MITCHELL S. GOLDBERG, District Judge.
Before me are three motions for summary judgment filed in the consolidated antitrust lawsuit known as the
The Defendants are Cephalon, Inc., a brand-name manufacturer of pharmaceuticals, and four generic manufacturers: Teva Pharmaceutical Industries, Ltd. and Teva Pharmaceuticals, USA, Inc. (collectively "Teva"); Ranbaxy Laboratories, Ltd. and Ranbaxy Pharmaceuticals, Inc. (collectively "Ranbaxy"); Mylan Pharmaceuticals, Inc. and Mylan Inc. (collectively "Mylan"), and Barr Laboratories, Inc. At the center of this case are four Hatch-Waxman reverse payment settlement agreements executed in 2005 and 2006 between Cephalon and each of the generic manufacturers. Those agreements resolved then-pending patent infringement lawsuits filed by Cephalon against the four generics (collectively, the Generic Defendants).
This opinion addresses whether these agreements were the product of an overall antitrust conspiracy between all of the Defendants. Based on the record before me, I conclude as a matter of law that such a conspiracy cannot be established. Accordingly, I will grant the motions for summary judgment filed by Cephalon and the Generic Defendants, and deny the motion for summary judgment filed by the Direct Purchaser Class Plaintiffs.
The facts giving rise to this litigation commenced on October 6, 1994, when Cephalon filed a U.S. patent application titled "Acetamide Derivative Having Defined Particle Size." (Ford. Decl. Ex. D, `845 patent.) On April 8, 1997, the Patent and Trademark Office issued the patent as U.S. Patent No. 5,618,845. (
Following the issuance of the `845 patent, the Food and Drug Administration (FDA) approved Cephalon's New Drug Application (NDA) for Provigil, which Cephalon began marketing in February 1999. (Ceph SOF ¶ 4.) The active ingredient in Provigil is modafinil, "a wakefulness-promoting agent" used to treat narcolepsy and other sleep disorders. (Ford Decl. Ex. A, NDA 20-717.) Provigil quickly became Cephalon's most successful product, with U.S. sales of approximately $475 million in 2005, accounting for 40% of Cephalon's worldwide revenue. (Ceph. SOF ¶ 5.) The FDA listed Provigil in the "Orange Book" as an approved drug, and Cephalon submitted the `845 patent (later substituted by the `516 patent) as covering Provigil. (DPCP SOF ¶7.)
At the same time it received FDA approval, Cephalon received "New Chemical Entity" exclusivity, entitling it to five-years of competition-free sales, a period that was set to expire on December 24, 2003. (DPCP SOF ¶ 3.);
Under federal law however, other drug companies did not have to wait until 2015 to seek approval to market a generic version of Provigil. The Hatch-Waxman Act, designed to encourage the development and marketing of generic versions of approved drugs, permits a generic drug manufacturer to receive approval after filing an "Abbreviated New Drug Application," otherwise known as an ANDA. An ANDA filer can piggyback on the NDA filer's safety and efficacy studies, which the FDA has already reviewed in approving the listed drug. To obtain approval, the ANDA filer must show that its generic drug and the relevant listed drug contain the same active ingredients and are otherwise "bioequivalent."
In the case of Provigil, the earliest date on which generic companies could submit an ANDA with a paragraph IV certification was December 24, 2002. (DPCP SOF ¶ 8.) The four Generic Defendants filed ANDAs with a paragraph IV certification on that date. (DPCP SOF ¶ 9.) This same-day filing was significant because, under Hatch-Waxman, as an incentive for generic companies to challenge weak patents, the first applicant to file an ANDA with a paragraph IV certification is entitled to a 180-day period of exclusivity for its generic drug, beginning on the day it first markets its drug commercially.
Filing a paragraph IV certification "automatically counts as patent infringement," and thus often prompts the patent-holder to file a lawsuit.
