What is the regulatory review period in patent term extension?

The regulatory review period is a crucial component in calculating patent term extension. According to 35 U.S.C. 156(g), the regulatory review period has specific meanings for different types of products. MPEP 2758 states: “The Office will rely on the Secretary’s determination of the length of the regulatory review period when calculating the length of the…

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What information about the regulatory review period must be included in a patent term extension application?

A patent term extension application must include specific information about the regulatory review period as outlined in 37 CFR 1.740(a)(10). The required information varies depending on the type of product: For human drugs, antibiotics, and biological products: Effective date and number of the investigational new drug (IND) application Date and number of the new drug…

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