The standard patent prosecution process — from filing an application to receiving a granted patent — can be a lengthy undertaking. In the United States, average pendency from filing to grant has historically ranged from two to three years, and in some technology areas it can be considerably longer. In Europe and other major jurisdictions, timelines can be similarly extended. For a life sciences startup, this timeline creates a practical tension: investors, partners, and acquirers want the certainty that comes with granted patents, while the normal pace of prosecution may mean that key patents remain pending throughout the most critical early stages of a company’s growth. Fortunately, most major patent offices around the world offer formal mechanisms for accelerating examination, allowing applicants who qualify — or who are willing to pay a premium — to move through the prosecution process significantly faster than the standard queue. Understanding these mechanisms and deploying them strategically can give a startup meaningful advantages in fundraising, licensing, and competitive positioning.
Track One Examination in the United States
In the United States, the United States Patent and Trademark Office (USPTO) offers a program called Track One prioritized examination, which allows applicants to request that their application be examined on an expedited basis in exchange for an additional government fee. Under Track One, the USPTO aims to provide a final disposition — either a grant or a final rejection — within approximately 12 months of the prioritization request being granted, compared to the two to three years that standard examination typically requires. The program is available for both utility and plant patent applications, subject to certain claim number limitations, and the number of applications accepted into Track One in any given year is capped, meaning that requests are not always immediately granted. For a life sciences startup approaching a funding round, a partnership negotiation, or a product launch, the ability to obtain a granted patent within a year rather than waiting two or more years can be commercially significant. A granted patent carries considerably more weight in due diligence than a pending application, and in competitive technology areas, reaching grant ahead of a rival can establish claim scope that shapes the entire competitive landscape. The additional cost of Track One is modest relative to the overall expense of patent prosecution, and for strategically important applications it is frequently worth the investment.
The PACE Program at the European Patent Office
At the European Patent Office (EPO), the equivalent accelerated examination mechanism is known as the PACE program — an acronym for the Programme for Accelerated Continued Examination. Under PACE, applicants can request accelerated processing of their European patent application at either the examination stage or, where applicable, the appeal stage, and unlike some accelerated programs at other offices, participation in PACE carries no additional official fee. The EPO aims to issue a first examination communication within approximately six months of a PACE request being acknowledged, which can meaningfully compress the overall timeline to grant compared to standard prosecution. It is worth noting that the PACE program applies to the centralized examination process at the EPO itself — once a European patent is granted, it must still be validated in individual member states, a process that involves its own timelines and translation requirements depending on the countries selected. Nevertheless, for startups seeking to establish European patent protection on an accelerated basis, PACE is a valuable and cost-effective tool that is underutilized by many applicants simply because they are unaware it exists.
Accelerated Examination in Other Key Jurisdictions
Beyond the United States and Europe, most major patent offices maintain their own mechanisms for accelerated or prioritized examination, and a well-coordinated international prosecution strategy will consider these options across all key filing territories. In Japan, the Japan Patent Office offers a system of accelerated examination available to applicants who can demonstrate, among other things, that the invention is already being worked commercially or that there is an urgent need for early grant. In China, the China National Intellectual Property Administration offers a prioritized examination program for applications in designated technology areas, including biotechnology and pharmaceuticals, which can reduce examination timelines substantially compared to standard prosecution. In addition to these national programs, the Patent Prosecution Highway — commonly known as the PPH — is a bilateral and multilateral framework that allows applicants to leverage a favorable examination outcome in one participating office to accelerate examination of a corresponding application in another. If the USPTO has allowed claims in a US application, for example, the applicant can request PPH acceleration at a participating foreign office, providing that office with the USPTO’s work product and asking it to expedite its own examination accordingly. This can be a highly efficient approach to building an international patent portfolio quickly, particularly when a strong result has already been achieved in the home jurisdiction.
Strategic Considerations for Acceleration
Deciding which applications to accelerate, and in which jurisdictions, requires careful strategic thinking rather than a blanket approach. Acceleration programs typically impose constraints — on the number of claims, on the breadth of amendments that can be made during prosecution, or on the obligation to respond to office actions within compressed timeframes — that may not be appropriate for every application. In some cases, a startup may benefit from allowing prosecution to proceed at a measured pace, preserving flexibility to amend claims in light of how the competitive landscape evolves or how a product’s design matures. Continuation applications, for example, which allow a startup to pursue additional claims based on an already-filed parent application, can be a powerful tool for adapting patent protection to a product as it develops — but this strategy requires that prosecution not close prematurely. The most effective approach is to work with patent counsel to identify the subset of applications that are most strategically critical at any given moment — those most directly tied to lead products, most relevant to upcoming investor milestones, or most vulnerable to competitive challenge — and to concentrate acceleration efforts there, while allowing broader portfolio development to proceed at a pace that preserves maximum flexibility.
This article is part of our Life Sciences Startup IP Resource Center.
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