United States Court of Appeals 

For the First Circuit 

Nos. 15-2005, 15-2006, 15-2007 

IN RE: NEXIUM (ESOMEPRAZOLE) ANTITRUST LITIGATION 

AMERICAN SALES COMPANY, LLC, on behalf of itself and all others 

similarly situated; VALUE DRUG COMPANY; BURLINGTON DRUG COMPANY 

INC.; ROCHESTER DRUG CO-OPERATIVE, INC., on behalf of itself and 

others similarly situated; MEIJER, INC.; MEIJER DISTRIBUTION, 

INC.; ALLIED SERVICES DIVISION WELFARE FUND; LABORERS 

INTERNATIONAL UNION OF NORTH AMERICA LOCAL 17 HEALTH CARE FUND; 

LABORERS INTERNATIONAL UNION OF NORTH AMERICA LOCAL 35 HEALTH 

CARE FUND; A.F. OF L. - A.G.C. BUILDING TRADES WELFARE PLAN; 

FRATERNAL ORDER OF POLICE MIAMI LODGE 20 INSURANCE TRUST FUND; 

NEW YORK HOTEL TRADES COUNCIL AND HOTEL ASSOC. OF NEW YORK CITY, 

INC. HEALTH BENEFITS FUND; UNITED FOOD & COMMERCIAL WORKERS 

UNIONS AND EMPLOYERS MIDWEST HEALTH BENEFITS FUND; MICHIGAN 

REGIONAL COUNCIL OF CARPENTERS EMPLOYEE BENEFITS FUND; 

INTERNATIONAL UNION OF MACHINISTS AND AEROSPACE WORKERS DISTRICT 

NO. 15 HEALTH FUND; INTERNATIONAL BROTHERHOOD OF ELECTRICAL 

WORKERS LOCAL 595 HEALTH AND WELFARE FUND; WALGREEN CO.; THE 

KROGER COMPANY; SAFEWAY INCORPORATED; SUPERVALU, INC.; HEB 

GROCERY CO. LP; GIANT EAGLE, INC.; RITE AID CORPORATION; RITE 

AID HEADQUARTERS CORPORATION; JCG (PJC) USA, LLC; MAXI DRUG, 

INC., d/b/a BROOKS PHARMACY; ECKERD CORPORATION; CVS, INC., 

Plaintiffs, Appellants, 

v. 

ASTRAZENECA LP; ASTRAZENECA AB; AKTIEBOLAGET HASSLE; RANBAXY 

PHARMACEUTICALS INC.; RANBAXY INC.; RANBAXY LABORATORIES LTD., 

Defendants, Appellees. 

APPEALS FROM THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF MASSACHUSETTS 

[Hon. William G. Young, U.S. District Judge] 
Before 

Lynch, Stahl, and Thompson, 

Circuit Judges. 

Thomas 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. 

Barry 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 appellants. 

Kannon 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 

Aktiebolaget Hassle. 

Jay P. 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 Laboratories Ltd. 

Mark 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. 

November 21, 2016 
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LYNCH, Circuit Judge. This 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 damages. 

Defendant 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 state analogues. 
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After 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. 

The 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. 

We find 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' 
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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. 

I. REGULATORY FRAMEWORK 

An 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 relevant here. 

First, 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,' 
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and is 'biologically equivalent' to, the already-approved brandname 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 lowcost generic drugs to market,' thereby furthering drug 

competition." Id. (third alteration in original) (quoting Caraco, 

132 S. Ct. at 1676). 

Second, 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 
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drug described in the [ANDA]." Id. (quoting 21 U.S.C. 

§ 355(j)(2)(A)(vii)(IV)). 

This 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. 

The 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. 
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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. 

Significantly, 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, 
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nonappealable judgment in that other manufacturer's suit. Id.; 

see also In re Nexium [Summary Judgment], 42 F. Supp. 3d at 246. 

In 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. 

Earlier 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 
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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. 

II. FACTS 

Nexium 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.

In 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 
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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 

Nexium. 

AstraZeneca 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 New Jersey. 

A. Settlement Agreements 

Ranbaxy 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 
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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. 

AstraZeneca 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. 

After 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.
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Dr. 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. Reddy's favor.

The 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). 

B. Ranbaxy's Regulatory Troubles

Throughout 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 
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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.

In 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 
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manufacturer failed to receive final FDA approval for its generic 

Nexium ANDA prior to May 27, 2014.

On 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. 

C. Dispute over Teva's Readiness to Launch Generic Nexium

The 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 generic Nexium. 

The 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 
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[Summary Judgment], 42 F. Supp. 3d at 288–89. The jury heard 

evidence from both sides on this issue. 

III. PROCEDURAL HISTORY 

A. Pretrial Proceedings 

Plaintiffs 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. 

On 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.1 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 

 1 The pharmaceutical retail outlets are CVS, Inc.; Eckerd 

Corporation; Giant Eagle, Inc.; HEB Grocery Co. LP; JCG (PJC) USA, 

LLC; the Kroger Company; Maxi Drug, Inc. d/b/a Brooks Pharmacy; 

Rite Aid Corporation; Rite Aid Headquarters Corporation; Safeway 

Incorporated; Supervalu, Inc.; and Walgreen Co. 
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AstraZeneca, Ranbaxy, Teva, and Dr. Reddy's. Teva and Dr. Reddy's 

have settled, leaving only AstraZeneca and Ranbaxy as defendants 

on appeal.

Consistent 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.

In 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:
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First, 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 conspiracy claim. 

Second, 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 
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suspicions to support a reasonable inference [of] improper reverse 

payments to induce Ranbaxy to delay its generic launch," id. at 

264. 

Nonetheless, 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. 

"The 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 reversed course. 

Third, 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 
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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 288–89.2 In sum, the plaintiffs could pursue 

the Teva settlement as a basis for antitrust liability at trial. 

Fourth, 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 291–95. 

Finally, 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. 

 2 The court rejected as too speculative another causal 

mechanism -- namely, that Teva could have won its paragraph IV 

suit and obtained a final, nonappealable judgment that 

AstraZeneca's Nexium patents were invalid or not infringed. That 

theoretical victory could, in turn, have triggered the regulatory 

75-day window within which Ranbaxy had to launch its generic or 

forfeit its first-filer exclusivity. Id. at 289–90. 
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In sum, 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. 

After 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 inhouse 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 
- 22 - 

"must make [their] objections known during the course of the 

trial."

Dr. Reddy's settled and dropped out of the lawsuit 

shortly before trial.

B. Trial 

A 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. 

1. Plaintiffs' Statement on Patent Invalidity and 

Evidence Introduced During Their Case in Chief 

At a conference on the second day of trial, the 

plaintiffs described their case in chief to the district court: 

[In order to show that Teva could have gotten 

to market before May 27, 2014, the district court 

said that the plaintiffs] would need to prove that 

Teva would have won its litigation [against 

AstraZeneca]. And then . . . [the court] also 

indicated though that we could also perhaps prove 

that Teva would have done a deal with Ranbaxy in 

order to have the 180 days lifted. 

. . . We plan to do the latter, primarily in 

our case in chief . . . . We don't plan on proving 

a patent case inside of an antitrust case [by 

pursuing the former]. . . . [W]e do not plan to be 

proving that Teva would have won the litigation. 

This choice by the plaintiffs was not mandated by the district 

court's ruling. At trial, consistent with the district court's 

order, the plaintiffs first presented evidence on the existence of 

a reverse payment from AstraZeneca to Teva. 
- 23 - 

Dr. McGuire, an economist and one of the plaintiffs' key 

expert witnesses, testified twice during the plaintiffs' case in 

chief. McGuire first testified to "the enormous financial stakes 

that turned on the entry date of a lower cost generic into a market 

hitherto dominated by a patented, more expensive brand name drug." 

In re Nexium (Esomeprazole) Antitrust Litig. ("In re Nexium [PostTrial Opinion]"), 309 F.R.D. 107, 119 (D. Mass. 2015). He further 

"detailed how the benefits AstraZeneca conferred on Teva through 

their mutual settlement exceeded the litigation costs the parties 

thereby avoided." Id. 

During McGuire's second testimony, despite the summary 

judgment order precluding the plaintiffs from introducing evidence 

of a reverse payment to Ranbaxy, the court allowed McGuire to 

testify "for context" on the "far greater reverse payment made by 

AstraZeneca to Ranbaxy to induce it to forego its challenge to 

AstraZeneca's Nexium patents." Id. The district court also 

allowed McGuire to testify about Ranbaxy's economic incentives to 

include a contingent launch provision in its settlement agreement 

with AstraZeneca. Specifically, McGuire noted that the provision 

made it "less likely" that subsequent ANDA filers would pursue 

generic entry. He further stated that the clause "had the effect 

of reducing the likelihood that Teva would challenge and break the 

bottleneck, which means for Ranbaxy[,] it became more likely that 
- 24 - 

[it was] able to use [its] 180-day exclusivity period and make the 

profits associated with that."

