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In re K-Dur Antitrust Litigation, Nos. 10-2077, 10-2078, 10-2079 (3d Cir.) (May 18, 2011)
Amicus brief before the United States Court of Appeals for the Third Circuit, supporting plaintiffs/appellants and urging reversal of a decision by the United States District Court for the District of New Jersey. That decision dismissed federal antitrust claims brought by direct and indirect purchasers of the drug K-Dur, a blood pressure medication. Plaintiffs alleged that, when K-Dur’s manufacturer, Schering Plough Corp., settled patent infringement litigation that it had brought against two generic drug companies, the settlement agreements, which restricted the generic companies from marketing their generic versions of K-Dur and provided for payments from Schering to the generic companies, violated the antitrust laws. The district court granted the drug companies’ motions for summary judgment on the grounds that the patent at issue trumped any application of the antitrust laws. In particular, the court held that there was no antitrust violation because the agreements settling the infringement litigation applied only to the generic versions of K-Dur, and did not restrict the marketing of those generics beyond the expiration date of Schering’s patent. In its amicus brief, the Commission argues that the district court’s decision is inconsistent with the antitrust laws and the Hatch-Waxman Act. The Commission further argues that such exclusion-payment settlements should be treated as presumptively unlawful.
Arkansas Carpenters Health and Welfare Fund, et. al v. Bayer AG, et. al (In re Ciprofloxacin Hydrochloride Antitrust Litigation), No. 05-2851 & 05-2852 (2nd Cir.) (May 20, 2010)
An amicus brief in support of plaintiffs-appellants’ petition for rehearing en banc. The case concerns a court of appeals panel decision upholding the dismissal of an antitrust challenge to a Hatch-Waxman patent settlement. Because of the “exceptional importance” of the issues involved, however, the panel also invited appellants to file a petition for rehearing en banc, in order for the full court to reconsider a circuit precedent that bound the panel’s decision. The Commission argues that the earlier circuit decision, In re Tamoxifen Citrate Antitrust Litig., 466 F.3d 187 (2d Cir. 2005), was based on mistaken assumptions about the pharmaceutical industry, which has contributed to a proliferation of exclusion-payment settlements such as the one at issue in the current case, and that the Tamoxifen panel decision did not properly consider the Hatch-Waxman Act, which encourages challenges to pharmaceutical patents to facilitate the early entry of generic drugs. The Commission urges the court of appeals to rehear the current case en banc, in order to correct that earlier circuit precedent.
In re Ciprofloxacin Hydrochloride Antitrust Litigation, No. 2008-1097 (Fed. Cir.) (January 25, 2008)
The Commission's amicus brief argues that the district court erred by holding that patent law immunizes the challenged pharmaceutical settlement agreement from antitrust scrutiny on the ground that the agreement's exclusionary terms are within the scope of the patent.
In re DDAVP Direct Purchaser Antitrust Litigation, No. 06-5525 (2nd Cir.) (May 25, 2007)
Joint brief of the United States and the Federal Trade Commission, as amici curiae before the United States Court of Appeals for the Second Circuit, in support of plaintiffs-appellants, who were direct purchasers of the prescription brand-name drug DDAVP. Plaintiffs had brought this putative class action under Section 4 of the Clayton Act, 15 U.S.C. § 15, alleging that defendants Ferring B.V. and Ferring Pharmaceuticals, Inc., who owned the patent for desmopressin acetate -- the active ingredient in DDAVP, and Aventis Pharmaceuticals, Inc., the patent's exclusive licensee in the United States, violated Section 2 of the Sherman Act, 15 U.S.C. § 2, by maintaining and enforcing a patent procured by intentional fraud on the Patent and Trademark Office (PTO). In their brief, the antitrust agencies urge the court of appeals to reverse the district court's holding that plaintiffs lacked antitrust standing to bring monopolization claims against defendant drug manufacturers arising out of the manufacturers' maintenance and enforcement of a patent allegedly procured through intentional fraud on the PTO (a so-called "Walker Process" antitrust claim).
In re Tamoxifen Citrate Antitrust Litigation , No. 03-7641 (2nd Cir.) (Nov. 30, 2005)
An amicus brief in support of plaintiffs-appellants' petition for panel rehearing and rehearing en banc. The case concerns a decision by a divided panel of the appeals court upholding the dismissal, pursuant to FRCP 12(b)(6), of an antitrust challenge to a Hatch-Waxman patent settlement between AstraZeneca, the manufacturer of a branded drug, and Barr Labs., an FDA applicant for a generic counterpart. The Commission argues that the panel did not properly consider the Hatch-Waxman Act, which encourages challenges to pharmaceutical patents to facilitate the early entry of generic drugs, and that, if not corrected, the panel decision would permit the holder of a challenged drug patent to harm competition, and thus consumers, substantially by impermissibly paying a would-be generic rival to stay off the market.
