and regimen” with ultra-low doses that are less daily than those then-available. Pls.' Opp'n to Summ. J. 5. Meanwhile, Loestrin 1/20 is a combination oral contraceptive “consisting of 21 active pills containing 1 mg [norethindrone acetate] and 20 mcg EE, and 7 inactive pills containing ferrous fumarate.” DSOF ¶ 5. It is undisputed that Loestrin 1/20 was the only combination oral contraceptive with less than 30 mcg of EE commercially available in the United States at that time. PSOF ¶ 23.

         While Defendants claim Loestrin 1/20 was specifically disclosed in the patent application in Example 1, it is not, as Defendants say, “obvious” that this would sufficiently alert the patent examiner of its relevance as prior art. In fact, Plaintiffs say Dr. Hodgen steered the patent examiner away from Loestrin 1/20 by maintaining that the prior art did not include any commercially available oral contraceptives with less than 30 mcg EE. PSOF ¶ 22. Mr. Meilman told the patent examiner in an office action that “the claimed regimen leaves the patient with a total estrogen exposure per annum which is well below the total annual dose of estrogen in all ...

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