Get the free Application for Patent Term Extension - fda

This document serves as an application for extending the patent term for the USPN 6,344,053 in accordance with 35 U.S.C. § 156, indicating eligibility and relevant details regarding regulatory approvals

How to fill out application for patent term

How to fill out Application for Patent Term Extension

1. Obtain the Application for Patent Term Extension form from the United States Patent and Trademark Office (USPTO) website.
2. Fill out the applicant's information, including name, address, and contact details.
3. Provide the patent number and title for the patent you are seeking an extension for.
4. Specify the regulatory review period that applies to the patent.
5. Include documentation that supports the request for an extension, such as proof of the regulatory review period.
6. Review the application for completeness and accuracy.
7. Sign and date the application.
8. Submit the application to the USPTO, along with the required fee.

Who needs Application for Patent Term Extension?

1. Patent holders whose patents have been delayed due to regulatory review processes.
2. Inventors or companies seeking to extend the exclusivity period of their patented inventions to maximize their market potential.
3. Entities that have invested in the development of products requiring regulatory approvals.

People Also Ask about

What is an example of a patent term extension?

For example, if an approved drug product which is eligible for the maximum of five years of extension had ten years of original patent term left at the end of its regulatory review period, then only four of the five years could be counted towards extension.

What is a PTE patent?

Patent Term. Extensions. Patent term extensions (PTE) extend the term of a patent covering a pharmaceutical product that undergoes regulatory review in order to obtain marketing authorization. There are two principal types of PTE: patent term restoration and pediatric exclusivity. Patent Term Restoration.

What is the difference between PTA and PTE?

• PTE is the sum of the “testing period” and the “approval period,” less: ◊ The number of days which were on or before the patent issued. ◊ The number of days during which the applicant did not act with due diligence. ◊ One-half the number of days of the testing period after the patent issued.

What is a PTE application?

Patents filed and granted on or after June 8, 1995 typically expire twenty years from the date of the first filing of the patent application ("patent term").[2] However, the patent term may be modified. Here, we discuss one way of extending patent term called "Patent Term Extension" or "PTE."[

How do you extend a patent term?

In order to obtain an extension under 35 USC § 156, the applicant must disclose information which indicates that a patent term extension is appropriate for the patent in question. The application must be submitted within 60 days of receiving regulatory approval.

What is a utility patent application?

* Utility Patent- Issued for the invention of a new and useful process, machine, manufacture, or composition of matter, or a new and useful improvement thereof, it generally permits its owner to exclude others from making, using, or selling the invention for a period of up to twenty years from the date of patent

How to calculate pte patent term extension?

The length of a PTE award is equal to the sum of one-half of the time in the testing phase and the time in the approval phase, after the date the patent is issued, less any period during which the applicant was not diligent. The equation is: Period of Extension (PTE) = RRP – PGRRP – DD – ½(TP-PGTP).

For pdfFiller’s FAQs

What is Application for Patent Term Extension?

An Application for Patent Term Extension is a request submitted to extend the duration of a patent beyond its standard term, usually due to regulatory delays in obtaining approval for the product the patent covers.

Who is required to file Application for Patent Term Extension?

The patent owner or the authorized agent of the patent owner is required to file the Application for Patent Term Extension.

How to fill out Application for Patent Term Extension?

To fill out the Application for Patent Term Extension, you need to complete the appropriate forms provided by the patent office, provide necessary information regarding the patent, including its details, the regulatory approval process, and justify the need for an extension.

What is the purpose of Application for Patent Term Extension?

The purpose of the Application for Patent Term Extension is to compensate patent owners for the time taken to obtain regulatory approvals, ensuring that they gain appropriate protection for their inventions.

What information must be reported on Application for Patent Term Extension?

The information that must be reported includes the patent number, the date of issuance, details of the regulatory approval process, the period of delay, and any other pertinent information supporting the request for an extension.