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.
When a court considers a case whose outcome may affect consumers or competition, the FTC may file a “friend of the court” brief to provide information that can help the court make its decision in a way that protects consumers or promotes competition. To find a specific FTC brief, use the filters on this page.Displaying 61 - 80 of 113
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.
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.
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.