Patent Term Extension Only Applies to Approved Product

Frequently Asked Questions on the Patent Term Restoration Program

Application for patent extension must be filed within 60 days of FDA approval of the drug product even if the product cannot be commercially ...

Patent Term Extension Only Applies to Approved Product - JD Supra

The US Court of Appeals for the Federal Circuit found that patent term extension (PTE) only applies to methods of using the approved product as defined under ...

Patent Term Extension - Sterne Kessler

Patent term extension (PTE) is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman ...

Federal Circuit Affirms Patent Term Extension Only Applies to FDA ...

§ 156. This extension of the patent term compensates owners of patents on drug products and medical devices for potential marketing time lost ...

2750-Patent Term Extension for Delays at other Agencies under 35 ...

2011). However, pursuant to 35 U.S.C. 156(b) , if the patent claims other products in addition to the approved product, the exclusive patent rights to the ...

Pharmaceutical Patent Term Extension: An Overview - Alacrita

A “timely” application must be filed within 60 days from the date the drug product receives approval after the applicable regulatory review period. For human ...

2752-Patent Term Extension Applicant - USPTO

If the applicant for patent term extension was not the marketing applicant before the regulatory agency, then there must have been an agency relationship ...

Introduction to Patent Term Extensions (PTE) - Fish & Richardson

For example, for a patent that claims the product, PTE only extends exclusive patent rights to any FDA-approved use for the product.[7] Thus ...

Patent Term Extension - Federal Register

Under 35 U.S.C. 156(d)(5), an interim extension may be granted if the applicable regulatory review period that began for a product is reasonably ...

We Received a Patent Term Extension - Now What?

The extension will cover only the uses that have been approved for the product before the extended patent term expires. If an applicant ...

Patent Term Extension Under 35 U.S.C. § 156 Covers an Active ...

The Federal Circuit affirmed. Section 156 entitles the NDA holder to extend the term of only one patent for the approved product, and limits the scope of that ...

Patent Term Extension Considerations For Regulated Products

A patent eligible for PTE must claim a product (e.g., a human drug), a method of using the product, or a method of manufacturing the product, a ...

Strategic Considerations for Seeking Patent Term Extension (PTE ...

Different indication – If a competitor seeks approval of a drug product for a new indication that was not previously the subject of regulatory ...

Patent Term Extensions and Adjustments - The Library of Congress

Authorization of term extensions for related patents may be granted only for patents that are subject to orders of extension in the recognized countries. The ...

Successfully Navigating the Patent Term Extension Process for FDA ...

Patent term extension (PTE), available for certain patents covering novel, FDA-regulated products, and is designed to restore the portion of a ...

Patent Term Extension under 35 USC § 156 - AIPLA

to the regulatory review period for the approved product: • Includes only time after the date the patent is issued. • Time where applicant failed to ...

Patent Term Extension and the Active Ingredient Problem

PTE exists as a regulatory mechanism to compensate inventors for patent term loss due to unfair regulatory delay during the drug approval ...

Frequently Asked Questions on Patents and Exclusivity - FDA

Exclusivity attaches upon approval of a drug product if the statutory requirements are met. Some drugs have both patent and exclusivity ...

Patent Term Extensions and the Last Man Standing

[45] The statute further specifies that no extension may extend a patent's expiration date beyond fourteen years from the time of the drug's FDA approval.[46] ...

Surely You Must be Kidding, PTO?!? “No, and Don't Call Me Shirley!”

§ 156 and interpretive case law, if an applicant for patent term extension has multiple NDA approvals of a product, PTE applicant can only rely ...