Helsinn v. Teva: Lingering Ambiguity after the U.S. Supreme Court Holds the AIA Did Not Alter the On-Sale Bar to Patentability
Biotechnology Law Report, 2019
23 Pages Posted: 27 May 2020
Date Written: March 1, 2019
The American Innovation Act of 2011 (AIA) retained §102 of the pre-AIA Patent Act’s “in public use” and “on-sale” bars to patentability, but introduced an additional “or otherwise available to the public” category of prior art. Federal Circuit precedent pre-dating the AIA has held that, as a general matter, a sale or offer for sale can create an on-sale bar to patentability even if the sale or offer for sale is “secret” and does not render the invention available to the public. Some believed that the AIA’s introduction of the phrase “or otherwise available to the public” altered the meaning of “on sale,” introducing a requirement that a sale or offer for sale render an invention “available to the public” in order to create a statutory bar to patentability. In other words, under this interpretation a “secret” offer for sale would no longer constitute an on-sale statutory bar. In January, 2019, the Supreme Court addressed this contention in Helsinn v. Teva, and essentially held that the AIA had not changed the meaning of “on sale” for purposes of §102. This article provides a historical overview of the pre-AIA on-sale bar, considers the argument that in enacting the AIA Congress intended to do away with non-public prior art, reviews Helsinn, including the decisions below and amicus curiae briefs filed with the Supreme Court in connection with the case, and concludes with a discussion of lingering questions with respect to the judicial interpretation of the on-sale and public use bars.
Keywords: patents, biotechnology, pharamceuticals, on-sale bar, AIA, Helsinn
Suggested Citation: Suggested Citation