82_FR_46694 82 FR 46502 - Determination of Regulatory Review Period for Purposes of Patent Extension; TECFIDERA

82 FR 46502 - Determination of Regulatory Review Period for Purposes of Patent Extension; TECFIDERA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 192 (October 5, 2017)

Page Range46502-46503
FR Document2017-21435

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECFIDERA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Federal Register, Volume 82 Issue 192 (Thursday, October 5, 2017) 
[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46502-46503]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21435]



[[Page 46502]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-E-0944, FDA-2014-E-0950, FDA-2014-E-0943, FDA-
2014-E-0945]


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

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 TECFIDERA and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of applications to the Director 
of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human drug 
product.

DATES: Anyone with knowledge that any of the dates as published (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by 
December 4, 2017. 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 3, 
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 December 4, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 4, 2017. 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-2014-E-0944, FDA-2014-E-0950, FDA-2014-E-0943, and FDA-2014-E-0945 
for ``Determination of Regulatory Review Period for Purposes of Patent 
Extension; TECFIDERA.'' 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 Office 
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 Office. 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 46503]]

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 TECFIDERA 
(dimethyl fumarate). TECFIDERA is indicated for treatment of patients 
with relapsing forms of multiple sclerosis. Subsequent to this 
approval, the USPTO received patent term restoration applications for 
TECFIDERA (U.S. Patent Nos. 6,509,376; 7,320,999; 7,619,001; and 
7,803,840) from Biogen Idec International GmbH, and the USPTO requested 
FDA's assistance in determining the patents' eligibility for patent 
term restoration. In a letter dated November 4, 2015, FDA advised the 
USPTO that this human drug product had undergone a regulatory review 
period and that the approval of TECFIDERA 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 
TECFIDERA is 2,480 days. Of this time, 2,085 days occurred during the 
testing phase and 395 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: June 14, 2006. FDA has verified the applicant's claim that 
the date the investigational new drug application (IND) became 
effective was on June 14, 2006.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: February 
27, 2012. FDA has verified the applicant's claim that the new drug 
application (NDA) for TECFIDERA (NDA 204063) was initially submitted on 
February 27, 2012.
    3. The date the application was approved: March 27, 2013. FDA has 
verified the applicant's claims that NDA 204063 was approved on March 
27, 2013.
    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 1,438 days, 1,144 days, 811 days, or 654 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: September 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21435 Filed 10-4-17; 8:45 am]
 BILLING CODE 4164-01-P

