FAQs Patent Questions

Question:Is there a specific format in which patent information needs to be submitted to the FDA agency?

Answer:
As of August 18, 2003, patent information is required to be submitted on FDA form 3542a or FDA form 3542 depending on the approval status of the application. Form FDA 3542 is the only form that will be used for Orange Book publication.

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.

Question:Is there a specific format in which patent information needs to be submitted to the FDA agency?

Answer:
As of August 18, 2003, patent information is required to be submitted on FDA form 3542a or FDA form 3542 depending on the approval status of the application. Form FDA 3542 is the only form that will be used for Orange Book publication.

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