Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

Patent extension applications would be subject to "due diligence" reviews by FDA only when the agency is petitioned by a third party to make the evaluation, according to the revised patent extension proposal contained in the April 25 draft of Rep. Waxman's bill. The revised patent extension section deletes from the original proposal a triggering mechanism for due diligence determinations. Under the original proposal, FDA would automatically determine if the patent holder pursued an NDA diligently if the IND phase of the regulatory review period exceeded four years, or if the NDA phase exceeded 18 months. If FDA's review concluded that a pioneer sponsor was responsible for prolonging the review period, that delay would be subtracted from the amount of patent extension granted to the applicant. The new draft adds a requirement that patent holders seeking patent extension must include in their applications "a brief description of the activities undertaken by the applicant during the applicable regulatory review period." The information could serve as a basis for third parties petitioning for due diligence reviews. The change in the due diligence provision is the one major revision in the patent extension section of Rep. Waxman's original draft. One other addition to the original draft would allow the Commissioner of Patents and Trademarks to grant a one year temporary patent extension to a product. The provision states that "if the term of a patent for which an application has been submitted expires before a determination is made concerning patent extension, the Commissioner may, in his discretion, extend the term of the patent for one year if he determines that the patent is eligible for extension."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts