83_FR_7225 83 FR 7191 - Determination of Regulatory Review Period for Purposes of Patent Extension; PORTRAZZA

83 FR 7191 - Determination of Regulatory Review Period for Purposes of Patent Extension; PORTRAZZA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 34 (February 20, 2018)

Page Range7191-7192
FR Document2018-03345

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

Federal Register, Volume 83 Issue 34 (Tuesday, February 20, 2018) 
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7191-7192]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03345]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1891]


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

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 PORTRAZZA and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Director of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human 
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 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 20, 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 No. 
FDA-2016-E-1891 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; PORTRAZZA.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and 
other applicable disclosure law. For more information about FDA's 
posting of comments to public dockets, see 80 FR 56469, September 18, 
2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term 
Restoration Act (Pub. L. 100-670) generally provide that a patent may 
be extended for a period of up to 5 years so long as the patented item 
(human drug product, animal drug product, medical device, food 
additive, or color additive) was subject to regulatory review by FDA 
before the item was marketed. Under these acts, a product's regulatory 
review period forms the basis for determining the amount of extension 
an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human 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

[[Page 7192]]

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 PORTRAZZA 
(necitumumab). PORTRAZZA is indicated, in combination with gemcitabine 
and cisplatin, for first-line treatment of patients with metastatic 
squamous non-small cell lung cancer. Subsequent to this approval, the 
USPTO received a patent term restoration application for PORTRAZZA 
(U.S. Patent No. 7,598,350) from Eli Lilly and Company, and the USPTO 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated August 30, 2016, FDA advised 
the USPTO that this human biological product had undergone a regulatory 
review period and that the approval of PORTRAZZA 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 
PORTRAZZA is 2,533 days. Of this time, 2,175 days occurred during the 
testing phase of the regulatory review period, while 358 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: December 
19, 2008. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on December 
19, 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 2, 2014. The applicant claims 
October 22, 2014, as the date the biologics license application (BLA) 
for PORTRAZZA (BLA 125547) was initially submitted. However, FDA 
records indicate that BLA 125547 was submitted on December 2, 2014.
    3. The date the application was approved: November 24, 2015. FDA 
has verified the applicant's claim that BLA 125547 was approved on 
November 24, 2015.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its application for patent extension, 
this applicant seeks 1,321 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 http://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: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03345 Filed 2-16-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices 7191 Dated: February 13, 2018. instructions for submitting comments. its consideration of comments. The Mary Lazare, Comments submitted electronically, second copy, which will have the Principal Deputy Administrator. including attachments, to https:// claimed confidential information [FR Doc. 2018–03390 Filed 2–16–18; 8:45 am] www.regulations.gov will be posted to redacted/blacked out, will be available BILLING CODE 4154–01–P the docket unchanged. Because your for public viewing and posted on comment will be made public, you are https://www.regulations.gov. Submit solely responsible for ensuring that your both copies to the Dockets Management DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and HUMAN SERVICES confidential information that you or a contact information to be made publicly third party may not wish to be posted, available, you can provide this Food and Drug Administration such as medical information, your or information on the cover sheet and not [Docket No. FDA–2016–E–1891] anyone else’s Social Security number, or in the body of your comments and you confidential business information, such must identify this information as Determination of Regulatory Review as a manufacturing process. Please note ‘‘confidential.’’ Any information marked Period for Purposes of Patent that if you include your name, contact as ‘‘confidential’’ will not be disclosed Extension; PORTRAZZA information, or other information that except in accordance with § 10.20 (21 identifies you in the body of your CFR 10.20) and other applicable AGENCY: Food and Drug Administration, comments, that information will be disclosure law. For more information HHS. posted on https://www.regulations.gov. about FDA’s posting of comments to ACTION: Notice. • If you want to submit a comment public dockets, see 80 FR 56469, with confidential information that you September 18, 2015, or access the SUMMARY: The Food and Drug do not wish to be made available to the Administration (FDA or the Agency) has information at: https://www.gpo.gov/ public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- determined the regulatory review period written/paper submission and in the 23389.pdf. for PORTRAZZA and is publishing this manner detailed (see ‘‘Written/Paper Docket: For access to the docket to notice of that determination as required Submissions’’ and ‘‘Instructions’’). read background documents or the by law. FDA has made the determination because of the Written/Paper Submissions electronic and written/paper comments submission of an application to the received, go to https:// Submit written/paper submissions as Director of the U.S. Patent and www.regulations.gov and insert the follows: docket number, found in brackets in the Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for of Commerce, for the extension of a heading of this document, into the written/paper submissions): Dockets patent which claims that human ‘‘Search’’ box and follow the prompts Management Staff (HFA–305), Food and biological product. and/or go to the Dockets Management Drug Administration, 5630 Fishers DATES: Anyone with knowledge that any Staff, 5630 Fishers Lane, Rm. 1061, Lane, Rm. 1061, Rockville, MD 20852. of the dates as published (see the • For written/paper comments Rockville, MD 20852. SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT: incorrect may submit either electronic Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory or written comments and ask for a well as any attachments, except for Policy, Food and Drug Administration, redetermination by April 23, 2018. information submitted, marked and 10903 New Hampshire Ave., Bldg. 51, Furthermore, any interested person may identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993, petition FDA for a determination as detailed in ‘‘Instructions.’’ 301–796–3600. regarding whether the applicant for Instructions: All submissions received SUPPLEMENTARY INFORMATION: extension acted with due diligence must include the Docket No. FDA– 2016–E–1891 for ‘‘Determination of I. Background during the regulatory review period by August 20, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes The Drug Price Competition and SUPPLEMENTARY INFORMATION section for of Patent Extension; PORTRAZZA.’’ Patent Term Restoration Act of 1984 more information. Received comments, those filed in a (Pub. L. 98–417) and the Generic ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be Animal Drug and Patent Term as follows. Please note that late, placed in the docket and, except for Restoration Act (Pub. L. 100–670) untimely filed comments will not be those submitted as ‘‘Confidential generally provide that a patent may be considered. Electronic comments must Submissions,’’ publicly viewable at extended for a period of up to 5 years be submitted on or before April 23, https://www.regulations.gov or at the so long as the patented item (human 2018. The https://www.regulations.gov Dockets Management Staff between 9 drug product, animal drug product, electronic filing system will accept a.m. and 4 p.m., Monday through medical device, food additive, or color comments until midnight Eastern Time Friday. additive) was subject to regulatory at the end of April 23, 2018. Comments • Confidential Submissions—To review by FDA before the item was received by mail/hand delivery/courier submit a comment with confidential marketed. Under these acts, a product’s (for written/paper submissions) will be information that you do not wish to be regulatory review period forms the basis considered timely if they are made publicly available, submit your for determining the amount of extension postmarked or the delivery service comments only as a written/paper an applicant may receive. submission. You should submit two A regulatory review period consists of sradovich on DSK3GMQ082PROD with NOTICES acceptance receipt is on or before that date. copies total. One copy will include the two periods of time: A testing phase and information you claim to be confidential an approval phase. For human Electronic Submissions with a heading or cover note that states biological products, the testing phase Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS begins when the exemption to permit following way: CONFIDENTIAL INFORMATION.’’ The the clinical investigations of the • Federal eRulemaking Portal: Agency will review this copy, including biological product becomes effective https://www.regulations.gov. Follow the the claimed confidential information, in and runs until the approval phase VerDate Sep<11>2014 17:55 Feb 16, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\20FEN1.SGM 20FEN1

