Determination of Regulatory Review Period for Purposes of Patent Extension; INTRAROSA

Published date18 February 2020
Citation85 FR 8879
Record Number2020-03115
SectionNotices
CourtFood And Drug Administration
Federal Register, Volume 85 Issue 32 (Tuesday, February 18, 2020)
[Federal Register Volume 85, Number 32 (Tuesday, February 18, 2020)]
                [Notices]
                [Pages 8879-8881]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-03115]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                [Docket Nos. FDA-2017-E-5899 and FDA-2017-E-5911]
                Determination of Regulatory Review Period for Purposes of Patent
                Extension; INTRAROSA
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Notice.
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                SUMMARY: The Food and Drug Administration (FDA or the Agency) has
                determined the regulatory review period for INTRAROSA and is publishing
                this notice of that determination as required by law. FDA has made the
                determination because of the submission of applications to the Director
                of the U.S. Patent and Trademark Office (USPTO), Department of
                Commerce, for the extension of a patent which claims that human drug
                product.
                DATES: Anyone with knowledge that any of the dates as published (see
                SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
                or written comments and ask for a redetermination by April 20, 2020.
                Furthermore, any interested person may petition FDA for a determination
                regarding whether the applicant for extension acted with due diligence
                during the regulatory review period by August 17, 2020. See
                ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
                information.
                ADDRESSES: You may submit comments as follows. Please note that late,
                untimely filed comments will not be considered. Electronic comments
                must be submitted on or before April 20, 2020. The https://www.regulations.gov electronic filing system will accept comments until
                11:59 p.m. Eastern Time at the end of April 20, 2020. Comments received
                by mail/hand delivery/courier (for written/paper submissions) will be
                considered timely if they are postmarked or the delivery service
                acceptance receipt is on or before that date.
                Electronic Submissions
                 Submit electronic comments in the following way:
                [[Page 8880]]
                 Federal eRulemaking Portal: https://www.regulations.gov.
                Follow the instructions for submitting comments. Comments submitted
                electronically, including attachments, to https://www.regulations.gov
                will be posted to the docket unchanged. Because your comment will be
                made public, you are solely responsible for ensuring that your comment
                does not include any confidential information that you or a third party
                may not wish to be posted, such as medical information, your or anyone
                else's Social Security number, or confidential business information,
                such as a manufacturing process. Please note that if you include your
                name, contact information, or other information that identifies you in
                the body of your comments, that information will be posted on https://www.regulations.gov.
                 If you want to submit a comment with confidential
                information that you do not wish to be made available to the public,
                submit the comment as a written/paper submission and in the manner
                detailed (see ``Written/Paper Submissions'' and ``Instructions'').
                Written/Paper Submissions
                 Submit written/paper submissions as follows:
                 Mail/Hand Delivery/Courier (for written/paper
                submissions): Dockets Management Staff (HFA-305), Food and 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-2017-E-5899 and FDA-2017-E-5911 for ``Determination of Regulatory
                Review Period for Purposes of Patent Extension; INTRAROSA.'' 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.
                 Confidential Submissions--To 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 Sec. 10.20 (21 CFR 10.20) and
                other applicable disclosure law. For more information about FDA's
                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-2015-09-18/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 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.
                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, 301-796-3600.
                SUPPLEMENTARY INFORMATION:
                I. Background
                 The Drug Price Competition and Patent Term Restoration Act of 1984
                (Pub. L. 98-417) and the Generic Animal Drug and Patent Term
                Restoration Act (Pub. L. 100-670) generally provide that a patent may
                be extended for a period of up to 5 years so long as the patented item
                (human drug 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 product's 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), FDA's
                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. 156(g)(1)(B).
                 FDA has approved for marketing the human drug product, INTRAROSA
                (prasterone), indicated for the treatment of moderate to severe
                dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
                Subsequent to this approval, the USPTO received patent term restoration
                applications for INTRAROSA (U.S. Patent Nos. 8,629,129 and 8,957,054)
                from Endorecherche, Inc., and the USPTO requested FDA's assistance in
                determining the patents' eligibility for patent term restoration. In a
                letter dated February 20, 2018, FDA advised the USPTO that this human
                drug product had undergone a regulatory review period and that the
                approval of INTRAROSA represented the first permitted commercial
                marketing or use of the product. Thereafter, the USPTO requested that
                FDA determine the product's regulatory review period.
                II. Determination of Regulatory Review Period
                 FDA has determined that the applicable regulatory review period for
                INTRAROSA is 3,381 days. Of this time, 2,983 days occurred during the
                testing phase of the regulatory review period, while 398 days occurred
                during the approval phase. These periods of time were derived from the
                following dates:
                 1. The date an exemption under section 505(i) of the Federal Food,
                Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
                August 17, 2007. FDA has verified the applicant's claim that the date
                the investigational new drug application became effective was August
                17, 2007.
                 2. The date the application was initially submitted with respect to
                the human drug product under section 505 of the FD&C Act: October 16,
                2015. FDA has verified the applicant's claim that the new drug
                application (NDA) for INTRAROSA (NDA 208470) was initially submitted on
                October 16, 2015.
                [[Page 8881]]
                 3. The date the application was approved: November 16, 2016. FDA
                has verified the applicant's claim that NDA 208470 was approved on
                November 16, 2016.
                 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 717 days or 518 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 Sec. 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 Sec. 60.30, including but not limited to: Must be timely (see
                DATES), must be filed in accordance with Sec. 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. 41-42,
                1984.) Petitions should be in the format specified in 21 CFR 10.30.
                 Submit petitions electronically to https://www.regulations.gov at
                Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
                required) to the Dockets Management Staff (HFA-305), Food and Drug
                Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                 Dated: February 12, 2020.
                Lowell J. Schiller,
                Principal Associate Commissioner for Policy.
                [FR Doc. 2020-03115 Filed 2-14-20; 8:45 am]
                 BILLING CODE 4164-01-P
                

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