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§ 124.1 - Scope.

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This parts sets forth procedures and requirements for APHIS review of applications for the extension of the term of certain patents for veterinary biological products pursuant to 35 U.S.C. 156—Extension of patent term. Responsibilities of APHIS include:

Assisting PTO in determining eligibility for patent term restoration;

Determining the length of a product's regulatory review period;

If petitioned, reviewing and ruling on due diligence challenges to APHIS's regulatory review period determinations; and

Conducting hearings to review initial APHIS findings on due diligence challenges.

The regulations in this part are designed to be used in conjunction with regulations issued by PTO concerning patent term extension which may be found at 37 CFR 1.710 through 1.791.

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§ 124.2 - Definitions.