Patent Strategy
U.S. patent law gives inventors time to file after disclosing their own invention, and some device teams treat this as permission to present first and file later. Much of the world does not follow the U.S. rule. A disclosure that the U.S. grace period may excuse can still be fatal in Europe and problematic elsewhere. For a company that expects to sell in more than one market, the U.S. grace period is a safety net for the U.S. application, not a filing strategy.
Under 35 U.S.C. §102(a)(1), a claimed invention is not patentable if it was patented, described in a printed publication, in public use, on sale, or otherwise available to the public before the effective filing date. Section 102(b)(1) creates two exceptions for disclosures made one year or less before the effective filing date. Under 102(b)(1)(A), a disclosure is not prior art if it was made by the inventor or a joint inventor, or by another who obtained the subject matter from them. Under 102(b)(1)(B), a later third-party disclosure is not prior art if the same subject matter had already been publicly disclosed by the inventor.
Both exceptions have limits. The period is one year before the effective filing date, and the exceptions protect only inventor-originated disclosures, not independent work by others. The USPTO's examination guidance in MPEP 2153.02 explains that the 102(b)(1)(B) exception applies only to the same subject matter the inventor previously disclosed; if a later third-party disclosure adds something, even an obvious variation, the added material can still be cited as prior art. A company that discloses early and then waits is relying on competitors not publishing anything close in the meantime.
The European Patent Convention takes a different approach. Article 54(2) EPC defines the state of the art as everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European application. There is no general exception for the applicant's own disclosures. A conference presentation, a published abstract, or a product shown publicly before filing can be cited against the applicant's own European application.
Article 55 EPC provides only two narrow exceptions, each limited to disclosures occurring no earlier than six months before filing. The first covers disclosures resulting from an evident abuse in relation to the applicant or its legal predecessor, such as a breach of confidence. The second covers display of the invention at an official, or officially recognised, international exhibition within the terms of the 1928 Paris Convention on international exhibitions. Very few events qualify under that second exception, and ordinary medical trade shows and scientific congresses generally do not.
The six-month period is also computed strictly. In decisions G 3/98 and G 2/99, the EPO Enlarged Board of Appeal held that it runs from the actual filing date of the European application, not from an earlier priority date.
Priority does, however, help in the right sequence. Under Article 89 EPC, a valid priority date counts as the filing date for purposes of Article 54(2). If a company files a first application, for example a U.S. provisional, and then discloses, a European application filed within the 12-month priority period can rely on the earlier date, but only for subject matter the first application actually discloses; a thin provisional does not carry its date forward to detail added later. The protection comes from filing before the disclosure, not from any European grace period.
Grace period rules in Asia differ from both models and have changed in recent years, so current rules should be confirmed for any specific filing.
Japan extended its exception to loss of novelty under Article 30 of its Patent Act from six months to one year, for applications filed on or after June 9, 2018 and disclosures made on or after December 9, 2017. The exception must be invoked: a statement is required at filing and supporting proof within 30 days, and the application must be filed in Japan, directly or through a PCT application designating Japan, within the one-year period.
Korea provides a 12-month grace period for an applicant's own disclosures. It may be claimed at filing and, under later amendments, after filing in certain circumstances.
China's grace period, under Article 24 of its Patent Law as amended effective June 1, 2021, is six months and applies only in defined circumstances: first disclosure for the public interest during a national emergency or extraordinary situation, first exhibition at an international exhibition sponsored or recognized by the Chinese government, first publication at certain designated academic or technical conferences, and disclosure by another person without the applicant's consent. Ordinary journal articles and commercial trade shows generally fall outside it. Implementing regulations and examination guidelines took effect on January 20, 2024.
Device development generates disclosures that do not always register as publications. Investigator meetings and advisory boards may involve clinicians without written confidentiality obligations. Conference abstracts are often published online before the presentation. Trade-show booths and prototype demonstrations show a design to anyone who attends. Investor decks circulate further than intended, and a pitch at a public competition is a public disclosure.
Clinical work requires particular care. Whether a clinical study makes a device available to the public in Europe depends on the facts. In T 670/20, an EPO Board of Appeal found that patients in a drug trial run under good clinical practice, who were required to use the study drug as directed and return what they did not use, were not members of the public, even without a separate confidentiality agreement; other decisions have reached different outcomes where the sponsor did not maintain control. That uncertainty is a reason to file before first-in-human work.
Regulatory filings follow their own timelines. Under 21 CFR 807.95, FDA generally keeps a premarket notification for an unmarketed device confidential before a decision where the submitter has not disclosed its intent to market, but a 510(k) summary of safety and effectiveness information becomes available to the public after a substantial equivalence determination. For applicable device clinical trials of devices not previously cleared or approved, 42 CFR 11.35 generally delays public posting of ClinicalTrials.gov registration information until clearance or approval, unless the responsible party authorizes earlier posting. Delayed posting applies only to applicable device clinical trials, and registries outside the United States follow their own publication rules, so regulatory and registry publication should be anticipated in the patent timeline.
Confidentiality agreements are essential, but they do not solve every problem. Under EPO practice, subject matter is generally not made available to the public where an express or tacit secrecy agreement exists and has not been broken. If the agreement is breached, the evident abuse exception may help, but only if the European application is filed within six months of the disclosure.
In the United States, confidentiality does not prevent every bar. In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. (2019), the Supreme Court held that a sale of an invention to a third party obligated to keep it confidential can place the invention "on sale" under the AIA. Supply, distribution, and development agreements entered before filing deserve review for that reason.
The approach that preserves the most options is simple to state: file first, then disclose. A provisional or other first application, drafted with enough detail to support the claims the company will eventually need, can be filed before an abstract deadline, a trade show, an investor roadshow, or a first-in-human study. That filing starts the 12-month priority period and lets the company decide on foreign coverage without having already lost it. A simple internal checkpoint, reviewing publications, presentations, and submissions against filing status before release, supports the same discipline.
Companies planning conference presentations, clinical studies, or market entry in several jurisdictions may find it useful to review their disclosure timeline with patent counsel before those events occur. This article provides general information and is not legal advice for any specific situation.