83_FR_54320 83 FR 54112 - Determination of Regulatory Review Period for Purposes of Patent Extension; REBINYN

83 FR 54112 - Determination of Regulatory Review Period for Purposes of Patent Extension; REBINYN

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 208 (October 26, 2018)

Page Range54112-54113
FR Document2018-23437

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REBINYN 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 biological product.

Federal Register, Volume 83 Issue 208 (Friday, October 26, 2018) 
[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54112-54113]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-6904 and FDA-2017-E-6909]


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

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 REBINYN 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 
biological product.

DATES: Anyone with knowledge that any of the dates as published (see 
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by 
December 26, 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 April 24, 
2019. 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 December 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 26, 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-2017-E-6904 and FDA-2017-E-6909--for ''Determination of Regulatory 
Review Period for Purposes of Patent Extension; REBINYN.'' 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

[[Page 54113]]

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 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), FDA's 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. 
156(g)(1)(B).
    FDA has approved for marketing the human biologic product REBINYN 
(Coagulation Factor IX (Recombinant) GlycoPEGylated). REBINYN is 
indicated for use in adults and children with hemophilia B for: (1) On-
demand treatment and control of bleeding episodes, and (2) 
Perioperative management of bleeding. Subsequent to this approval, the 
USPTO received a patent term restoration application for REBINYN (U.S. 
Patent Nos. 7,138,371 and 7,179,617) from Novo Nordisk A/S, and the 
USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated February 6, 
2018, FDA advised the USPTO that this human biological product had 
undergone a regulatory review period and that the approval of REBINYN 
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 
REBINYN is 2,793 days. Of this time, 2,412 days occurred during the 
testing phase of the regulatory review period, while 381 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 (21 U.S.C. 355(i)) became effective: October 9, 
2009. The applicant claims May 16, 2009, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was October 9, 2009, 
which was the first date after receipt of the IND that the 
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): May 16, 2016. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
REBINYN (BLA 125611/0) was initially submitted on May 16, 2016.
    3. The date the application was approved: May 31, 2017. FDA has 
verified the applicant's claim that BLA 125611/0 was approved on May 
31, 2017.
    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 1,660 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: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23437 Filed 10-25-18; 8:45 am]
 BILLING CODE 4164-01-P

