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This document provides a determination from the FDA regarding the regulatory review periods for various drug products and their eligibility for patent extension under specific acts related to drug

How to fill out determination of regulatory review

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

1. Obtain the appropriate form for Determination of Regulatory Review Period for Purposes of Patent Extension from the relevant regulatory authority.
2. Gather all necessary information regarding the patent, including its number, title, and filing date.
3. Collect data about the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) submission related to the patent.
4. Identify the date of approval of the NDA or ANDA, along with any other relevant milestones during the regulatory process.
5. Fill out the form accurately, providing detailed information on the review period and any pertinent timelines.
6. Review the completed form for accuracy and completeness before submission.
7. Submit the form to the regulatory authority along with any required documents or fees.

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

1. Patent holders seeking to extend the life of their patents related to products approved by the FDA.
2. Pharmaceutical companies looking to maximize the time their exclusive rights apply to their patented drugs.
3. Applicants who have a patent expiring soon and are looking to determine if they qualify for an extension.

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 establishes the length of time a pharmaceutical or biological product was under review by regulatory authorities before it received market approval. This period can be used to calculate potential extensions to the patent term of the product.

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

The applicant of the original New Drug Application (NDA) or Biologics License Application (BLA) is required to file the Determination of Regulatory Review Period for Purposes of Patent Extension with the U.S. Patent and Trademark Office (USPTO).

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 details including the product name, application number, approval date, and the relevant regulatory review periods as determined by the FDA. The form must be completed accurately and submitted to the USPTO for consideration.

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 calculate any eligible patent term extensions for drugs or biologics that have undergone a lengthy regulatory review process. This extension helps compensate for the time during which the patent holder could not commercially exploit the product due to regulatory requirements.

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

The information that must be reported includes the product name, the NDA or BLA number, the approval date, the date of any significant patent-related events, and details regarding the regulatory review history. This includes both the duration of the review and any applicable delays.