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US Patent Term Adjustments - Extending Patent Life Through Strategic Prosecution
In high-investment sectors such as pharmaceuticals and biotechnology, where every additional day of patent protection can translate into significant financial benefits, Patent Term Adjustment (PTA) is a critical tool that compensates for delays caused by the USPTO during the prosecution process.
In this article we will go over the fundamentals of PTA, outline its calculation methods, and discuss strategic approaches. We will also compare PTA with other extension mechanisms like Patent Term Extension (PTE) and Supplementary Protection Certificates (SPCs).
Understanding Patent Term Adjustment
PTA is a mechanism set forth under 35 U.S.C. § 154(b) that provides patent applicants with additional days on top of the standard 20-year patent term. This extension is earned when the USPTO fails to meet certain deadlines during patent prosecution. These extra days help ensure that the patent’s effective life reflects only the period of exclusivity the applicant could control, excluding delays attributable to USPTO inaction.
The "14-4-4-4-36" Timeframe
One of the central components of the PTA calculation is meeting the USPTO’s specific deadlines, often referred to by the industry shorthand “14-4-4-4-36.” This represents:
- 14 months for issuance of the first Office Action following a nonprovisional filing;
- 4 months for subsequent Office actions or examiner responses after an applicant’s reply;
- 4 months for responses following a PTAB or court decision;
- 4 months to issue a patent after payment of the issue fee;
- 36 months as the target for total prosecution time from filing to issuance.
By compensating for these delays, the PTA can extend a patent’s exclusivity.
Delay Categories and Calculation Methods
PTA is calculated by summing delays caused by the USPTO and subtracting any delays attributable to the applicant’s actions. Let’s break down these categories:
1. Type A Delay
Type A delays occur when the USPTO misses statutory deadlines, such as failing to issue a first Office Action within 14 months of filing or not responding to an applicant’s reply within 4 months. These deadlines form part of the USPTO’s commitment to timely examination processes.
2. Type B Delay
Type B delays arise when a patent is not issued within three years from its filing date. These delays are calculated from the three-year mark until the actual issuance date, excluding periods caused by actions like Requests for Continued Examination (RCEs) that the applicant initiates.
3. Type C Delay
Type C delays compensate for additional USPTO delays due to appeals, secrecy orders, or interference proceedings. Each day in these categories is added to the PTA, ensuring that any substantial procedural holdups are accounted for.
In addition to these USPTO delays, any delay attributable to the applicant, such as late responses to Office Actions or supplemental filings, will reduce the total PTA. These delays are subtracted from the total PTA since they reflect a lack of diligence on the applicant’s part.
Overall Calculation Formula
In essence, the Total PTA is calculated as:
Total PTA = (Type A + Type B + Type C Delays) – Applicant Delay – Overlapping Days
This “day-for-day” adjustment ensures that only USPTO-caused delays add extra days to a patent’s life.
Strategic Approaches to get the most out of PTA
Effective patent prosecution isn’t just about drafting strong applications. It’s also about managing the process to avoid unnecessary delays. Here are several key strategies:
Timely & Complete Responses:
Respond to USPTO communications within the standard three‑month period and ensure all submissions, including amendments, are thorough and filed on time to avoid applicant delay and unnecessary extensions.
Leveraging Office Actions & Appeals:
Consider strategic appeals (e.g., filing a notice of appeal instead of an RCE) to continue accruing beneficial delays.
Utilizing Patent Analytics:
Use real-time patent dashboards like PatSeer for patent monitoring, track PTA accrual trends, and make data-driven decisions to proactively manage your patent prosecution strategy.
Comparing PTA with PTE and SPCs
| Mechanism | Scope & Focus | Calculation / Extension Limits | Region | Purpose |
|---|---|---|---|---|
| Patent Term Adjustment (PTA) | Compensates for delays during USPTO prosecution | Earns additional days based on USPTO delays (Type A, B, C) minus any applicant delays; "day-for-day" adjustment | United States | Ensures the patent term reflects delays caused by the USPTO during prosecution |
| Patent Term Extension (PTE) | Addresses delays in regulatory approval (e.g., FDA review) | Can extend the patent term by up to 5 years, or ensure protection lasts up to a maximum of 14 years post-approval | United States | Recovers time lost during regulatory review to extend market exclusivity |
| Supplementary Protection Certificates (SPCs) | Compensates for regulatory delays after the patent's expiry | Provides an extension of protection that covers the period of regulatory delay beyond the patent term | Europe | Extends protection to compensate for regulatory delays after the original patent expires |
Read more about PTE and SPCs here.
Current Trends and Their Impact
Recent data from the USPTO Patent Term Adjustment Dashboard shows that:
- A growing number of patents in pharmaceuticals and biotechnology benefit from PTA due to complex and extended prosecution phases.
- Companies are increasingly monitoring PTA metrics to optimize their patent litigation strategies.
A few recent court decisions have significantly impacted PTA calculation and strategy. Two of the most prominent ones are:
These cases underscore the importance of properly asserting PTA rights.
- Supernus Pharm. v. Iancu – In this case, the court clarified that USPTO-induced delays occurring on the same calendar day, (overlapping delays) are counted only once in the calculation of PTA. The ruling ensures that only those delays that the applicant cannot control are rewarded. This decision reinforces that applicants should not be penalized for periods during which they had no opportunity to advance prosecution.
- Gilead v. Lee and Supernus v. Iancu. – Recent Gilead decisions have underscored a similar principle, focusing on the impact of applicant-caused delays. The courts in these cases have held that any delay by the applicant (such as late responses to Office actions or other procedural missteps) must be deducted from the available PTA.
Conclusion
Extending patent terms is not merely a procedural need, it’s a critical business strategy. By understanding PTA calculation, actively managing timelines, and utilizing patent analytics tools, patent holders can secure valuable additional days of market exclusivity. Staying updated with evolving legal precedents and emerging technologies further enhances the ability to protect and capitalize on your IP portfolio.
PatSeer caters to a diverse clientele, transforming information into actionable intelligence. This allows companies to develop strategic patent portfolios and anticipate market entry opportunities. With precise exclusivity timelines that factor both PTA and Terminal Disclaimers, and robust legal status field codes for filtering extension data, we help you make informed R&D decisions.
