83_FR_7768 83 FR 7732 - Determination of Regulatory Review Period for Purposes of Patent Extension; ESBRIET

83 FR 7732 - Determination of Regulatory Review Period for Purposes of Patent Extension; ESBRIET

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 36 (February 22, 2018)

Page Range7732-7733
FR Document2018-03612

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ESBRIET 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 83 Issue 36 (Thursday, February 22, 2018) 
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7732-7733]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-4674, FDA-2015-E-4696, FDA-2015-E-4700, FDA-
2015-E-4703, and FDA-2015-E-4704]


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

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 ESBRIET 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 April 
23, 2018. Furthermore, any interested person may petition FDA for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period by August 21, 2018. 
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 23, 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-2015-E-4674, FDA-2015-E-4696, FDA-2015-E-4700, FDA-2015-E-4703, and 
FDA-2015-E-4704 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; ESBRIET.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the dockets 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.

[[Page 7733]]

     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and 
other applicable disclosure law. For more information about FDA's 
posting of comments to public dockets, see 80 FR 56469, September 18, 
2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term 
Restoration Act (Pub. L. 100-670) generally provide that a patent may 
be extended for a period of up to 5 years so long as the patented item 
(human drug product, animal drug product, medical device, food 
additive, or color additive) was subject to regulatory review by FDA 
before the item was marketed. Under these acts, a product's regulatory 
review period forms the basis for determining the amount of extension 
an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants 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 ESBRIET 
(pirfenidone). ESBRIET is indicated for the treatment of idiopathic 
pulmonary fibrosis. Subsequent to this approval, the USPTO received 
patent term restoration applications for ESBRIET (U.S. Patent Nos. 
7,767,225; 7,767,700; 7,988,994; 8,383,150; and 8,420,674) from 
InterMune Inc., and the USPTO requested FDA's assistance in determining 
the patents' eligibility for patent term restoration. In a letter dated 
January 20, 2016, FDA advised the USPTO that this human drug product 
had undergone a regulatory review period and that the approval of 
ESBRIET 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 
ESBRIET is 14,993 days. Of this time, 13,186 days occurred during the 
testing phase of the regulatory review period, while 1,807 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: September 29, 1973. The applicant claims August 1, 1973, as 
the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was September 29, 1973, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: November 
4, 2009. FDA has verified the applicant's claim that the new drug 
application (NDA) for ESBRIET (NDA 22-535) was initially submitted on 
November 4, 2009.
    3. The date the application was approved: October 15, 2014. FDA has 
verified the applicant's claim that NDA 22-535 was approved on October 
15, 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 596 days or 754 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 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 Nos. FDA-2013-S-0610. Submit written petitions (two copies are 
required) to the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03612 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P

