Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could not be marketed. PTE is available for patents covering certain human drugs, food or color additives, animal drugs, veterinary biological products, and medical devices. On average, a granted PTE application adds 1059 days (nearly three years) to a patent’s term.[1]
Although PTE is available for medical device patents, it has previously been underutilized in this area. A study examining PTE applications from 1984-2024 found that only 125 PTE applications were granted for medical devices during that period, while 670 PTE applications were granted for drugs and an additional 140 were granted for biologics.[2] The study’s authors speculated that this may be due at least in part to the fact that not all medical devices are eligible for PTE. However, even taking this into account, the number of PTE applications for medical devices still appears lower than expected based on the total number of eligible device-related regulatory submissions.[3]
Medical Device Eligibility Criteria
As noted above, not all medical devices are eligible for PTE. Devices subject to review under section 515 of the Federal Food, Drug, and Cosmetic Act (FFDCA) are eligible for PTE under 35 U.S.C. § 156. Section 515 applies to class III medical devices, which are high-risk medical devices that are life-sustaining or critical to human health and must undergo pre-market approval.[4] Other types of medical devices, including class II devices that undergo regulatory review under section 510(k) of the FFDCA instead of section 515, are not eligible for PTE.
As with all PTE-eligible products, only one patent corresponding to a given regulatory review period can receive PTE.[5] Thus, if multiple patents cover a medical device subject to a single regulatory review period, only one of those patents can receive PTE. Furthermore, the PTE must be based on the first approval for the product under the provision of law under which such regulatory review period occurred.[6]
Patent Term Extension Application Process
Any application for PTE, regardless of whether the application is for a medical device, drug, or other eligible product, must be submitted to the USPTO Director within the 60-day period beginning on the date when the product received regulatory approval.[7] A narrow exception is available if the patent is set to expire before regulatory approval is obtained, in which case an interim extension may be requested starting six months before and ending 15 days before the patent is set to expire.[8]
An application for PTE must contain the identity of the approved product and the federal statute under which regulatory review occurred. The application must also identify the patent for which PTE is being sought and list one or more claims that cover the approved product. Additionally, the application must contain “information to enable the Director to determine…the eligibility of a patent for extension and the rights that will be derived from the extension.”[9] This includes information about the term of the patent, the nature of the product, details regarding the regulatory review period, and approved uses for the product. Furthermore, the application must include a brief description of activities undertaken by the applicant during the applicable regulatory review period and “such patent or other information as the Director may require.”
If the Director determines that the patent is eligible for PTE and that the above requirements have been satisfied, the Director will issue a certificate of extension.
Length of Patent Term Extension
The length of PTE for a medical device is calculated based on the portion of the regulatory review period for the device that occurred after the patent’s issue date. The post-issuance regulatory review period is reduced by any amount of time that the applicant failed to exercise due diligence during the regulatory review period.[10] That figure is then reduced by one-half of the post-issuance testing period to arrive at the final PTE duration.[11]
In any case, the amount of PTE available for any given application may not exceed five years, and the PTE may not extend the term of the patent beyond fourteen years from regulatory approval.[12] As noted above, the average amount of PTE granted is almost three years. It should be noted that there are limitations on a patent holder’s enforcement rights during the PTE period of a patent’s term. During this period, enforcement of the patent is limited to any use of the approved device that was approved before the expiration of the original term of the patent and on or after the expiration of the regulatory review period upon which the PTE was based.[13]
Practice Tips for Effective Medical Device Patent Term Extension Applications
As a preliminary matter, applicants should reach out to patent and regulatory counsel when seeking to patent a medical device to determine if the patent is eligible for PTE. If an applicant is seeking multiple potentially eligible patents directed to a single device, the applicant should work with counsel to select the best patent(s) for which to request PTE. As noted above, 35 U.S.C. § 156(c)(4) provides that only one patent corresponding to a given regulatory review period can receive PTE. However, applicants can still apply for PTE on multiple patents and withdraw all but one of the applications near the end of the process. Because the PTE application process can be lengthy, this approach can maximize the amount of time available to applicants to decide which patent should ultimately receive PTE. When it comes time to select which patents should receive PTE, applicants should consider factors such as the scope of protection afforded by each patent, the strength of the patent against potential invalidity challenges, and the expiration date of the patent.
In addition, applicants should ensure that their applications comply with all statutory requirements and include sufficient details to allow the Director to make a determination regarding PTE eligibility. Under 35 U.S.C. § 156(e), the Director’s determination that a patent is eligible for extension may be made “solely on the basis of the representations contained in the application for the extension” (emphasis added). Accordingly, applicants should ensure that their applications for PTE are thorough and complete prior to submission.
Finally, applicants should take actions that maximize PTE duration. For example, applicants should prioritize early issuance of patents that may be candidates to receive PTE. Because the PTE calculation is based on the post-issuance regulatory review period, achieving early issuance can help an applicant accrue as much PTE as possible. Applicants should also act with due diligence during regulatory review. As discussed above, PTE is reduced by any amount of time that the applicant fails to exercise due diligence during the regulatory review period. Thus, applicants should take care to abide by deadlines and be responsive to requests or other communications from the FDA to avoid unnecessary reductions in PTE.
[1] “Applications for patent term extension and patent terms extended under 35 U.S.C. § 156.” United States Patent and Trademark Office, https://www.uspto.gov/patents/laws/patent-term-extension/patent-terms-extended-under-35-usc-156, accessed Nov. 19, 2024.
[2] Kuo, C. Benson, and Frances Richmond. “Use of patent term extensions to restore regulatory time for medical devices in the United States.” Expert review of medical devices, 1-7, June 3 2024, doi:10.1080/17434440.2024.2363298.
[3] Id.
[4] 21 U.S.C. § 360e.
[5] 35 U.S.C. § 156(c)(4).
[6] 35 U.S.C. § 156(a)(5).
[7] 35 U.S.C. § 156(d)(1).
[8] 35 U.S.C. § 156(d)(5).
[9] 35 U.S.C. § 156(d)(1)(C).
[10] 35 U.S.C. § 156(c).
[11] Id.; MPEP § 2758.
[12] 35 U.S.C. § 156(g)(6)(A); 35 U.S.C. 156(c)(3).
[13] 35 U.S.C. § 156(b)(1).