At one point during McGuire's second testimony, the 

court forbade him from quantifying Ranbaxy's incentive to 

participate in the overarching conspiracy as "about $700 million 

in [Ranbaxy's] pocket that [it] otherwise wouldn't have." It ruled 

as such because the existence of contingent launch provisions, and 

not that theory, was what kept the plaintiffs' "case against 

Ranbaxy alive." The court nonetheless allowed McGuire to testify 

that AstraZeneca netted "hundreds of millions of dollars" by 

settling with Ranbaxy to "strengthen the 180-day [first-filer] 

barrier." 

Plaintiffs were permitted to introduce expert testimony 

on the but-for entry dates. For three days, starting on November 

18 and after the district court articulated its "misconception," 

the plaintiffs presented the testimony of Dr. Cheryl Blume, their 

"lead witness on the issue of the crucial 'but for entry date.'" 

Id. at 120. Looking back at trial, the district court noted that 

"Blume did not fare very well, especially under the searching 

cross-examination by Teva's counsel. The Court was left with the 

distinct impression that much of her testimony was a priori 

rationalization." Id. 
- 25 - 

2. The District Court's Mid-Trial Shift, Defendants' 

Mistrial Motion, and the Exclusion of McGuire's Event 

Study and Other Testimony 

On November 18, 2014, the seventeenth day of the trial, 

the court admitted that it had had a "fairly fundamental 

misconception" of the plaintiffs' theory of the case. The court 

then adjusted its thinking about the relevance of the AstraZeneca–

Ranbaxy settlement by noting that "[t]he large and unjustified 

payment to Ranbaxy, which keeps Ranbaxy, given its blocking 

position [as first filer], off the market until May 27th, 2014, 

has an effect on all the later ANDA filers, such that if it were 

to be proved that but for that agreement, . . . Teva could have 

partnered with Ranbaxy and come to market prior to that date." 

In light of this shift, the district court announced 

that it would alter the jury verdict form and allow the plaintiffs 

to recall McGuire to testify for a third time. The court also 

emphasized that its shift in thinking did "not injure[]" the 

plaintiffs because "they seem to have in the record enough evidence 

of a large and unjustified payment to Ranbaxy and based upon their 

expert's testimony it can be argued that it was anticompetitive." 

In response to the district court's stated reversal of 

its position, the defendants filed two motions, to both of which 

the plaintiffs objected. The first motion was for a mistrial. 

The second was to exclude McGuire's additional proffered testimony 

-- an "Event Study" that postulated an earlier entry date had there 
- 26 - 

not been a reverse payment in the AstraZeneca-Ranbaxy settlement 

-- under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 

579 (1993). The district court first excluded McGuire's Event 

Study testimony under Daubert. That Study purported to "use 

econometric analysis of the stock market's reaction to the actual 

settlement reached by AstraZeneca and Ranbaxy to estimate an 

objective entry date without [a reverse] payment." While the court 

acknowledged McGuire's expertise and stated that the Event Study's 

methodology was "perhaps reliable," the Study did not meet Daubert 

requirements because there was "no fit" "between the event study 

and this culmination of the case." The court recognized that the 

plaintiffs might nonetheless want to call McGuire a third time to 

testify to "other things" besides the Event Study. It ruled, 

however, that it still would not allow him to testify to those 

"additional matters" because to do so would be "simply unfair." 

Given that the court had said on November 18 that it 

would allow the plaintiffs to recall McGuire, the court 

acknowledged that its "no more McGuire" ruling could "change the 

plaintiffs' position on mistrial." It directed the plaintiffs to 

make "tactical decisions" on whether to reassess their initial 

opposition to the defendants' mistrial motion. 

The plaintiffs continued to oppose a mistrial. They 

pointed out that despite the summary judgment ruling precluding 

evidence of AstraZeneca's reverse payment to Ranbaxy, such 
- 27 - 

evidence had nonetheless been presented to the jury under another 

theory. Indeed, the plaintiffs had introduced evidence on that 

payment because it was relevant and admissible under the claim of 

overarching conspiracy.3 Plaintiffs also argued that the "chopped 

up" way in which McGuire's earlier testimony was presented to the 

jury and the court's exclusion of McGuire's Event Study went "a 

long way to curing whatever prejudice . . . these defendants may 

have incurred." 

Immediately following these statements, the court denied 

the motion for mistrial. 

3. Judgment as a Matter of Law on Conspiracy and Patent 

Invalidity 

At the close of the plaintiffs' case, the defendants 

moved for judgment as a matter of law on the overarching conspiracy 

claim, as well as on the question of antitrust causation. The 

court granted the motion on the conspiracy claim, noting that 

 3 The vigor with which the plaintiffs acknowledged the 

admission of evidence on the Ranbaxy reverse payment is worth 

noting: 

From the very beginning of this case the payment to 

Ranbaxy has been in clearly as at least an overt 

act in furtherance of the conspiracy. . . . But 

for [the defendants] to come here now and say, Oh, 

this was never in the case, that simply from our 

perspective is not true. It was unclear exactly 

how much and what role that payment was going to 

make, but it was clear it was in this as an overt 

act . . . . And we made our tactical choices and 

[the defendants] made theirs. 
- 28 - 

"[t]here [wa]s no sufficient evidence here that Ranbaxy and Teva 

conspired together, [or] that they acted otherwise than in their 

own individual best interest." Although the court "came within an 

ace" of granting the motion on causation as well, it decided to 

deny the motion for "prudential reasons" and let that question go 

to the jury. The court did grant the defendants' motion on 

causation with regard to any theory of antitrust causation based 

on patent invalidity, as it found "no adequate evidence that any 

of these patents would be adjudicated invalid." Earlier in the 

trial, the plaintiffs had already told the court that they would 

not pursue such a theory. 

To be sure of the accuracy and consequences of its ruling 

on patent invalidity, the court invited the parties to present 

further arguments on that issue following its initial ruling. The 

court subsequently refined its judgment regarding patent 

invalidity. Specifically, the court credited the plaintiffs' 

argument that, as a matter separate from the absolute validity of 

the Nexium patents, patent holders like AstraZeneca protect their 

patent monopoly and maximize profit in a world in which patent 

infringement litigation may loom but has not taken place. 

Accordingly, the court allowed the plaintiffs, independent of the 

ruling on patent invalidity, to argue that the defendants could 

have been incentivized to reduce the risk of patent invalidation 

-- for instance, by paying to delay the market entry of generics. 
- 29 - 

On November 24, 2014, Teva settled and dropped out of 

the suit, leaving only AstraZeneca and Ranbaxy as defendants. 

4. Exclusion of Plaintiffs' Proposed Rebuttal Evidence 

At the close of the defendants' case on December 2, 2014, 

the plaintiffs unsuccessfully sought to admit rebuttal evidence, 

which included the McGuire Event Study that the court had already 

excluded; a report published by Federal Trade Commission ("FTC") 

staff and entitled "Pay-for-Delay: How Drug Company Pay-Offs Cost 

Consumers Billions"; and expert testimony from Dr. Keith Leffler. 

Leffler, an economist, proffered testimony that "virtually all 

Hatch-Waxman cases can be settled without reverse payments" and 

that it would have been in both AstraZeneca's and Ranbaxy's 

economic interest to enter into a payment-free settlement with a 

February 2012 entry date. The court refused to admit any of this 

evidence "because it [was] not true rebuttal" and should have been 

introduced during the plaintiffs' case in chief. 

5. Special Verdict Form and Jury Instructions 

The district court first provided the parties with the 

revised verdict form at a December 2, 2014 conference. This form 

contained the following seven questions: 

1. Did AstraZeneca exercise market power within the 

relevant market? 

2. Did the settlement of the AstraZeneca-Ranbaxy 

patent litigation include a large and unjustified 

payment by AstraZeneca to Ranbaxy? 
- 30 - 

3. Was AstraZeneca's Nexium settlement with Ranbaxy 

unreasonably anticompetitive, i.e. did the 

anticompetitive effects of that settlement 

outw[ei]gh any pro-competitive justifications? 

4. Had it not been for the unreasonably 

anticompetitive settlement, would AstraZeneca have 

agreed with Ranbaxy that Ranbaxy might launch a 

generic version of Nexium before May 27, 2014? 

5. If so, what would be the effective date of such a 

license? 

6. a. Had it not been for the unreasonably 

anticompetitive settlement, would Ranbaxy have 

agreed with Teva to launch a generic version of 

Nexium before May 27, 2014? b. If so, when would 

Teva have launched? 

7. If a generic version of Nexium had come to market, 

would an authorized generic have entered at or 

about the same time? 

After the court explained its revisions, it engaged in a colloquy 

with the parties, which focused, in relevant part, on the 

plaintiffs' objection that Question 4 applied a legally incorrect 

"subjective" test for antitrust causation.

