FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF
MASSACHUSETTS [Hon. William G. Young, U.S. District Judge]
M. Sobol, with whom David S. Nalven, Kristen A. Johnson,
James J. Nicklaus, Kristie A. LaSalle, Hagens Berman Sobol
Shapiro LLP, Bruce E. Gerstein, Joseph Opper, Elena K. Chan,
Ephraim R. Gerstein, Garwin Gerstein & Fisher, LLP, David
F. Sorensen, Ellen Noteware, Daniel C. Simons, Caitlin G.
Coslett, Berger & Montague, P.C., Linda P. Nussbaum,
Nussbaum Law Group, P.C., Steve D. Shadowen, Hilliard &
Shadowen LLP, Kenneth A. Wexler, Bethany R. Turke, Justin N.
Boley, Wexler Wallace LLP, J. Douglas Richards, Sharon K.
Robertson, Donna M. Evans, Cohen Milstein Sellers & Toll,
PLLC, Jayne A. Goldstein, Pomerantz LLP, Matthew Wessler, and
Gupta Wessler PLLC were on brief, for direct purchaser and
end-payor class appellants.
L. Refsin, Monica L. Rebuck, Maureen S. Lawrence, Hangley
Aronchick Segal Pudlin & Schiller, Bernard D. Marcus,
Moira Cain-Mannix, Marcus & Shapira LLP, Richard A.
Arnold, Scott E. Perwin, Lauren C. Ravkind, Anna T. Neill,
and Kenny Nachwalter, P.A. on brief for individual retailer
K. Shanmugam, with whom Dane H. Butswinkas, Paul B. Gaffney,
John E. Schmidtlein, and Williams & Connolly LLP were on
brief, for appellees AstraZeneca LP, AstraZeneca AB, and
Lefkowitz, P.C., with whom Steven J. Menashi, Amanda Elbogen,
Jonathan D. Janow, Kirkland & Ellis LLP, James Douglas
Baldridge, Lisa Jose Fales, Danielle R. Foley, Vincent E.
Verrocchio, and Venable LLP were on brief, for appellees
Ranbaxy Inc., Ranbaxy Pharmaceuticals Inc., and Ranbaxy
S. Hegedus, Attorney, Office of the General Counsel, Federal
Trade Commission, Deborah L. Feinstein, Director, Markus H.
Meier, Acting Deputy Director, Bradley S. Albert, Deputy
Assistant Director, Elizabeth R. Hilder, Attorney, Bureau of
Competition, Daniel W. Butrymowicz, Attorney, Bureau of
Competition, Jonathan E. Nuechterlein, General Counsel, and
Joel Marcus, Director of Litigation, on brief for Federal
Trade Commission, amicus curiae.
Lynch, Stahl, and Thompson, Circuit Judges.
appeal arises from the first pharmaceutical-settlement
antitrust action tried before a jury since the Supreme
Court's decision in FTC v. Actavis,
Inc., 133 S.Ct. 2223 (2013). The jury found that
although the plaintiffs had proved an antitrust violation in
the form of a large and unjustified reverse payment from
AstraZeneca to Ranbaxy, the plaintiffs had not shown that
they had suffered an antitrust injury that entitled them to
AstraZeneca is a brand-name drug manufacturer that owns the
patents covering Nexium, a prescription heartburn medication
that has grossed billions of dollars in annual sales. After
defendant Ranbaxy notified the Food and Drug Administration
("FDA") that it sought to market a generic version
of Nexium, AstraZeneca sued Ranbaxy for patent infringement.
The two companies reached a settlement agreement, under which
Ranbaxy agreed to delay the launch of its generic until a
certain date in return for various promises from AstraZeneca.
