The issues to be decided in this case are as follows: (1) whether a plaintiff, who is appealing the denial of an application of a patent by commencing a civil action against the Director of the United States Patent and Trademark Office (PTO) in a federal district court pursuant to 35 U.S.C. § 145, 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 Section 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.  

On January 23, 2012, the Supreme Court issued a unanimous opinion in the case of National Meat Association v. Harris, No. 10-224. 

In its decision, the Court reversed the Ninth Circuit Court of Appeals, reasoning that the Federal Meat Inspection Act (“FMIA”), 21 U.S.C 601, et seq., expressly preempts inconsistent state law. This decision is the latest in a long line of Supreme Court opinions that have historically and consistently affirmed the preemptive effect of the FMIA.