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Time Ins. Co. v. Astrazeneca AB, Civil Action No. 14–4149.
Barbara J. Hart, Gerald Lawrence, Jr., Lowey Dannenberg Cohen PC, Peter St. Phillip, Lowey Dannenberg Cohen & Hart, P.C., White Plains, NY, for Plaintiffs.
Raymond McGarry, Wynn McGarry LLC, King of Prussia, PA, Dane H. Butswinkas, James M. McDonald, John E. Schmidtlein, Williams & Connolly LLP, Washington, DC, for Defendants.
This is an antitrust action brought under a variety of state statutes in which the issue presently before me is the propriety of federal jurisdiction. Plaintiffs are health insurance companies who ultimately paid for Nexium prescriptions purchased by individuals who maintained insurance coverage. Defendants are Astrazeneca, the patent-holding pharmaceutical company that produces name-brand Nexium, as well as three generic drug manufacturers who sought to produce generic Nexium.
Under the regulatory framework for pharmaceuticals, companies maintain exclusive patents on their drugs for a set period of time. However, the Hatch–Waxman Act, which amended the Food, Drug, and Cosmetics Act, 21 U.S.C. §§ 301 –392, and other legislation, have created incentives for generic manufacturers to seek generic approval prior to the expiration of the patent. The patent-holder then files an infringement suit in order to prevent entrance of the generics to the market. This ensures an efficient system in which patent-holders are not abusing the patenting system to maintain a monopoly. First-filing generic manufacturers receive a 180–day window in which no other generic brands may sell on the market with the exception of any generic produced by the patent-holder. This provides strong incentive to challenge the validity of patents.
Plaintiffs allege that after the three generic manufacturers challenged the Nexium patents, and were subsequently sued for patent infringement in the District of New Jersey, Astrazeneca entered into reverse payment settlement agreements with them through which Astrazeneca provided compensation in exchange for stipulations that the Nexium patents were valid and promises not enter the market until the expiration of those patents. The generic companies did not receive direct payments, but allegedly received compensation in the form of outsized payments for other services and nullification of potential liabilities to Astrazeneca.
Currently, other suits based on these same agreements have been aggregated as multi-district litigation within the District of Massachusetts. The Plaintiffs filed this action in the Philadelphia Court of Common Pleas based entirely on state law antitrust claims. The Defendants removed the action on the basis that: (1) resolution of the state law antitrust claims will necessarily involve litigation of the validity of the Nexium patents; (2) any such litigation will involve a collateral attack on the federal consent judgments entered by the District of New Jersey; and (3) The Class Action Fairness Act (CAFA) requires that this action be combined with a related action filed in state court and removed here, Cariten v. Astranzeneca,1 as a “mass action” capable of conferring federal jurisdiction.2
211 U.S. 149, 152, 29 S.Ct. 42, 53 L.Ed. 126 (1908). Defenses that may be raised are not a part of the plaintiff's well-pleaded complaint. Metropolitan Life Ins. Co. v. Taylor, 481 U.S. 58, 63, 107 S.Ct. 1542, 95 L.Ed.2d 55 (1987). “[A] case may not be removed to federal court on the basis of a federal defense, ... even if the defense is anticipated in the plaintiff's complaint, and even if both parties admit that the defense is the only question truly at issue in the case.” Franchise Tax Bd. of Cal. v. Construction Laborers Vacation Trust for Southern Cal., 463 U.S. 1, 14, 103 S.Ct. 2841, 77 L.Ed.2d 420 (1983). Furthermore, federal jurisdiction extends “only to those cases in which a well-pleaded complaint establishes either that federal patent law creates the cause of action, or that the plaintiff's right to relief necessarily depends on resolution of a substantial question of federal patent law, in that patent law is a necessary element of one of the well-pleaded claims.” Christianson v. Colt Industries Operating Corp., 486 U.S. 800, 809, 108 S.Ct. 2166, 100 L.Ed.2d 811 (1988).
