FAQs Patent Questions

Question:What is FDA’s role in the Patent Term Restoration Program?

Answer:
FDA’s primary responsibility is to assist the Patent Trademark Office (PTO) in determining a product’s eligibility for patent term restoration and to provide information to PTO regarding a product’s regulatory review period.

Question:Is there any danger that the USPTO will give others information contained in my application while it is pending?

Answer:
Most patent applications filed on or after November 29, 2000, will be published 18 months after the filing date of the application, or any earlier filing date relied upon under Title 35, United States Code. Otherwise, all patent applications are maintained in the strictest confidence until the patent is issued or the application is published. After the application has been published, however, a member of the public may request a copy of the application file.

Question:What is a regulatory review period determination?

Answer:
The regulatory review period is the basis for patent extension. Basically, a regulatory review period is composed of two parts: a testing phase, and an approval phase. The testing phase for a human drug product is the period between the effective date of an investigational product exemption (Investigational New Drug Application) and the initial submission of the marketing application (New Drug Application).

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