AstraZeneca similarly sued and subsequently settled two
patent infringement suits with generic manufacturers Teva and
Dr. Reddy's, who were (but no longer remain) defendants
in this case. The plaintiffs -- various pharmaceutical retail
outlets and certified classes of direct purchasers and end
payors -- brought suit, arguing that the terms of these
settlement agreements violated federal antitrust laws and
summary judgment proceedings that winnowed down the number of
causal mechanisms through which the plaintiffs could attempt
to prove antitrust violation and injury, the case proceeded
to a jury, which found as we have described. Following the
verdict, the district court denied the plaintiffs'
motions for a permanent injunction and for a new trial.
plaintiffs appeal, raising four categories of claims. First,
they challenge various evidentiary rulings. Second, they
argue that the district court erroneously granted judgment as
a matter of law in the defendants' favor on the issue of
overarching conspiracy. Third, they argue that the special
verdict form and jury instructions contained reversible
error. The final argument, which lies at the heart of this
appeal, is that the district court, at summary judgment,
impermissibly cut down the number of causal mechanisms
through which the plaintiffs could make their case to the
jury. See In re Nexium (Esomeprazole) Antitrust
Litig. ("In re Nexium [Summary
Judgment]"), 42 F.Supp.3d 231 (D. Mass. 2014). This
error at summary judgment pervaded the entire trial, the
plaintiffs argue, and constitutes grounds to vacate the jury
verdict and award a new trial.
no reversible error in the district court's evidentiary
rulings, the formulation of the special verdict form and jury
instructions, or its judgment as a matter of law on
overarching conspiracy. In fact, many of the plaintiffs'
objections have been forfeited or mooted by the jury's
findings. We further hold that the jury verdict, finding an
antitrust violation but not an antitrust injury, coupled with
developments at trial on the issue of patent invalidity,
renders harmless any error that may have occurred during the
summary judgment proceedings. Accordingly, we need not, and
indeed should not, review the summary judgment order for
error. We affirm.
overview of the intricate pharmaceutical regulatory framework
is necessary to understand the issues presented. A
manufacturer that seeks to market a new brand-name drug must
file a New Drug Application ("NDA") with the FDA
and "undergo a long, comprehensive, and costly testing
process." Actavis, 133 S.Ct. at 2228.
Generic-drug manufacturers formerly underwent similarly
rigorous processes to obtain FDA approval to market generic
versions of the brand-name drug. In order to accelerate the
entry of generic competitors into the market and decrease
healthcare costs, Congress enacted the Drug Price Competition
and Patent Term Restoration Act of 1984 ("Hatch-Waxman
Act"), Pub. L. No. 98-417, 98 Stat. 1585. The
Hatch-Waxman Act has three regulatory components that are
the Act permits generic manufacturers to file the notably
less costly Abbreviated New Drug Application
("ANDA"), "specifying that the generic has the
'same active ingredients as, ' and is
'biologically equivalent' to, the already-approved
brand-name drug." Actavis, 133 S.Ct. at 2228
(quoting Caraco Pharm. Labs., Ltd. v.
Novo Nordisk A/S, 132 S.Ct. 1670, 1676 (2012)).
"[B]y allowing the generic to piggy-back on the
pioneer's approval efforts, [the Hatch-Waxman Act]
'speed[s] the introduction of low-cost generic drugs to
market, ' thereby furthering drug competition."
Id. (third alteration in original) (quoting
Caraco, 132 S.Ct. at 1676).
the Act requires brand-name manufacturers to list the numbers
and expiration dates of all relevant patents in their NDAs,
which are then published in the FDA's "Orange Book,
" an annual publication of all approved drugs and the
reported patents or statutory exclusivities that cover those
drugs. In turn, generic manufacturers filing ANDAs must
"'assure the FDA' that the generic 'will not
infringe' the brand-name's patents, " and may
provide this assurance in one of four ways. Id.
(quoting Caraco, 132 S.Ct. at 1676). The generic
manufacturer may (1) certify that the brand-name manufacturer
has failed to list any relevant patents; (2) certify that any
relevant patents have expired; (3) request the FDA's
approval to market its generic upon the expiration of any
still active patents covering the brand name; or (4) certify
that "any listed, relevant patent 'is invalid or
will not be infringed by the manufacture, use, or sale'
of the drug described in the [ANDA]." Id.
