After June 8, 1995, U.S. utility patent terms changed from 17 years from issuance to 20 years from filing to harmonize with the rest of the world under the Uruguay Rounds Agreement Act. For design patents, after the Hague Agreement on May 13, 2015, design patent terms changed to from 14 years from issuance to 15 years from the date of grant/issuance.
In the United States, patent term is subject to the following: patent term adjustment (PTAs), patent term extension (PTEs) and terminal disclaimers. While many other countries also have PTAs and PTEs, terminal disclaimer practice exists only in the United States because we are the only country that issues judicially-created, non-statutory double patenting rejections.
Patent Term Adjustments and Patent Term Extensions
PTAs and PTEs both compensate for delays during prosecution of the patent.PTA compensates applicants for USPTO-caused delays, and is available to almost all utility patent applications. PTE compensates for delays caused by the regulatory review process before a product can be commercially marketed. PTEs mostly apply for pharmaceutical patents, as they are subject to U.S. Food and Drug Administration (FDA) review, which can take a long time. PTE is designed to extend the life of a patent because the applicant was not able to practice the invention during the regulatory review process, unlike other applications not subject to regulatory review, which the applicant can practice at any point during the pendency of their application before the U.S. Patent and Trademark Office (USPTO).
Terminal disclaimers are filed to obviate double patenting rejections, in which an applicant’s claims are rejected in view of earlier filed claims by the same applicant in a separate application. For double patenting rejections, the pending claims are rejected either on the grounds of being obvious or not novel in view of the prior filed claims that are commonly owned. The idea is to prevent applicants from owning duplicate claims having different patent terms and effectively having an unduly long patent term over a particular claim scope.
With a terminal disclaimer, the applicant dedicates to the public the non-overlapping terminal term of the patent that received a double patenting rejection. The terminal disclaimer is recorded at the USPTO such that if the pending application would have had a term that surpassed the expiration of the prior filed patent, then that term is disclaimed, such that the two patents expire on the same date.
Applicants typically file these once the claims are basically in condition for allowance and all rejections have been overcome but for the double patenting rejection. By and large, I have found that applicants are willing to file a terminal disclaimer at this point to get their application allowed because they are tired of fighting and want to move on with their lives. But to those of you with a pharmaceutical client, meet the hill you’re going to die on!
Terminal Disclaimers on PTAs and PTEs
Because terminal disclaimers make it such that the patent expires at the same time as the commonly owned patent, terminal disclaimers can obviate all your PTA days so that the patents expire on the same date. PTEs, in contrast, are explicitly meant to extend the term of the patent; terminal disclaimers cannot impact the duration of PTEs.
PTAs and Applicant Delay
Because PTAs only compensate for prosecution delays caused by the Office, they will not compensate for delays caused by the applicant. Basically, applicant delay occurs when filing outside of the three-month statutory period (e.g., filing requests for extensions, or filing post-issuance or allowance).
One of the ways the applicant can hold up the pace of prosecution is by failing to timely submit information disclosure statements (IDS’s). You typically file an IDS when you file the application with references your client has provided or you found via a search, before prosecution begins. After prosecution begins, you are likely to file an IDS if your client filed the invention in several countries, and the corresponding foreign applications received office actions abroad that cited new or different references against those applications. Depending on what stage of prosecution you’re in, you may or may not have to make certain certification statements and submit fees.
Utilizing the Safe Harbor Period to Avoid Reduction in PTA
When you get one of these foreign office actions citing new relevant art that wasn’t previously considered, the applicant is entitled to a safe harbor period during which they can submit their IDS without risking any reduction to their PTA. That safe harbor is given when the applicant files the IDS within 30 days of receiving the foreign office action and applicant makes the safe harbor statements under 37 CFR 1.704(d).
Each item of information contained in the information disclosure statement was first cited in any communication from a patent office in a counterpart foreign or international application or from the Office, and this communication was not received by any individual designated in 37 CFR 1.56(c) more than thirty days prior to the filing of the information disclosure statement.
Each item of information contained in the information disclosure statement is a communication that was issued by a patent office in a counterpart foreign or international application or by the Office, and this communication was not received by any individual designated in 37 CFR 1.56(c) more than thirty days prior to the filing of the information disclosure statement.
These safe harbor statements are actually just like the certification statements on the SB/08 forms, except for one key difference – the certification statements on the IDS form says that the foreign office action came in no more than three months ago, whereas the safe harbor statements say that the foreign office action came within the past 30 days. So basically, applicant can file within three months of receiving the foreign office action to comply with the USPTO rules, but 30 days is a safe harbor in which you’re guaranteed to not get any reduction in PTAs.
All this really only matters after prosecution has already begun – that is, after you’ve received a first office action on the merits. Same with the certification statements – you don’t have to make them unless prosecution has begun because applicant cannot delay prosecution when prosecution has not started. And prosecution has started after Request for Continued Examination. So, even if prosecution has re-started, it has technically already started for the purposes of making these statements.
The USPTO recently proposed a rule change that applicants must fill out form PTO/SB/133 to submit the safe harbor statements. This proposed rule will likely go into effect, so be sure to submit that with your IDS within 30 days of the foreign office action to avoid reduction in PTAs.
Also, tune in to the video to watch a short practical exercise on calculating patent term!
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One comment so far.
Pro SayNovember 18, 2022 12:00 pm
Thanks Wen. Great, actionable information as usual.