FAQs Patent Questions

Question:What is a regulatory review period determination?

Answer:
The regulatory review period is the basis for patent extension. Basically, a regulatory review period is composed of two parts: a testing phase, and an approval phase. The testing phase for a human drug product is the period between the effective date of an investigational product exemption (Investigational New Drug Application) and the initial submission of the marketing application (New Drug Application).

Question:An application is abandonned if payments are not made in time

Answer:
If timely payment of the fee(s) is not made, the application will be regarded as abandoned.

Question:Amendment documents that changes an existing claim must include a complete listing of all claims presented

Answer:
Any amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented.

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