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This document outlines the FDA's determination of the regulatory review period for the drug JEVTANA, which is necessary for patent term extension applications.

How to fill out determination of regulatory review

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

1. Obtain the official form for the Determination of Regulatory Review Period for Purposes of Patent Extension.
2. Review the guidance provided by the relevant regulatory authority regarding the patent extension process.
3. Gather all necessary data regarding the drug JEVTANA, including approval dates and any significant milestones.
4. Fill out the required sections of the form accurately, ensuring that all dates correspond to the information on record.
5. Attach any supplementary documentation that supports the determination of the regulatory review period.
6. Double-check for accuracy and completeness before submission.
7. Submit the completed form to the appropriate regulatory authority for review.

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

1. Pharmaceutical companies that have developed JEVTANA and wish to seek patent extension.
2. Legal teams within pharmaceutical companies managing intellectual property rights.
3. Regulatory affairs professionals involved in the compliance of patent laws for drug extensions.

People Also Ask about

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.

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

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.

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.

How long is a drug patent effective once FDA approval is obtained?

Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Many other factors can affect the duration of a patent. 3.

What is a patent term extension for biologics?

Patent Term Extension (PTE) under 35 U.S.C. 156 enables the owners of patent that claim certain human drug products, medical device products, animal drug products, veterinary biological products to restore to the terms of those patents some of the time lost while awaiting premarket regulatory approvals.

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 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.

For pdfFiller’s FAQs

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

The Determination of Regulatory Review Period for Purposes of Patent Extension for JEVTANA is a process that establishes the duration of the regulatory review period before a drug can be granted patent extension, allowing for additional market exclusivity beyond the original patent expiration date.

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

The manufacturer or the sponsor of the drug JEVTANA is required to file the Determination of Regulatory Review Period for Purposes of Patent Extension.

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

To fill out the Determination of Regulatory Review Period, one must provide specific information regarding the drug’s approval date, patent details, and any related regulatory actions, ensuring that all necessary fields are completed accurately.

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

The purpose of the Determination of Regulatory Review Period is to identify the eligible time frame during which a drug was reviewed by regulatory bodies to justify an extension of its patent term, thereby enabling ongoing market protection for the brand.

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

The information that must be reported includes the drug’s approval date, the duration of the regulatory review period, patent numbers, and any relevant correspondence or actions taken by the FDA during the review process.