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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices ADDRESSES, will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 2404027500.
Confidential SubmissionsTo submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as confidential. Any information marked as confidential will not be disclosed except in accordance with 10.20 21
CFR 10.20 and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https
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FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 3017963600.
SUPPLEMENTARY INFORMATION:

I. Background The Drug Price Competition and Patent Term Restoration Act of 1984
Pub. L. 98417 and the Generic Animal Drug and Patent Term
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Restoration Act Pub. L. 100670
generally provide that a patent may be extended for a period of up to 5 years so long as the patented item human drug or biologic product, animal drug product, medical device, food additive, or color additive was subject to regulatory review by FDA before the item was marketed. Under these acts, a products regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued, FDAs determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C.
156g1B.
FDA has approved for marketing the human biologic product ENHERTU
fam-trastuzumab deruxtecan-nxki.
ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Subsequent to this approval, the USPTO received a patent term restoration application for ENHERTU U.S. Patent Nos. 9,808,537;
10,155,821; and 10,195,288 from Daiichi Sankyo Company, Limited, and the USPTO requested FDAs assistance in determining the patents eligibility for patent term restoration. In a letter dated October 13, 2020, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of ENHERTU represented the first permitted commercial marketing or use
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of the product. Thereafter, the USPTO
requested that FDA determine the products regulatory review period.
II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for ENHERTU is 1,395 days. Of this time, 186 days occurred during the testing phase of the regulatory review period, while 1,209 days occurred during the approval phase. These periods of time were derived from the following dates:
1. The date an exemption under section 505i of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 355i became effective: February 26, 2016.
FDA has verified the applicants claim that the date the investigational new drug application became effective was on February 26, 2016.
2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act 42
U.S.C. 262: August 29, 2019. FDA has verified the applicants claim that the biologics license application BLA for ENHERTU BLA 761139 was initially submitted on August 29, 2019.
3. The date the application was approved: December 20, 2019. FDA has verified the applicants claim that BLA
761139 was approved on December 20, 2019.
This determination of the regulatory review period establishes the maximum potential length of a patent extension.
However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension.
In its applications for patent extension, this applicant seeks 71 days of patent term extension.
III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination see DATES.
Furthermore, as specified in 60.30 21
CFR 60.30, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of 60.30, including but not limited to:
must be timely see DATES, must be filed in accordance with 10.20, must contain sufficient facts to merit an FDA
investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 4142, 1984.

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