81_FR_37038 81 FR 36928 - Determination of Regulatory Review Period for Purposes of Patent Extension; ALPROLIX

81 FR 36928 - Determination of Regulatory Review Period for Purposes of Patent Extension; ALPROLIX

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 110 (June 8, 2016)

Page Range36928-36929
FR Document2016-13526

The Food and Drug Administration (FDA) has determined the regulatory review period for ALPROLIX 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 patents which claim that human biological product.

Federal Register, Volume 81 Issue 110 (Wednesday, June 8, 2016) 
[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Pages 36928-36929]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-E-2351, FDA-2014-E-2352, and FDA-2014-E-2350]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ALPROLIX 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 patents which claim 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 August 
8, 2016. 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 December 5, 2016. 
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2014-E-2351, FDA-2014-E-2352, and FDA-2014-E-2350 for 
``Determination of Regulatory Review Period for Purposes of Patent 
Extension; ALPROLIX.''
    Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets

[[Page 36929]]

Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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 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 ALPROLIX 
(Coagulation Factor IX (Recombinant), Fc Fusion Protein). ALPROLIX is a 
recombinant DNA derived, coagulation Factor IX concentrate indicated in 
adults and children with hemophilia B for control and prevention of 
bleeding episodes, perioperative management, and routine prophylaxis to 
prevent or reduce the frequency of bleeding episodes. Subsequent to 
this approval, the USPTO received patent term restoration applications 
for ALPROLIX (U.S. Patent Nos. 7,348,004, 7,862,820, and 8,329,182) 
from Biogen Idec Hemophilia Inc., and the USPTO requested FDA's 
assistance in determining the patents' eligibility for patent term 
restoration. In a letter dated May 11, 2015, FDA advised the USPTO that 
this human biological product had undergone a regulatory review period 
and that the approval of ALPROLIX 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 
ALPROLIX is 2,223 days. Of this time, 1,767 days occurred during the 
testing phase of the regulatory review period, while 456 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: February 
27, 2008. FDA has verified the applicant's claim that the date the 
investigational new drug application (IND) became effective was on 
February 27, 2008.
    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): December 28, 2012. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
ALPROLIX (BLA 125444/0) was initially submitted on December 28, 2012.
    3. The date the application was approved: March 28, 2014. FDA has 
verified the applicant's claim that BLA 125444/0 was approved on March 
28, 2014.
    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 1,326 days, 465 days, or 818, days, respectively, 
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 ask for 
a redetermination (see DATES). 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. 
To meet its burden, the petition must be timely (see DATES) and contain 
sufficient facts to merit an FDA investigation. (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 http://www.regulations.gov at 
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are 
required) to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13526 Filed 6-7-16; 8:45 am]
 BILLING CODE 4164-01-P

