The U.S. Supreme Court held the America Invents Act (AIA) did not alter the meaning of the on-sale bar. The reenactment of the phrase “on sale” in the AIA did not alter the original meaning. A commercial sale to a third person who is required to keep the invention confidential may place the invention “on-sale” under the AIA. Click here for a copy of the decision.
Helsinn entered into license and supply and purchase agreement with MGI to distribute, promote, market and sell the 0.25 mg and 0.75 mg doses of palonosetron in the U.S. The dosages were not made public in the 8-K filing nor the press releases. Teva sought approval from FDA to market the 0.25mg dose and Helsinn sued it for patent infringement. Teva asserted the patent was invalid because the 0.25mg dose was “on-sale” more than one year before Helsinn filed the provisional patent application.
The District Court determined that the on-sale provision did not apply, because under the AIA, an invention is not “on-sale” unless the sale or offer in question made the claimed invention available to the public. The Federal Circuit reversed and concluded that the if the existence of the sale is public, the details of the invention need not be publicly disclosed to fall within the AIA’s on-sale bar. The Supreme Court found that under the AIA, an inventor’s sale of an invention to a third party who is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.