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:The requirements for filing a substitute specification is stated under the 37 CFR 1.125

Answer:
When applicants file a substitute specification, the following are required under 37 CFR 1.125: (1) a statement that the substitute specification includes no new matter; (2) a marked-up version of the specification with markings to show all the changes relative to the immediate prior version; and (3) a clean version of the substitute specification.

Question:Applicants can reinstate a cancelled claim by presenting the text of the canceled claim with the changes in a new claim

Answer:
Applicant can reinstate a canceled claim by presenting the text of the canceled claim with any desired changes in a new claim with a new claim number and use the status identifier, (new).

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