Requests for patent term extension are submitted to the PTO. The request includes an application which identifies the relevant patent for which the extension is sought along with the patent claims which cover the recently approved product. The application must also disclose other relevant information, such as key dates related to when the government agency first approved commencement of clinical trials, when an application for product approval was submitted, and when approval was obtained.1 These dates are used to determine the regulatory period, which consists of a clinical testing phase and a regulatory approval phase. The regulatory period is used to calculate the patent term extension. While the formulas used to calculate the extension contain a number of exceptions and can be cumbersome, generally speaking, patent term extension is half the clinical phase plus the entire approval phase, not to exceed five years.
The request for extension must be made within 60 days of the product's approval. Generally speaking, this time limit is rigid; however, the U.S. House of Representatives recently approved legislation extending the timeframe for filing a patent term extension application. If the bill becomes law, it will allow applicants to extend the deadline for up to three days upon payment of a $65 million fee.2
Applicants must also demonstrate that significant activities were carried out during the regulatory review period. Finally, applicants must also acknowledge their duty to disclose any information which is material to the determination of entitlement to the extension sought. The fee for requesting a patent term extension is just over $1000.3
After the PTO receives the application for extension, the approval process involves the combined effort of FDA and the PTO. The PTO has 60 days after receipt of an application to notify FDA and request the agency's assistance in verifying the regulatory period. FDA then has 30 days to review its records and determine if the proper regulatory period has been used in the application for term extension. FDA publishes this information in the Federal Register, and that starts a 180-day period, during which the public may file protest petitions. FDA reviews any protests filed within 90 days of receiving the petition and comes to a final determination of the regulatory period. That determination is communicated to the PTO, which then publishes the information in the Federal Register.
Protestors have one last opportunity to challenge the application for patent term extension by requesting a hearing with FDA, which may either revise or affirm the final determination of the regulatory period. This information is then shared with the PTO, which publishes the final decision in the Federal Register. Any further challenges to the decision must be made in court under the Administrative Procedure Act.
Given that the process for reviewing and adjudicating a patent term extension application can easily take a year or more, applicants can also request up to four interim extensions of up to one year each if it appears that the relevant patent may expire before a final decision is made.4 The PTO grants or denies this request based solely on the information disclosed in the original application for extension.
1. Code of Federal Regulations, 37 CFR sect. 1.710–1.785 (July 19, 2007).
2. The U.S. House of Representatives approved HR 6344 by voice vote on June 23, 2008.
3. 37 CFR sect. 1.20(j) (July 19, 2007).
4. 35 USC sect. 156(e)(2) (2006).
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