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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:How many weeks of the Electronic Official Gazette - Patents will be available on the USPTO web site?

Answer:
Current plans are to maintain one year on the web site. To locate patents announced in earlier OGs, search the USPTO Patent Full Text Database by patentee name, keyword, current classification, or patent number.

Question:What is FDA’s role in the Patent Term Restoration Program?

Answer:
FDA’s primary responsibility is to assist the Patent Trademark Office (PTO) in determining a product’s eligibility for patent term restoration and to provide information to PTO regarding a product’s regulatory review period.

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Did You Know?

You may apply for a patent for your invention.

Inventors may apply for one of two types of patent applications: (1) A non-provisional application, which begins the examination process and may lead to a patent and (2) A provisional application, which establishes a filing date but does not begin the examination process.

Contact our Patent Professionals to ensure you complete the patent filing process correctly or for violation of your patent rights.

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 Helpful Patent Terms

Comprising

Definition:
A transitional phrase that is synonymous with means the same thing as inclusive or open-ended and does not exclude additional, unrecited elements or method steps.

Domestic Representative

Definition:
A person residing within the United States who is appointed by a patentee or assignee of a trademark application or registration that does not reside in or is not domiciled within the United States.

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