FAQs Patent Questions

Question:All submitted drawings must be drawn on strong, white, smooth, non-shiny paper

Answer:
Drawings submitted to the Office must be made on paper which is flexible, strong, white, smooth, non-shiny, and durable. All sheets must be reasonably free from cracks, creases, and folds. Only one side of the sheet may be used for the drawing.

Question:Amendments to drawings filed after allowance are entered by the office of publications.

Answer:
Amendments to drawings filed after allowance are entered by the Office of Publications. If such amendment is forwarded to the examiner, the examiner should forward or return the application to the Office of Publications.

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.

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