54112 Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued Number of Average Number of Total annual 21 CFR section disclosures burden per Total hours respondents disclosures per respondent disclosure Distributing and Dispensing a Medication Guide to Pa- tient—§ 208.24(e) ......................................................... 88,736 5,705 506,238,880 * 0.05 25,311,944 Total .......................................................................... ........................ ............................ ........................ ........................ 27,460,694 1 There are no capital costs or operating and maintenance costs associated with this collection of information. * 3 minutes. Our estimated annual reporting Furthermore, any interested person may Written/Paper Submissions burden for the information collection petition FDA for a determination Submit written/paper submissions as reflects an increase of 51 respondents regarding whether the applicant for follows: and responses and a corresponding extension acted with due diligence • Mail/Hand delivery/Courier (for overall increase of 4,664 total hours. We during the regulatory review period by written/paper submissions): Dockets attribute this adjustment to an increase April 24, 2019. See ‘‘Petitions’’ in the Management Staff (HFA–305), Food and in the number of submissions we SUPPLEMENTARY INFORMATION section for Drug Administration, 5630 Fishers received over the last few years. Based more information. Lane, Rm. 1061, Rockville, MD 20852. on a review of the information ADDRESSES: You may submit comments • For written/paper comments collection since our last request for as follows. Please note that late, submitted to the Dockets Management OMB approval, we have made no untimely filed comments will not be Staff, FDA will post your comment, as adjustments to our annual third-party considered. Electronic comments must well as any attachments, except for disclosure burden estimate, except for be submitted on or before December 26, information submitted, marked and correction in calculations. 2018. The https://www.regulations.gov identified, as confidential, if submitted Dated: October 22, 2018. electronic filing system will accept as detailed in ‘‘Instructions.’’ Leslie Kux, comments until 11:59 p.m. Eastern Time Instructions: All submissions received Associate Commissioner for Policy. at the end of December 26, 2018. must include the Docket Nos. FDA– [FR Doc. 2018–23422 Filed 10–25–18; 8:45 am] Comments received by mail/hand 2017–E–6904 and FDA–2017–E–6909— delivery/courier (for written/paper for ’’Determination of Regulatory BILLING CODE 4164–01–P submissions) will be considered timely Review Period for Purposes of Patent if they are postmarked or the delivery Extension; REBINYN.’’ Received DEPARTMENT OF HEALTH AND service acceptance receipt is on or comments, those filed in a timely HUMAN SERVICES before that date. manner (see ADDRESSES), will be placed in the docket and, except for those Electronic Submissions Food and Drug Administration submitted as ‘‘Confidential Submit electronic comments in the Submissions,’’ publicly viewable at [Docket Nos. FDA–2017–E–6904 and FDA– following way: 2017–E–6909] https://www.regulations.gov or at the • Federal eRulemaking Portal: https:// Dockets Management Staff between 9 Determination of Regulatory Review www.regulations.gov. Follow the a.m. and 4 p.m., Monday through Period for Purposes of Patent instructions for submitting comments. Friday. Extension; REBINYN Comments submitted electronically, • Confidential Submissions—To including attachments, to https:// submit a comment with confidential AGENCY: Food and Drug Administration, www.regulations.gov will be posted to information that you do not wish to be HHS. the docket unchanged. Because your made publicly available, submit your ACTION: Notice. comment will be made public, you are comments only as a written/paper solely responsible for ensuring that your submission. You should submit two SUMMARY: The Food and Drug comment does not include any copies total. One copy will include the Administration (FDA or the Agency) has confidential information that you or a information you claim to be confidential determined the regulatory review period third party may not wish to be posted, with a heading or cover note that states for REBINYN and is publishing this such as medical information, your or ‘‘THIS DOCUMENT CONTAINS notice of that determination as required anyone else’s Social Security number, or CONFIDENTIAL INFORMATION.’’ The by law. FDA has made the confidential business information, such Agency will review this copy, including determination because of the as a manufacturing process. Please note the claimed confidential information, in submission of applications to the that if you include your name, contact its consideration of comments. The Director of the U.S. Patent and information, or other information that second copy, which will have the Trademark Office (USPTO), Department identifies you in the body of your claimed confidential information of Commerce, for the extension of a comments, that information will be redacted/blacked out, will be available patent which claims that human posted on https://www.regulations.gov. for public viewing and posted on khammond on DSK30JT082PROD with NOTICES biological product. • If you want to submit a comment https://www.regulations.gov. Submit DATES: Anyone with knowledge that any with confidential information that you both copies to the Dockets Management of the dates as published (see the do not wish to be made available to the Staff. If you do not wish your name and SUPPLEMENTARY INFORMATION section) are public, submit the comment as a contact information to be made publicly incorrect may submit either electronic written/paper submission and in the available, you can provide this or written comments and ask for a manner detailed (see ‘‘Written/Paper information on the cover sheet and not redetermination by December 26, 2018. Submissions’’ and ‘‘Instructions’’). in the body of your comments and you VerDate Sep<11>2014 18:32 Oct 25, 2018 Jkt 247001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\26OCN1.SGM 26OCN1

Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices 54113 must identify this information as was issued), FDA’s determination of the This determination of the regulatory ‘‘confidential.’’ Any information marked length of a regulatory review period for review period establishes the maximum as ‘‘confidential’’ will not be disclosed a human biological product will include potential length of a patent extension. except in accordance with § 10.20 (21 all of the testing phase and approval However, the USPTO applies several CFR 10.20) and other applicable phase as specified in 35 U.S.C. statutory limitations in its calculations disclosure law. For more information 156(g)(1)(B). of the actual period for patent extension. about FDA’s posting of comments to FDA has approved for marketing the In its applications for patent extension, public dockets, see 80 FR 56469, human biologic product REBINYN this applicant seeks 1,660 days of patent September 18, 2015, or access the (Coagulation Factor IX (Recombinant) term extension. information at: https://www.gpo.gov/ GlycoPEGylated). REBINYN is indicated III. Petitions fdsys/pkg/FR-2015-09-18/pdf/2015- for use in adults and children with 23389.pdf. hemophilia B for: (1) On-demand Anyone with knowledge that any of Docket: For access to the docket to treatment and control of bleeding the dates as published are incorrect may read background documents or the episodes, and (2) Perioperative submit either electronic or written electronic and written/paper comments management of bleeding. Subsequent to comments and, under 21 CFR 60.24, ask received, go to https:// this approval, the USPTO received a for a redetermination (see DATES). www.regulations.gov and insert the patent term restoration application for Furthermore, as specified in § 60.30 (21 docket number, found in brackets in the REBINYN (U.S. Patent Nos. 7,138,371 CFR 60.30), any interested person may heading of this document, into the and 7,179,617) from Novo Nordisk A/S, petition FDA for a determination ‘‘Search’’ box and follow the prompts and the USPTO requested FDA’s regarding whether the applicant for and/or go to the Dockets Management assistance in determining this patent’s extension acted with due diligence Staff, 5630 Fishers Lane, Rm. 1061, eligibility for patent term restoration. In during the regulatory review period. To Rockville, MD 20852. a letter dated February 6, 2018, FDA meet its burden, the petition must comply with all the requirements of FOR FURTHER INFORMATION CONTACT: advised the USPTO that this human § 60.30, including but not limited to: Beverly Friedman, Office of Regulatory biological product had undergone a must be timely (see DATES), must be Policy, Food and Drug Administration, regulatory review period and that the filed in accordance with § 10.20, must 10903 New Hampshire Ave., Bldg. 51, approval of REBINYN represented the contain sufficient facts to merit an FDA Rm. 6250, Silver Spring, MD 20993, first permitted commercial marketing or investigation, and must certify that a 301–796–3600. use of the product. Thereafter, the true and complete copy of the petition SUPPLEMENTARY INFORMATION: USPTO requested that FDA determine has been served upon the patent the product’s regulatory review period. I. Background applicant. (See H. Rept. 857, part 1, 98th II. Determination of Regulatory Review Cong., 2d sess., pp. 41–42, 1984.) The Drug Price Competition and Period Petitions should be in the format Patent Term Restoration Act of 1984 specified in 21 CFR 10.30. (Pub. L. 98–417) and the Generic FDA has determined that the Submit petitions electronically to Animal Drug and Patent Term applicable regulatory review period for https://www.regulations.gov at Docket Restoration Act (Pub. L. 100–670) REBINYN is 2,793 days. Of this time, No. FDA–2013–S–0610. Submit written generally provide that a patent may be 2,412 days occurred during the testing petitions (two copies are required) to the extended for a period of up to 5 years phase of the regulatory review period, Dockets Management Staff (HFA–305), so long as the patented item (human while 381 days occurred during the Food and Drug Administration, 5630 drug product, animal drug product, approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD medical device, food additive, or color were derived from the following dates: 20852. additive) was subject to regulatory 1. The date an exemption under section 505(i) of the Federal Food, Drug, Dated: October 22, 2018. review by FDA before the item was marketed. Under these acts, a product’s and Cosmetic Act (21 U.S.C. 355(i)) Leslie Kux, regulatory review period forms the basis became effective: October 9, 2009. The Associate Commissioner for Policy. for determining the amount of extension applicant claims May 16, 2009, as the [FR Doc. 2018–23437 Filed 10–25–18; 8:45 am] an applicant may receive. date the investigational new drug BILLING CODE 4164–01–P A regulatory review period consists of application (IND) became effective. two periods of time: A testing phase and However, FDA records indicate that the an approval phase. For human IND effective date was October 9, 2009, DEPARTMENT OF HEALTH AND biological products, the testing phase which was the first date after receipt of HUMAN SERVICES begins when the exemption to permit the IND that the investigational studies were allowed to proceed. Food and Drug Administration the clinical investigations of the biological product becomes effective 2. The date the application was [Docket No. FDA–2007–D–0369] and runs until the approval phase initially submitted with respect to the begins. The approval phase starts with human biological product under section Product-Specific Guidance; Revised the initial submission of an application 351 of the Public Health Service Act (42 Draft Guidance for Industry on to market the human biological product U.S.C. 262): May 16, 2016. FDA has Sucralfate; Reopening of Comment and continues until FDA grants verified the applicant’s claim that the Period permission to market the biological biologics license application (BLA) for khammond on DSK30JT082PROD with NOTICES AGENCY: Food and Drug Administration, product. Although only a portion of a REBINYN (BLA 125611/0) was initially HHS. regulatory review period may count submitted on May 16, 2016. ACTION:Notice of availability; reopening toward the actual amount of extension 3. The date the application was of comment period. that the Director of USPTO may award approved: May 31, 2017. FDA has (for example, half the testing phase must verified the applicant’s claim that BLA SUMMARY: The Food and Drug be subtracted as well as any time that 125611/0 was approved on May 31, Administration (FDA or the Agency) is may have occurred before the patent 2017. reopening the comment period for a VerDate Sep<11>2014 18:32 Oct 25, 2018 Jkt 247001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\26OCN1.SGM 26OCN1


Document Created: 2018-10-26 02:27:24
Document Modified: 2018-10-26 02:27:24
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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 26, 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 April 24, 2019. 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 54112 
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