83_FR_6887 83 FR 6855 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADDYI

83 FR 6855 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADDYI

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 32 (February 15, 2018)

Page Range6855-6856
FR Document2018-03130

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADDYI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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.

Federal Register, Volume 83 Issue 32 (Thursday, February 15, 2018) 
[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6855-6856]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03130]



[[Page 6855]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-2501 and FDA-2016-E-2502]


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

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 ADDYI and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of an application 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 (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by April 
16, 2018. 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 14, 2018. 
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 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 16, 2018. 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:
     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-2016-E-2501 and FDA-2016-E-2502 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; ADDYI.'' 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.thefederalregister.org/fdsys/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

[[Page 6856]]

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 ADDYI 
(flibanserin). ADDYI is indicated for the treatment of premenopausal 
women with acquired, generalized hypoactive sexual desire disorder as 
characterized by low sexual desire that causes a marked distress or 
interpersonal difficulty and is NOT due to: (1) A co-existing medical 
or psychiatric condition, (2) problems within the relationship, or (3) 
the effects of a medication or other drug substance. Subsequent to this 
approval, the USPTO received patent term restoration applications for 
ADDYI (U.S. Patent Nos. 7,151,103 and 7,420,057) from Sprout 
Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated September 23, 2016, FDA advised the USPTO that this human 
drug product had undergone a regulatory review period and that the 
approval of ADDYI 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 
ADDYI is 6,852 days. Of this time, 4,730 days occurred during the 
testing phase and 2,122 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: 
November 15, 1996. FDA has verified Sprout Pharmaceuticals, Inc. claims 
that November 15, 1996, is the date the investigational new drug 
application became effective.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505 of the FD&C Act: October 27, 
2009. FDA has verified the applicant's claims that the new drug 
application (NDA) for ADDYI (NDA 22-526) was initially submitted on 
October 27, 2009.
    3. The date the application was approved: August 18, 2015. FDA has 
verified the applicant's claims that NDA 22-526 was approved on August 
18, 2015.
    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 5 years 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 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03130 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices 6855 DEPARTMENT OF HEALTH AND the docket unchanged. Because your redacted/blacked out, will be available HUMAN SERVICES comment will be made public, you are for public viewing and posted on solely responsible for ensuring that your https://www.regulations.gov. Submit Food and Drug Administration comment does not include any both copies to the Dockets Management [Docket Nos. FDA–2016–E–2501 and FDA– confidential information that you or a Staff. If you do not wish your name and 2016–E–2502] third party may not wish to be posted, contact information to be made publicly such as medical information, your or available, you can provide this Determination of Regulatory Review anyone else’s Social Security number, or information on the cover sheet and not Period for Purposes of Patent confidential business information, such in the body of your comments and you Extension; ADDYI as a manufacturing process. Please note must identify this information as that if you include your name, contact ‘‘confidential.’’ Any information marked AGENCY: Food and Drug Administration, information, or other information that as ‘‘confidential’’ will not be disclosed HHS. identifies you in the body of your except in accordance with § 10.20 (21 ACTION: Notice. comments, that information will be CFR 10.20) and other applicable SUMMARY: The Food and Drug posted on https://www.regulations.gov. disclosure law. For more information • If you want to submit a comment about FDA’s posting of comments to Administration (FDA or the Agency) has with confidential information that you public dockets, see 80 FR 56469, determined the regulatory review period do not wish to be made available to the September 18, 2015, or access the for ADDYI and is publishing this notice public, submit the comment as a information at: https://www.gpo.gov/ of that determination as required by written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015- law. FDA has made the determination manner detailed (see ‘‘Written/Paper 23389.pdf. because of the submission of an Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to application to the Director of the U.S. Patent and Trademark Office (USPTO), Written/Paper Submissions read background documents or the Department of Commerce, for the electronic and written/paper comments Submit written/paper submissions as extension of a patent which claims that received, go to https:// follows: www.regulations.gov and insert the human drug product. • Mail/Hand delivery/Courier (for DATES: Anyone with knowledge that any docket number, found in brackets in the written/paper submissions): Dockets of the dates as published (in the heading of this document, into the Management Staff (HFA–305), Food and SUPPLEMENTARY INFORMATION section) are ‘‘Search’’ box and follow the prompts Drug Administration, 5630 Fishers incorrect may submit either electronic and/or go to the Dockets Management Lane, Rm. 1061, Rockville, MD 20852. or written comments and ask for a • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061, redetermination by April 16, 2018. submitted to the Dockets Management Rockville, MD 20852. Furthermore, any interested person may Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT: petition FDA for a determination well as any attachments, except for Beverly Friedman, Office of Regulatory regarding whether the applicant for information submitted, marked and Policy, Food and Drug Administration, extension acted with due diligence identified, as confidential, if submitted 10903 New Hampshire Ave., Bldg. 51, during the regulatory review period by as detailed in ‘‘Instructions.’’ Rm. 6250, Silver Spring, MD 20993, August 14, 2018. See ‘‘Petitions’’ in the Instructions: All submissions received 301–796–3600. SUPPLEMENTARY INFORMATION section for must include the Docket Nos. FDA– SUPPLEMENTARY INFORMATION: more information. 2016–E–2501 and FDA–2016–E–2502 for ‘‘Determination of Regulatory I. Background ADDRESSES: You may submit comments as follows. Please note that late, Review Period for Purposes of Patent The Drug Price Competition and untimely filed comments will not be Extension; ADDYI.’’ Received Patent Term Restoration Act of 1984 considered. Electronic comments must comments, those filed in a timely (Pub. L. 98–417) and the Generic be submitted on or before April 16, manner (see ADDRESSES), will be placed Animal Drug and Patent Term 2018. The https://www.regulations.gov in the docket and, except for those Restoration Act (Pub. L. 100–670) electronic filing system will accept submitted as ‘‘Confidential generally provide that a patent may be comments until midnight Eastern Time Submissions,’’ publicly viewable at extended for a period of up to 5 years at the end of April 16, 2018. The https:// https://www.regulations.gov or at the so long as the patented item (human www.regulations.gov electronic filing Dockets Management Staff between 9 drug product, animal drug product, system will accept comments until a.m. and 4 p.m., Monday through medical device, food additive, or color midnight Eastern Time at the end of Friday. additive) was subject to regulatory April 16, 2018. Comments received by • Confidential Submissions—To review by FDA before the item was mail/hand delivery/courier (for written/ submit a comment with confidential marketed. Under these acts, a product’s paper submissions) will be considered information that you do not wish to be regulatory review period forms the basis timely if they are postmarked or the made publicly available, submit your for determining the amount of extension delivery service acceptance receipt is on comments only as a written/paper an applicant may receive. or before that date. submission. You should submit two A regulatory review period consists of copies total. One copy will include the two periods of time: A testing phase and Electronic Submissions information you claim to be confidential an approval phase. For human drug with a heading or cover note that states products, the testing phase begins when sradovich on DSK3GMQ082PROD with NOTICES Submit electronic comments in the following way: ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes https://www.regulations.gov. Follow the Agency will review this copy, including effective and runs until the approval instructions for submitting comments. the claimed confidential information, in phase begins. The approval phase starts Comments submitted electronically, its consideration of comments. The with the initial submission of an including attachments, to https:// second copy, which will have the application to market the human drug www.regulations.gov will be posted to claimed confidential information product and continues until FDA grants VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1

