LYNCH, Circuit Judge.
This appeal arises from the first pharmaceutical-settlement antitrust action tried before a jury since the Supreme Court's decision in
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.
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.
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' objections have
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."
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,' and is `biologically equivalent' to, the already-approved brand-name drug."
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.
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.
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.
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
In 2013, the Supreme Court held that reverse payment settlements in paragraph IV litigation "can sometimes violate the antitrust laws."
Earlier this year, in
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 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.
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 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
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.
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 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."
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.
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.
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.
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.
Consistent with
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.
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.
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
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.
"The net effect of these rulings [wa]s that the Ranbaxy Settlement [could] not [be] a basis for imposing antitrust liability."
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.
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."
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.
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 in-house lawyer at a nondefendant generic manufacturer. The plaintiffs sought Upadhye's testimony to "augment Dr. McGuire's economic testimony with a real world business perspective on settlement negotiations for drug patent lawsuits." The court reasoned that Upadhye, along with another proposed expert witness (John Thomas), could not testify because they were "lawyers, not economists, and ... they d[id] not have the requisite qualifications to testify." At an October 15, 2014 charge conference, the court reminded both parties that its decisions regarding motions in limine were "not rulings" and that the parties "must make [their] objections known during the course of the trial."
Dr. Reddy's settled and dropped out of the lawsuit shortly before 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.
At a conference on the second day of trial, the plaintiffs described their case in chief to the district court:
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.
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."
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."
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.'"
On November 18, 2014, the seventeenth day of the trial, the court admitted that it
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 not been a reverse payment in the AstraZeneca-Ranbaxy settlement — under
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 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.
Immediately following these statements, the court denied the motion for mistrial.
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 "[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
On November 24, 2014, Teva settled and dropped out of the suit, leaving only AstraZeneca and Ranbaxy as defendants.
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.
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:
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":
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.
The plaintiffs' closing expressly reminded the jury of the "large and unjustified payment" from AstraZeneca to Ranbaxy. 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
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 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.
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 earlier than May 27, 2014. Heeding the court's earlier instructions, the jury stopped after its "no" answer.
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.
This appeal followed.
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
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 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.
The plaintiffs challenge numerous evidentiary rulings of the district court. We find no error and affirm.
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
We conclude on the merits
The plaintiffs also accuse the district court of improperly forbidding McGuire
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 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 mistrial-motion 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 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.
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 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."
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.
But even if the plaintiffs had properly objected to the exclusion of Upadhye's testimony, there would be no error. "Whether a witness is qualified to express an opinion is a matter left to the sound discretion of the trial judge."
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."
The plaintiffs sought to admit three pieces of evidence, purportedly in an effort to rebut the testimony of two defense witnesses, "that AstraZeneca never
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'
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."
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 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.
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
We review de novo a district court's decision to grant JMOL.
The law distinguishes illegal tacit agreements from "mere conscious parallelism" through evidence of "uniform behavior among competitors,
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 among" the generic manufacturers, the plaintiffs did not have a viable claim of
The three cases that the plaintiffs string cite do not alter our assessment.
First, contrary to the plaintiffs' argument,
The second case that the plaintiffs cite,
Finally,
In
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.
Finally, the Individual Retailer plaintiffs misrepresent the district court's opinion denying them a new trial. They 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,
The final verdict form that went to the jury asked seven questions and was structured so that a "no" answer to any question
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.
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.'"
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.
The Supreme Court has consistently held private plaintiffs to this standard of proving both antitrust violation and antitrust injury.
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 launched a generic earlier than May 27, 2014 but for the antitrust violation found in Question 3.
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.
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 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,"
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
Likewise, the plaintiffs' concern that Question 4 imprecisely used the phrase "anti-competitive 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."
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
Even accepting dubitante the level of generality at which the plaintiffs characterize their causation theory, we agree
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 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."
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 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.
But there, as here, the plaintiffs did not present such evidence that the brandname'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."
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 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
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...
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
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
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 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.
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