The U.S. Supreme Court returned for a new term on October 3, 2011, with two of the 48 cases already calendared for oral argument involving IP matters. The Court will hear Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150, on December 7 to consider whether “a patent claim that covers observed correlations between blood test results and patient health” is valid. Additional information about the Federal Circuit Court of Appeals ruling in the case appears in Issue 5 of this Bulletin, and details about the U.S. Supreme Court’s grant of the Mayo Clinic’s certiorari petition appear in Issue 16.

In Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, the Court will consider a Federal Circuit interpretation of the Hatch-Waxman Act in the context of whether a generic drug maker can file a counterclaim in a patent infringement lawsuit to correct information the brand name manufacturer submitted to the Food and Drug Administration (FDA). According to the petitioner, the Act “allows generic drug makers to market a drug for specific uses not claimed by any patent. But FDA lacks the expertise needed to determine whether particular uses are patented, so it defers to brand-name drug companies’ descriptions of the scope of their patents.” Here, the Federal Circuit apparently determined that the Act’s “counterclaim provision authorizes ‘delet[ing]’ improperly listed patents but not ‘correct[ing]’ information that misrepresents the scope of the patent.” The Court has scheduled oral argument in this case for December 5.  

While an argument date is yet to be determined, the Court has agreed to hear a case asking whether an inventor may introduce new evidence in a section 145 civil action if the evidence was available when her patent application was filed and whether the court must defer to the U.S. Patent and Trademark Office on the factual issues to which the new evidence relates. Kappos v. Hyatt, No. 10-1219. More detail about the case appears in Issue 16 of this Bulletin.