Following passage of the America Invents Act, questions arose as to whether a secret sale by the inventor more than one year before patenting was prior art under section 102(a)(1) that would prohibit patenting of the invention. The language of the statute provides an invention cannot be patented if “in public use, on sale, or otherwise available to the publicbefore the effective filing date of the claimed invention.” Questions arose as to whether the phrase “otherwise available to the public” qualified reference to the sale, meaning it had to make the invention available to the public. The Supreme Court has now answered the question in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc., No. 17-1229 (2019). The unanimous opinion says the law did not change, and if a patent owner sells an invention to a third party before a patent application is filed, even if that sale is confidential, the on-sale bar applies.
The Helsinn patent in this situation was to an intravenous formulation for reducing nausea and vomiting caused by chemotherapy treatments. The application was filed January 30, 2003. On April 6, 2001,Helsinn entered into an exclusive license, supply and purchase agreement with MGI Pharma. The existence of the agreement was made public but not the details. Certain patents filed prior to AIA were found valid by the district court, as the invention was determined to not be ready for patenting. Post AIA patents were found were also found valid, the lower court finding the sale was not public. The Federal Circuit reversed, saying it did not matter if the sale was confidential. The Supreme Court affirmed.
With this unanimous ruling it becomes clear that those wanting to file a patent application need to file prior to a sale or offer for sale, and to carefully examine agreements regarding the invention to ensure they cannot be interpreted to constitute a sale.