On March 28, 2003, Cephalon chose to sue all four Generic Defendants for infringement in the District of New Jersey, triggering the 30-month stay. (DPCP SOF ¶ 13-14.) Each of the Generic Defendants filed Answers alleging that their respective generic drugs would not infringe the `516 patent, and asserting that the `516 patent was invalid. (EPCP SOF ¶ 5.) Three of these Answers (Teva, Ranbaxy, and Mylan) were amended to add allegations of inequitable conduct in the procurement of the `516 patent. (EPCP SOF ¶ 6.) During the course of this litigation, the Generic Defendants shared a number of expert witnesses. (EPCP SOF ¶ 9.) At the summary judgment stage, each of the four Generic Defendants filed a motion for summary judgment: Teva sought summary judgment on non-infringement, Ranbaxy sought summary judgment on invalidity and non-infringement, Mylan sought summary judgment on invalidity, and Barr sought summary judgment on non-infringement. (DPCP SOF ¶ 16.)
These motions were never decided, because between October 2005 and February 2006, Cephalon entered into settlement agreements whereby each Generic Defendant was paid a substantial amount of money.
In addition to the April 6, 2012 generic entry date, each settlement agreement contained a "contingent launch" provision, which permitted each settling Generic to sell its product prior to April 6, 2012 if any other company brought a generic version of Provigil to market. (Ceph. SOF ¶ 23.) Following the execution of each settlement agreement, Cephalon announced these two core terms (the April 2012 date certain and the contingent launch provision) via press releases.
The private Plaintiffs' complaints all allege a conspiracy between all of the Defendants to restrain trade and monopolize the market for modafinil. I previously ruled that this allegation, along with the other evidence alleged in the Complaint, was sufficient to withstand a motion to dismiss.
The Direct Purchaser Class Plaintiffs have moved for summary judgment, asserting that the undisputed evidence establishes that Cephalon helped to broker an illegal "inter-generic" conspiracy to keep generic Provigil off the market until April 2012. In their view, the substantially identical contingent launch provisions ensured that no Generic Defendant would lose out on the 180-day exclusivity period should another Generic Defendant launch earlier than the agreed April 6, 2012 date certain. It is alleged that this assurance served to dull the incentive each Generic Defendant would otherwise have had to launch its product as early as possible. The Direct Purchasers point to Cephalon's company newsletter, in which it described the contingent launch provisions as "provid[ing] the comfort level each generic litigant needed to settle, serving to assure them that no opportunity would be lost should another firm launch at risk." (Hennings Decl. Ex. 12 (Brainwaves Article).) The Direct Purchasers urge that this type of agreement, coordinated by Cephalon, was essentially a conspiracy among the Generic Defendants to avoid competition with one another and cede the modafinil market to Cephalon in exchange for large settlement payments. They assert that this agreement, as a form of market division among horizontal competitors, is per se illegal under the Sherman Act.
Defendants acknowledge that the contingent launch provision was important to each Generic's decision to settle, but point out that each Generic had an independent incentive to demand such a provision. Specifically, each Generic qualified for the 180-day exclusivity period, and it was only natural to attempt to protect their entitlement to that exclusivity by negotiating a provision that permitted them to enter the market whenever that period started (i.e., upon the entry of any of the other Generic Defendants).
Defendants rely in part on numerous cases that stand for the proposition that in order to prove a conspiracy, an antitrust plaintiff must present evidence that tends to exclude the possibility that the defendants acted independently. Because the Plaintiffs have not presented evidence tending to exclude the possibility that each Generic Defendant acted independently, Defendants urge that summary judgment in their favor is appropriate on the inter-generic conspiracy claim. Defendants also stress that "conscious parallelism," that is, similar conduct undertaken without agreement or coordination, does not violate the antitrust laws.
While the above motions are essentially cross-motions for summary judgment on the overall conspiracy issue, other, non-moving Plaintiffs urge in their opposition that, even if the Direct Purchasers are not entitled to summary judgment, the evidence of record is sufficient to permit a jury to find an overall conspiracy.
Under the Sherman Act, "[e]very . . . conspiracy, in restraint of trade or commerce among the several States, . . . is declared to be illegal." 15 U.S.C. § 1. Thus, the "existence of an agreement is the hallmark of a Section 1 claim."
The problem with circumstantial evidence, however, is the risk that a fact-finder may draw the incorrect inferences, and therefore mistake legitimate competitive activity for unlawful collusion. In the antitrust context, these mistakes are especially harmful, because they risk punishing—and thus discouraging—the pro-competitive conduct that the antitrust laws are designed to promote and protect.