Plaintiffs' claims are brought under the antitrust laws of many separate states. As Defendants point out,3 and Plaintiffs do not dispute, these claims all seem to involve very similar elements that can be reduced to two components. An antitrust plaintiff must demonstrate (1) the existence of anticompetitive conduct by the defendant and (2) that the conduct caused the plaintiff's alleged injuries. In this case, on the issue of remand, the key question is whether Plaintiffs can assert a theory in which they can demonstrate these two elements without litigating the validity of Astrazeneca's patents at the time the agreements were entered into.
As to the first element, the anticompetitive conduct, the threshold issue is whether settlements between Defendants can be shown to have been anticompetitive irrespective of the validity of the patents. Defendants argue that anticompetitive conduct cannot be proven without a showing that the patents were invalid. According to Defendants, if the patents had been valid at the time the settlements were entered into, Astrazeneca would have had every right to exclude the generic manufacturers from the market. Therefore, Defendants conclude, Plaintiffs must now prove the invalidity of the patents in their prima facie case. Plaintiffs combat this by relying on the Supreme Court's recent decision in F.T.C. v. Actavis, Inc., ––– U.S. ––––, 133 S.Ct. 2223, 186 L.Ed.2d 343 (2013). In Actavis, the Court examined an almost identical scenario where a patent-holding drug manufacturer entered into reverse payment settlements with generic manufacturers akin to those in the case before this Court. In its decision, the Court observed that “it is normally not necessary to litigate patent validity in order to answer the antitrust question.” Id. at 2236. In a reverse payment settlement case, “[a]n unexplained large reverse payment itself would normally suggest that the patentee has serious doubts about the patent's survival.” Id. Such a large payment “suggests that the payment's objective is to maintain supracompetitive prices to be shared among the patentee and the challenger rather than face what might have been a competitive market—the very anticompetitive consequence that underlies the claim of antitrust unlawfulness.” Id. The size of such a settlement “can provide a workable surrogate for a patent's weakness, all without forcing a court to conduct a detailed exploration of the validity of the patent itself.” Id. at 2236–37.
In light of Actavis, it seems as though the Plaintiffs can conceivably prove the existence of anticompetitive conduct in violation of state antitrust laws without litigating the patent issue, but by instead relying on the nature of settlements themselves. As the Court points out, the relevant inquiry is the reasoning behind the alleged anticompetitive conduct. Id. at 2237. “If the basic reason is a desire to maintain and to share patent-generated monopoly profits, then, in the absence of some other justification, the antitrust laws are likely to forbid the arrangement.”Id. An improper motive may be determined without litigating the patent issue, and thus the plaintiff is not forced into federal court by the initial “anticompetitive conduct” element. Nonetheless, the defendants in such a case may unquestionably assert that the patents were valid as a defense to characterization of the conduct as anticompetitive.
As noted above, there were no direct payments in this case: reverse payments took the form of outsized payments for other services and nullification of potential liabilities to Astrazeneca. There is currently a rift within the federal judiciary over whether Actavis applies to reverse payment agreements under which the compensation provided by the patent-holder takes a form other than direct cash settlements. The issue has been considered by four district courts in the wake of Actavis. Two have interpreted Actavis to require cash payments: In re Lamictal Direct Purchaser Antitrust Litigation, 18 F.Supp.3d 560, 567–68, 2014 WL 282755, at *7 (D.N.J.2014) ; In re Loestrin 24 Fe Antitrust Litigation, 45 F.Supp.3d 180, 194–95, MDL No. 13–2472–S–PAS, 2014 WL 4368924, at *13 (D.R.I. Sept. 4, 2014). Having carefully considered the competing analyses, I am persuaded by Judge Dubois, who sits within this district, and Judge Young, who is currently handling the other suits stemming from these transactions, and who made his reverse payment determination in the...
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