FAQs Patent Questions

Question:Applicants must submit amendments to drawings as replacement or new drawings together with explanations of the changes

Answer:
Applicant must submit any amendments to drawings as replacement or new drawings accompanied by explanations of the changes in either the drawing amendment section or remarks section of the amendment paper. Any replacement sheets of drawings must be labeled as "Replacement Sheet" and any new sheets of drawings must be labeled as "New Sheet" in the header.

Question:How long does an applicant holder have to submit patent information?

Answer:
Patent information is required to be submitted with all new drug applications at the time of submission of the NDA. If appropriate, the patent information is published at the time of approval of the NDA. For patents issued after approval of the NDA, the applicant holder has 30 days in which to file the patent to have it considered as a timely filed patent. Patents may still be submitted beyond the 30 day timeframe but the patent is not considered a timely filed patent.

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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