Get the free Application for Patent Term Extension Pursuant to 35 U.S.C. § 156 - fda

This document is an application for a patent term extension for a coronary stent system, detailing the ownership, assignment history, and regulatory compliance related to the patent in question.

How to fill out application for patent term

How to fill out Application for Patent Term Extension Pursuant to 35 U.S.C. § 156

1. Obtain the correct form for the Application for Patent Term Extension from the USPTO website.
2. Fill in the applicant's details, including name, address, and contact information.
3. Provide the patent number and title for the patent you wish to extend.
4. Specify the regulatory review period and the date the patent was issued.
5. Include a statement detailing the period of marketing approval from the FDA or relevant agency.
6. Attach supporting documents that demonstrate the eligibility for extension under 35 U.S.C. § 156.
7. Sign and date the application where indicated.
8. Include the required filing fee and any necessary payment information.
9. Review the completed application for accuracy and completeness.
10. Submit the application to the USPTO using the prescribed methods (online or by mail).

Who needs Application for Patent Term Extension Pursuant to 35 U.S.C. § 156?

1. Individuals or entities holding a valid U.S. patent for a drug or medical device that has received regulatory approval and who wish to extend the term of their patent.
2. Patent owners seeking additional time to market their patented invention after regulatory delays.
3. Companies involved in pharmaceuticals or biotechnology industries that require extensions due to lengthy FDA review processes.

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.

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 patents are eligible for patent term extension?

The Act allows the extension of the term of a patent claiming a product that requires regulatory approval prior to being sold, or a method of using or manufacturing the product. Such products include human and veterinary pharmaceuticals, food additives, color additives and medical devices.

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 necessary conditions to grant a patent ing to Title 35 of the US Code?

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 Section 156 of the patent term extension?

156 enables the owners of patents that claim certain human drug products, medical device products, animal drug products, veterinary biological products, and food or color additive products to restore to the terms of those patents some of the time lost while awaiting premarket Government approval for the products from a

Who is eligible for patent term extension?

Requirements for eligibility: The patent claims a product, a method of using the product, or a method of manufacturing. The patent has not expired. The term of the patent has never been extended.

For pdfFiller’s FAQs

What is Application for Patent Term Extension Pursuant to 35 U.S.C. § 156?

The Application for Patent Term Extension Pursuant to 35 U.S.C. § 156 is a legal request submitted to the United States Patent and Trademark Office (USPTO) to extend the term of a patent due to delays that occurred during the regulatory approval process for a patented product.

Who is required to file Application for Patent Term Extension Pursuant to 35 U.S.C. § 156?

The owner of the patent or the patentee is required to file the Application for Patent Term Extension. This can also include an authorized representative acting on behalf of the patent owner.

How to fill out Application for Patent Term Extension Pursuant to 35 U.S.C. § 156?

To fill out the Application for Patent Term Extension, the applicant must complete the prescribed form provided by the USPTO, provide detailed information regarding the patent, including the number, title, and patent term, as well as information about the regulatory approval that caused the delay.

What is the purpose of Application for Patent Term Extension Pursuant to 35 U.S.C. § 156?

The purpose of the Application for Patent Term Extension is to compensate inventors for time lost due to the regulatory process, thereby ensuring that the effective patent life of the invention is fair and equitable considering the time spent in obtaining necessary approvals.

What information must be reported on Application for Patent Term Extension Pursuant to 35 U.S.C. § 156?

The information that must be reported includes the patent number, a description of the product or process covered by the patent, details about the regulatory approval process, and the specific period of delay caused by such regulatory review.