82_FR_56479 82 FR 56252 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAVAYSA

82 FR 56252 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAVAYSA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 227 (November 28, 2017)

Page Range56252-56253
FR Document2017-25703

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAVAYSA 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 82 Issue 227 (Tuesday, November 28, 2017) 
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56252-56253]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1237]


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

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 SAVAYSA 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 January 
29, 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 May 29, 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 January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 29, 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 No. 
FDA-2016-E-1237 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; SAVAYSA.'' 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

[[Page 56253]]

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 SAVAYSA 
(edoxaban tosylate monohydrate). SAVAYSA is indicated to reduce the 
risk of stroke and systemic embolism in patients with nonvalvular 
atrial fibrillation and is also indicated for the treatment of deep 
vein thrombosis and pulmonary embolism following 5-10 days of initial 
therapy with a parenteral anticoagulant. Subsequent to this approval, 
the USPTO received a patent term restoration application for SAVAYSA 
(U.S. Patent No. 7,365,205) from Daiichi Sankyo Co., Ltd., and the 
USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated July 12, 
2016, FDA advised the USPTO that this human drug product had undergone 
a regulatory review period and that the approval of SAVAYSA 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 
SAVAYSA is 3,845 days. Of this time, 3,479 days occurred during the 
testing phase of the regulatory review period, while 366 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 (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: July 1, 2004. FDA has verified the applicant's claim that 
July 1, 2004, is the date the investigational new drug application 
(IND) became effective.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: January 8, 
2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for SAVAYSA (NDA 206316) was initially submitted on 
January 8, 2014.
    3. The date the application was approved: January 8, 2015. FDA has 
verified the applicant's claim that NDA 206316 was approved on January 
8, 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 application for patent extension, 
this applicant seeks 1,406 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: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25703 Filed 11-27-17; 8:45 am]
 BILLING CODE 4164-01-P