(quoting 21 U.S.C. § 355(j)(2)(A)(vii)(IV)).
last route, known as a "paragraph IV certification,
" usually triggers an immediate patent infringement suit
from the brand-name manufacturer. If that suit is brought
within 45 days of the paragraph IV certification, the FDA
must withhold approval of the generic ANDA, usually for a
30-month period, during the course of litigation on patent
validity or infringement. Id. If the court decides
the patent matter within 30 months, the FDA follows the
court's determination. But if the court does not, the FDA
may approve an ANDA before a court rules on patent validity
or infringement. Id. (citing 21 U.S.C. §
355(j)(5)(B)(iii)). This pre-ruling approval, in turn, allows
the generic manufacturer to launch its product "at
risk" -- that is, "with the risk of losing the
infringement case against it hanging over its head. Losing an
infringement case after launching at risk can result in
significant liability for the generic manufacturer, as
damages typically are calibrated by the amount of its at-risk
sales." In re Nexium [Summary Judgment], 42
F.Supp.3d at 245.
final relevant component of the Hatch-Waxman Act is that it
rewards the first generic manufacturer to file an ANDA with a
paragraph IV certification by granting that first filer a
180-day period of exclusivity. Actavis, 133 S.Ct. at
2228-29. During that 180-day window, the FDA cannot approve
ANDAs from competing manufacturers for the same generic,
leaving only the first filer with the ability to market its
generic. Accordingly, this period of exclusivity can be
"worth several hundred million dollars."
Id. at 2229 (quoting Hemphill, Paying for Delay:
Pharmaceutical Patent Settlement as a Regulatory Design
Problem, 81 N.Y.U. L. Rev. 1553, 1579 (2006)). In fact,
the "vast majority of potential profits for a generic
drug manufacturer materialize during the 180-day exclusivity
period." Id. From the market perspective,
however, the first filer may create a bottleneck, as all
other generic manufacturers must wait for the exclusivity
period to end before launching their own generics.
this lucrative 180-day exclusivity period is not absolute.
Under the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat.
2066, a first filer may forfeit its exclusivity period if it
fails to come to market within 75 days of a final,
nonappealable court judgment that the first filer's
product does not infringe the brand-name's patents. 21
U.S.C. §§ 355(j)(5)(D)(i)(I)(bb), (D)(ii).
Alternatively, first-filer exclusivity can be forfeited if
another generic manufacturer successfully challenges
the brand-name patents at issue and if the first filer fails
to market its generic within 75 days of a final,
nonappealable judgment in that other manufacturer's suit.
Id.; see also In re Nexium [Summary
Judgment], 42 F.Supp.3d at 246.
2013, the Supreme Court held that reverse payment settlements
in paragraph IV litigation "can sometimes violate the
antitrust laws." Actavis, 133 S.Ct. at 2227. A
reverse payment refers to an arrangement in which the
brand-name manufacturer and patent holder compensates the
generic manufacturer and alleged patent infringer to settle
the paragraph IV litigation and delay the generic's
market entry. Id. at 2229. When a brand-name
manufacturer pays to delay the first filer's generic
launch, that reverse payment postpones not only the first
filer's product but also those of all other generic
manufacturers, who must wait out the 180-day exclusivity
period before going to market. Given that "a reverse
payment, where large and unjustified, can bring with it
th[is] risk of significant anticompetitive effects, "
the Supreme Court held that the potential anticompetitive
effects of a reverse payment are subject to the antitrust
"rule of reason" test. Id. at 2237.
this year, in In re Loestrin 24 Fe Antitrust
Litigation, 814 F.3d 538 (1st Cir. 2016), this circuit
ruled that improper reverse payments may take the form of
"non-monetary" advantages. Id. at 549. The
language and logic of Actavis dictated that outcome.
