On May 1, 2017, the Federal Circuit held that an agreement for sale of the claimed invention contingent on regulatory approval, absent more, is a commercial sale for the purposes of AIA 102(a), the "on-sale bar" provision. Helsinn Healthcare S.A., v. Teva Pharmaceuticals USA, Inc., et al., Case Nos. 2016-1284, 2016-1787 (Fed. Cir. May 1, 2017). Helsinn Healthcare owned three patents that pre-dated AIA and one post-AIA, the patents were directed to formulations for reducing chemo-induced nausea. After Teva filed an ANDA, Helsinn sued for infringement and Teva asserted invalidity under the on-sale bar provision. Prior to AIA, the “on-sale bar” required that the invention not be “on sale … more than one year prior to the date of application.” The district court held the three pre-dated AIA patents valid finding that the supply and purchase agreement that Helsinn entered into was a sale under 102(b) but the claimed invention was not reduced to practice before the critical date and not ready for patenting under Pfaff’s second prong. On the post-AIA dated patent, the district court held that the “otherwise available to the public”, under 102(a) of the AIA, means that only public sales trigger the bar and the purchase agreement failed to disclose the details of the invention. In reversing the decision, the Federal Circuit held that details of the invention need not be publicly disclosed in the terms of the sale if the existence of the sale is public. Because the drugs were developed and subject to a contract for sale that identified price and quantity, the “on-sale bar” is triggered despite the sale being contingent on FDA’s approval of the drugs.
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