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2761 Multiple Applications for Extension of Term of the Same Patent or of Different Patents for the Same Regulatory Review Period for a Product [R-10.2019]

35 U.S.C. 156   Extension of patent term.

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  • (c)(4) in no event shall more than one patent be extended under subsection (e)(1) for the same regulatory review period for any product.

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37 CFR 1.785  Multiple applications for extension of term of the same patent or of different patents for the same regulatory review period for a product.

  • (a) Only one patent may be extended for a regulatory review period for any product (§ 1.720(h)). If more than one application for extension of the same patent is filed, the certificate of extension of patent term, if appropriate, will be issued based upon the first filed application for extension.
  • (b) If more than one application for extension is filed by a single applicant which seeks the extension of the term of two or more patents based upon the same regulatory review period, and the patents are otherwise eligible for extension pursuant to the requirements of this subpart, in the absence of an election by the applicant, the certificate of extension of patent term, if appropriate, will be issued upon the application for extension of the patent term having the earliest date of issuance of those patents for which extension is sought.
  • (c) If an application for extension is filed which seeks the extension of the term of a patent based upon the same regulatory review period as that relied upon in one or more applications for extension pursuant to the requirements of this subpart, the certificate of extension of patent term will be issued on the application only if the patent owner or its agent is the holder of the regulatory approval granted with respect to the regulatory review period.
  • (d) An application for extension shall be considered complete and formal regardless of whether it contains the identification of the holder of the regulatory approval granted with respect to the regulatory review period. When an application contains such information, or is amended to contain such information, it will be considered in determining whether an application is eligible for an extension under this section. A request may be made of any applicant to supply such information within a non-extendable period of not less than one month whenever multiple applications for extension of more than one patent are received and rely upon the same regulatory review period. Failure to provide such information within the period for reply set shall be regarded as conclusively establishing that the applicant is not the holder of the regulatory approval.
  • (e) Determinations made under this section shall be included in the notice of final determination of eligibility for extension of the patent term pursuant to § 1.750 and shall be regarded as part of that determination.

Only one patent may be extended for a single regulatory review period for any product. If more than one application for extension is filed for a single patent by different applicants, the certificate of extension of the term of the patent, if appropriate, would be issued based upon the first filed application for extension of patent term. If a single applicant files more than one application for patent term extension for a single patent based upon the regulatory review period of different products, then the final determination under 37 CFR 1.750 will provide a period of time (usually one month) for the patent owner to elect the product for which extension is desired. An express withdrawal of the applications for extension of the nonelected products should accompany the election. The final determination will indicate that if the patent owner fails to elect a single product within the set time period, the Office will issue a certificate of extension for the patent for a specified one of the products.

If more than one application for extension is filed by a single applicant for the extension of the terms of different patents based upon the same regulatory review period for a product, the certificate of extension will be issued on the application for extension of the patent having the earliest date of issuance of those for which extension is sought unless one patent for which extension has been sought is expressly elected and all others are voluntarily withdrawn by the applicant. This withdrawal is a different situation as compared to MPEP § 2764 where the withdrawal is an express withdrawal under 37 CFR 1.770. When plural patents are found to be eligible for patent term extension based on the same regulatory review of a product, the final determination under 37 CFR 1.750 will provide a period of time (usually one month) for the patent owner to elect the patent for which extension is desired. An express withdrawal of the application(s) for extension of the nonelected patent(s) should accompany the election. A failure to elect within the set time period will result in issuance of a certificate of extension for the patent having the earliest date of issue.

If applications for extension are filed by different applicants for the extension of the terms of different patents based upon the same regulatory review period of a product, the certificate of extension will be issued on the application of the holder of the regulatory approval (marketing applicant). If the marketing applicant is not an applicant for extension, the certificate of extension will issue to the applicant for extension which holds an express authorization from the marketing applicant to rely upon the regulatory review period as the basis for the application for extension. See also 37 CFR 1.785(d).

When multiple applications for term extension are filed for different patents based on the same regulatory review period, it is incumbent upon the applicant for term extension to inform the Office of the various applications for term extension, pursuant to 37 CFR 1.740(a)(13) and 37 CFR 1.765.

In circumstances where extensions of multiple patents have been sought based on a single regulatory review period as per 37 CFR 1.785, where those patents expire on the same day, multiple interim extensions under 35 U.S.C. 156(e)(2) would be permitted. This is possible because 35 U.S.C. 156(c)(4) recites the prohibition that, "in no event shall more than one patent be extended under subsection (e)(1) for the same regulatory review period for any product." The language "under subsection (e)(1)" refers to the certificate of extension only. This language was added in 1993 by section 5 of Public Law 103-179, which was the same time when the interim extension provisions of 35 U.S.C. 156(d)(5) were added, so as to distinguish a final certificate of extension from interim extensions granted under either 35 U.S.C. 156(e)(2) or 35 U.S.C. 156(d)(5).

When multiple approval applications (e.g., more than one NDA or more than one BLA) for the same product are approved on the same day that means that more than one patent can be extended under 35 U.S.C. 156 because each approval application embodies a separate regulatory review period and each approval constitutes the first permitted commercial marketing or use of the product. See, e.g. U.S. Patent No. 6,197,819 and U.S. Patent No. 6,001,876, both patents extended for the same human drug product, Lyrica, where one NDA involved the approval of Lyrica for treatment of neuropathic pain associated with diabetic peripheral neuropathy, and the second NDA for Lyrica (approved on the same day) involved treatment of neuropathic pain associated with herpes zoster (post neuralgia).

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Last Modified: 06/25/2020 18:22:56