Statutory Bar

A statutory bar is a specific category of prior art or event that prevents a patent from being granted or that invalidates an issued patent — regardless of whether the applicant was the first inventor. Under the AIA, the primary statutory bars are codified in 35 U.S.C. § 102(a)(1): 'A person shall be entitled to a patent unless the claimed invention 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.' The critical phrase is 'before the effective filing date' — any qualifying event (sale, publication, public use, prior patent) that occurred before the patent's effective filing date creates prior art. Under the pre-AIA system (35 U.S.C. § 102(b)), the statutory bar had a one-year grace period that ran from the actual filing date, not the effective filing date — meaning even the inventor's own activities more than one year before filing could create a bar. The AIA preserved a grace period for inventor disclosures (§ 102(b)(1)(A)) but eliminated the grace period for third-party activity.

The on-sale bar under § 102(a)(1) prevents patenting when the claimed invention was 'on sale' before the effective filing date. KEY ISSUE — DO SECRET SALES COUNT? HELSINN HEALTHCARE v. TEVA PHARMACEUTICALS (S.Ct. 2019): The Supreme Court held that the AIA's on-sale bar, like the pre-AIA bar, does NOT require that the sale be publicly known or publicized — a commercial sale or offer for sale that is made under confidentiality can still trigger the on-sale bar. Facts: Helsinn entered into a confidential supply and purchase agreement with MGI Pharma for a drug (palonosetron for chemotherapy-induced nausea) more than one year before Helsinn filed its NDA-triggering patent application; the agreement was commercially disclosed in a SEC filing but the specific dose was kept confidential. S.Ct. held: 'on sale' in the AIA encompasses secret sales, just as it did under pre-AIA law; Congress's use of the existing phrase 'on sale' without change presumed it retained the established meaning; Helsinn's patents were invalid. WHAT CONSTITUTES A SALE: the Federal Circuit applies the UCC definition — a contract for the sale of goods; the invention must be the subject of a commercial offer for sale; the invention must be ready for patenting (reduced to practice or described in sufficient detail to enable a POSITA).

The AIA provides a grace period in § 102(b)(1)(A) that protects certain disclosures from becoming prior art against the disclosing inventor's own patent application. RULE: A disclosure made 1 year or less before the effective filing date is not prior art under § 102(a)(1) IF: the disclosure was made by the inventor or joint inventor, OR by another who obtained the subject matter from the inventor or joint inventor. SCOPE: The grace period covers: publications by the inventor; public use by the inventor; sales by the inventor (including the Helsinn-type secret sales — this is one exception where the grace period may save an inventor's own secret sale if within 12 months); presentations by the inventor at a conference. LIMITATION: The grace period applies ONLY to disclosures BY THE INVENTOR (or someone who derived the subject matter from the inventor). A completely independent third party who discloses the invention (even on the same day as the inventor) creates prior art under § 102(a)(1) with NO grace period — this is the most significant difference from pre-AIA, where all disclosures had a one-year grace period. BEST PRACTICE: file the patent application BEFORE any public disclosure; if that's not possible, file within 12 months of the first disclosure.

The AIA (effective March 16, 2013 for applications with effective filing dates on or after that date) made significant changes to the statutory bar framework: PRE-AIA § 102(b): any of the following more than 1 year before the actual U.S. filing date barred patenting: (1) the invention was patented or described in a printed publication anywhere; (2) the invention was in public use in the U.S.; (3) the invention was on sale in the U.S. — crucially, the 1-year grace period applied to ALL disclosures, including those by third parties; and the period ran from the actual filing date (not an earlier priority date). AIA § 102(a)(1) + § 102(b)(1): the effective date test now runs from the 'effective filing date' (which incorporates the benefit of priority to earlier applications under §§ 119/120); the 1-year grace period (§ 102(b)(1)) applies ONLY to inventor disclosures (and disclosures derived from the inventor), NOT to independent third-party activity; third-party activity before the effective filing date is prior art with no grace period. FOREIGN ACTIVITY: pre-AIA required 'in public use in the United States' — use outside the U.S. was not a § 102(b) bar; the AIA's 'otherwise available to the public' standard is global, potentially making foreign public use a statutory bar under AIA.

AIA § 102(a)(1) adds 'or otherwise available to the public' as a catchall after the enumerated categories (patented, printed publication, in public use, on sale). PURPOSE: this catchall addresses disclosure types that don't fit neatly into the specific categories — for example: posters at a scientific conference that may not rise to 'printed publication' if not formally published; demonstrations at a trade show; disclosures in social media, video, or audio formats; oral presentations that were attended by the public even without a published transcript. WHAT IS 'AVAILABLE TO THE PUBLIC': courts interpret this consistently with the prior art categories — the key question is whether a person of ordinary skill in the art (POSITA) could access the information; secret or confidential disclosures (that don't otherwise constitute sales) would NOT be 'available to the public.' PRACTICAL IMPLICATIONS: the catchall reinforces that any public disclosure — whether or not it falls within a named category — creates prior art; combined with the elimination of the third-party grace period, even a brief third-party public demonstration of the invention anywhere in the world, before the effective filing date, is prior art under the AIA.