36928 Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued Total Number of operating Total Average Activity/21 CFR Number disclosures Total and annual burden per section of respondents per hours 2 maintenance disclosures disclosure respondent costs (in dollars) Notification of requirement to correct major deficiencies—900.24(a) .............. 0.4 1 0.4 200 80 68 Notification of loss of approval; major de- ficiencies—900.24(a)(2) ....................... 0.15 1 0.15 100 15 25.50 Notification of probationary status— 900.24(b)(1) .......................................... 0.3 1 0.3 200 60 51 Notification of loss of approval; minor de- ficiencies—900.24(b)(3) ....................... 0.15 1 0.15 100 15 25.50 Total .................................................. ........................ ........................ ........................ ........................ 3,691,842 24,259,921 1 There are no capital costs associated with this collection of information. 2 Total hours have been rounded. 3 Refers to the facility component of the burden for this requirement. 4 Refers to the AB component of the burden for this requirement. 5 Refers to the situation where a patient specifically does not want to receive the lay summary of her exam. Dated: June 2, 2016. December 5, 2016. See ‘‘Petitions’’ in and Drug Administration, 5630 Fishers Leslie Kux, the SUPPLEMENTARY INFORMATION section Lane, Rm. 1061, Rockville, MD 20852. Associate Commissioner for Policy. for more information. • For written/paper comments [FR Doc. 2016–13522 Filed 6–7–16; 8:45 am] ADDRESSES: You may submit comments submitted to the Division of Dockets BILLING CODE 4164–01–P as follows: Management, FDA will post your comment, as well as any attachments, Electronic Submissions except for information submitted, DEPARTMENT OF HEALTH AND Submit electronic comments in the marked and identified, as confidential, HUMAN SERVICES following way: if submitted as detailed in ‘‘Instructions.’’ Food and Drug Administration • Federal eRulemaking Portal: http:// Instructions: All submissions received www.regulations.gov. Follow the must include the Docket Nos. FDA– [Docket Nos. FDA–2014–E–2351, FDA– instructions for submitting comments. 2014–E–2351, FDA–2014–E–2352, and 2014–E–2352, and FDA–2014–E–2350] Comments submitted electronically, FDA–2014–E–2350 for ‘‘Determination including attachments, to http:// of Regulatory Review Period for Determination of Regulatory Review www.regulations.gov will be posted to Period for Purposes of Patent Purposes of Patent Extension; the docket unchanged. Because your ALPROLIX.’’ Extension; ALPROLIX comment will be made public, you are Received comments will be placed in AGENCY: Food and Drug Administration, solely responsible for ensuring that your the docket and, except for those HHS. comment does not include any submitted as ‘‘Confidential confidential information that you or a Submissions,’’ publicly viewable at ACTION: Notice. third party may not wish to be posted, http://www.regulations.gov or at the SUMMARY: The Food and Drug such as medical information, your or Division of Dockets Management Administration (FDA) has determined anyone else’s Social Security number, or between 9 a.m. and 4 p.m., Monday the regulatory review period for confidential business information, such through Friday. ALPROLIX and is publishing this notice as a manufacturing process. Please note • Confidential Submissions—To of that determination as required by that if you include your name, contact submit a comment with confidential law. FDA has made the determination information, or other information that information that you do not wish to be because of the submission of identifies you in the body of your made publicly available, submit your applications to the Director of the U.S. comments, that information will be comments only as a written/paper Patent and Trademark Office (USPTO), posted on http://www.regulations.gov. submission. You should submit two Department of Commerce, for the • If you want to submit a comment copies total. One copy will include the extension of patents which claim that with confidential information that you information you claim to be confidential human biological product. do not wish to be made available to the with a heading or cover note that states DATES: Anyone with knowledge that any public, submit the comment as a ‘‘THIS DOCUMENT CONTAINS of the dates as published (see the written/paper submission and in the CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION section) are manner detailed (see ‘‘Written/Paper Agency will review this copy, including incorrect may submit either electronic Submissions’’ and ‘‘Instructions’’). the claimed confidential information, in mstockstill on DSK3G9T082PROD with NOTICES or written comments and ask for a Written/Paper Submissions its consideration of comments. The redetermination by August 8, 2016. second copy, which will have the Furthermore, any interested person may Submit written/paper submissions as claimed confidential information petition FDA for a determination follows: redacted/blacked out, will be available regarding whether the applicant for • Mail/Hand delivery/Courier (for for public viewing and posted on http:// extension acted with due diligence written/paper submissions): Division of www.regulations.gov. Submit both during the regulatory review period by Dockets Management (HFA–305), Food copies to the Division of Dockets VerDate Sep<11>2014 17:30 Jun 07, 2016 Jkt 238001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\08JNN1.SGM 08JNN1

Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices 36929 Management. If you do not wish your actual amount of extension that the 3. The date the application was name and contact information to be Director of USPTO may award (for approved: March 28, 2014. FDA has made publicly available, you can example, half the testing phase must be verified the applicant’s claim that BLA provide this information on the cover subtracted as well as any time that may 125444/0 was approved on March 28, sheet and not in the body of your have occurred before the patent was 2014. comments and you must identify this issued), FDA’s determination of the This determination of the regulatory information as ‘‘confidential.’’ Any length of a regulatory review period for review period establishes the maximum information marked as ‘‘confidential’’ a human biological product will include potential length of a patent extension. will not be disclosed except in all of the testing phase and approval However, the USPTO applies several accordance with 21 CFR 10.20 and other phase as specified in 35 U.S.C. statutory limitations in its calculations applicable disclosure law. For more 156(g)(1)(B). of the actual period for patent extension. information about FDA’s posting of FDA has approved for marketing the In its applications for patent extension, comments to public dockets, see 80 FR human biologic product ALPROLIX this applicant seeks 1,326 days, 465 56469, September 18, 2015, or access (Coagulation Factor IX (Recombinant), days, or 818, days, respectively, of the information at: http://www.fda.gov/ Fc Fusion Protein). ALPROLIX is a patent term extension. regulatoryinformation/dockets/ recombinant DNA derived, coagulation Factor IX concentrate indicated in III. Petitions default.htm. Docket: For access to the docket to adults and children with hemophilia B Anyone with knowledge that any of read background documents or the for control and prevention of bleeding the dates as published are incorrect may electronic and written/paper comments episodes, perioperative management, submit either electronic or written received, go to http:// and routine prophylaxis to prevent or comments and ask for a redetermination www.regulations.gov and insert the reduce the frequency of bleeding (see DATES). Furthermore, any interested docket number, found in brackets in the episodes. Subsequent to this approval, person may petition FDA for a heading of this document, into the the USPTO received patent term determination regarding whether the ‘‘Search’’ box and follow the prompts restoration applications for ALPROLIX applicant for extension acted with due and/or go to the Division of Dockets (U.S. Patent Nos. 7,348,004, 7,862,820, diligence during the regulatory review Management, 5630 Fishers Lane, Rm. and 8,329,182) from Biogen Idec period. To meet its burden, the petition 1061, Rockville, MD 20852. Hemophilia Inc., and the USPTO must be timely (see DATES) and contain requested FDA’s assistance in sufficient facts to merit an FDA FOR FURTHER INFORMATION CONTACT: determining the patents’ eligibility for investigation. (See H. Rept. 857, part 1, Beverly Friedman, Office of Regulatory patent term restoration. In a letter dated 98th Cong., 2d sess., pp. 41–42, 1984.) Policy, Food and Drug Administration, May 11, 2015, FDA advised the USPTO Petitions should be in the format 10903 New Hampshire Ave., Bldg. 51, that this human biological product had Rm. 6250, Silver Spring, MD 20993, specified in 21 CFR 10.30. undergone a regulatory review period Submit petitions electronically to 301–796–3600. and that the approval of ALPROLIX http://www.regulations.gov at Docket SUPPLEMENTARY INFORMATION: represented the first permitted No. FDA–2013–S–0610. Submit written I. Background commercial marketing or use of the petitions (two copies are required) to the product. Thereafter, the USPTO Division of Dockets Management (HFA– The Drug Price Competition and requested that FDA determine the 305), Food and Drug Administration, Patent Term Restoration Act of 1984 product’s regulatory review period. 5630 Fishers Lane, Rm. 1061, Rockville, (Pub. L. 98–417) and the Generic MD 20852. Animal Drug and Patent Term II. Determination of Regulatory Review Restoration Act (Pub. L. 100–670) Period Dated: June 2, 2016. generally provide that a patent may be FDA has determined that the Leslie Kux, extended for a period of up to 5 years applicable regulatory review period for Associate Commissioner for Policy. so long as the patented item (human ALPROLIX is 2,223 days. Of this time, [FR Doc. 2016–13526 Filed 6–7–16; 8:45 am] drug product, animal drug product, 1,767 days occurred during the testing BILLING CODE 4164–01–P medical device, food additive, or color phase of the regulatory review period, additive) was subject to regulatory while 456 days occurred during the review by FDA before the item was approval phase. These periods of time DEPARTMENT OF HEALTH AND marketed. Under these acts, a product’s were derived from the following dates: HUMAN SERVICES regulatory review period forms the basis 1. The date an exemption under for determining the amount of extension section 505(i) of the Federal Food, Drug, Food and Drug Administration an applicant may receive. and Cosmetic Act (21 U.S.C. 355(i)) [Docket Nos. FDA–2014–E–2365, FDA– A regulatory review period consists of became effective: February 27, 2008. 2014–E–2368, FDA–2014–E–2367, and FDA– two periods of time: A testing phase and FDA has verified the applicant’s claim 2014–E–2366] an approval phase. For human that the date the investigational new biological products, the testing phase drug application (IND) became effective Determination of Regulatory Review begins when the exemption to permit was on February 27, 2008. Period for Purposes of Patent the clinical investigations of the 2. The date the application was Extension; ELOCTATE biological becomes effective and runs initially submitted with respect to the AGENCY: Food and Drug Administration, until the approval phase begins. The human biological product under section mstockstill on DSK3G9T082PROD with NOTICES HHS. approval phase starts with the initial 351 of the Public Health Service Act (42 ACTION: Notice. submission of an application to market U.S.C. 262): December 28, 2012. FDA the human biological product and has verified the applicant’s claim that SUMMARY: The Food and Drug continues until FDA grants permission the biologics license application (BLA) Administration (FDA) has determined to market the biological product. for ALPROLIX (BLA 125444/0) was the regulatory review period for Although only a portion of a regulatory initially submitted on December 28, ELOCTATE and is publishing this review period may count toward the 2012. notice of that determination as required VerDate Sep<11>2014 17:30 Jun 07, 2016 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\08JNN1.SGM 08JNN1


Document Created: 2016-06-08 03:10:15
Document Modified: 2016-06-08 03:10:15
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 August 8, 2016. 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 December 5, 2016. 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 Citation81 FR 36928 
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