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:Any member of the U.S. Patent and Trademark office are prohibited from applying for a patent.

Answer:
Officers and employees of the United States Patent and Trademark Office are prohibited by law from applying for a patent or acquiring, directly or indirectly, except by inheritance or bequest, any patent or any right or interest in any patent.

Question:Applicants must submit amendments to drawings as replacement or new drawings together with explanations of the changes

Answer:
Applicant must submit any amendments to drawings as replacement or new drawings accompanied by explanations of the changes in either the drawing amendment section or remarks section of the amendment paper. Any replacement sheets of drawings must be labeled as "Replacement Sheet" and any new sheets of drawings must be labeled as "New Sheet" in the header.

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