7732 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued Number of Number of disclosures Total annual Average burden per Activity/21 CFR section Total hours respondents per disclosures disclosure respondent Menstrual tampons, ranges of absorbency— 16 8 128 2 ................................ 256 801.430(e)(2). User labeling for latex condoms—801.435(b), (c), 51 6 306 100 ............................ 30,600 and (h). Labeling for IVDs—809.10(a) and (b) ..................... 1,700 6 10,200 80 .............................. 816,000 Labeling for general purpose laboratory reagents— 300 2 600 40 .............................. 24,000 809.10(d)(1). Labeling for analyte specific reagents—809.10(e) .. 300 25 7,500 1 ................................ 7,500 Labeling for OTC test sample collection systems 20 1 20 100 ............................ 2,000 for drugs of abuse testing—809.10(f). Advertising and promotional materials for ASRs— 300 25 7,500 1 ................................ 7,500 809.30(d). Labeling of sunlamp products—1040.20(d) ............. 19 1 19 10 .............................. 190 Total .................................................................. ........................ ........................ ........................ .................................... 9,024,946 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The number of recordkeepers/ incorrect may submit either electronic as a manufacturing process. Please note respondents and records/disclosures has or written comments and ask for a that if you include your name, contact been adjusted to reflect updated Agency redetermination by April 23, 2018. information, or other information that data. These adjustments result in an Furthermore, any interested person may identifies you in the body of your increase of 1,598,48 hours since the last petition FDA for a determination comments, that information will be OMB approval. regarding whether the applicant for posted on https://www.regulations.gov. Dated: February 14, 2018. extension acted with due diligence • If you want to submit a comment Leslie Kux, during the regulatory review period by with confidential information that you August 21, 2018. See ‘‘Petitions’’ in the do not wish to be made available to the Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION section for public, submit the comment as a [FR Doc. 2018–03608 Filed 2–21–18; 8:45 am] more information. written/paper submission and in the BILLING CODE 4164–01–P ADDRESSES: You may submit comments manner detailed (see ‘‘Written/Paper as follows. Please note that late, Submissions’’ and ‘‘Instructions’’). DEPARTMENT OF HEALTH AND untimely filed comments will not be Written/Paper Submissions HUMAN SERVICES considered. Electronic comments must be submitted on or before April 23, Submit written/paper submissions as Food and Drug Administration 2018. The https://www.regulations.gov follows: electronic filing system will accept • Mail/Hand delivery/Courier (for [Docket Nos. FDA–2015–E–4674, FDA– written/paper submissions): Dockets 2015–E–4696, FDA–2015–E–4700, FDA– comments until midnight Eastern Time 2015–E–4703, and FDA–2015–E–4704] at the end of April 23, 2018. Comments Management Staff (HFA–305), Food and received by mail/hand delivery/courier Drug Administration, 5630 Fishers Determination of Regulatory Review (for written/paper submissions) will be Lane, Rm. 1061, Rockville, MD 20852. Period for Purposes of Patent considered timely if they are • For written/paper comments Extension; ESBRIET postmarked or the delivery service submitted to the Dockets Management acceptance receipt is on or before that Staff, FDA will post your comment, as AGENCY: Food and Drug Administration, date. well as any attachments, except for HHS. information submitted, marked and ACTION: Notice. Electronic Submissions identified, as confidential, if submitted Submit electronic comments in the as detailed in ‘‘Instructions.’’ SUMMARY: The Food and Drug following way: Instructions: All submissions received Administration (FDA or the Agency) has • Federal eRulemaking Portal: must include the Docket Nos. FDA– determined the regulatory review period https://www.regulations.gov. Follow the 2015–E–4674, FDA–2015–E–4696, for ESBRIET and is publishing this instructions for submitting comments. FDA–2015–E–4700, FDA–2015–E–4703, notice of that determination as required Comments submitted electronically, and FDA–2015–E–4704 for by law. FDA has made the including attachments, to https:// ‘‘Determination of Regulatory Review determination because of the www.regulations.gov will be posted to Period for Purposes of Patent Extension; submission of applications to the the docket unchanged. Because your ESBRIET.’’ Received comments, those Director of the U.S. Patent and comment will be made public, you are filed in a timely manner (see daltland on DSKBBV9HB2PROD with NOTICES Trademark Office (USPTO), Department solely responsible for ensuring that your ADDRESSES), will be placed in the of Commerce, for the extension of a comment does not include any dockets and, except for those submitted patent which claims that human drug confidential information that you or a as ‘‘Confidential Submissions,’’ publicly product. third party may not wish to be posted, viewable at https://www.regulations.gov DATES: Anyone with knowledge that any such as medical information, your or or at the Dockets Management Staff of the dates as published (in the anyone else’s Social Security number, or between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION section) are confidential business information, such through Friday. VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1

Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices 7733 • Confidential Submissions—To review by FDA before the item was (IND) became effective. However, FDA submit a comment with confidential marketed. Under these acts, a product’s records indicate that the IND effective information that you do not wish to be regulatory review period forms the basis date was September 29, 1973, which made publicly available, submit your for determining the amount of extension was 30 days after FDA receipt of the comments only as a written/paper an applicant may receive. IND. submission. You should submit two A regulatory review period consists of 2. The date the application was copies total. One copy will include the two periods of time: A testing phase and initially submitted with respect to the information you claim to be confidential an approval phase. For human drug human drug product under section with a heading or cover note that states products, the testing phase begins when 505(b) of the FD&C Act: November 4, ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical 2009. FDA has verified the applicant’s CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes claim that the new drug application Agency will review this copy, including effective and runs until the approval (NDA) for ESBRIET (NDA 22–535) was the claimed confidential information, in phase begins. The approval phase starts initially submitted on November 4, its consideration of comments. The with the initial submission of an 2009. second copy, which will have the application to market the human drug claimed confidential information product and continues until FDA grants 3. The date the application was redacted/blacked out, will be available permission to market the drug product. approved: October 15, 2014. FDA has for public viewing and posted on Although only a portion of a regulatory verified the applicant’s claim that NDA https://www.regulations.gov. Submit review period may count toward the 22–535 was approved on October 15, both copies to the Dockets Management actual amount of extension that the 2014. Staff. If you do not wish your name and Director of USPTO may award (for This determination of the regulatory contact information to be made publicly example, half the testing phase must be review period establishes the maximum available, you can provide this subtracted as well as any time that may potential length of a patent extension. information on the cover sheet and not have occurred before the patent was However, the USPTO applies several in the body of your comments and you issued), FDA’s determination of the statutory limitations in its calculations must identify this information as length of a regulatory review period for of the actual period for patent extension. ‘‘confidential.’’ Any information marked a human drug product will include all In its applications for patent extension, as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase this applicant seeks 596 days or 754 except in accordance with § 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). days of patent term extension. CFR 10.20) and other applicable FDA has approved for marketing the human drug product ESBRIET III. Petitions disclosure law. For more information about FDA’s posting of comments to (pirfenidone). ESBRIET is indicated for the treatment of idiopathic pulmonary Anyone with knowledge that any of public dockets, see 80 FR 56469, the dates as published are incorrect may fibrosis. Subsequent to this approval, September 18, 2015, or access the submit either electronic or written the USPTO received patent term information at: https://www.gpo.gov/ comments and ask for a redetermination restoration applications for ESBRIET fdsys/pkg/FR-2015-09-18/pdf/2015- (see DATES). Furthermore, as specified in (U.S. Patent Nos. 7,767,225; 7,767,700; 23389.pdf. § 60.30 (21 CFR 60.30), any interested 7,988,994; 8,383,150; and 8,420,674) Docket: For access to the docket to person may petition FDA for a from InterMune Inc., and the USPTO read background documents or the determination regarding whether the requested FDA’s assistance in electronic and written/paper comments applicant for extension acted with due determining the patents’ eligibility for received, go to https:// diligence during the regulatory review patent term restoration. In a letter dated www.regulations.gov and insert the period. To meet its burden, the petition January 20, 2016, FDA advised the docket number, found in brackets in the must comply with all the requirements USPTO that this human drug product heading of this document, into the of § 60.30, including but not limited to: had undergone a regulatory review ‘‘Search’’ box and follow the prompts Must be timely (see DATES), must be period and that the approval of and/or go to the Dockets Management filed in accordance with § 10.20, must ESBRIET represented the first permitted Staff, 5630 Fishers Lane, Rm. 1061, contain sufficient facts to merit an FDA commercial marketing or use of the Rockville, MD 20852. investigation, and must certify that a product. Thereafter, the USPTO FOR FURTHER INFORMATION CONTACT: requested that FDA determine the true and complete copy of the petition Beverly Friedman, Office of Regulatory product’s regulatory review period. has been served upon the patent Policy, Food and Drug Administration, applicant. (See H. Rept. 857, part 1, 98th 10903 New Hampshire Ave, Bldg. 51, II. Determination of Regulatory Review Cong., 2d sess., pp. 41–42, 1984.) Rm. 6250, Silver Spring, MD 20993, Period Petitions should be in the format 301–796–3600. FDA has determined that the specified in 21 CFR 10.30. SUPPLEMENTARY INFORMATION: applicable regulatory review period for Submit petitions electronically to ESBRIET is 14,993 days. Of this time, https://www.regulations.gov at Docket I. Background 13,186 days occurred during the testing Nos. FDA–2013–S–0610. Submit written The Drug Price Competition and phase of the regulatory review period, petitions (two copies are required) to the Patent Term Restoration Act of 1984 while 1,807 days occurred during the Dockets Management Staff (HFA–305), (Pub. L. 98–417) and the Generic approval phase. These periods of time Food and Drug Administration, 5630 Animal Drug and Patent Term were derived from the following dates: Fishers Lane, Rm. 1061, Rockville, MD daltland on DSKBBV9HB2PROD with NOTICES Restoration Act (Pub. L. 100–670) 1. The date an exemption under 20852. generally provide that a patent may be section 505(i) of the Federal Food, Drug, extended for a period of up to 5 years and Cosmetic Act (the FD&C Act) (21 Dated: February 14, 2018. so long as the patented item (human U.S.C. 355(i)) became effective: Leslie Kux, drug product, animal drug product, September 29, 1973. The applicant Associate Commissioner for Policy. medical device, food additive, or color claims August 1, 1973, as the date the [FR Doc. 2018–03612 Filed 2–21–18; 8:45 am] additive) was subject to regulatory investigational new drug application BILLING CODE 4164–01–P VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00080 Fmt 4703 Sfmt 9990 E:\FR\FM\22FEN1.SGM 22FEN1


Document Created: 2018-02-22 02:50:45
Document Modified: 2018-02-22 02:50:45
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 23, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 21, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation83 FR 7732 
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