Patent Information

Because the goal behind all intellectual property types is to further the advancement of innovation in society, all three of the designations have their own parameters for protection expiration. 

When a patent expires or lapses, the invention enters the public domain which anyone can make, use, sell, or import the invention without infringement which helps expand market value and growth. At the time of lapse or expiration, the original creator loses their rights to exclude others from using their work without licensing with the inventor. 

Patent Term Extension (PTE)

PTE compensates patent owners for regulatory delays during the pre-market approval process—mainly time spent waiting for FDA or EPA approval before a drug or product can be sold.

Without this extension, a company might lose years of patent protection while the product sits in regulatory limbo.

How PTE is Calculated

The extension is based on:

• Half the time spent in the investigational phase (clinical trials).
• All the time spent in the review phase (FDA’s review of the New Drug Application).
• Minus any delays caused by the applicant.

Maximum extension: 5 years

The 14-Year Cap Rule

Even if the extension granted is 5 years, the total effective life of the patent after product approval cannot exceed 14 years. Why? Because Congress wanted to strike a balance between:

• Rewarding innovation and investment in drug development
• Ensuring eventual public access to lower-cost generics

Note: "Effective life" is the time between the date the product is first approved for sale (e.g., FDA approval) and the expiration of the extended patent.

So:

• Extended expiration date = Date of FDA approval + up to 14 years (maximum)
• Even if your original patent + extension would last 18 years post-approval, the 14-year limit applies.

Patent Term Adjustment (PTA)

PTA adds extra days to the standard 20-year patent term if the USPTO doesn’t meet certain timeliness benchmarks during the patent examination process. This adjustment can only be applied to utility and plant patents, not design patents. 

Categories of USPTO Delay

PTA is calculated based on three categories of USPTO delay:

• Missed USPTO Deadlines

  • Failure to act within certain time limits:

  • Not issuing a first office action within 14 months of filing

  • Not responding to applicant’s replies within 4 months

  • Not issuing a patent within 4 months of payment of issue fee

• Application Pendency > 3 Years

  • If the patent isn't granted within 3 years of its filing date (excluding delays caused by the applicant).

• Interferences, Appeals, or Secrecy Orders

  • Unusual delays due to:

  • Interference proceedings

  • Appeals to the Patent Trial and Appeal Board (PTAB)

  • Secrecy orders for national security

Can PTA Be Challenged?

Yes!  Applicants can file a request for reconsideration within 2 months if they believe the USPTO miscalculated the delayed applied to the patent. If still dissatisfied, they can appeal to the U.S. District Court for the Eastern District of Virginia.