Skip to main content
Citation Number

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.