July 2011

Looking Ahead

On June 27, 2011, the Supreme Court granted review in both Hyatt v. Kappos, 625 F.3d 1320 (Fed. Cir. 2010) (en banc), and Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 601 F.3d 1359 (Fed. Cir. 2010). 

When the PTO denies an application for a patent, the applicant may seek judicial review of that decision in one of two ways: (1) obtain direct review of the agency’s determination in the Federal Circuit under 35 U.S.C. § 141; or (2) commence a civil action against the Director of the PTO in federal district court under 35 U.S.C. § 145.  The questions presented in Hyatt are:

(1) Whether the plaintiff in a § 145 action may introduce new evidence that could have been presented to the agency in the first instance; and

(2) Whether, when new evidence is introduced under § 145, the district court may decide de novo the factual questions to which the evidence pertains, without giving deference to the prior decision of the PTO.

The Federal Circuit previously held that the district court must allow new evidence and that factual conclusions to which the evidence pertains must be decided de novo, even if previously determined by the PTO.

A brand-name manufacturer may sue an ANDA applicant for infringement if, inter alia, the ANDA seeks approval for a patented use before the brand-name manufacturer’s patent has expired.  The ANDA applicant may respond with a counterclaim seeking an order requiring the brand-name manufacturer to correct or delete the patent information it previously submitted on the ground that the patent does not claim either (1) the drug for which the application was approved, or (2) an approved method of using the drug.  21 U.S.C. § 355(j)(5)(C)(ii)(I).  The question presented in Novo Nordisk is whether an ANDA applicant may assert a counterclaim under § 355(j)(5)(C)(ii)(I) by alleging that the brand-name manufacturer’s patent information does not accurately and precisely describe the method of use claimed by its patent.  The Federal Circuit previously held that the Hatch-Waxman Act allows only for the deletion of improperly listed patents.  The petitioner here argues that the Act also allows for correction of misstatements of patent scope.

Both cases will likely be briefed over the summer, argued later this year, and decided before the Supreme Court’s term ends in June 2012.