On December 4, 2018, the Supreme Court heard argument in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. This case arose out of a dispute over the validity of a patent covering a product used to reduce the likelihood of chemotherapy-induced nausea and vomiting. At issue in this case is whether agreements entered into by Helsinn more than one year prior to filing for patent protection put the invention “on sale” and thus would invalidate the patent. Although the meaning of “on sale” in the Patent Act was long believed to be settled, the 2011 America Invents Act (AIA) made changes to the statutory provisions that include the “on sale” bar. The question for the Supreme Court is whether these changes to the statute change the previous understanding of the term “on sale.”
In April 2001, Helsinn entered into two agreements with MGI Pharma. Although these agreements were announced in a press release, specific information about the products, like dosing formulations, were omitted. In 2003, Helsinn filed a provisional patent application covering the product. Three patents arose from this provisional patent application prior to the enactment of the AIA; however, one patent was subject to the new provisions of the AIA.
In 2011, Teva sought FDA approval to make a generic version of the patented product. Helsinn sued Teva for patent infringement based on this ANDA filing. Teva argued that the patent was invalid because Helsinn’s agreements with MGI put the product “on sale” before the relevant date. The district court rejected Teva’s argument, concluding that the AIA had changed the meaning of “on sale” to require the invention be made public by the sale. Because the dosing information was not provided in the press release regarding the agreements, the district court concluded the agreements did not make the invention public and there was no “on sale” bar.
The Federal Circuit reversed, holding that inventions are made available to the public whenever there is a commercial offer for sale and that the sale is public even when the details of the invention are not disclosed to the public by the sale. Thus, the “on sale” bar applied to Helsinn’s patent.
The U.S. Supreme Court then granted certiorari to address whether under the AIA, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.
To the discuss the case, we have Kristen Osenga, Professor of Law at University of Richmond School of Law.