Source: http://openjurist.org/405/f3d/990/teva-pharmaceuticals-usa-inc-v-pfizer-inc
Timestamp: 2014-04-20 04:19:19
Document Index: 139515133

Matched Legal Cases: ['§ 2201', '§ 271', '§ 2201', '§ 2201', '§ 2201', '§ 2201', '§ 2201']

405 F3d 990 Teva Pharmaceuticals Usa Inc v. Pfizer Inc | OpenJurist
405 F. 3d 990 - Teva Pharmaceuticals Usa Inc v. Pfizer Inc	Home405 f3d 990 teva pharmaceuticals usa inc v. pfizer inc
405 F3d 990 Teva Pharmaceuticals Usa Inc v. Pfizer Inc 405 F.3d 990
TEVA PHARMACEUTICALS USA, INC., Plaintiff-Appellant,v.PFIZER INC., Defendant-Appellee.
Appealed from: United States District Court for the District of Massachusetts. Judge Richard G. Stearns.
On Petition for Panel Rehearing and Rehearing En Banc.
Henry C. Dinger, Goodwin Procter LLP, of Boston, Massachusetts, filed a combined petition for panel rehearing and rehearing en banc for plaintiff-appellant. Of counsel on the petition was Thomas J. Meloro, Jr., Kenyon & Kenyon, of New York, New York.
Dimitrios T. Drivas, White & Case LLP, of New York, New York, filed an opposition to the petition for defendant-appellee. With him on the opposition were Jeffrey J. Oelke and Adam Gahtan.
Brian T. Moriarty, filed an amicus curiae brief for the Generic Pharmaceutical Association.
William L. Mentlik, Lerner, David, Littenberg, Krumholz & Mentlik, LLP, of Westfield, New Jersey, filed an amicus curiae brief for IVAX Pharmaceuticals, Inc. With him on the brief was Roy H. Wepner.
Lawrence DeMille-Wagman, Attorney, Federal Trade Commission, of Washington, DC, filed an amicus curiae brief for the Federal Trade Commission. With him on the brief were John D. Graubert, Acting General Counsel; Susan A. Creighton, Director, Bureau of Competition; John F. Daly, Deputy General Counsel for Litigation; and Lore A. Unt, Counsel for Intellectual Property.
Theodore Case Whitehouse, Willkie Farr & Gallagher LLP, of Washington, DC, filed an amici curiae brief for United States Senators Edward M. Kennedy, John S. McCain, and Charles E. Schumer.
A combined petition for panel rehearing and rehearing en banc was filed by the Appellant, and a response thereto was invited by the court and filed by the Appellee.1 The petition for rehearing was referred first to the merits panel that heard the appeal. Thereafter, the petition for rehearing en banc, response, and the amici curiae briefs were referred to the circuit judges who are authorized to request a poll whether to rehear the appeal en banc. A poll was requested, taken, and failed.
(3) The mandate of the court will issue on April 11, 2005.
MAYER, GAJARSA, and DYK, Circuit Judges, would rehear the appeal en banc.
GAJARSA, Circuit Judge, with whom DYK, Circuit Judge, joins, dissents in a separate opinion.
DYK, Circuit Judge, with whom GAJARSA, Circuit Judge, joins, dissents in a separate opinion.
GAJARSA, Circuit Judge, with whom DYK, Circuit Judge, joins, dissenting from the order declining rehearing en banc.
The Court has denied the petition to review this case en banc. I must respectfully dissent from that denial. This is a critical issue under the Hatch-Waxman Act.1 The failure of this court by en banc action to correct the Teva court's decision, 395 F.3d 1324 (Fed.Cir.2005), allows the statutory procedures to be manipulated by the patent holders to the clear and foreseeable detriment of the generic drug industry.
