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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices
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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 AJOVY
fremanezumab-vfrm. AJOVY is indicated for the preventive treatment of migraine in adults. Subsequent to this approval, the USPTO received a patent term restoration application for AJOVY
U.S. Patent No. 8,007,794 from Teva Pharmaceuticals International GmbH, and the USPTO requested FDAs assistance in determining this patents eligibility for patent term restoration. In a letter dated July 14, 2020, FDA
advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of AJOVY represented the first permitted commercial marketing or use 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 AJOVY is 3,216 days. Of this time, 2,882
days occurred during the testing phase of the regulatory review period, while 334 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: November 26, 2009.
The applicant claims November 19, 2009, as the date the investigational new drug application IND became effective.
However, FDA records indicate that the IND effective date was November 26, 2009, which was 30 days after FDA
receipt of the IND.
2. The date the application was initially submitted with respect to the
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human biological product under section 351 of the Public Health Service Act 42
U.S.C. 262: October 16, 2017. FDA has verified the applicants claim that the biologics license application BLA for AJOVY BLA 761089 was initially submitted on October 16, 2017.
3. The date the application was approved: September 14, 2018. FDA has verified the applicants claim that BLA
761089 was approved on September 14, 2018.
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 application for patent extension, this applicant seeks 1,454 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.
Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https www.regulations.gov at Docket No. FDA2013S0610. Submit written petitions two copies are required to the Dockets Management Staff HFA305, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: July 2, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10d of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552bc4 and 552bc6, Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis Panel;
Neurodevelopmental and Neurological Disorders.
Date: August 3, 2021.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 Virtual Meeting.
Contact Person: Samuel C. Edwards, Ph.D., Chief, BDCN IRG, Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, 301 4351246, edwardss@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Eye Disease and Infections.
Date: August 5, 2021.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 Virtual Meeting.
Contact Person: Alessandra C. Rovescalli, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Rm 5205, MSC 7846, Bethesda, MD 20892, 301 435
1021, rovescaa@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cognitive and Neuropathological Signatures of Alzheimers Disease, Brain Injury and Aging.
Date: August 5, 2021.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
Virtual Meeting.
Contact Person: Samuel C. Edwards, Ph.D., Chief, BDCN IRG, Center for Scientific Review, National Institutes of Health, 6701

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