The district court instructed the jury the next day. On 

Question 4, the court explained that answering "yes" to the first 

three questions was insufficient because "[j]ust making a 

deal . . . is not enough for liability[;] there has to be a harm." 

The court further explained that although the question mentioned 

by name AstraZeneca and Ranbaxy, it was "not necessarily just 

focusing on the AstraZeneca–Ranbaxy settlement":

Now, the test here is an objective test. In other 

words I use the names "AstraZeneca" and "Ranbaxy" 
- 31 - 

because those are the folks we're talking about 

here, but the test is not what they did . . . we 

know what agreement they entered into, you would 

have found [in Question 3] that agreement is 

unreasonably anticompetitive. So then you're asked 

the question, "Well, suppose they didn't enter into 

such an agreement, suppose they were settling 

straight up without any anticompetitive effects, 

would that settlement license entry date have been 

earlier than the date they agreed to, May 27th, 

2014?" 

The court also reviewed Teva's role in the plaintiffs' theory -- 

namely, that had AstraZeneca not made a reverse payment to Ranbaxy, 

their settlement agreement would have contained an earlier entry 

date, which would have allowed Teva to obtain that same earlier 

date or to partner with Ranbaxy for a joint launch of generic 

Nexium. Finally, the court informed the jury that a "no" to any 

question meant that the jury should not consider any subsequent 

question. 

During the sidebar following the charge, each party 

objected to certain aspects of the court's instructions. The court 

had earlier warned that the parties had to raise their objections 

at the end of the charge to preserve them for appeal. The 

plaintiffs' objections to Question 4 were limited to the district 

court's colloquial framing of that question. They also objected 

to other aspects of the instructions unrelated to Question 4. 

6. Plaintiffs' Closing Statement 

The plaintiffs' closing expressly reminded the jury of 

the "large and unjustified payment" from AstraZeneca to Ranbaxy. 
- 32 - 

Plaintiffs' counsel argued that "[i]t's large because it was worth 

about $690 million to Ranbaxy, or according to [one witness], about 

$300 million. It was going to cost AstraZeneca, in terms of lost 

sales, about $500 million of its own revenues that it might be 

able to get from the sale of [an authorized generic]." The 

plaintiffs further urged the jury to draw inferences from that 

payment: "By the fact that there was a payment you can infer that 

there was a movement of that entry date. Absolutely. And [by] 

the fact that this payment was so large you can infer that the 

entry date was moved back and should have been earlier."

Notwithstanding the court's judgment as a matter of law 

on the issue of patent invalidity, the plaintiffs' closing also 

questioned the strength of AstraZeneca's Nexium patents and the 

relevance of those patents to the defendants' settlement 

agreement. The closing emphasized that the two defendants denied 

"ever talk[ing] about the strengths and weaknesses of the patent 

in order to negotiate some kind of date." Further, "[b]ecause 

. . . there was never a negotiation here where the two companies 

sat down and said we've got these claims on the patents . . . 

here's infringement issues, let's see how we can negotiate on the 

merits of this case a resolution," the plaintiffs urged the jury 

to find that the AstraZeneca-Ranbaxy deal consisted of "payoffs 

that weren't related to the merits." Upon the defendants' 

objections to the plaintiffs' characterization of "the patent 
- 33 - 

merits a[s] a coin flip" during the closing, the court reminded 

the jury that "on this record there is no evidence that any of 

these patents at the end of the day would have been held invalid."

Finally, the plaintiffs' closing discussed at least two 

mechanisms through which the Ranbaxy reverse payment could have 

led to an antitrust injury in the form of a delayed generic launch. 

First, they explained that AstraZeneca faced a "major risk of 

potential at-risk launch . . . in late 2007 and early 2008" and 

thus had an incentive to settle with Ranbaxy to avoid that outcome. 

Next, the plaintiffs reminded the jury about the Lipitor analogy. 

Articulating the "striking" similarities between Nexium and 

Lipitor, the plaintiffs emphasized that generic Lipitor launched 

despite Ranbaxy's regulatory troubles, while generic Nexium did 

not, because the Lipitor settlement agreement did not contain a 

no-AG clause and thus provided for an earlier entry date compared 

to the Nexium settlement agreement. 

7. Jury Verdict 

After deliberating for two and a half days, the jury 

returned a verdict for the defendants. The jury answered "yes" to 

the first three questions, finding that the AstraZeneca-Ranbaxy 

settlement contained a "large and unjustified payment" and had an 

"unreasonably anticompetitive" market impact. But the jury 

answered "no" to Question 4, finding that the plaintiffs had failed 

to prove that AstraZeneca would have negotiated an entry date 
- 34 - 

earlier than May 27, 2014. Heeding the court's earlier 

instructions, the jury stopped after its "no" answer. 

C. Post-Trial Proceedings 

On December 31, 2014, the plaintiffs moved for a new 

trial based in part on allegedly contradictory evidence that 

Ranbaxy had presented in litigation against the FDA in December 

2014. One week later, a subset of plaintiffs moved for a permanent 

injunction under Section 16 of the Clayton Antitrust Act, Pub. L. 

63-212, 38 Stat. 730 (codified at 15 U.S.C. §§ 12-27, 29 U.S.C. 

§§ 52-53). The district court denied both motions. See In re 

Nexium [Post-Trial Opinion], 309 F.R.D. at 134, 143. 

This appeal followed. 

IV. ANALYSIS 

Plaintiffs have chosen to focus their appeal on the 

partial grant of summary judgment, the exclusion of certain 

evidence at trial, alleged errors in the district court's special 

verdict form and jury instructions, and the grant of judgment as 

a matter of law on the claim of overarching conspiracy. Plaintiffs 

argue that any one of these alleged errors entitles them to a new 

trial. 

We disagree and affirm the district court's evidentiary 

rulings, judgment as a matter of law on overarching conspiracy, 

and decision to structure the special verdict form and jury 

instructions in the manner that it did. Further, in light of the 
- 35 - 

jury verdict and other critical developments at trial on the issue 

of patent invalidity, we decline to revisit the district court's 

summary judgment rulings. It would be improper for an appeals 

court to wade into such pretrial matters when, as here, a 

confluence of the plaintiffs' trial strategy, the district court's 

rulings, and the jury verdict rendered harmless any alleged error 

at the summary judgment stage. 

A. Evidentiary Rulings 

The plaintiffs challenge numerous evidentiary rulings of 

the district court. We find no error and affirm. 

1. Exclusion of McGuire's Event Study Testimony 

The plaintiffs argue that the district court committed 

reversible error by refusing to allow Dr. Thomas McGuire to testify 

for a third time after it concluded that the subject of his 

testimony, the Event Study, was inadmissible under Daubert. We 

review Daubert determinations for abuse of discretion. RuizTroche v. Pepsi Cola of P.R. Bottling Co., 161 F.3d 77, 81 (1st 

Cir. 1998) (citing General Elec. Co. v. Joiner, 522 U.S. 136, 141-

42 (1997)). Federal Rule of Evidence 702 requires district courts 

to "ensur[e] that an expert's testimony both rests on a reliable 

foundation and is relevant to the task at hand" before admitting 

it into evidence. Daubert, 509 U.S. at 597. The district court, 

as gatekeeper, must "ensure that there is an adequate fit between 
- 36 - 

the expert's methods and his conclusions." Samaan v. St. Joseph 

Hosp., 670 F.3d 21, 32 (1st Cir. 2012). 

We conclude on the merits4 that the district court did 

not abuse its discretion in excluding the Event Study and McGuire's 

corresponding testimony. The court properly found that the Event 

Study methodology -- which purported to use econometric analysis 

of stock market data to "estimate an objective entry date without 

[a reverse] payment" -- did not fit the conclusions for which it 

was offered. Although such studies had previously been "admitted 

on valuation, something much more germane to stock price," the 

study had questionable relevance to hypothesizing the outcome of 

a settlement agreement, especially one as crucial as the but-for 

entry date in a reverse-payment case. Furthermore, when asked to 

offer an example of another study that had used the Event Study 

methodology to predict settlement terms, the plaintiffs could not 

produce anything but an unpublished, non-peer-reviewed working 

paper that McGuire co-authored during the course of this 

litigation. The exclusion of McGuire's Event Study testimony under 

these circumstances did not constitute an abuse of discretion. 

 4 As a threshold matter, the defendants argue that the 

plaintiffs are judicially estopped from appealing the exclusion of 

McGuire's Event Study, as they agreed to give up that evidence to 

defeat the defendants' mistrial motion. We need not reach this 

claim. 
- 37 - 

2. Exclusion of Other Aspects of McGuire's Testimony 

The plaintiffs also accuse the district court of 

improperly forbidding McGuire from testifying about three other 

issues: (1) specific but-for entry dates, (2) "the purpose and 

effect of the side deals" between AstraZeneca and Ranbaxy, and 

(3) the exact size of the reverse payment from AstraZeneca to 

Ranbaxy. We can quickly dispose of these arguments. 