56252 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices Dated: November 22, 2017. instructions for submitting comments. its consideration of comments. The Leslie Kux, Comments submitted electronically, second copy, which will have the Associate Commissioner for Policy. including attachments, to https:// claimed confidential information [FR Doc. 2017–25684 Filed 11–27–17; 8:45 am] www.regulations.gov will be posted to redacted/blacked out, will be available BILLING CODE 4164–01–P the docket unchanged. Because your for public viewing and posted on comment will be made public, you are https://www.regulations.gov. Submit solely responsible for ensuring that your both copies to the Dockets Management DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and HUMAN SERVICES confidential information that you or a contact information to be made publicly third party may not wish to be posted, available, you can provide this Food and Drug Administration such as medical information, your or information on the cover sheet and not [Docket No. FDA–2016–E–1237] anyone else’s Social Security number, or in the body of your comments and you confidential business information, such must identify this information as Determination of Regulatory Review as a manufacturing process. Please note ‘‘confidential.’’ Any information marked Period for Purposes of Patent that if you include your name, contact as ‘‘confidential’’ will not be disclosed Extension; SAVAYSA information, or other information that except in accordance with § 10.20 (21 identifies you in the body of your CFR 10.20) and other applicable AGENCY: Food and Drug Administration, comments, that information will be disclosure law. For more information HHS. posted on https://www.regulations.gov. about FDA’s posting of comments to ACTION: Notice. • If you want to submit a comment public dockets, see 80 FR 56469, with confidential information that you September 18, 2015, or access the SUMMARY: The Food and Drug do not wish to be made available to the Administration (FDA or the Agency) has information at: https://www.gpo.gov/ public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- determined the regulatory review period written/paper submission and in the 23389.pdf. for SAVAYSA and is publishing this manner detailed (see ‘‘Written/Paper Docket: For access to the docket to notice of that determination as required Submissions’’ and ‘‘Instructions’’). read background documents or the by law. FDA has made the determination because of the Written/Paper Submissions electronic and written/paper comments submission of an application to the received, go to https:// Submit written/paper submissions as Director of the U.S. Patent and www.regulations.gov and insert the follows: Trademark Office (USPTO), Department docket number, found in brackets in the • Mail/Hand delivery/Courier (for of Commerce, for the extension of a heading of this document, into the written/paper submissions): Dockets patent which claims that human drug ‘‘Search’’ box and follow the prompts Management Staff (HFA–305), Food and product. and/or go to the Dockets Management Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments Rockville, MD 20852. of the dates as published (in the SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT: incorrect may submit either electronic Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory or written comments and ask for a well as any attachments, except for Policy, Food and Drug Administration, redetermination by January 29, 2018. information submitted, marked and 10903 New Hampshire Ave., Bldg. 51, Furthermore, any interested person may identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993, petition FDA for a determination as detailed in ‘‘Instructions.’’ 301–796–3600. regarding whether the applicant for Instructions: All submissions received SUPPLEMENTARY INFORMATION: extension acted with due diligence must include the Docket No. FDA– 2016–E–1237 for ‘‘Determination of I. Background during the regulatory review period by May 29, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes The Drug Price Competition and SUPPLEMENTARY INFORMATION section for of Patent Extension; SAVAYSA.’’ Patent Term Restoration Act of 1984 more information. Received comments, those filed in a (Pub. L. 98–417) and the Generic ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be Animal Drug and Patent Term as follows. Please note that late, placed in the docket and, except for Restoration Act (Pub. L. 100–670) untimely filed comments will not be those submitted as ‘‘Confidential generally provide that a patent may be considered. Electronic comments must Submissions,’’ publicly viewable at extended for a period of up to 5 years be submitted on or before January 29, https://www.regulations.gov or at the so long as the patented item (human 2018. The https://www.regulations.gov Dockets Management Staff between 9 drug product, animal drug product, electronic filing system will accept a.m. and 4 p.m., Monday through medical device, food additive, or color comments until midnight Eastern Time Friday. additive) was subject to regulatory at the end of January 29, 2018. • Confidential Submissions—To review by FDA before the item was Comments received by mail/hand submit a comment with confidential marketed. Under these acts, a product’s delivery/courier (for written/paper information that you do not wish to be regulatory review period forms the basis submissions) will be considered timely made publicly available, submit your for determining the amount of extension if they are postmarked or the delivery comments only as a written/paper an applicant may receive. service acceptance receipt is on or submission. You should submit two A regulatory review period consists of ethrower on DSK3G9T082PROD with NOTICES before that date. copies total. One copy will include the two periods of time: A testing phase and information you claim to be confidential an approval phase. For human drug Electronic Submissions with a heading or cover note that states products, the testing phase begins when Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical following way: CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes • Federal eRulemaking Portal: Agency will review this copy, including effective and runs until the approval https://www.regulations.gov. Follow the the claimed confidential information, in phase begins. The approval phase starts VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1

Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices 56253 with the initial submission of an SAVAYSA (NDA 206316) was initially ACTION: Notice. application to market the human drug submitted on January 8, 2014. product and continues until FDA grants 3. The date the application was SUMMARY: The Food and Drug permission to market the drug product. approved: January 8, 2015. FDA has Administration (FDA or the Agency) has Although only a portion of a regulatory verified the applicant’s claim that NDA determined the regulatory review period review period may count toward the 206316 was approved on January 8, for ZERBAXA and is publishing this actual amount of extension that the 2015. notice of that determination as required Director of USPTO may award (for This determination of the regulatory by law. FDA has made the example, half the testing phase must be review period establishes the maximum determination because of the subtracted as well as any time that may potential length of a patent extension. submission of an application to the have occurred before the patent was However, the USPTO applies several Director of the U.S. Patent and statutory limitations in its calculations Trademark Office (USPTO), Department issued), FDA’s determination of the of the actual period for patent extension. of Commerce, for the extension of a length of a regulatory review period for In its application for patent extension, patent which claims that human drug a human drug product will include all this applicant seeks 1,406 days of patent product. of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). term extension. DATES: Anyone with knowledge that any FDA has approved for marketing the III. Petitions of the dates as published (in the human drug product SAVAYSA SUPPLEMENTARY INFORMATION section) are Anyone with knowledge that any of incorrect may submit either electronic (edoxaban tosylate monohydrate). the dates as published are incorrect may SAVAYSA is indicated to reduce the or written comments and ask for a submit either electronic or written redetermination by January 29, 2018. risk of stroke and systemic embolism in comments and, under 21 CFR 60.24, ask patients with nonvalvular atrial Furthermore, any interested person may for a redetermination (see DATES). petition FDA for a determination fibrillation and is also indicated for the Furthermore, as specified in § 60.30 (21 treatment of deep vein thrombosis and regarding whether the applicant for CFR 60.30), any interested person may extension acted with due diligence pulmonary embolism following 5–10 petition FDA for a determination days of initial therapy with a parenteral during the regulatory review period by regarding whether the applicant for May 29, 2018. See ‘‘Petitions’’ in the anticoagulant. Subsequent to this extension acted with due diligence approval, the USPTO received a patent SUPPLEMENTARY INFORMATION section for during the regulatory review period. To more information. term restoration application for meet its burden, the petition must SAVAYSA (U.S. Patent No. 7,365,205) ADDRESSES: You may submit comments comply with all the requirements of as follows. Please note that late, from Daiichi Sankyo Co., Ltd., 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 this patent’s eligibility for filed in accordance with § 10.20, must patent term restoration. In a letter dated be submitted on or before January 29, contain sufficient facts to merit an FDA 2018. The https://www.regulations.gov July 12, 2016, FDA advised the USPTO investigation, and must certify that a that this human drug product had electronic filing system will accept true and complete copy of the petition comments until midnight Eastern Time undergone a regulatory review period has been served upon the patent and that the approval of SAVAYSA at the end of January 29, 2018. applicant. (See H. Rept. 857, part 1, 98th Comments received by mail/hand represented the first permitted Cong., 2d sess., pp. 41–42, 1984.) commercial marketing or use of the delivery/courier (for written/paper Petitions should be in the format submissions) will be considered timely product. Thereafter, the USPTO specified in 21 CFR 10.30. requested that FDA determine the if they are postmarked or the delivery Submit petitions electronically to service acceptance receipt is on or product’s regulatory review period. https://www.regulations.gov at Docket before that 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: https:// SAVAYSA is 3,845 days. Of this time, 20852. www.regulations.gov. Follow the 3,479 days occurred during the testing instructions for submitting comments. Dated: November 22, 2017. phase of the regulatory review period, Comments submitted electronically, Leslie Kux, while 366 days occurred during the including attachments, to https:// approval phase. These periods of time Associate Commissioner for Policy. www.regulations.gov will be posted to were derived from the following dates: [FR Doc. 2017–25703 Filed 11–27–17; 8:45 am] the docket unchanged. Because your 1. The date an exemption under BILLING CODE 4164–01–P comment will be made public, you are section 505(i) of the Federal Food, Drug, solely responsible for ensuring that your and Cosmetic Act (the FD&C Act) (21 comment does not include any U.S.C. 355(i)) became effective: July 1, DEPARTMENT OF HEALTH AND HUMAN SERVICES confidential information that you or a 2004. FDA has verified the applicant’s third party may not wish to be posted, claim that July 1, 2004, is the date the Food and Drug Administration such as medical information, your or investigational new drug application anyone else’s Social Security number, or ethrower on DSK3G9T082PROD with NOTICES (IND) became effective. [Docket No. FDA–2016–E–0623] 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 information, or other information that Extension; ZERBAXA 505(b) of the FD&C Act: January 8, 2014. identifies you in the body of your FDA has verified the applicant’s claim AGENCY: Food and Drug Administration, comments, that information will be that the new drug application (NDA) for HHS. posted on https://www.regulations.gov. VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1


Document Created: 2017-11-28 01:50:44
Document Modified: 2017-11-28 01:50:44
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 January 29, 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 May 29, 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 Citation82 FR 56252 
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