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This document provides a notice from the FDA regarding the determination of the regulatory review period for specific human and animal drug products for the purposes of patent extensions under the

How to fill out determination of regulatory review

How to fill out Determination of Regulatory Review Period for Purposes of Patent Extension

1. Read the instructions for the Determination of Regulatory Review Period form carefully.
2. Gather all necessary information about the drug product, including its approval date and any relevant patent numbers.
3. Complete the identification section, providing details such as the name of the product, the applicant’s name, and contact information.
4. Fill out the regulatory review period section by providing the dates of the regulatory submissions and approvals.
5. Detail any significant actions taken by the regulatory agency during the review process.
6. Review the completed form for accuracy and completeness.
7. Submit the form to the appropriate regulatory agency along with any required fees or documentation.

Who needs Determination of Regulatory Review Period for Purposes of Patent Extension?

1. Pharmaceutical companies seeking to extend the patent life of their drug products.
2. Research organizations involved in drug development.
3. Legal professionals handling intellectual property matters in the pharmaceutical industry.

People Also Ask about

Who is eligible for patent term extension?

(a) A patent is eligible for extension of the patent term if the patent claims a product as defined in paragraph (b) of this section, either alone or in combination with other ingredients that read on a composition that received permission for commercial marketing or use, or a method of using such a product, or a

Can a US patent be extended beyond 20 years?

Patents in the U.S. typically have a set lifespan that cannot be extended under normal circumstances. For utility patents, which protect the functional aspects of an invention, the duration is 20 years from the filing date.

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.

How to calculate patent term extension in the US?

Calculation of the Length of 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 the rule 7 of the patent law?

Explanation - Where a startup or small entity, having filed an application for a patent, ceases to be a startup or small entity due to the lapse of the period during which it is recognized by the competent authority, or its turnover subsequently crosses the financial threshold limit as notified by the competent

What's the time frame for a patent extension?

How many months can a patent response be extended? If more time is needed to respond to a substantive Office Action, a maximum three-month extension of time may be requested giving the applicant a maximum total of six months from the date of the Office Action.

What are the rules for patent extension?

In all cases, the total patent life for the product with the patent extension cannot exceed 14 years from the product's approval date, or in other words, 14 years of potential marketing time. If the patent life of the product after approval has 14 or more years, the product would not be eligible for patent extension.

Can you extend a patent term?

An applicant may not apply for more than four interim extensions and each extension may be for no more than one year. 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.

What's the time frame for a patent extension?

How many months can a patent response be extended? If more time is needed to respond to a substantive Office Action, a maximum three-month extension of time may be requested giving the applicant a maximum total of six months from the date of the Office Action.

For pdfFiller’s FAQs

What is Determination of Regulatory Review Period for Purposes of Patent Extension?

The Determination of Regulatory Review Period for Purposes of Patent Extension is a process that evaluates the length of time a drug product has undergone regulatory review by the FDA. This review period is used to calculate eligibility for patent term extension under the Drug Price Competition and Patent Term Restoration Act.

Who is required to file Determination of Regulatory Review Period for Purposes of Patent Extension?

The applicant seeking a patent term extension, typically the patent owner or an authorized representative, is required to file the Determination of Regulatory Review Period for Purposes of Patent Extension with the FDA.

How to fill out Determination of Regulatory Review Period for Purposes of Patent Extension?

To fill out the Determination of Regulatory Review Period, applicants must provide specific information including the product name, the patent number, the date of approval by the FDA, and the dates of the regulatory review period, along with any relevant supporting documentation.

What is the purpose of Determination of Regulatory Review Period for Purposes of Patent Extension?

The purpose of the Determination of Regulatory Review Period is to establish the time period during which the FDA reviewed a drug product, which is crucial for determining the length of any patent term extension that the patent owner may be entitled to.

What information must be reported on Determination of Regulatory Review Period for Purposes of Patent Extension?

The information that must be reported includes the FDA application number, product name, patent number, dates pertinent to the regulatory review (including submission and approval dates), and the basis for the regulatory review period calculation.