See id. ("[T]he Supreme Court recognized that a
disguised above-market deal, in which a brand manufacturer
effectively overpays a generic manufacturer for services
rendered, may qualify as a reverse payment subject to
antitrust scrutiny and militates against limiting the Supreme
Court's decision to pure cash payments."). Under
this functional approach, "no-AG" provisions -- in
which the brand-name manufacturer agrees not to market an
"authorized generic" version of the drug for a
certain period of time -- and other settlement provisions in
which some advantage is transferred from the patent holder to
the alleged infringer may constitute a reverse payment
subject to antitrust scrutiny.
is a proton-pump inhibitor whose active ingredient is
esomeprazole magnesium. The FDA approved AstraZeneca's
NDA to market Nexium in 2001. Between 2008 and 2014, Nexium
grossed at least $3 billion annually in U.S. sales and joined
the ranks of "blockbuster" drugs -- those that
generate annual sales of at least $1 billion. In 2001,
AstraZeneca held fourteen active patents covering Nexium. As
relevant here, two medical patents expired on May 27, 2014,
two other patents expired in February 2015 and July 2015, and
two more are set to expire in May 2018.
August 2005, Ranbaxy first filed an ANDA with a paragraph IV
certification in order to market a generic version of Nexium.
The filing stated that Ranbaxy's launch would await the
2007 expiration of some of AstraZeneca's Nexium patents,
but certified that other patents were either not infringed or
invalid. As to patent invalidity, Ranbaxy contended that
there was "nothing new" about Nexium, as the active
compound in Nexium was effectively "one-half" of
the compound in Prilosec, another blockbuster drug for
stomach-acid treatment that AstraZeneca had marketed prior to
promptly brought suit, alleging that Ranbaxy had violated six
of its patents: two that would expire on May 27, 2014, two
that would expire in 2015, and two that would expire in May
2018. The suit stayed FDA approval of Ranbaxy's ANDA
until April 2008. Meanwhile, Teva filed its ANDA for generic
Nexium in November 2005, and Dr. Reddy's filed in
December 2007. AstraZeneca sued Teva and Dr. Reddy's as
well, and all three patent infringement suits were
consolidated in the U.S. District Court for the District of
was the first defendant to settle after reaching an agreement
with AstraZeneca in April 2008. Under the settlement
agreement, Ranbaxy received a license to all relevant Nexium
patents starting on May 27, 2014. The settlement also
contained a no-AG clause, under which AstraZeneca agreed not
to market an authorized generic version of Nexium during
Ranbaxy's 180-day period of exclusivity. The clause thus
ensured that Ranbaxy's generic would be the only one on
the market if it could launch in time to avoid triggering the
statutory forfeiture provisions. AstraZeneca could still
continue to market its brand-name drug during that period. In
return, Ranbaxy stipulated to patent validity and
infringement and consented to the entry of an injunction
against the sale of its generic before the license took
effect on May 27, 2014.
and Ranbaxy also executed three other agreements, under which
Ranbaxy would serve as AstraZeneca's subcontractor and
manufacture certain quantities of branded Nexium, and would
also serve as AstraZeneca's distributor for authorized
generic versions of two other AstraZeneca drugs, Prilosec and
Plendil. For the distribution agreement, Ranbaxy would
receive 20% of AstraZeneca's profits.
litigating for a few more years, Teva settled with
AstraZeneca in January 2010. Like Ranbaxy, Teva received a
license to the Nexium patents starting on May 27, 2014 and
also consented to an injunction barring the sale of its
generic before that license took effect. Simultaneously,
AstraZeneca and Teva agreed to settle another pending patent
infringement lawsuit regarding Prilosec. In that multiyear
litigation, AstraZeneca had succeeded in establishing
Teva's liability, but Teva had been contesting the
damages amount based on its past infringing sales. Teva paid
AstraZeneca $9 million to resolve that suit.
