FAQs Patent Questions

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.

Question:May I write to the USPTO directly about my application after it is filed?

Answer:
The Office will answer an applicant’s inquiries as to the status of the application, and inform you whether your application has been rejected, allowed, or is awaiting action. However, if you have a patent attorney or agent of record in the application file the Office will not correspond with both you and the attorney/agent concerning the merits of your application.

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