FAQs Patent Questions

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).

Question:How many weeks of the Electronic Official Gazette - Patents will be available on the USPTO web site?

Answer:
Current plans are to maintain one year on the web site. To locate patents announced in earlier OGs, search the USPTO Patent Full Text Database by patentee name, keyword, current classification, or patent number.

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.

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