Reddy's settled with AstraZeneca in January 2011. Like
Ranbaxy and Teva, Dr. Reddy's received a license for the
Nexium patents starting on May 27, 2014 and also consented to
an injunction barring sales before that date. Simultaneously,
AstraZeneca and Dr. Reddy's settled another pending
patent infringement lawsuit in which AstraZeneca agreed to
drop its appeal of the entry of summary judgment in Dr.
three settlement agreements contained parallel contingent
launch provisions under which each generic manufacturer
agreed to delay launching its generic in the United States
until (1) May 27, 2014; (2) a hypothetical date prior to May
27, 2014 on which any third party launched generic Nexium
pursuant to a final, nonappealable court order that
AstraZeneca's Nexium patents were invalid, unenforceable,
or not infringed by the generic; or (3) a hypothetical date
prior to May 27, 2014 on which AstraZeneca authorized any
third party to manufacture a generic Nexium. In re Nexium
[Summary Judgment], 42 F.Supp.3d at 249 (citing ¶
5.2 in the three settlement agreements).
Ranbaxy's Regulatory Troubles
Ranbaxy's paragraph IV litigation challenging
AstraZeneca's Nexium patents, Ranbaxy faced serious
issues with the FDA. Specifically, Ranbaxy had filed its ANDA
for generic Nexium out of its manufacturing facility in
Paonta Sahib, India, which meant that any FDA approval to
launch generic Nexium would extend only to that facility. In
February 2009, after issuing several warnings about quality
control problems with the India facility, the FDA ultimately
invoked its Application Integrity Policy ("AIP")
against Paonta Sahib. The AIP "halted FDA's
substantive review and approval of all pending ANDAs,
including amendments and post-approval supplements that
relied on supporting data from the Paonta Sahib site --
including the generic Nexium ANDA." Id. at 266.
The agency then rejected Ranbaxy's proposed Corrective
Action Operating Plan and further turned down Ranbaxy's
request that it grant a public health exception to the AIP
and continue the approval process for the generic Nexium
ANDA. Meanwhile, the FDA granted a public health exception
for generic Lipitor, another Ranbaxy product manufactured out
of the Paonta Sahib facility.
2010, Ranbaxy and the FDA began negotiating a Consent Decree,
which they finalized on January 25, 2012. Under its terms,
Ranbaxy could meet "several onerous and time-consuming
milestones" to obtain potential FDA approval for generic
Nexium or to obtain a site-transfer amendment to change the
manufacturing site for the drug. The Consent Decree also
contained a "key relinquishment date" of September
30, 2014. Id. at 274. If Ranbaxy could not meet the
requisite milestones before that date, it would forfeit its
180-day exclusivity period. Id. Ranbaxy took over
two and a half years to prepare a site-transfer amendment,
and the manufacturer failed to receive final FDA approval for
its generic Nexium ANDA prior to May 27, 2014.
November 4, 2014, the FDA rescinded its tentative approval of
Ranbaxy's generic Nexium ANDA, and Ranbaxy promptly sued
the FDA in the U.S. District Court for the District of
Columbia. See Ranbaxy Labs, Ltd. v.
Burwell, 82 F.Supp.3d 159, 163 (D.D.C. 2015).
Subsequently, in January 2015, the FDA notified Ranbaxy that
it had forfeited its first-filer exclusivity period by
failing to obtain approval for its generic within 30 months
of submitting its ANDA. The FDA simultaneously approved
Teva's ANDA for generic Nexium, which launched on
February 17, 2015.
Dispute over Teva's Readiness to Launch Generic
plaintiffs' evidence at summary judgment and at trial
showed that Teva was closer than Ranbaxy to obtaining FDA
approval and launching generic Nexium before May 27, 2014. An
internal Teva email from February 2007 approximated
Teva's "Launch Readiness date" as July 2008.