First, as to McGuire's testimony on the but-for entry 

dates, examining the district court's decision in the context of 

the overall record makes clear that the exclusion did not prejudice 

the plaintiffs. During McGuire's second testimony, which took 

place before the district court's mid-trial epiphany on the Ranbaxy 

reverse payment's relevance, the court did not allow McGuire to 

testify that Ranbaxy and Teva "would have been able to enter in 

2011" but for the reverse payments. This ruling did not constitute 

reversible error in light of events at trial that took place both 

before and after the court's epiphany. 

Even before its shift in thinking, the district court 

gave McGuire leeway to testify about Ranbaxy's economic incentives 

to enter into the settlement agreement with AstraZeneca. That 

testimony, in turn, implied how the AstraZeneca-Ranbaxy settlement 

could have led to delayed generic entry. In particular, McGuire 

testified, during his second time on the stand, that the contingent 

launch provision in Ranbaxy's settlement agreement diminished the 
- 38 - 

likelihood of subsequent ANDA filers seeking to enter the generic 

Nexium market. "In fact," McGuire testified, "there were no 

subsequent ANDA filers that pursued this [generic entry] through 

litigation." The district court also permitted plaintiffs' 

counsel to ask McGuire whether he had "reach[ed] a conclusion as 

to whether Ranbaxy had an economic motive to agree to the 

[contingent launch] clause." McGuire answered in the affirmative 

and, over an objection, was allowed to elaborate that the 

contingent launch provision "had the effect of reducing the 

likelihood that Teva would challenge and break the bottleneck, 

which mean[t] for Ranbaxy[,] it became more likely that [it was] 

able to use [its] 180-day exclusivity period and make the profits 

associated with that." Notwithstanding McGuire's inability to 

testify to exact but-for entry dates, the district court afforded 

him great latitude to give testimony on Ranbaxy's economic 

incentives to block other ANDA filers and thus delay generic entry. 

Next, after the court's adjustment in thinking, it 

informed the parties that it would not allow McGuire to testify a 

third time out of principles of fairness and that the plaintiffs 

should consider this ruling's implications on their mistrialmotion calculus. In addition, independent of its rulings regarding 

McGuire, the court allowed testimony on but-for entry dates from 

another expert, Dr. Cheryl Blume, whom the court described as the 

plaintiffs' "lead witness" on this very issue. Blume testified as 
- 39 - 

part of the plaintiffs' case in chief over three days of trial 

(November 18 to 20). 

In the context of the court's rulings on McGuire and 

Blume, the plaintiffs continued to oppose a mistrial. The record 

does not show that they made any objections that they should have 

been allowed to present cumulative evidence on specific but-for 

entry dates through McGuire in addition to Blume. In short, the 

plaintiffs had an opportunity to present evidence on hypothetical 

earlier entry dates through Blume, and the district court was under 

no obligation to also permit McGuire to testify on that same issue. 

The plaintiffs' argument to the contrary seems to be little more 

than an effort to admit cumulative and weaker evidence. See 

McDonald v. Fed. Labs., Inc., 724 F.2d 243, 248 (1st Cir. 1984); 

cf. Fed. R. Evid. 403 ("The [trial] court may exclude relevant 

evidence if its probative value is substantially outweighed by a 

danger of . . . unfair prejudice, confusing the issues, misleading 

the jury, undue delay, wasting time, or needlessly presenting 

cumulative evidence."). Plaintiffs have not shown any prejudice 

resulting from the district court's decision not to permit 

cumulative evidence, particularly from a witness who had already 

been allowed to testify twice. 

Next, the alleged errors in excluding McGuire's 

testimony on the side deals and the size of the reverse payment 

were harmless in light of the jury verdict. The "yes" answer to 
- 40 - 

Question 2 reflects the jury's finding that AstraZeneca made a 

large and unjustified payment to Ranbaxy. Furthermore, as to the 

size of the reverse payment, although McGuire could not assign a 

specific dollar figure to the value of the reverse payment, the 

district court did allow him to testify that it was worth "hundreds 

of millions of dollars." 

3. Pretrial Exclusion of Upadhye's Testimony 

The plaintiffs also fault the district court for its 

pretrial decision in limine to exclude testimony from Shashank 

Upadhye, who sought to provide "a real world business perspective 

on settlement negotiations for drug patent lawsuits." 

Before reaching the merits, we must point out that, 

despite the district court's clear instructions that its pretrial 

decisions were "not rulings" and that the parties "must make 

[their] objections known during the course of the trial," the 

plaintiffs did not renew at trial their objections to the court's 

in limine decision regarding Upadhye. In fact, although the 

plaintiffs listed Upadhye as a witness whom they "m[ight] call" at 

trial, they never actually attempted to do so. Under these 

circumstances, the district court's in limine decision may not 

even serve as proper grounds for a reversal. See, e.g., Littleton 

v. McNeely, 562 F.3d 880, 891 (8th Cir. 2009). 

But even if the plaintiffs had properly objected to the 

exclusion of Upadhye's testimony, there would be no error. 
- 41 - 

"Whether a witness is qualified to express an opinion is a matter 

left to the sound discretion of the trial judge." McDonald, 724 

F.2d at 248 (quoting A. Belanger & Sons, Inc. v. U.S. for Use & 

Benefit of Nat'l U.S. Radiator Corp., 275 F.2d 372, 376 (1st Cir. 

1960)). Here, the district court excluded Upadhye's proposed 

testimony because he was "not [an] economist[]" and "d[id] not 

have the requisite qualifications to testify." That decision, 

especially given Upadhye's reliance on his general experience and 

his failure to cite any methodology undergirding his opinions, was 

not an abuse of discretion. The district court may also have 

"regarded [Upadhye's] proffered testimony as cumulative," as 

McGuire had already testified about the Ranbaxy reverse payment 

and Upadhye would have offered only a "real world" spin on that 

testimony. Id. 

4. Exclusion of Plaintiffs' Proposed Rebuttal Evidence 

The plaintiffs next seek reversal on the ground that the 

district court's exclusion of their "rebuttal" evidence was error. 

Not so. "The principal objective of rebuttal is to permit a 

litigant to counter new, unforeseen facts brought out in the other 

side's case." Faigin v. Kelly, 184 F.3d 67, 85 (1st Cir. 1999). 

"[T]he decisions as to what constitutes proper rebuttal 

evidence . . . lie within the sound discretion of the trial judge 

and are subject to substantial deference." United States v. 

LiCausi, 167 F.3d 36, 52 (1st Cir. 1999). 
- 42 - 

The plaintiffs sought to admit three pieces of evidence, 

purportedly in an effort to rebut the testimony of two defense 

witnesses, "that AstraZeneca never 'express[ed] any willingness to 

agree to any' date other than May 27, 2014." The proposed rebuttal 

evidence consisted of (1) McGuire's Event Study testimony, which 

the district court had already rejected as part of the plaintiffs' 

case in chief; (2) an economic analysis of a no-payment settlement 

by another expert, Dr. Keith Leffler; and (3) a study published by 

FTC staff. At oral argument, the plaintiffs insisted that their 

inability to admit any rebuttal evidence, coupled with other 

alleged errors of the district court, meant that "all the jury 

heard was some officers of [the defendants'] company saying they 

wouldn't do things differently." 

Contrary to the plaintiffs' statement, the district 

court properly refused to admit the plaintiffs' proposed rebuttal 

evidence, reasoning that it "was hardly true rebuttal testimony 

because establishing [the date on which the defendants would have 

agreed to a generic launch but for a reverse payment] was an 

essential part of the Plaintiffs' prima facie case." Indeed, given 

the centrality of this date to the entire litigation and especially 

to the plaintiffs' need to prove an antitrust injury, it was 

entirely foreseeable that the defendants would assert that the 

date would not have been earlier than May 27, 2014. It was thus 

within the district court's discretion to rule that the defendants' 
- 43 - 

testimony to that effect offered nothing "new" to warrant use of 

the plaintiffs' proffered evidence as rebuttal. See Faigin, 184 

F.3d at 85. 

The plaintiffs respond by emphasizing the unique 

circumstances of this trial. Given that the district court first 

directed them to focus their case on the Teva reverse payment but 

radically adjusted its understanding mid-trial to recognize the 

relevance of the Ranbaxy reverse payment, the plaintiffs argue 

that the district court was required to give them an opportunity, 

at rebuttal, "to present evidence relating to the newly revived 

issue." Alberty-Vélez v. Corporación de Puerto Rico para la 

Difusión Pública, 242 F.3d 418, 422 (1st Cir. 2001) (quoting Leddy 

v. Standard Drywall, Inc., 875 F.2d 383, 386 (2d Cir. 1989)). But 

the record does not support the plaintiffs' contention that the 

district court did not afford them such an opportunity. Instead, 

the record portrays the plaintiffs' neglect in seeking to admit 

relevant testimony after the court course-corrected (with the 

exception of McGuire's Event Study, which was supportably excluded 

on Daubert grounds, as discussed above). 