Teva Pharmaceuticals USA, Inc. v. Pfizer, Inc., No. 04-1186 (Fed. Cir.) (Feb. 8, 2005)
In this amicus brief in support of Teva's combined petition for rehearing and rehearing en banc, the Commission argues that the court erred in affirming the district court's dismissal of Teva's complaint in this Hatch-Waxman Act case. The brief argues that the court applied the wrong test to assess jurisdiction under the Declaratory Judgment Act. The court only considered the likelihood that Teva would face a patent infringement suit, but failed to take account of the injury Teva will suffer. The brief argues that Teva will face injury even in the absence of a patent infringement suit because the FDA cannot approve Teva's generic sertraline hydrochloride drug unless Teva can obtain a court decision regarding Pfizer's patent.
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Andrx Pharmaceuticals, Inc. v. Kroger Co., No. 03-779 (S. Ct.) (July 8, 2004)
Joint brief of the United States and the Federal Trade Commission, urging the Court to deny a writ of certiorari in this case, regarding private patent litigation and the legal standards applicable to “reverse payment” patent litigation settlements in the Hatch-Waxman context.
Jackson, Tennessee Hospital Co. v. West Tennessee Healthcare, Inc., No. 04-5387 (6th Cir.)
(June 1, 2004)
Joint brief of the United States and the Federal Trade Commission urging reversal of district court order dismissing private antitrust action on grounds of the state action doctrine.
Teva Pharmaceuticals USA, Inc. v. Pfizer, Inc., No. 04-1186 (Fed. Cir.) (March 31, 2004)
The Commission argues that the district court erred by dismissing Teva's complaint against Pfizer in this Hatch-Waxman Act case. Teva sought a declaratory judgment that its generic version of sertraline hydrochloride would not infringe a patent held by Pfizer (or that the patent was invalid). The brief argues that the court applied the wrong test to assess jurisdiction. It failed to take account of the fact that, unless Teva can obtain a court decision regarding Pfizer's patent, the FDA cannot give Teva approval to market its generic drug until 180 days after the first generic applicant (Ivax Pharmaceuticals) enters the market with its version. The brief also explains that the district court's holding will leave subsequent generic applicants (such as Teva) powerless to prevent brand-name manufacturers and first generic applicants from greatly delaying other generic manufacturers from entering the market.
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SmithKline Beecham Corp. v. Apotex Corp., No. 99-CV-4304 (E.D. Pa.) (Jan. 28, 2003)
Memorandum of the Federal Trade Commission, as amicus curiae , addressing the propriety of de-listing a patent from FDA's "Orange Book," as a remedy for patent invalidity. The brief explains that improperly-maintained Orange Book listings may serve as a barrier to competition, and that there may be substantial consumer benefits to a de-listing remedy.
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In re: Buspirone Antitrust Litigation., MDL Docket No. 1410 (JGK) (January 8, 2002)
Amicus brief for the Federal Trade Commission, supporting argument of generic drug manufacturer that allegedly wrongful listing of patents in the FDA's "Orange Book" is not immune from antitrust liability. [PDF 82KB]
In re: First Databank Antitrust Litigation Master File No. 1:01CV00879 (TPJ) (January 2, 2002)
Federal Trade Commission memorandum as amicus curiae (in the alternative to motion to intervene) to oppose grant of fees to private class action counsel, where much of the consumer recovery at issue resulted from the Commission's disgorgement action. [PDF 52K]
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Armstrong Surgical Center, Inc., Petitioner v. Armsrong County Memorial Hospital, et al., No. 99-905 (June 2, 2000)
Amicus brief for the United States and the Federal Trade Commission urging denial of Supreme Court review in a case raising the issue whether misrepresentations to state agency, in the course of petitioning activity, precludes a claim of immunity from antitrust liability. [PDF 83KB]
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Surgical Care Center v. Hospital Service District No., 1, No. 97-30887 (5th Cir.)
Amicus brief for the United States and the Federal Trade Commission as Amici Curiae in support of suggestion of rehearing en banc.
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