And by 2009, Teva had passed FDA review in two out of the
three categories necessary for tentative approval of its
parties vehemently disagreed at summary judgment on whether
the third remaining category for FDA approval was "a
significant hurdle or a minor one, " an issue material
to determine whether Teva was indeed close to FDA approval.
In re Nexium [Summary Judgment], 42 F.Supp.3d at
288-89. The jury heard evidence from both sides on this
commenced six different actions in three different federal
district courts, alleging that AstraZeneca made improper
reverse payments to Ranbaxy, Teva, and Dr. Reddy's in
order to delay the market entry of generic Nexium. On
December 7, 2012, the U.S. Judicial Panel on Multidistrict
Litigation consolidated and assigned the six pending actions
to the U.S. District Court for the District of Massachusetts.
See 28 U.S.C. § 1407. This appeal arises from
that consolidated case.
appeal, plaintiffs are a class of wholesale drug distributors
(the "Direct Purchasers"); a class of individual
consumers, third-party payors, union plan sponsors, and
certain insurance companies (the "End Payors"); and
numerous pharmaceutical retail outlets. In January 2015,
a panel of this circuit affirmed the certification of the End
Payors damages class over a dissent. See In re Nexium
Antitrust Litig., 777 F.3d 9 (1st Cir. 2015). The
original defendants in this litigation were AstraZeneca,
Ranbaxy, Teva, and Dr. Reddy's. Teva and Dr. Reddy's
have settled, leaving only AstraZeneca and Ranbaxy as
defendants on appeal.
with In re Loestrin 24 Fe, the plaintiffs'
complaints identified aspects of AstraZeneca's
settlements with each of the three generic manufacturers that
allegedly were reverse payments in violation of the antitrust
laws. In the Ranbaxy settlement, the plaintiffs pointed to
the no-AG clause, as well as the side manufacturing and
distribution agreements. In the Teva settlement, the
plaintiffs argued that Teva's payment of only $9 million
to settle the Prilosec lawsuit, rather than the higher amount
that Teva actually owed AstraZeneca, constituted the reverse
payment. In the Dr. Reddy's settlement, the plaintiffs
cited AstraZeneca's agreement to drop its appeal
challenging Dr. Reddy's summary judgment win in another
patent infringement lawsuit.
December 2013, the defendants collectively filed eleven
motions for summary judgment. Following the court's
initial rulings from the bench, both parties filed various
motions for reconsideration. In a September 4, 2014 opinion,
the district court memorialized its rationale as to each
summary judgment motion that it decided. See In re Nexium
[Summary Judgment], 42 F.Supp.3d 231. This opinion
grouped the motions into five categories:
the district court denied the defendants' motions for
partial summary judgment on the existence of an overarching
antitrust conspiracy, among all four original defendants, to
restrain trade in the market for generic Nexium. Id.
at 248-60. At the pretrial stage, the court found that the
plaintiffs had "met their burden of establishing a
reasonable inference of overarching conspiracy, "
id. at 249, as the evidence demonstrated that each
generic "manufacturer's calculus [on its entry date
into the generic Nexium market] changed . . . when it
received assurance that it would only have to restrict its
business if its competitors did the same, " id.
at 258. The denial of summary judgment to the defendants
imposed no restrictions on the plaintiffs' ability to
produce evidence at trial. Following the plaintiffs' case
in chief, the district court granted judgment as a matter of
law in the defendants' favor on this overarching
although the district court denied the defendants' motion
for summary judgment as to the existence of an improper
reverse payment from AstraZeneca to Ranbaxy, the court
granted the motion as to the argument that such a reverse
payment caused the plaintiffs' injury.