The plaintiffs made no effort to seek admission of the 

FTC study or Leffler's testimony as part of their case in chief, 

even though they had two days between the district court's epiphany 

and the end of their case in chief to do so. They offer no 

explanation on appeal of their failure to seek admission of the 
- 44 - 

FTC study before resting their case. And while they do explain 

that they could not call Leffler on short notice because he resided 

in Seattle, the record does not indicate that the plaintiffs 

brought this geographical limitation to the district court's 

attention. In short, the plaintiffs had a window of opportunity 

to seek admission of the FTC study and Leffler's testimony before 

resting their case. Given their own failure to do so, we conclude 

that it was within the district court's discretion to refuse to 

admit that evidence, which properly belonged in the plaintiffs' 

case in chief, and not in their rebuttal. 

B. Judgment as a Matter of Law on Overarching Conspiracy 

The plaintiffs argue that the district court erroneously 

granted judgment as a matter of law ("JMOL") on the overarching 

conspiracy claim. They argue that they had proved the existence 

of contingent launch provisions in the defendants' settlement 

agreements, that this evidence had sufficed to survive summary 

judgment, and that thus it necessarily was enough to defeat JMOL. 

But this reasoning mixes apples and oranges. 

We review de novo a district court's decision to grant 

JMOL. Malone v. Lockheed Martin Corp., 610 F.3d 16, 19 (1st Cir. 

2010). An antitrust conspiracy claim under Section 1 of the 

Sherman Act, 15 U.S.C. § 1, requires evidence of an actual 

"'agreement[]' -- whether tacit or express." White v. R.M. Packer 

Co., 635 F.3d 571, 575 (1st Cir. 2011). "[I]ndependent decisions, 
- 45 - 

even if they lead to the same anticompetitive result as an actual 

agreement among market actors," are insufficient to sustain a 

Section 1 conspiracy claim. Id. As a result, mere parallel 

conduct and "[e]ven 'conscious parallelism,' a common reaction of 

firms in a concentrated market that recognize their shared economic 

interests and their interdependence with respect to price and 

output decisions[,] is not in itself unlawful." Bell Atl. Corp. 

v. Twombly, 550 U.S. 544, 553–54 (2007) (alterations omitted) 

(quoting Brooke Grp. Ltd. v. Brown & Williamson Tobacco Corp., 509 

U.S. 209, 227 (1993)). 

The law distinguishes illegal tacit agreements from 

"mere conscious parallelism" through evidence of "uniform behavior 

among competitors, preceded by conversations implying that later 

uniformity might prove desirable or accompanied by other conduct 

that in context suggests that each competitor failed to make an 

independent decision." White, 635 F.3d at 576 (emphasis added) 

(quoting Brown v. Pro Football, Inc., 518 U.S. 231, 241 (1996)); 

see also Dickson v. Microsoft Corp., 309 F.3d 193, 203 (4th Cir. 

2002) (concluding that a "rimless wheel conspiracy" -- in which 

"various defendants enter into separate agreements with a common 

defendant, but where the defendants have no connection with one 

another, other than the common defendant's involvement in each 

transaction" -- is "not a single, general conspiracy but instead 

amounts to multiple conspiracies between the common defendant and 
- 46 - 

each of the other defendants" (citing Kotteakos v. United States, 

328 U.S. 750, 755 (1946))). 

The plaintiffs point to parallel contingent launch 

provisions in AstraZeneca's settlements with each generic 

manufacturer as evidence of the existence of one overarching 

conspiracy. Under these provisions, the generic manufacturers 

agreed to delay launching generic Nexium until May 27, 2014, or an 

earlier date on which AstraZeneca or a court order permitted them 

to do so. Beyond the provisions, however, the plaintiffs fail to 

present any evidence that Ranbaxy and Teva agreed to engage in 

anticompetitive conduct. 

Given the dearth of additional evidence, the district 

court correctly recognized that "[t]here is no sufficient evidence 

here that Ranbaxy and Teva conspired together, that they acted 

otherwise than in their own individual best interest." Indeed, 

some evidence that Ranbaxy and Teva, independent of AstraZeneca, 

agreed to engage in anticompetitive conduct was critical because 

self-interest could explain equally well why each might execute a 

contingent launch provision. After all, as defendant Ranbaxy 

explains, "[e]ach generic company would have wanted to ensure that 

no other generic preceded its entry into the market -- and would 

have sought that assurance by obtaining a contingent launch 

provision in its settlement agreement." In short, without proving 

"the existence of a 'rim' to the wheel in the form of an agreement 
- 47 - 

among" the generic manufacturers, the plaintiffs did not have a 

viable claim of overarching conspiracy to survive JMOL. United 

States v. Apple, Inc., 791 F.3d 290, 314 n.15 (2d Cir. 2015). 

The three cases that the plaintiffs string cite do not 

alter our assessment. See United States v. Masonite Corp., 316 

U.S. 265 (1942); Interstate Circuit v. United States, 306 U.S. 208 

(1939); Toys "R" Us, Inc. v. FTC, 221 F.3d 928 (7th Cir. 2000). 

The cases do not say, as plaintiffs argue, that interdependent 

conduct, absent more, suffices to establish overarching 

conspiracy. Properly read, they in fact reinforce the opposite 

proposition. 

First, contrary to the plaintiffs' argument, Masonite 

makes no holding on horizontal conspiracy. There, Masonite, a 

manufacturer of building materials, developed a product called 

hardboard and obtained patents for both the product and the process 

for manufacturing it. 316 U.S. at 267–68. When competitors began 

manufacturing hardboard, Masonite sued each of them for patent 

infringement, id. at 268–70, but eventually settled each suit on 

identical terms, including a price-fixing term, id. at 270–73. 

The Supreme Court upheld the district court's factual findings 

that each of Masonite's competitors had "acted independently of 

the others, negotiated only with Masonite, desired the agreement 

regardless of the action that might be taken by any of the others, 

did not require as a condition of its acceptance that Masonite 
- 48 - 

make such an agreement with any of the others, and had no 

discussions with any of the others." Id. at 275. The Court then 

held that the individual vertical contracts between Masonite and 

each competitor violated § 1 of the Sherman Act. Id. That was 

the extent of Masonite's holding. Indeed, to read Masonite as 

having found an overarching horizontal conspiracy would be 

"nonsensical" because "an essential conspiracy element [wa]s 

missing -- namely, a motive for joint action or interdependence." 

6 Areeda & Hovenkamp, Antitrust Law ¶ 1427d (2d ed. 2003). 

The second case that the plaintiffs cite, Interstate 

Circuit, is also of no help to their claim of error. Unlike this 

case, in which the district court found no evidence to infer any 

agreement between Ranbaxy and Teva, the Court in Interstate Circuit 

saw enough circumstantial evidence to find a "tacit agreement" 

among all defendants. 306 U.S. at 225-27; White, 635 F.3d at 576. 

There, "a dominant movie theater company sent a letter openly 

addressed to all eight major national film distributors stating 

that it would show a distributor's films only if the distributor 

imposed certain restrictions on later runs of the films in 

secondary theaters." White, 635 F.3d at 576. "[T]he economic 

context made it clear that all eight needed to act uniformly or 

all would lose business, and all eight did in fact impose the 

conditions." Id. By contrast, here, the district court found 
- 49 - 

that the plaintiffs had presented insufficient evidence from which 

to infer even a tacit agreement. 

Finally, Toys "R" Us is also inapposite because evidence 

in that case showed that entering into parallel agreements with 

Toys "R" Us ("TRU") was against each toy manufacturer's interest 

unless all of them did so. TRU, "a giant in the toy retailing 

industry," had executed agreements with various toy manufacturers 

that TRU would carry the manufacturers' toys only if they promised 

to curb sales to warehouse club stores like Costco that sold toys 

at lower prices than did TRU. 221 F.3d at 930. The Seventh 

Circuit affirmed an FTC finding of a horizontal conspiracy among 

the toy manufacturers for two reasons. First, "the record . . . 

included the direct evidence of communications" among the toy 

manufacturers. Id. at 935. Second, the evidence showed that it 

was actually against the toy manufacturers' economic interest to 

curb sales to warehouse clubs unless they all did so: 

The evidence showed that the companies wanted to 

diversify from TRU, not to become more dependent 

upon it; it showed that each manufacturer was 

afraid to curb its sales to the warehouse clubs 

alone, because it was afraid its rivals would cheat 

and gain a special advantage in that popular new 

market niche. . . . [T]he only condition on which 

each toy manufacturer would agree to TRU's demands 

was if it could be sure its competitors were doing 

the same thing. 

