US Federal Circuit Considers On-Sale Bar under the America Invents Act

On May 1, 2017, the US Federal Circuit issued an important decision interpreting the on-sale bar provision under the America Invents Act (AIA) in Helsinn Healthcare SA v Teva Pharmaceuticals USA, Inc. Section 102 of the AIA bars the patentability of an “invention [that] was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention”. The Court concluded that “after the AIA, if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale” to trigger the on-sale bar. In coming to this conclusion, the Court has confirmed that to trigger the on-sale bar, there is no requirement that the details of the invention be disclosed in the terms of sale.

In this case, the asserted claims in Helsinn’s patent covered intravenous formulations containing 0.25 mg dose of palonosetron for reducing or reducing the likelihood of chemotherapy-induced nausea and vomiting. Two years before the patent filing, Helsinn and MGI Pharma Inc (MGI) entered into a licence agreement and a supply and purchase agreement. These agreements were announced in a joint press release and in MGI’s Form 8-K filing with the US Securities and Exchange Commission. MGI’s Form 8-K filing also included partially redacted copies of the agreements. The terms and the specific dosage formulations (0.25 and 0.75 mg doses), both covered by the agreements, were not publicly disclosed. The Court found that although the specific details of the claimed invention were not made public by the announcement of the agreements, the on-sale bar was triggered when there was a commercial offer or contract to sell a product embodying the invention.