United States District Court, D. Rhode Island
IN RE LOESTRIN 24 FE ANTITRUST LITIGATION THIS DOCUMENT RELATES TO ALL ACTIONS
OPINION AND ORDER ON SUMMARY JUDGMENT AND ORDER
REGARDING MOTIONS TO EXCLUDE CERTAIN EXPERT OPINIONS
WILLIAM E. SMITH, DISTRICT JUDGE
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
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.
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.
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.
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.
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
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
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.
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
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.
Market Power Summary Judgment
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).
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)).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.
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
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.
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.
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.
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).
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.
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.
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.
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).
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
Plaintiffs' But-For World
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 and ignores the reality of the
anticompetitive conduct as alleged.
Walker Process Fraud
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”). 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).
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
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.
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.” 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.” Therasense, 649 F.3d at 1290
(quoting Star Scientific, Inc. v. R.J. Reynolds Tobacco
Co., 537 F.3d 1357, 1366 (Fed. Cir. 2008)).
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.
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.
Defendants' Motion to Exclude Certain Opinions and
Testimony of Edward Lentz, John Doll, and Nicholas Jewell,
ECF No. 890
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
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.
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. 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
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
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. The Court is again satisfied that Dr.
Jewell is qualified to offer these opinions; Defendants'
concerns are best addressed on cross-examination.
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. See Solodyn I, 2018 WL 563144,
at *18 n.25. Further, neither side will be permitted to offer
cumulative opinions. 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.
Plaintiffs' Evidence of Walker Process
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.
Chilcott did not own or license the ´394 patent when it
was prosecuted; it came to own the patent nine years after it
issued. 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.
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
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.
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
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.”
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.”
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.
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
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
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
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.
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.,  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.
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.
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.
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.
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.
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
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,  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.
Loestrin 1/20 Reference
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.
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 ...