Id. at 936. The record in this case contains no such evidence. 
- 50 - 

In Interstate Circuit and Toys "R" Us, there were "plus 

factors" -- i.e. "additional facts or factors required . . . as a 

prerequisite to finding that parallel action amounts to a 

conspiracy." 6 Areeda & Hovenkamp, supra, ¶ 1433e ("Even those 

courts that say that conscious parallelism is a factor 'to be 

weighed, and generally to be weighed heavily' in establishing a 

§ 1 violation are usually speaking about fact situations in which 

there is other evidence of conspiracy." (emphasis added) (footnote 

omitted)). 

The plaintiffs' briefs do not focus on the lack of 

evidence to prove their claim of overarching conspiracy. Instead, 

they primarily argue that the district court initially ruled in 

their favor at summary judgment and that the court should not have 

reversed itself at the JMOL stage. In so doing, the plaintiffs 

fail to consider that the summary judgment ruling may have been in 

error. Nor do they recognize that the JMOL reasoning, not the 

summary judgment reasoning, has found agreement in at least two 

other trial courts that have considered the issue. See In re Actos 

End Payor Antitrust Litig., No. 13-CV-9244(RA), 2015 WL 5610752, 

at *24 (S.D.N.Y. Sept. 22, 2015); King Drug Co. of Florence, Inc. 

v. Cephalon, Inc., No. 2:06-CV-1797, 2014 WL 2813312, at *14 (E.D. 

Pa. June 23, 2014). There was no error. 

Finally, the Individual Retailer plaintiffs misrepresent 

the district court's opinion denying them a new trial. They 
- 51 - 

contend that after the court recognized its summary judgment ruling 

as "a bit too sweeping," it nonetheless "reverted to the summary 

judgment rationale . . . that the evidence was sufficient to 

support a finding that 'AstraZeneca was the hub of a hub-and-spoke 

conspiracy.'" Quoted in full, however, the district court actually 

reaffirmed its JMOL ruling, noting that "[a]t trial, the evidence 

warranted, at most, a finding that AstraZeneca was the hub of a 

hub-and-spoke conspiracy with the three generic manufacturers 

acting as competitors vis-à-vis each other, not conspirators." In 

re Nexium [Post-Trial Opinion], 309 F.R.D. at 115 n.13 (emphasis 

added). In other words, the court recognized that although the 

evidence might show one conspiracy between AstraZeneca and Ranbaxy 

and another disparate conspiracy between AstraZeneca and Teva, the 

evidence was legally insufficient to tie all three players in an 

overarching conspiracy. We find no error in the district court's 

decision to grant JMOL on the overarching conspiracy claim in light 

of the plaintiffs' inability to cite any supporting evidence other 

than the parallel contingent launch provisions. 

C. Special Verdict Form and Jury Instructions 

The final verdict form that went to the jury asked seven 

questions and was structured so that a "no" answer to any question 

meant that the jury could stop considering the rest. As relevant 

here, the first four questions asked: 
- 52 - 

1. Did AstraZeneca exercise market power within the 

relevant market? 

2. Did the settlement of the AstraZeneca-Ranbaxy 

patent litigation include a large and unjustified 

payment by AstraZeneca to Ranbaxy? 

3. Was AstraZeneca's Nexium settlement with Ranbaxy 

unreasonably anticompetitive, i.e. did the 

anticompetitive effects of that settlement 

outw[ei]gh any pro-competitive justifications? 

4. Had it not been for the unreasonably 

anticompetitive settlement, would AstraZeneca have 

agreed with Ranbaxy that Ranbaxy might launch a 

generic version of Nexium before May 27, 2014? 

On appeal, the plaintiffs argue that Question 4 impermissibly 

"require[d] a specific factual sequence of causation," that it was 

duplicative of Question 3, that it erroneously posed a "subjective" 

test about the intent of the defendants, and that its wording was 

"confusing" and "misled the jury." The defendants respond that 

all of these objections were either waived or forfeited. 

If a party fails to preserve its objections to jury 

instructions after the jury is charged, those objections are 

forfeited on appeal and reviewed only for plain error. Booker v. 

Mass. Dep't of Pub. Health, 612 F.3d 34, 42 (1st Cir. 2010). Plain 

error, "a hard-to-meet standard," requires the appellant to show 

"that '(1) an error occurred (2) which was clear or obvious and 

which not only (3) affected the [appellant's] substantial rights, 

but also (4) seriously impaired the fairness, integrity, or public 

reputation of the judicial proceedings.'" Tasker v. DHL Ret. 
- 53 - 

Savings Plan, 621 F.3d 34, 40–41 (1st Cir. 2010) (alteration in 

original) (quoting Dávila v. Corp. de P.R. Para La Difusión 

Pública, 498 F.3d 9, 14–15 (1st Cir. 2007)). 

Furthermore, "with respect to special verdicts, 'the law 

is perfectly clear that parties waive any claim of internal 

inconsistency by failing to object after the verdict is read and 

before the jury is discharged.'" Trainor v. HEI Hosp., LLC, 699 

F.3d 19, 34 (1st Cir. 2012) (alterations omitted) (quoting Peckham 

v. Cont'l Cas. Ins. Co., 895 F.2d 830, 836 (1st Cir. 1990)). This 

has been an "iron-clad rule" in our circuit. Rodriguez-Garcia v. 

Mun. of Caguas, 495 F.3d 1, 9 (1st Cir. 2007). Although we could 

altogether decline to hear the plaintiffs' arguments about the 

verdict form on waiver grounds, the FTC's amicus brief highlights 

the importance of straightening out the conflation of antitrust 

violation and antitrust injury that crept into the district court's 

post-trial opinion and into some of the parties' arguments on 

appeal. We accept the FTC's invitation to provide greater clarity. 

Two of the plaintiffs' four objections seem to arise 

from this wrongful conflation. The plaintiffs protest that 

Question 4 was duplicative of Question 3 and that Question 4 held 

the plaintiffs to an impermissibly stringent causation standard.5 

 5 In their proposed special jury verdict form, the 

plaintiffs suggested precisely the same split in questions between 

antitrust violation and antitrust injury (in the form of a delayed 

generic entry).
- 54 - 

Neither argument holds water, and in fact each shows that the 

plaintiffs may have obscured the clear law that, as private 

plaintiffs seeking damages, they must prove not only an antitrust 

violation but also an antitrust injury that allows recovery of 

damages.6

Private plaintiffs and the FTC as government enforcer 

stand in different shoes. Under the governing antitrust statutes, 

the FTC is empowered to directly enforce the substantive antitrust 

laws. See 15 U.S.C. § 45(a)(2). Meanwhile, private plaintiffs 

derive their authority to sue from Section 4 or 16 of the Clayton 

Act and must therefore satisfy the additional evidentiary burdens 

that those provisions impose. See id. §§ 15, 26. As the FTC's 

amicus brief aptly explains, "[t]his distinction is rooted in 

public policy. The interest of private plaintiffs is to remediate 

an injury they have suffered or may suffer. The interest of the 

government is to 'prevent and restrain' violations of the antitrust 

laws along with the attendant social costs such violations can 

cause." 

The Supreme Court has consistently held private 

plaintiffs to this standard of proving both antitrust violation 

and antitrust injury. See, e.g., Atl. Richfield Co. v. USA 

 6 Because the plaintiffs do not appeal the district 

court's denial of their post-trial motion for an injunction, they 

evidently seek a new trial in order to recover damages. 
- 55 - 

Petroleum Co., 495 U.S. 328, 344 (1990) ("'[P]roof of [an 

antitrust] violation and of antitrust injury are distinct matters 

that must be shown independently.' For this reason, . . . the 

right of action under § 4 of the Clayton Act is available only to 

those private plaintiffs who have suffered antitrust injury." 

(quoting Areeda & Hovenkamp, Antitrust Law ¶ 334.2c (1989 Supp.))). 

A private plaintiff seeking monetary relief must show actual, 

quantifiable damages "by reason of" the antitrust violation. 

Associated Gen. Contractors of Cal., Inc. v. Cal. State Council of 

Carpenters, 459 U.S. 519, 543 (1983); see also Brunswick Corp. v. 

Pueblo Bowl-O-Mat, Inc., 429 U.S. 477, 489 (1977) (defining 

"antitrust injury" as "injury of the type the antitrust laws were 

intended to prevent and that flows from that which makes 

defendants' acts unlawful"). 

Assessed under this framework, Questions 3 and 4 are 

neither duplicative nor both aimed at causation. Rather, the 

former asks the jury about antitrust violation, while the latter 

asks about antitrust injury. The jury's "yes" answers to Questions 

2 and 3 (large and unjustified payment with anticompetitive 

effects) confirm its finding that some antitrust violation 

resulted from the AstraZeneca-Ranbaxy settlement. Question 4, by 

contrast, inquires whether these private plaintiffs have suffered 

an "injury of the type the antitrust laws were intended to prevent" 

by asking whether Ranbaxy (in partnership with Teva) would have 
- 56 - 

launched a generic earlier than May 27, 2014 but for the antitrust 

violation found in Question 3. Brunswick, 429 U.S. at 489. The 

"no" answer to Question 4 thus confirms the jury's finding that 

notwithstanding the existence of an antitrust violation, the 

plaintiffs failed to establish an antitrust injury that entitled 

them to monetary relief. 

