FAQs Patent Questions

Question:Applications must be in data query within six days under normal circumstances

Answer:
Under normal circumstances the application should be in Data Query (PALM location 7550) less than 6 days. If the application involves special circumstances, (i.e., waiting for drawings, a signed declaration/oath, etc.) the timetable will vary depending on the response needed.

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: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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