Circumstantial evidence of conspiracy often takes the form of "conscious parallelism," that is, similar conduct by the alleged conspirators, of which each of the conspirators are aware. For example, one seller might raise its prices, only to have other sellers in the market follow suit with a similar price increase. Although this would benefit the sellers and hurt consumers, the Supreme Court "ha[s] made it clear that neither parallel conduct nor conscious parallelism, taken alone, raise the necessary implication of conspiracy."
Despite the more specific inquiry required at the summary judgment stage in an antitrust case, the familiar rules still apply. Under Rule 56(a), I am required to view the facts in the light most favorable to the non-movant in deciding whether summary judgment is appropriate.
In assessing whether the evidence dictates that summary judgment be granted for either the Direct Purchasers or the Defendants, it is important to keep in mind precisely which claims these motions address. The motions at issue do not concern the legality of the individual, bilateral settlement agreements between Cephalon and each Generic Defendant. What is at issue is Plaintiffs' claim that the separate settlement agreements were in fact the manifestation of a horizontal conspiracy between all Defendants—with Cephalon at the center—to restrain trade in the modafinil market. At the summary judgment stage, the question is thus whether there is sufficient evidence to allow a jury to consider whether all Defendants were parties to a single agreement. (Or, for the Direct Purchasers, whether the evidence compels a finding as a matter of law, that all Defendants were parties to a single agreement.)
Plaintiffs proffer the following as direct evidence of an overall, anticompetitive conspiracy: (1) the settlement agreements themselves, which contain substantially similar language and structure; (2) press releases announcing each settlement, including that each release contained the April 6, 2012 market entry date certain and the contingent launch provision; and (3) statements by negotiators for the Generic Defendants indicating that they were aware of the contingent launch and date certain provisions in negotiating their own agreements, including a statement that the Ranbaxy agreement was "modeled on the terms of the Teva settlement."
Whether this evidence is properly considered `direct' depends on whether the fact-finder would have to take an additional logical step in order to conclude that a conspiracy occurred. In other words, an additional step is indicative of circumstantial evidence. Direct evidence requires no extrapolation, as with "a document or conversation explicitly manifesting the existence of the agreement in question."
The Third Circuit has cited examples of evidence found to be direct evidence of an antitrust conspiracy: "(1) a direct threat to the plaintiff from a competitor that if [the plaintiff] went into business, his competitors would do anything they could to stop him, including cutting prices or supplies; (2) advising distributors that a supplier would cut off access if the distributor failed to maintain a certain price level; (3) a memorandum produced by a defendant conspirator detailing the discussions from a meeting of a group of alleged conspirators; (4) a public resolution by a professional association recommending that its members withdraw their affiliation with an insurer."
In contrast, even evidence that competitors exchanged extensive pricing information may not be direct evidence of a price-fixing conspiracy, because it still requires inferences to be drawn about whether the exchange was related to an agreement to adopt particular pricing policies.
After examination of the direct evidence of record, I disagree with Plaintiffs that this evidence indisputably establishes a conspiracy such that summary judgment should be granted in their favor. The settlement agreements themselves are individual agreements, not global agreements amongst all Defendants. Plaintiffs are unable to point to any direct evidence that the Generics agreed amongst themselves, let alone that such overall agreement also included Cephalon. Indeed, each agreement runs only between Cephalon and a single Generic. While Plaintiffs are correct that the settlements contain similar terms, and it could be argued that this similarity is evidence of an overall conspiracy, that is classic circumstantial, not direct evidence.
Similarly, the press releases, like the pricing information exchanged in
The Direct Purchasers urge that the circumstantial evidence of record indisputably demonstrates an agreement between Cephalon and the Generic Defendants to restrain trade in the modafinil market. I will examine each piece of circumstantial evidence cited by Plaintiffs in a light most favorable to their position.
