If you want a patent, be careful about when you make your first sale. Helsinn Healthcare S.A. applied to patent a formula that would reduce nausea and vomiting resulting from chemotherapy. When it sued Teva Pharmaceuticals USA Inc. for patent infringement, Teva argued that the patent was barred because Helsinn sold the formula more than a year before it applied for the patent. The Patent Act 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.” An invention is made available to the public when there is a commercial offer or contract to sell a product embodying the invention and that sale is made public. There was no question that Helsinn had entered into a distribution agreement more than a year before the patent application. So the issue was whether the agreement between Helsinn and its distributor was a “sale” which would bar the patent. The Federal Circuit Court of Appeals ruled that the sale to the distributor qualified as a commercial sale that would bar the application.

WHY YOU SHOULD KNOW THIS. Although this case involves big pharma, every inventor can benefit from Helsinn’s sad experience. There is some discussion among the Patent Bar as to whether making the sale “confidential” would mean the sale wasn’t “commercial”. But it may not be an easy fix. The issue involves an analysis of both commercial law as well as patent law. To be safe, a first sale shouldn’t take place before the patent application is filed. Failing that, advice of counsel is absolutely necessary.