Id. at 260. The court elaborated that the no-AG
clause in the AstraZeneca-Ranbaxy settlement agreement
"may be considered part of an illegal reverse payment,
" id. at 265, while the lucrative
"side" agreements granting Ranbaxy supply and
distribution contracts likewise "raise enough
suspicions to support a reasonable inference [of] improper
reverse payments to induce Ranbaxy to delay its generic
launch, " id. at 264.
in light of the quality control issues that Ranbaxy's
Paonta Sahib facility had experienced, the court found that
the plaintiffs did not show how Ranbaxy could still have
obtained final FDA approval and launched its generic before
May 27, 2014. Id. at 270-75. The court was skeptical
of the plaintiffs' analogy to generic Lipitor, which had
been manufactured out of Paonta Sahib and had faced similar
regulatory issues but had nonetheless launched after Ranbaxy
reached a compromise with the FDA. Id. at 273-74.
net effect of these rulings [wa]s that the Ranbaxy Settlement
[could] not [be] a basis for imposing antitrust
liability." Id. at 279. However, later at
trial, the court acknowledged its error as to this ruling and
the court denied the defendants' motions for summary
judgment based on the Teva settlement. The court found that
the plaintiffs' evidence -- that Teva's $9 million
payment to AstraZeneca to settle the Prilosec lawsuit was so
low a sum that it "constituted a significant forgiveness
of debt" by AstraZeneca to delay the launch of
Teva's generic -- was sufficient to proceed to trial.
Id. at 286. The court next found that the plaintiffs
had also met their burden as to, what it called, antitrust
causation because they showed (1) that Teva was close to
obtaining tentative FDA approval but slowed down its efforts
toward that goal after settling with AstraZeneca, and (2)
that Teva could have entered the market before May 2014,
notwithstanding Ranbaxy's first-filer exclusivity period,
by partnering with Ranbaxy on a joint launch. Id. at
288-89. In sum, the plaintiffs could pursue the
Teva settlement as a basis for antitrust liability at trial.
the district court granted the defendants' motion for
summary judgment based on the Dr. Reddy's settlement,
finding that the plaintiffs had proffered insufficient
evidence both on the existence of an improper reverse payment
and on "antitrust causation." Id. at
the district court denied three miscellaneous motions for
summary judgment that AstraZeneca had filed: (1) a motion
against the Direct Purchaser and Individual Retailer
plaintiffs for lack of actual injury and seeking exclusion of
testimony from two experts; (2) a motion barring assigned
claims; and (3) a motion on the basis of the statute of
limitations. Id. at 295-300.
after the summary judgment proceedings, the plaintiffs were
allowed to present evidence on AstraZeneca's improper
reverse payment to Teva and any antitrust liability flowing
from that payment, as well as the existence of an overarching
antitrust conspiracy among AstraZeneca, Ranbaxy, Teva, and
Dr. Reddy's. That evidence would include testimony from
the plaintiffs' expert, Dr. Thomas McGuire. The court
further directed the plaintiffs to present all evidence
supporting an antitrust violation arising out of the Teva
settlement first, before presenting any other evidence.
summary judgment, at a January 21, 2014 pretrial motion
hearing, the district court granted the defendants'
motion in limine to exclude testimony from Shashank Upadhye,
a former in-house lawyer at a nondefendant generic
manufacturer. The plaintiffs sought Upadhye's testimony
to "augment Dr. McGuire's economic testimony with a
real world business perspective on settlement negotiations
for drug patent lawsuits." The court reasoned that
Upadhye, along with another proposed expert witness (John
Thomas), could not testify because they were "lawyers,
not economists, and . . . they d[id] not have the requisite
qualifications to testify." At an October 15, 2014
charge conference, the court reminded both parties that its
decisions regarding motions in limine were "not
rulings" and that the parties "must make [their]
objections known during the course of the trial." Dr.
Reddy's settled and dropped out of the lawsuit shortly
six-week trial commenced on October 20, 2014. The trial
transcript, exhibits, and filings comprise thousands of pages
in the record. We summarize only the aspects of trial that
are relevant to the arguments on appeal.
Plaintiffs' Statement on Patent Invalidity and