FAQs Patent Questions

Question:Applicants may be required to provide speciments of the composition of their invention if necessary.

Answer:
The applicant may be required to furnish specimens of the composition, or of its ingredients or intermediates, for inspection or experiment. If the invention is a microbiological invention, a deposit of the micro-organism involved is required.

Question:The Paris Convention for the Protection of Industrial Property is a treaty relating to patents which is adhered to by 168 countries

Answer:
There is a treaty relating to patents which is adhered to by 168 countries, including the United States, and is known as the Paris Convention for the Protection of Industrial Property.

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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