As Questions 3 and 4 played discrete and independently 

necessary roles in adjudicating an antitrust suit brought by 

private plaintiffs, we reject the plaintiffs' protests that the 

questions led to an "absurd" outcome. There was nothing absurd in 

the jury verdict. In fact, this circuit has reached similar 

conclusions in past antitrust cases. See, e.g., Ocean State 

Physicians Health Plan, Inc. v. Blue Cross & Blue Shield of R.I., 

883 F.2d 1101, 1105 (1st Cir. 1989) (observing that district court 

granted a renewed motion for JMOL in defendant's favor in part 

because "the jury's award of 'no damages' on the antitrust claim 

meant that plaintiffs had failed to prove that they had been 

injured by any illegal conduct by [the defendant]"). 

The plaintiffs next object that Question 4 erroneously 

used the defendants' names and framed the relevant inquiry as a 

subjective, rather than an objective, test. The record refutes 

this argument. After the plaintiffs initially raised these 

concerns at the December 2, 2014 conference, the court clarified 

to the jury that "the test here is an objective test. In other 
- 57 - 

words[,] I use the names 'AstraZeneca' and 'Ranbaxy' because those 

are the folks we're talking about here, but the test is not what 

they did." The plaintiffs failed to renew their objections 

following these instructions. Examining Question 4 in the context 

of the verdict form and jury instructions "as a whole," Johnson v. 

Teamsters Local 559, 102 F.3d 21, 28 (1st Cir. 1996), we conclude 

that the use of defendants' names did not constitute reversible 

error. 

The plaintiffs lastly argue that Question 4 was 

confusingly worded and capable of multiple "legally erroneous" 

interpretations. This objection suffers from the same defect as 

the others in that it was not preserved during the post-charge 

sidebar. The forfeited argument is unable to withstand plain error 

review, especially when examined in the context of the 

comprehensive instructions that the court provided to facilitate 

the jury's understanding of the verdict form. First, the 

plaintiffs' suggestion that the jury could have interpreted 

Question 4 to be asking "whether AstraZeneca would allow Ranbaxy 

to get Ranbaxy's product to market" is meritless in light of the 

court's jury charge: 

The plaintiffs' claim is not that Ranbaxy would 

have launched, no evidence of that, their claim is 

that had AstraZeneca not made a large payment to 

Ranbaxy, they would have settled with a date for 

generic entry before May 27th, 2014. . . . And 

that Teva then would have obtained the same or 
- 58 - 

earlier date . . . or that . . . Teva would have 

made a deal with Ranbaxy allowing Teva to launch. 

Likewise, the plaintiffs' concern that Question 4 imprecisely used 

the phrase "anticompetitive settlement," rather than "large and 

unjustified payment," is alleviated by jury instructions 

explaining how the presence of a large and unjustified payment in 

a paragraph IV litigation settlement renders that settlement 

anticompetitive. 

Perhaps the verdict form was inartfully phrased. But in 

the context of the thorough jury instructions and the plaintiffs' 

own failure to preserve objections, the plaintiffs cannot argue 

that any phrasing imperfection "seriously impaired the fairness, 

integrity, or public reputation of the judicial proceedings." 

Tasker, 621 F.3d at 41 (quoting Dávila, 498 F.3d at 14–15). 

D. Summary Judgment 

We finally arrive at the core of the plaintiffs' appeal. 

The plaintiffs argue that they had but one antitrust causation 

theory at trial: "In this regulatory climate, generics will get to 

market in some way, and we can't know exactly how." The district 

court erred, they say, in prematurely cutting off at summary 

judgment many causal mechanisms through which they could have 

proved this theory to a jury. The defendants respond in three 

ways: (1) the plaintiffs' theory of antitrust causation is actually 

a hodgepodge of disparate theories, none of which independently 
- 59 - 

proves causation, (2) later events at trial moot any potential 

summary judgment error, and (3) the summary judgment ruling was 

correct on its merits. 

Even accepting dubitante the level of generality at 

which the plaintiffs characterize their causation theory, we agree 

with the defendants that any error at summary judgment was rendered 

harmless by the jury verdict and by later trial proceedings on the 

issue of patent invalidity. We are satisfied that the evidence in 

support of even those causal mechanisms purportedly excluded at 

summary judgment was in fact put before the jury, as that evidence 

was relevant under other concededly admitted theories. The 

district court recognized the relevance of that evidence and 

generously admitted much of it notwithstanding the summary 

judgment ruling (which it later reversed). 

Plaintiffs identify four causal theories they say were 

cut off at summary judgment. First, Ranbaxy could have launched 

its generic Nexium at risk before February 2009. Second, Teva 

could have won a final, nonappealable judgment in its paragraph IV 

suit against AstraZeneca, thereby forcing Ranbaxy to launch its 

generic within 75 days or forfeit its exclusivity, which would 

have allowed Teva to launch before May 2014. Third, Ranbaxy could 

have negotiated an earlier license date with AstraZeneca and 

launched (either alone or in partnership with Teva) before May 

2014. Finally, Ranbaxy could have negotiated an earlier license 
- 60 - 

date with AstraZeneca and then forfeited its first-filer 

exclusivity, which would have allowed another manufacturer like 

Teva to launch before May 2014. 

Ordinarily, "[w]e review the merits of the entry of 

partial summary judgment de novo." Vélez v. Awning Windows, Inc., 

375 F.3d 35, 41 (1st Cir. 2004). But we have refused to "reenter 

th[e] morass" of summary judgment where it was "perfectly clear 

that, even if [a plaintiff's claim] should not have been dismissed 

on partial summary judgment, any such mistake was harmless, given 

the jury's verdict in [the defendant's] favor on [other claims] 

addressed to the very same [factual circumstances]." Fite v. Dig. 

Equip. Corp., 232 F.3d 3, 6 (1st Cir. 2000). We have so held in 

the antitrust context. See Fraser v. Major League Soccer, LLC, 

284 F.3d 47, 60-61 (1st Cir. 2002). 

An examination of the four supposedly foreclosed causal 

mechanisms, in light of later events at trial, reveals that the 

outcome would have been in the defendants' favor even had the 

mechanisms been explicitly put in questions to the jury. In 

particular, the first two mechanisms were mooted by the district 

court's grant of JMOL on any theory involving the invalidity of 

AstraZeneca's patents. Indeed, the argument that Ranbaxy would 

have incurred the risk of launching at risk or that Teva would 

have won its paragraph IV suit against AstraZeneca depends on the 

theory that AstraZeneca's Nexium patents were invalid or not 
- 61 - 

infringed by a generic version. The district court's JMOL ruling, 

however, found "no adequate evidence that any of [the Nexium] 

patents would be adjudicated invalid." Accordingly, even if the 

district court had allowed the plaintiffs to present these two 

causal mechanisms at trial, the court's later judgment would have 

yielded the same outcome in favor of the defendants. 

Plaintiffs respond that they should not have to prove 

patent invalidity or noninfringement to be able to present their 

at-risk launch causation theory. They principally rely on two 

circuit cases to advance this argument, but to no avail. See In 

re Cardizem CD Antitrust Litig., 332 F.3d 896 (6th Cir. 2003); 

Andrx Pharm., Inc. v. Biovail Corp. Int'l, 256 F.3d 799 (D.C. Cir. 

2001). Both of these cases were decided before the Supreme Court's 

Actavis decision, which may call into question aspects of their 

analyses. Even assuming that the two decisions survive Actavis, 

they are still inapposite to our inquiry because both cases 

evaluated allegations of antitrust injury at the Rule 12(b)(6) 

stage. See In re Wellbutrin XL Antitrust Litig., 133 F. Supp. 3d 

734, 765 n.46 (E.D. Pa. 2015), appeal pending, No. 15-3559 (3d 

Cir.). In In re Cardizem, for instance, the Sixth Circuit held 

that the defendants' argument -- that their decision to stay out 

of the generic market was motivated not by a reverse payment, but 

rather by a fear of damages resulting from patent infringement 

litigation -- "merely raise[d] a disputed issue of fact that [could 
- 62 - 

not] be resolved on a motion to dismiss." 332 F.3d at 900. The 

Cardizem court did not altogether reject the potential relevance 

of patent invalidity or noninfringement evidence in evaluating the 

viability of an antitrust-injury theory based on an at-risk launch. 

So too in Andrx, 256 F.3d at 805, and United Food & Commercial 

Workers Local 1776 v. Teikoku Pharma USA, Inc., 74 F. Supp. 3d 

1052, 1074 (N.D. Cal. 2014), yet another case that the plaintiffs 

cite.7

In re Wellbutrin XL, a post-Actavis decision at the 

summary judgment stage, is persuasive. 133 F. Supp. 3d 734. 

