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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in Instructions.
Instructions: All submissions received must include the Docket Nos. FDA
2020E1318, FDA2020E1319, FDA2020E1320, FDA2020E1321, FDA2020E1322, and FDA2020E
1323 for Determination of Regulatory Review Period for Purposes of Patent Extension; VYONDYS 53. Received comments, those filed in a timely manner see 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
www.regulations.gov and insert the docket number, found in brackets in the
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heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
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 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 drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug 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 drug 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 drug product VYONDYS 53
golodirsen. VYONDYS 53 is indicated for the treatment of Duchenne muscular dystrophy DMD in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53. Continued approval for this indication may be
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contingent upon verification of a clinical benefit in confirmatory trials.
Subsequent to this approval, the USPTO
received patent term restoration applications for VYONDYS 53 U.S.
Patent Nos. 9,024,007; 9,994,851;
10,227,590; 10,266,827; 10,421,966; and RE47,691 from The University of Western Australia, and the USPTO
requested FDAs assistance in determining the patents eligibility for patent term restoration. In a letter dated July 14, 2020, FDA advised the USPTO
that this human drug product had undergone a regulatory review period and that the approval of VYONDYS 53
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 VYONDYS 53 is 1,833 days. Of this time, 1,474 days occurred during the testing phase of the regulatory review period, while 359 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 FD&C Act 21 U.S.C.
355i became effective: December 7, 2014. The University of Western Australia claims that January 28, 2016, is the date the investigational new drug application IND became effective.
However, FDA records indicate that the INDs first effective date was December 7, 2014, which was 30 days after FDA
receipt of the IND.
2. The date the application was initially submitted with respect to the human drug product under section 505
of the FD&C Act: December 19, 2018.
FDA has verified the applicants claim that the new drug application NDA for VYONDYS 53 NDA 211970 was initially submitted on December 19, 2018.
3. The date the application was approved: December 12, 2019. FDA has verified the applicants claim that NDA
211970 was approved on December 12, 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 80 days, 124 days, 276 days, 454 days, or 888 days of patent term extension.

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