Posts Tagged: "Helsinn v. Teva"

Last week, the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet, held an oversight hearing on the U.S. Patent and Trademark Office (USPTO) with Director Andre Iancu as the sole witness. A particular inquiry from Rep. Zoe Lofgren (D-CA) regarding the USPTO’s allegedly lax examination quality under 35 U.S.C. § 112 caught my attention. She remarked [at 1:33:30]:  “Theranos, the blood testing company whose founder is being investigated for fraud, was granted nearly 100 patents based on an invention that didn’t work; and it concerns me that a patent application for an invention that doesn’t work gets approved.”  She generally questioned examiners’ attention to Section 112 requirements. Rep. Lofgren’s statement was no doubt primed by information from the Electronic Frontier Foundation (EFF) in the Ars Technica blog post titled “Theranos: How a broken patent system sustained its decade-long deception.” In this article, the author, who was introduced as holding the “Mark Cuban Chair to Eliminate Stupid Patents” at EFF, declares with no evidence or proof, that the “USPTO generally does a terrible job of ensuring that applications meet the utility and enablement standards.” The article cited no study, identified no patent, nor any claim to any “invention that didn’t work.” This outrageous, baseless allegation is outright reckless and irresponsible.

To the casual observer, the Supreme Court’s January 23 decision in Helsinn v. Teva may seem like no big deal. In just a few pages of text, the Court informs us that Congress did not change the established meaning of “on sale” prior art when it rewrote Section 102 of the Patent Act in 2011. Move along, nothing to see here, right? More than a few commentators seem to assume that we’ll simply return to the pre-America Invents Act (AIA) status quo, and that sales of an invention, whether public or private, will just continue to trigger a familiar statutory one-year clock for filing a patent application. But nothing could be further from the truth. In fact, the impact of private sales (and of non-public commercial uses) on the patentability of later-filed patent applications will be significant, and very different from pre-AIA law. Patent applicants and owners of patents that were issued under the AIA have every reason to worry about traps for the unwary.