6856 Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices permission to market the drug product. ADDYI (NDA 22–526) was initially ACTION: Notice. Although only a portion of a regulatory submitted on October 27, 2009. review period may count toward the 3. The date the application was SUMMARY: The Food and Drug actual amount of extension that the approved: August 18, 2015. FDA has Administration (FDA or the Agency) has Director of USPTO may award (for verified the applicant’s claims that NDA determined the regulatory review period example, half the testing phase must be 22–526 was approved on August 18, for BRIDION and is publishing this subtracted as well as any time that may 2015. notice of that determination as required have occurred before the patent was This determination of the regulatory by law. FDA has made the issued), FDA’s determination of the review period establishes the maximum determination because of the length of a regulatory review period for potential length of a patent extension. submission of an application to the a human drug product will include all However, the USPTO applies several Director of the U.S. Patent and statutory limitations in its calculations Trademark Office (USPTO), Department of the testing phase and approval phase of the actual period for patent extension. of Commerce, for the extension of a as specified in 35 U.S.C. 156(g)(1)(B). In its applications for patent extension, patent which claims that human drug FDA has approved for marketing the product. human drug product ADDYI this applicant seeks 5 years of patent (flibanserin). ADDYI is indicated for the term extension. DATES: Anyone with knowledge that any treatment of premenopausal women III. Petitions of the dates as published (in the with acquired, generalized hypoactive SUPPLEMENTARY INFORMATION section) are Anyone with knowledge that any of incorrect may submit either electronic sexual desire disorder as characterized the dates as published are incorrect may by low sexual desire that causes a or written comments and ask for a submit either electronic or written redetermination by April 16, 2018. marked distress or interpersonal comments and, under 21 CFR 60.24, ask difficulty and is NOT due to: (1) A co- Furthermore, any interested person may for a redetermination (see DATES). petition FDA for a determination existing medical or psychiatric Furthermore, as specified in § 60.30 (21 condition, (2) problems within the regarding whether the applicant for CFR 60.30), any interested person may extension acted with due diligence relationship, or (3) the effects of a petition FDA for a determination medication or other drug substance. during the regulatory review period by regarding whether the applicant for August 14, 2018. See ‘‘Petitions’’ in the Subsequent to this approval, the USPTO extension acted with due diligence received patent term restoration SUPPLEMENTARY INFORMATION section for during the regulatory review period. To more information. applications for ADDYI (U.S. Patent meet its burden, the petition must Nos. 7,151,103 and 7,420,057) from ADDRESSES: You may submit comments comply with all the requirements of as follows. Please note that late, Sprout Pharmaceuticals, Inc., and the § 60.30, including but not limited to: USPTO requested FDA’s assistance in untimely filed comments will not be Must be timely (see DATES), must be considered. Electronic comments must determining the patents’ eligibility for filed in accordance with § 10.20, must patent term restoration. In a letter dated be submitted on or before April 16, contain sufficient facts to merit an FDA 2018. The https://www.regulations.gov September 23, 2016, FDA advised the investigation, and must certify that a USPTO that this human drug product electronic filing system will accept true and complete copy of the petition comments until midnight Eastern Time had undergone a regulatory review has been served upon the patent period and that the approval of ADDYI at the end of April 16, 2018. Comments applicant. (See H. Rept. 857, part 1, 98th received by mail/hand delivery/courier represented the first permitted Cong., 2d sess., pp. 41–42, 1984.) commercial marketing or use of the (for written/paper submissions) will be Petitions should be in the format considered timely if they are product. Thereafter, the USPTO specified in 21 CFR 10.30. requested that FDA determine the postmarked or the delivery service Submit petitions electronically to acceptance receipt is on or before that product’s regulatory review period. https://www.regulations.gov at Docket date. II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written Period petitions (two copies are required) to the Electronic Submissions Dockets Management Staff (HFA–305), Submit electronic comments in the FDA has determined that the Food and Drug Administration, 5630 following way: applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD • Federal eRulemaking Portal: ADDYI is 6,852 days. Of this time, 4,730 20852. https://www.regulations.gov. Follow the days occurred during the testing phase instructions for submitting comments. Dated: February 9, 2018. and 2,122 days occurred during the Comments submitted electronically, Leslie Kux, approval phase. These periods of time including attachments, to https:// were derived from the following dates: Associate Commissioner for Policy. www.regulations.gov will be posted to 1. The date an exemption under [FR Doc. 2018–03130 Filed 2–14–18; 8:45 am] the docket unchanged. Because your section 505(i) of the Federal Food, Drug, BILLING CODE 4164–01–P comment will be made public, you are and Cosmetic Act (FD&C Act) (21 U.S.C. solely responsible for ensuring that your 355(i)) became effective: November 15, comment does not include any 1996. FDA has verified Sprout DEPARTMENT OF HEALTH AND HUMAN SERVICES confidential information that you or a Pharmaceuticals, Inc. claims that third party may not wish to be posted, November 15, 1996, is the date the Food and Drug Administration such as medical information, your or investigational new drug application sradovich on DSK3GMQ082PROD with NOTICES anyone else’s Social Security number, or became effective. [Docket No. FDA–2016–E–2524] confidential business information, such 2. The date the application was as a manufacturing process. Please note Determination of Regulatory Review initially submitted with respect to the that if you include your name, contact Period for Purposes of Patent human drug product under section 505 information, or other information that Extension; BRIDION of the FD&C Act: October 27, 2009. FDA identifies you in the body of your has verified the applicant’s claims that AGENCY: Food and Drug Administration, comments, that information will be the new drug application (NDA) for HHS. posted on https://www.regulations.gov. VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\15FEN1.SGM 15FEN1


Document Created: 2018-02-15 00:20:50
Document Modified: 2018-02-15 00:20:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 16, 2018. 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 14, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation83 FR 6855 
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