What is FDA’s role in the Patent Term Restoration Program?
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. As described below, FDA also has the responsibility for due diligence petitions and due diligence hearings. PTO is responsible for determining the period of patent extension. FDA defers to PTO on all matters involving the construction and validity of patent claims. 5. When is a patent extension application submitted and where is it submitted? Application for patent extension must be filed within 60 days of FDA approval of the drug product even if the product cannot be commercially marketed at that time. For example, if a drug product is a controlled substance and cannot be commercially marketed at the time of its approval due to domestic drug scheduling activities, approval occurs on the date FDA notifies the marketing applicant that the NDA for the drug product is
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. As described below, FDA also has the responsibility for due diligence petitions and due diligence hearings. PTO is responsible for determining the period of patent extension. FDA defers to PTO on all matters involving the construction and validity of patent claims.
