The Federal Circuit ruled yesterday that public sales of a product do not need to disclose the details of an invention to bar a patent application under post-America Invents Act (“AIA”) 35 U.S.C. § 102. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. et al. In reaching this decision, the court rejected Helsinn’s argument that Congress intended to limit the bar to sales that “disclose the invention to the public” when they changed the language of § 102 from “patented or described in a printed publication in this or a foreign country or in public use or on sale in this country. . .” to “patented, described in a printed publication, or in public use, on sale, or otherwise available to the public . . .” This decision marks a win for ANDA filers.
This was the Federal Circuit’s first decision interpreting the bar, and it directly contradicts the MPEP’s guidance, which states:
The phrase “on sale” in AIA 35 U.S.C. 102(a)(1) is treated as having the same meaning as “on sale” in pre-AIA 35 U.S.C. 102(b), except that the sale must make the invention available to the public.
MPEP 2152.02(d). Thus, while on-sale bars are not typically considered by the patent office during examination, it is possible the patent office has issued patents under an incorrect interpretation of the statute.
The court did leave some questions unanswered. In the case at hand, the existence of the sale had been publicly disclosed in SEC filings. Thus, it remains unclear whether a so-called “secret sale” would prevent patenting of an invention. The purpose of the on-sale bar—to prevent a patentee from commercializing an invention before securing patent protection—would seem to apply regardless of whether the existence of a sale was kept secret. But ANDA-filers will have to wait for another day to convince the Court of that argument.