There, the district court granted summary judgment to the 

defendants, who were producers and distributors of a branded 

antidepressant drug, on the plaintiffs' at-risk theory of 

antitrust injury because the plaintiffs proffered no evidence of 

patent invalidity or noninfringement. Id. at 764–67. The court 

acknowledged that, if shown, "[t]he existence of a valid and 

uninfringed patent would interfere with the plaintiffs' chain of 

causation: a valid patent independently precludes competition 

apart from any agreement and an 'at risk' launch is unlawful absent 

 7 In fact, the district court in Teikoku expressly 

distinguished In re Nexium, describing it as "a case where the 

generic manufacturer moved for summary judgment, and offered 

unrebutted evidence 'that an at risk launch was "unlikely" and 

"extremely risky."'" 74 F. Supp. 3d at 1074. In contrast, Teikoku 

dealt with "a motion to dismiss and defendants cite[d] to no 

comparable evidence that [wa]s properly before the [c]ourt at 

th[at] juncture." Id. 
- 63 - 

a later finding of patent invalidity or non-infringement." Id. at 

764 (citation and alterations omitted). 

But there, as here, the plaintiffs did not present such 

evidence that the brand-name's patents would have been declared 

invalid or that an at-risk launch would not have infringed the 

patents. And without such evidence, the "patent served as an 

independent regulatory bar to [a generic's] launch." Id. at 767. 

So too here. Upon the conclusion of the plaintiffs' case in chief, 

the district court saw no evidence that would allow the plaintiffs 

to overcome the likelihood that AstraZeneca's patents, not its 

reverse payment to Ranbaxy, were the bar to a generic launch. The 

district court thus did not err by requiring some evidence of the 

patents' invalidity or noninfringement before allowing the 

plaintiffs to pursue an at-risk launch theory. 

Furthermore, the district court's ruling on patent 

invalidity did not prejudice the plaintiffs, for two reasons. 

First, the plaintiffs are simply wrong to insist that the district 

court decided and ruled out of the case the issue of patent 

invalidity at summary judgment. In fact, the plaintiffs 

acknowledged the availability of that line of reasoning -- and 

their strategic choice not to pursue it -- at a conference on the 

second day of trial: "We don't plan on proving a patent case inside 

of an antitrust case. . . . [W]e do not plan to be proving that 

Teva would have won the [paragraph IV] litigation." The plaintiffs 
- 64 - 

then reaffirmed their strategic choice on November 20, 2014, at 

the same conference during which they opposed the defendants' 

motion for a mistrial. At that conference, they assented to the 

court's characterization of their position as not having "proved 

that the patents would have been declared invalid, and [arguing] 

that that plays no role in this [trial]." 

The district court's statements during trial likewise 

reveal its consistent understanding that the summary judgment 

ruling did not prevent the plaintiffs from offering patent 

invalidity evidence if they chose to do so. For instance, in its 

initial instructions to the jury at the beginning of trial, the 

district court explained that the plaintiffs would have to 

"convince [the jury] . . . that Teva entered into its deal with 

AstraZeneca, staying out of the market, letting AstraZeneca charge 

its supracompetitive prices for its branded Nexium product, and if 

it hadn't done that, it could . . . have defeated the patent, 

AstraZeneca's patents," received FDA approval, and partnered with 

Ranbaxy to jointly launch a generic. The district court's view of 

the impact of its summary judgment ruling on patent invalidity did 

not change by the end of trial. At the December 2, 2014 charge 

conference, it reminded the plaintiffs: "I think that you will 

find, when you look at the record, I've never prevented the patent 

evidence[;] I've said you have to lay an adequate foundation for 

it." Because the ruling on patent invalidity did not take place 
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until after the plaintiffs' case in chief, at the JMOL stage, the 

timing of the ruling could not have foreclosed any evidence that 

the plaintiffs wished to put forth at trial. Any decision to limit 

evidence on patent invalidity was a voluntary and strategic choice 

on the plaintiffs' part. 

Second, even after the JMOL ruling, the district court 

was careful to point out, and correctly so, that its decision did 

not foreclose the plaintiffs from making any arguments based on 

AstraZeneca's assessment of risk to its patent monopoly. That is, 

the court recognized that regardless of the absolute validity or 

invalidity of patents, business players make reverse payment 

decisions in an environment in which that validity has not yet 

been adjudicated. They take into account the risk of litigation 

and the possibility that patents may be adjudicated invalid or 

uninfringed. The court explained this distinction between patent 

invalidity and assessment of risk to the jury: "I went into the 

case thinking . . . that one of the things the plaintiffs had to 

prove was that Teva would have won its patent case against 

AstraZeneca. And I've come to think now that legally that's not 

key, that's not what the plaintiffs have to prove." In sum, while 

the JMOL ruling on patent invalidity mooted the causal mechanisms 

based on at-risk launch and Teva's ability to win a paragraph IV 

litigation against AstraZeneca, the JMOL ruling did not prejudice 

the plaintiffs' argument that the defendants had incentives to 
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violate antitrust laws. Indeed, the jury verdict confirms this 

lack of prejudice, as it found that AstraZeneca made a large and 

unjustified payment to Ranbaxy and that their settlement agreement 

had unreasonably anticompetitive effects. 

As for the next two causal mechanisms claimed to have 

been cut off at summary judgment, the jury's "no" answer to 

Question 4 renders any error harmless. That answer reflected the 

jury's finding that AstraZeneca would not have agreed to settlement 

terms with a license date earlier than May 27, 2014, the date on 

which two of its medical patents expired. In light of that 

finding, it made no difference to the outcome of the trial whether 

the plaintiffs were able to present their theory that Ranbaxy could 

have negotiated an earlier license date with AstraZeneca and 

themselves launched or allowed Teva to launch before May 2014. 

The plaintiffs respond that the jury had insufficient 

evidence upon which to answer Question 4 differently. At oral 

argument, the plaintiffs emphasized that their inability to 

introduce evidence on the possibility of a Ranbaxy or Teva at-risk 

launch,8 or of Ranbaxy's forfeiture of its first-filer status, had 

meant that the jury had had no information on what "would have 

 8 Of course, as we have now repeated numerous times, the 

plaintiffs voluntarily chose not to pursue the causal mechanism 

involving Teva's at-risk launch after the district court informed 

them that such an argument would trigger jury instructions about 

their need to prove patent invalidity.
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motivated AstraZeneca to accept an earlier entry date." In other 

words, the plaintiffs argue that without evidence on at-risk launch 

or forfeiture, the jury could not appreciate the threat that 

Ranbaxy posed to AstraZeneca or the incentive that AstraZeneca had 

to cut a deal with an earlier entry date. 

However, the jury answered "yes" to Questions 2 and 3 in 

the plaintiffs' favor, despite the supposed exclusion of such 

evidence. Indeed, this exact evidence -- about Ranbaxy's potential 

adverse impact on AstraZeneca's bottom line -- must have, and did, 

come in because the jury in fact found that AstraZeneca felt enough 

of a threat to offer a large and unjustified payment to Ranbaxy 

(Question 2) and offer settlement terms in violation of the 

antitrust laws (Question 3). The plaintiffs fail to explain what 

other evidence, unique to Question 4, the district court 

impermissibly excluded to impede the jury's ability to answer that 

question. To elaborate, while the plaintiffs recycle their 

grievances about the exclusion of Leffler's and McGuire's 

testimony on the Event Study, possible but-for entry dates, the 

purpose and effect of AstraZeneca's side deals with Ranbaxy, and 

the value of the reverse payment to Ranbaxy, we have already found 

above that all of this evidence was properly excluded. Ultimately, 

the jury had sufficient evidence to answer "yes" to Question 4, as 

well as Questions 2 and 3. Because the plaintiffs cannot point to 

improperly excluded evidence specific to Question 4, we cannot 
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accept their argument on the insufficiency of the evidence 

underlying the jury verdict. 

In light of the jury verdict and other events at trial 

that mooted any summary judgment error, we find no occasion to 

readjudicate the merits of the district court's pretrial decision. 

The plaintiffs are not entitled to set aside the jury verdict. 

V. CONCLUSION 

In any litigation, each party must make "tactical 

choices" about what pretrial motions to file, what evidence to 

present, and what objections to renew or forfeit. This case was 

no different. And despite doubts that the district court harbored 

about the merits of the plaintiffs' causation theory even before 

trial commenced, the plaintiffs were able to present their 

arguments to an attentive jury over six weeks. They were 

represented by able counsel in every step of the proceeding. 

Having had that opportunity but having failed to convince the jury 

that an antitrust injury occurred, the plaintiffs cannot now rehash 

summary judgment and JMOL rulings, scattered evidentiary 

decisions, and unpreserved objections to the verdict form in search 

of a do-over. 

We affirm.