2756 Correspondence Between the USPTO and the Regulatory Agency
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It is the Director’s responsibility to decide whether an applicant has satisfied the requirements of the statute and whether the patent qualifies for patent term extension.
The regulatory agency possesses expertise and records regarding some of the statutory requirements and has certain direct responsibilities under 35 U.S.C. 156 for determining the length of the regulatory review period.
- Consequently, to facilitate eligibility decisions and permit the regulatory agency and the Office to carry out their responsibilities, both the Food and Drug Administration and the Department of Agriculture have entered into an “agreement” of cooperation with the Office.
The agreements establish the procedures whereby the regulatory agency assists the Office in determining a patent’s eligibility for patent term extension under 35 U.S.C. 156.
- It also establishes procedures for exchanging information between the regulatory agency and the Office regarding regulatory review period determinations, due diligence petitions and informal regulatory agency hearings under the law.
- The patent term extension applicant receives a copy of all correspondence between the Office and the regulatory agency.
I. INFORMATION REGARDING ELIGIBILITY FOR EXTENSION
If the Office has no clear reason to deny eligibility for patent term extension (even if there are questions concerning eligibility), or if the applicant has been notified of any informalities and it is anticipated that the informalities will be corrected or explained, a first letter is sent to the regulatory agency to request information regarding eligibility.
- The letter is accompanied by a copy of the patent term extension application.
- This letter does not request the determination of the applicable regulatory review period.
While the Office has primary responsibility for the eligibility determination, the regulatory agency often possesses information which is not readily available to the Office.
- The assistance on the part of the regulatory agency enables both the Office and the agency to process applications efficiently and to conserve resources.
II. PRELIMINARY ELIGIBILITY DECISION
Upon receipt of a reply from the regulatory agency to the first letter from the Office requesting assistance on determining eligibility, a preliminary eligibility decision (not the final decision) is made as to whether the patent is eligible for an extension of its term.
» 2757 Regulatory Agency Determination of the Length of the Regulatory Review Period