46502 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices DEPARTMENT OF HEALTH AND comment will be made public, you are redacted/blacked out, will be available HUMAN SERVICES solely responsible for ensuring that your for public viewing and posted on comment does not include any https://www.regulations.gov. Submit Food and Drug Administration confidential information that you or a both copies to the Dockets Management [Docket Nos. FDA–2014–E–0944, FDA– third party may not wish to be posted, Staff Office. If you do not wish your 2014–E–0950, FDA–2014–E–0943, FDA– such as medical information, your or name and contact information to be 2014–E–0945] anyone else’s Social Security number, or made publicly available, you can confidential business information, such provide this information on the cover Determination of Regulatory Review as a manufacturing process. Please note sheet and not in the body of your Period for Purposes of Patent that if you include your name, contact comments and you must identify this Extension; TECFIDERA information, or other information that information as ‘‘confidential.’’ Any identifies you in the body of your information marked as ‘‘confidential’’ AGENCY: Food and Drug Administration, comments, that information will be will not be disclosed except in HHS. posted on https://www.regulations.gov. accordance with § 10.20 (21 CFR 10.20) ACTION: Notice. • If you want to submit a comment and other applicable disclosure law. For SUMMARY: The Food and Drug with confidential information that you more information about FDA’s posting Administration (FDA or the Agency) has do not wish to be made available to the of comments to public dockets, see 80 determined the regulatory review period public, submit the comment as a FR 56469, September 18, 2015, or access for TECFIDERA and is publishing this written/paper submission and in the the information at: https://www.gpo.gov/ notice of that determination as required manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015- by law. FDA has made the Submissions’’ and ‘‘Instructions’’). 23389.pdf. determination because of the Written/Paper Submissions Docket: For access to the docket to submission of applications to the read background documents or the Submit written/paper submissions as electronic and written/paper comments Director of the U.S. Patent and follows: Trademark Office (USPTO), Department received, go to https:// • Mail/Hand delivery/Courier (for of Commerce, for the extension of a www.regulations.gov and insert the written/paper submissions): Dockets patent which claims that human drug docket number, found in brackets in the Management Staff (HFA–305), Food and product. heading of this document, into the Drug Administration, 5630 Fishers DATES: Anyone with knowledge that any ‘‘Search’’ box and follow the prompts Lane, Rm. 1061, Rockville, MD 20852. of the dates as published (in the • For written/paper comments and/or go to the Dockets Management SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, incorrect may submit either electronic Staff, FDA will post your comment, as Rockville, MD 20852. or written comments and ask for a well as any attachments, except for FOR FURTHER INFORMATION CONTACT: redetermination by December 4, 2017. information submitted, marked and Beverly Friedman, Office of Regulatory Furthermore, any interested person may identified, as confidential, if submitted Policy, Food and Drug Administration, petition FDA for a determination as detailed in ‘‘Instructions.’’ 10903 New Hampshire Ave., Bldg. 51, regarding whether the applicant for Instructions: All submissions received Rm. 6250, Silver Spring, MD 20993, extension acted with due diligence must include the Docket Nos. FDA– 301–796–3600. during the regulatory review period by 2014–E–0944, FDA–2014–E–0950, SUPPLEMENTARY INFORMATION: April 3, 2018. See ‘‘Petitions’’ in the FDA–2014–E–0943, and FDA–2014–E– 0945 for ‘‘Determination of Regulatory I. Background SUPPLEMENTARY INFORMATION section for more information. Review Period for Purposes of Patent The Drug Price Competition and ADDRESSES: You may submit comments Extension; TECFIDERA.’’ Received Patent Term Restoration Act of 1984 as follows. Please note that late, comments, those filed in a timely (Pub. L. 98–417) and the Generic untimely filed comments will not be manner (see ADDRESSES), will be placed Animal Drug and Patent Term considered. Electronic comments must in the docket and, except for those Restoration Act (Pub. L. 100–670) be submitted on or before December 4, submitted as ‘‘Confidential generally provide that a patent may be 2017. The https://www.regulations.gov Submissions,’’ publicly viewable at extended for a period of up to 5 years electronic filing system will accept https://www.regulations.gov or at the so long as the patented item (human comments until midnight Eastern Time Dockets Management Staff Office drug product, animal drug product, at the end of December 4, 2017. between 9 a.m. and 4 p.m., Monday medical device, food additive, or color Comments received by mail/hand through Friday. additive) was subject to regulatory delivery/courier (for written/paper • Confidential Submissions—To review by FDA before the item was submissions) will be considered timely submit a comment with confidential marketed. Under these acts, a product’s if they are postmarked or the delivery information that you do not wish to be regulatory review period forms the basis service acceptance receipt is on or made publicly available, submit your for determining the amount of extension before that date. comments only as a written/paper an applicant may receive. submission. You should submit two A regulatory review period consists of Electronic Submissions copies total. One copy will include the two periods of time: A testing phase and Submit electronic comments in the information you claim to be confidential an approval phase. For human drug following way: with a heading or cover note that states products, the testing phase begins when ethrower on DSK3G9T082PROD with NOTICES • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes instructions for submitting comments. Agency will review this copy, including effective and runs until the approval Comments submitted electronically, the claimed confidential information, in phase begins. The approval phase starts including attachments, to https:// its consideration of comments. The with the initial submission of an www.regulations.gov will be posted to second copy, which will have the application to market the human drug the docket unchanged. Because your claimed confidential information product and continues until FDA grants VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1

Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46503 permission to market the drug product. This determination of the regulatory meeting entitled ‘‘Animal Drug User Fee Although only a portion of a regulatory review period establishes the maximum Act.’’ The topic to be discussed is review period may count toward the potential length of a patent extension. proposed recommendations for the actual amount of extension that the However, the USPTO applies several reauthorization of the Animal Drug User Director of USPTO may award (for statutory limitations in its calculations Fee Act (ADUFA IV). The meeting will example, half the testing phase must be of the actual period for patent extension. be open to the public. subtracted as well as any time that may In its applications for patent extension, DATES: The public meeting will be held have occurred before the patent was this applicant seeks 1,438 days, 1,144 on November 2, 2017, from 9 a.m. to 12 issued), FDA’s determination of the days, 811 days, or 654 days of patent noon. Submit either electronic or length of a regulatory review period for term extension. written comments on this public a human drug product will include all III. Petitions meeting to the docket by November 17, of the testing phase and approval phase 2017. See the SUPPLEMENTARY as specified in 35 U.S.C. 156(g)(1)(B). Anyone with knowledge that any of INFORMATION section for registration date FDA has approved for marketing the the dates as published are incorrect may and information. human drug product TECFIDERA submit either electronic or written ADDRESSES: The public meeting will be (dimethyl fumarate). TECFIDERA is comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). held at 7500 Standish Pl., Room N149 indicated for treatment of patients with (first floor), Rockville, MD 20855. Free relapsing forms of multiple sclerosis. Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may parking is available onsite. Attendees Subsequent to this approval, the USPTO must provide a valid government issued received patent term restoration petition FDA for a determination regarding whether the applicant for photo ID (driver’s license, identification applications for TECFIDERA (U.S. card, or passport) to enter the facility. Patent Nos. 6,509,376; 7,320,999; extension acted with due diligence during the regulatory review period. To Entrance for the public meeting 7,619,001; and 7,803,840) from Biogen participants (non-FDA employees) is Idec International GmbH, and the meet its burden, the petition must comply with all the requirements of through the front of the building where USPTO requested FDA’s assistance in routine security check procedures will determining the patents’ eligibility for § 60.30, including but not limited to: Must be timely (see DATES), must be be performed. patent term restoration. In a letter dated You may submit comments as November 4, 2015, FDA advised the filed in accordance with § 10.20, must contain sufficient facts to merit an FDA follows. Please note that late, untimely USPTO that this human drug product filed comments will not be considered. had undergone a regulatory review investigation, and must certify that a true and complete copy of the petition Comments must be submitted on or period and that the approval of before November 17, 2017.1 The https:// TECFIDERA represented the first has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th www.regulations.gov electronic filing permitted commercial marketing or use system will accept comments until of the product. Thereafter, the USPTO Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format midnight Eastern Time at the end of requested that FDA determine the November 17, 2017. Comments received product’s regulatory review period. specified in 21 CFR 10.30. Submit petitions electronically to by mail/hand delivery/courier (for II. Determination of Regulatory Review https://www.regulations.gov at Docket written/paper submissions) will be Period No. FDA–2013–S–0610. Submit written considered timely if they are petitions (two copies are required) to the postmarked or the delivery service FDA has determined that the acceptance receipt is on or before that applicable regulatory review period for Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 date. TECFIDERA is 2,480 days. Of this time, 2,085 days occurred during the testing Fishers Lane, Rm. 1061, Rockville, MD Electronic Submissions phase and 395 days occurred during the 20852. Submit electronic comments in the approval phase. These periods of time Dated: September 29, 2017. following way: were derived from the following dates: Anna K. Abram, • Federal eRulemaking Portal: 1. The date an exemption under Deputy Commissioner for Policy, Planning, https://www.regulations.gov. Follow the section 505(i) of the Federal Food, Drug, Legislation, and Analysis. instructions for submitting comments. and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2017–21435 Filed 10–4–17; 8:45 am] Comments submitted electronically, U.S.C. 355(i)) became effective: June 14, BILLING CODE 4164–01–P including attachments, to https:// 2006. FDA has verified the applicant’s www.regulations.gov will be posted to claim that the date the investigational the docket unchanged. Because your new drug application (IND) became DEPARTMENT OF HEALTH AND comment will be made public, you are effective was on June 14, 2006. HUMAN SERVICES solely responsible for ensuring that your 2. The date the application was comment does not include any initially submitted with respect to the Food and Drug Administration confidential information that you or a human drug product under section [Docket No. FDA–2011–N–0656] third party may not wish to be posted, 505(b) of the FD&C Act: February 27, such as medical information, your or 2012. FDA has verified the applicant’s Animal Drug User Fee Act; Public anyone else’s Social Security number, or claim that the new drug application Meeting; Request for Comments confidential business information, such (NDA) for TECFIDERA (NDA 204063) AGENCY: Food and Drug Administration, as a manufacturing process. Please note ethrower on DSK3G9T082PROD with NOTICES was initially submitted on February 27, HHS. that if you include your name, contact 2012. information, or other information that ACTION: Notice of public meeting; 3. The date the application was request for comments. 1 This date corrects the comment closing date of approved: March 27, 2013. FDA has December 1, 2017, stated in the Federal Register verified the applicant’s claims that NDA SUMMARY: The Food and Drug notice announcing the initial ADUFA 204063 was approved on March 27, Administration (FDA, the Agency, or reauthorization public meeting held on May 16, 2013. we) is announcing a forthcoming public 2016 (81 FR 23313, April 20, 2016). VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1


Document Created: 2017-10-05 00:53:54
Document Modified: 2017-10-05 00:53:54
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 December 4, 2017. 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 3, 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 46502 
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