First, Apotex points out that the legal effect of the settlement agreements, in conjunction with the Hatch-Waxman regime, was to create a "bottleneck," whereby no other generic was able to enter the market. This is because, at the times relevant to this case, the 180-day exclusivity period granted to an initial ANDA paragraph IV filer (in this case, the four Generic Defendants) operated by preventing the FDA from approving a subsequent paragraph IV filer's ANDA until the end of the 180-day exclusivity period. 21 U.S.C. § 355(j)(5)(B)(iv);
Ordinarily, Apotex might obtain this judicial determination by filing a declaratory judgment action, but that was not an option after the settlements with the Generic Defendants. Under the prevailing law at the time, Apotex could not file a declaratory judgment action seeking a judicial determination of invalidity or non-infringement unless it was in "reasonable apprehension" of an infringement lawsuit.
Second, Plaintiffs point to the substantial similarities between the four individual settlement agreements as evidence of an overall conspiracy. They observe, for example, that each agreement contained the same "date certain" of April 6, 2012 for entry into the generic modafinil market.
Third, as further circumstantial evidence of an overall conspiracy, Plaintiffs point to public disclosures of key settlement terms that followed the execution of each agreement. Specifically, each settlement was followed by the issuance of one or more press releases announcing three terms: (1) the April 2012 date certain for market entry; (2) the contingent launch provision; and (3) business arrangements, such as licenses to intellectual property or modafinil supply agreements. (Hennings Decl. Ex. 22-23, 25-26, 28-31.) Similar information was also disclosed in filings with the Securities and Exchange Commission. (E.g., GD Ex. 24.) Plaintiffs also stress that each Generic Defendant acknowledged being aware of the respective settlement agreements and the details disclosed in the press releases prior to or during negotiations with Cephalon, and always before its own settlement agreement was executed.
Fourth, in negotiating the contingent launch provisions (as well as the royalty-matching provisions in the Ranbaxy and Mylan agreements), Plaintiffs point out that each Generic Defendant admitted that its motive was to preserve for itself the 180-day exclusivity period and to ensure that a launch by another Generic Defendant prior to the date certain would not "unduly harm" its interests. (DPCP SOF ¶ 36.) For example, Plaintiffs highlight the deposition testimony of Brian Seth Roman, Mylan's Senior Vice President, when he was asked whether anyone at Mylan told Cephalon "that you wanted the same entry conditions that Teva and Ranbaxy got":
(Hennings Decl. Ex. 36, Roman Dep., at 119:23 to 120:16.) The Direct Purchasers also point to similar statements from representatives of the other Generic Defendants, all indicating that in negotiating a settlement with Cephalon, one of their primary objectives was to ensure that they were not disadvantaged relative to the other settling generics.
According to Plaintiffs, the evidence and legal framework discussed above paint a picture of an overall conspiracy that looks something like this: Cephalon, with its monopoly over modafinil products, stood to gain more in profits from its continued monopoly than the Generic Defendants could hope to earn by launching competing low-cost generic products.
Where antitrust conspiracy claims are levied, it is not sufficient to show that the participants in the alleged conspiracy acted in parallel ways, especially where there are equally plausible independent explanations.
Under these circumstances, where parallel conduct with non-conspiratorial explanations is present, the "plus" factors set forth in
Under this test, Plaintiffs assert that the settlement agreements were against Defendants' economic self-interest because "[a]bsent the conspiracy, it was in each Generic Defendant's independent self-interest to enter the market as early as possible without regard to the entry date of its fellow Generic Defendants." (Br. of Individual Pls. 15.) Cephalon responds that the similarity between the settlement agreements resulted from the "independent dynamics of each settlement negotiation," in that Cephalon stood firm on the April 6, 2012 date certain, while the contingent launch provisions resulted from each Generic Defendant's "plainly logical desire . . . to retain the Hatch-Waxman benefits of `first-filer' status." (Br. of Ceph. 2.) Thus, Defendants stress that all of the Generic Defendants had independent reasons for accepting the settlements.
The economic self-interest inquiry seems to be especially useful in cases like this one, where the antitrust plaintiff attempts to infer a horizontal agreement among signatories to separate agreements with a common participant.
The
The conspiracy between Apple and the publishers took the form of "agency" agreements that each publisher signed with Apple. Under this agency pricing model, the retailer (Apple) would sell e-books at prices set by the publisher (within limits), and take a 30% commission for each sale.
In addition to these terms, the agency agreements required each publisher to agree to adopt the agency pricing model with all its e-book retailers.
