How should the marketing applicant’s activities be described in a patent term extension application?
The description of the marketing applicant’s activities is an important component of a patent term extension application. According to 37 CFR 1.740(a)(11), the application must include:
“A brief description of the activities undertaken by the marketing applicant before the regulatory agency with respect to the approved product and the significant dates applicable to such activities.“
The MPEP provides guidance on what should be included:
- Identification of significant communications with the regulatory agency
- Dates related to such communications
- Submissions of new data to the FDA
- Communications regarding appropriate testing protocols
- Attempts to define particular requirements for premarketing approval
The MPEP clarifies: “It is sufficient that the description of the activities briefly identify those significant activities undertaken by the marketing applicant directed toward regulatory approval, and a submission of insignificant details or identification of non-substantive communications is not required.“
It’s important to note that the applicant is not required to establish the existence of due diligence during the regulatory review period for a complete application. The focus should be on significant activities that contributed to the regulatory approval process.
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