June 27, 2011
This morning, during an active year for patent cases at the Supreme Court, the Court granted certiorari in two patent cases: Caraco Pharmaceutical v. Novo Nordisk A/S and Kappos v. Hyatt.
The Caraco case concerns so-called label carve-outs ("skinny labeling") to an approved method of using the drug that the patent does not claim. The issue is whether a generic drug manufacturer seeking such a label carve-out can compel correction, under the counterclaim provisions in the Hatch-Waxman Act (21 U.S.C. 355(j)(5)(C)(ii)), when a patent-holder allegedly submits patent information to the FDA that misstates the scope of the patented method. This case has attracted significant interest in the pharmaceutical patent area and is expected to resolve an important unresolved issue in Hatch-Waxman litigation.
The Hyatt case concerns whether a patent applicant can introduce new evidence in a civil action against the U.S. Patent and Trademark Office (USPTO) under 35 U.S.C. 145. Generally, this decision has significant ramifications for appellants proceeding before the USPTO Board of Patent Appeals and Interferences after an adverse decision of the Board.
Fitch Even attorneys are monitoring these cases and will report once the Supreme Court has issued its decisions. For more information, please contact Fitch Even partners Kendrew H. Colton or Jon A. Birmingham.