Although there was ample direct evidence of a conspiracy among the publishers, there was also evidence that the parallel agency agreements were contrary to the publishers' self-interest unless all of the publishers agreed to go along. As the District Court described it, "[t]he economics of the Agreements were, simply put, `terrible' for the Publishers."
The Seventh Circuit made similar observations in
As to the horizontal conspiracy, the Seventh Circuit affirmed, noting that an inference of conspiracy was supported by the fact that the agreement to limit sales to the warehouse stores was "an abrupt shift from the past"—the warehouse stores' share of toy sales had been growing prior to the agreements—and that the manufacturers would not normally be expected to "deprive [themselves] of a profitable sales outlet."
Here, the situation facing the Generic Defendants stands in stark contrast to those in
It is true that in
Additionally, as noted previously, in evaluating circumstantial evidence of an overall conspiracy, a Defendant's motive to enter into the conspiracy must also be considered.
A conspiratorial motive can arise where individual decisions are "interdependent," meaning that the optimal action for one party depends on the behavior of a competitor (and vice versa). Areeda & Hovenkamp,
Here, there simply is no evidence of significant motive for the Generics to collude amongst themselves. Indeed, Plaintiffs have difficulty positing exactly what the Generic Defendants stood to gain from an overall conspiracy that they could not achieve through the one-on-one settlements with Cephalon. The Generic Defendants could only overcome Cephalon's RE `516 patent for Provigil by obtaining a judgment that the patent was invalid, unenforceable, or not infringed or by being invited as a licensee to sell Provigil. Naturally, the parties could negotiate on when the license would begin, and could condition the license on the occurrence of certain events, such as entry by another generic version of Provigil. Importantly, none of this required agreement or participation by other Generic Defendants. On the contrary, the contingent launch provision would make the settling party indifferent to entry dates negotiated by any of the others. And with the presence of the contingent launch provisions, there was nothing to gain from conspiring with the other Generic Defendants to fix the April 6, 2012 entry date. Cephalon had little incentive to resist the contingent launch provisions because, as Plaintiffs observe, the real harm to the Provigil monopoly came from the first generic entry into the market. (
The contingent launch provision, in addition to holding significant value for the Generic Defendants, was a contractual protection they could obtain entirely through independent negotiations with Cephalon. In fact, Teva (the first Generic Defendant to settle) might well have benefitted had another Generic Defendant continued the litigation and obtained a judgment that the RE `516 patent was invalid, since that would have allowed Teva to enter the market earlier, while still reaping substantial benefits from the agreement it made with Cephalon. As Apotex points out, Cephalon made approximately $132,000,000 in payments to Teva under the terms of the Cephalon-Teva settlement. (Apotex SOF ¶ 29.) The Generic Defendants had no reason to conspire amongst themselves when they could obtain the best deal by agreeing to Cephalon's terms and hoping that the independent actions of the other Generic Defendants would produce a still better deal. This lack of motive is yet further reason why a jury could not conclude that Defendants' actions resulted from an overall conspiracy.
In taking the contrary view, Plaintiffs repeatedly conflate the existence of an agreement with its legality. The Direct Purchasers argue that "Defendants' perverse view of the law . . . would permit four competing companies who are contemplating entering a new territory held by the same long-term incumbent to agree to stay out of the market as long as their competitors did the same thing." (Opp. Br. of DPCP 19 n.20.) But this hypothetical assumes the proposition that Plaintiffs have the burden of proving: that an entry date/contingent launch agreement existed between all Generic Defendants and Cephalon. Without that proof, whether such an agreement would be illegal is simply irrelevant.
The record demonstrates that, over the course of several months in 2005 and 2006, Cephalon entered into four bilateral agreements to settle the then-pending patent infringement litigation against the Generic Defendants. These agreements contained identical entry dates and contingent launch provisions, and also had substantially similar structures. Plaintiffs posit that these features are explained by an overall agreement encompassing Cephalon and all of the Generic Defendants. There is, however, no direct evidence of such an agreement. Further, the circumstantial evidence does not support an inference of concerted, as opposed to independent, action. Accordingly, summary judgment must be granted to Defendants.
An appropriate order follows.