Does the America Invents Act change the on sale bar for patents?

The on sale bar is a limitation which will stop an inventor from getting a patent on their invention. To be granted a patent in the United States an inventor must submit a patent application to the United States Patent and Trademark Office. The United States Patent and Trademark Office will review the patent application to see if the invention qualifies for a patent. To qualify for a patent the invention must be new, useful and not obvious in light of the prior art. Prior art is any evidence that the invention was already known. One example of prior art is when the invention is made available for sale more than one year before the patent application is filed. This requirement can be found in 35 U.S.C. § 102 of the United States patent statute.

The America Invents Act was a major overhaul for patent law in the United States. The America Invents Act explicitly changed the United States from a first to invent to a first to file system. The America Invents Act also touched on when a sale of a product is considered prior art under 35 U.S.C. § 102.

Before the America Invents Act, § 102(b) barred a patent on an invention that was “patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent.” 35 U.S.C. § 102(b).

When Congress amended § 102 the wording of the statute was change to bar 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.” 35 U.S.C. § 102(a)(1).

This change in the wording of the statute has lead to some litigation regarding the precise meaning of the updated statute.

An example of litigation related to the changes the America Invents Act made to 35 U.S.C. § 102 is HELSINN HEALTHCARE v. TEVA PHARMACEUTICALS, 2016-1284 (Fed. Cir. 2017). In that case Helsinn sued Teva for infringing patents Helsinn owned related to medications which prevent certain negative side effects related to chemotherapy. Teva defended itself by claiming that the patents were invalid because documents filed with the Securities and Exchange Commission proved that the the drug was offered for sale more than a year before the patent application was filed. The district court concluded that there was no commercial offer for sale because the American Invents Act changed the relevant standard and that, in any event, the invention was not ready for patenting before the critical date. Helsinn appealed to the Court of Appeals for the Federal Circuit. The Federal Circuit found for Helsinn.

In its decision the Federal Circuit noted that the America Invents Act did not change the statutory meaning of on sale and that the patents were offered for sale more than a year before the filing of the patent applications. The Federal Circuit stated that the on sale bar still applies when details of the claimed invention are not made public, and even if the sale never actually happens. The Federal Circuit held that the sale, which was disclosed in the documents filed with the Securities and Exchange Commission, of the patented invention was prior art under 35 U.S.C. § 102 and therefore the Helsinn patents were invalid.

Helsinn has appealed the decision to the United States Supreme Court and the Supreme Court has agreed to hear the case.

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