Federal Circuit Clarifies The Post-AIA On-Sale Bar

May 01, 2017
Post by Blog Staff

Yesterday, in Helsinn v. Teva, the Federal Circuit added greater clarity to the restrictions the sale of inventions pose to patentability. Under 35 U.S.C. § 102, an invention cannot be patented if the claimed invention was on sale before the effective filing date of the claimed invention. In Helsinn, the Federal Circuit took steps to define exactly what is meant by “on sale.”
Helsinn owns four patents for formulations meant to reduce chemotherapy-induced nausea and vomiting (CINV). Almost two years before applying for a patent, Helsinn entered into an agreement with another pharmaceutical company, specifically a License Agreement and a Supply and Purchase Agreement. These agreements were announced in a joint press release of the two corporations and also with the corporations’ filings with the SEC. Parts of the agreements were redacted from the public release, specifically the price terms and the specific dosage formulations covered by the agreements. As such, not all the details of the invention were publicly disclosed when the sales were disclosed.

The lower courts and the USPTO had suggested that the America Invents Act (AIA) changed the meaning of the on-sale bar. Part of this rationale was that the way Post-AIA § 102 is written, it seems to suggest that only offers which were public, and offers involving an actual sale acted as a bar to patentability. However, the Federal Circuit concluded that the Post-AIA on sale bar attaches “if the existence of the sale is public” and if the sale is public, “the details of the invention need not be publicly disclosed in the terms of sale.” “Requiring such disclosure as a condition of the on-sale bar would work a foundational change in the theory of the statutory on-sale bar. . . . Failing to find such a sale [where the sale is public and the details of the invention are withheld] invalidating . . . would materially retard the progress of science and the useful arts, and give a premium to those who should be least prompt to communicate their discoveries.”

Since the Federal Circuit’s ruling in this case will change the way the USPTO views the on-sale bar, patent holders preparing to file with the USPTO should be careful to file before disclosing details of any sale. Additionally, although the Federal Circuit did not address secretive sales (i.e. sales which are not disclosed to the public), because the ruling in Helsinn expands the language of the § 102 on-sale bar, this suggests the on-sale bar could apply to secret sales as well.

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