The Teva court's reasonable apprehension analysis is the wrong test for a concrete, actual, or imminent injury in fact when considering the problem of a generic with a second-filed ANDA certification.2 Article III does not compel it, and the Supreme Court has rejected the doctrinal rigidity that Teva introduces. Our cases recognize reasonable apprehension, in the typical patent infringement case, as but a pragmatic attempt to give operational guidance against which patentees can structure their conduct, and control their litigation costs, in a fact-specific area of law. The ANDA facts correspond to the typical infringement case in name only, and it is this court's constitutional duty to look at those facts in their proper context. The Teva court's misguided Article III analysis further thwarts Congress's clear intent to foster, through the detailed provisions of Hatch-Waxman, greater competition in generic pharmaceuticals.
The question is whether Teva has shown a justiciable case or controversy within Article III. Congress unambiguously swept aside any additional limitation on jurisdiction potentially introduced by the Declaratory Judgment Act, 28 U.S.C. § 2201.
[T]he courts of the United States shall, to the extent consistent with the Constitution, have subject matter jurisdiction in any action brought by such person under section 2201 of title 28 for a declaratory judgment that such patent is invalid or not infringed.
35 U.S.C.A. § 271(e)(5) (West Supp.2004), as added by Pub. L. 108-173, 117 Stat. 2457 (Dec. 8, 2003). The law is clear that this justiciability issue has three elements: (1) a concrete, actual or imminent injury in fact; (2) fairly traceable causation between the injury and defendant's conduct; and (3) redressability. See Steel Co. v. Citizens for a Better Env't, 523 U.S. 83, 103-04, 118 S.Ct. 1003, 140 L.Ed.2d 210 (1998); Valley Forge Christian Coll. v. Ams. United for Separation of Church and State, Inc., 454 U.S. 464, 472, 102 S.Ct. 752, 70 L.Ed.2d 700 (1982). Only the concrete injury in fact is disputed.
The cases treat the controversy requirements of Article III and § 2201 together and their approach is instructive here. Jurisdiction under § 2201 can be no broader than jurisdiction under Article III, yet the cases show that § 2201 is very broad indeed. Article III is no narrower. See Aetna Life Ins. Co. of Hartford, Conn. v. Haworth, 300 U.S. 227, 240, 57 S.Ct. 461, 81 L.Ed. 617 (1937) (§ 2201 "has regard to the constitutional provision and is operative only in respect to controversies which are such in the constitutional sense[.]"). As the Supreme Court recognizes, the § 2201 controversy requirement is highly fact specific.
Md. Cas. Co. v. Pac. Coal & Oil Co., 312 U.S. 270, 273, 61 S.Ct. 510, 85 L.Ed. 826 (1941). The Supreme Court,3 this court,4 and our sister circuits5 consistently apply this holding by looking to all the circumstances surrounding a controversy.
The Teva majority opinion does not, and its reasons for failing to do so are not convincing. In far more difficult factual contexts the courts have nonetheless found "a concrete, actual or imminent injury in fact" satisfying Article III. In Duke Power Co. v. Carolina Envtl. Study Group, Inc., 438 U.S. 59, 98 S.Ct. 2620, 57 L.Ed.2d 595 (1978), for example, the appellees challenged the constitutionality of the Price-Anderson Act. By that Act, Congress limited the aggregate tort liability of nuclear power plant operators for a single nuclear "incident." The appellant was a utility that was constructing nuclear power plants. The appellees, including persons "who live within close proximity of the planned facilities," challenged the statute under the Fifth Amendment. Id. at 67, 98 S.Ct. 2620 (emphasis added). Their theory was that "in the event of a nuclear accident their property would be `taken' without any assurance of just compensation." Id. at 69, 98 S.Ct. 2620 (emphasis added). The court concluded that this theory stated a justiciable Article III controversy. See id. at 81, 98 S.Ct. 2620 ("[A]ppellees will sustain immediate injury from the operation of the disputed power plants.").
The breadth of Article III standing in environmental cases sharply contrasts with the Teva court's narrow construction in this ANDA context. The Supreme Court has held that a concrete injury in fact, for Article III, is shown where a non-profit's members allege that a polluter's discharges, "and the affiant members' reasonable concerns about the effects of those discharges, directly affected those affiants' recreational, aesthetic, and economic interests." Fr