Under the Leahy-Smith America Invents Act, an invention may not be patented if it has been “in public use, sold, or otherwise available to the public before the effective filing date of the claimed invention.” In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the issue was whether an invention had been “sold” within the ambit of the Act and if the sale was to a third party that agreed to keep details of the invention secret.
Helsinn manufactured a drug that could be administered in two different doses. It entered into an agreement with another company to market and distribute the doses, but the marketer agreed to keep the dosage amounts secret. Helsinn then applied for patents over the dosage amounts of the drug. The district court held that the drug was not “on sale” under the Act because the sale was not to the public itself, but the Federal Circuit reversed. The Court, in a unanimous opinion by Justice Thomas, affirmed, holding that a “sale” need not be to the public in order to trigger the Act, affirming the Federal Circuit’s longstanding practice of deeming “secret sales” as sufficient to invalidate a patent.