7192 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices begins. The approval phase starts with application (BLA) for PORTRAZZA DEPARTMENT OF HEALTH AND the initial submission of an application (BLA 125547) was initially submitted. HUMAN SERVICES to market the human biological product However, FDA records indicate that and continues until FDA grants BLA 125547 was submitted on Food and Drug Administration permission to market the biological December 2, 2014. [Docket No. FDA–2016–E–1888] product. Although only a portion of a 3. The date the application was regulatory review period may count Determination of Regulatory Review toward the actual amount of extension approved: November 24, 2015. FDA has Period for Purposes of Patent that the Director of USPTO may award verified the applicant’s claim that BLA Extension; DARZALEX (for example, half the testing phase must 125547 was approved on November 24, be subtracted as well as any time that 2015. AGENCY: Food and Drug Administration, may have occurred before the patent This determination of the regulatory HHS. was issued), FDA’s determination of the review period establishes the maximum ACTION: Notice. length of a regulatory review period for potential length of a patent extension. SUMMARY: The Food and Drug a human biological product will include However, the USPTO applies several Administration (FDA or the Agency) has all of the testing phase and approval statutory limitations in its calculations determined the regulatory review period phase as specified in 35 U.S.C. of the actual period for patent extension. for DARZALEX and is publishing this 156(g)(1)(B). In its application for patent extension, notice of that determination as required FDA has approved for marketing the this applicant seeks 1,321 days of patent by law. FDA has made the human biologic product PORTRAZZA term extension. determination because of the (necitumumab). PORTRAZZA is submission of an application to the indicated, in combination with III. Petitions Director of the U.S. Patent and gemcitabine and cisplatin, for first-line Anyone with knowledge that any of Trademark Office (USPTO), Department treatment of patients with metastatic squamous non-small cell lung cancer. the dates as published are incorrect may of Commerce, for the extension of a Subsequent to this approval, the USPTO submit either electronic or written patent which claims that human received a patent term restoration biological product. comments and, under 21 CFR 60.24, ask application for PORTRAZZA (U.S. DATES: Anyone with knowledge that any for a redetermination (see DATES). Patent No. 7,598,350) from Eli Lilly and Furthermore, as specified in § 60.30 (21 of the dates as published (see the Company, and the USPTO requested SUPPLEMENTARY INFORMATION section) are CFR 60.30), any interested person may FDA’s assistance in determining this incorrect may submit either electronic petition FDA for a determination patent’s eligibility for patent term or written comments and ask for a regarding whether the applicant for restoration. In a letter dated August 30, redetermination by April 23, 2018. extension acted with due diligence Furthermore, any interested person may 2016, FDA advised the USPTO that this during the regulatory review period. To human biological product had petition FDA for a determination meet its burden, the petition must regarding whether the applicant for undergone a regulatory review period comply with all the requirements of extension acted with due diligence and that the approval of PORTRAZZA § 60.30, including but not limited to: during the regulatory review period by represented the first permitted commercial marketing or use of the Must be timely (see DATES), must be August 20, 2018. See ‘‘Petitions’’ in the product. Thereafter, the USPTO filed in accordance with § 10.20, must SUPPLEMENTARY INFORMATION section for requested that FDA determine the contain sufficient facts to merit an FDA more information. product’s regulatory review period. investigation, and must certify that a ADDRESSES: You may submit comments true and complete copy of the petition as follows. Please note that late, II. Determination of Regulatory Review has been served upon the patent untimely filed comments will not be Period applicant. (See H. Rept. 857, part 1, 98th considered. Electronic comments must FDA has determined that the Cong., 2d sess., pp. 41–42, 1984.) be submitted on or before April 23, applicable regulatory review period for Petitions should be in the format 2018. The https://www.regulations.gov PORTRAZZA is 2,533 days. Of this specified in 21 CFR 10.30. electronic filing system will accept time, 2,175 days occurred during the comments until midnight Eastern Time Submit petitions electronically to testing phase of the regulatory review at the end of April 23, 2018. Comments http://www.regulations.gov at Docket period, while 358 days occurred during received by mail/hand delivery/courier No. FDA–2013–S–0610. Submit written the approval phase. These periods of (for written/paper submissions) will be time were derived from the following petitions (two copies are required) to the considered timely if they are dates: Dockets Management Staff (HFA–305), postmarked or the delivery service 1. The date an exemption under Food and Drug Administration, 5630 acceptance receipt is on or before that section 505(i) of the Federal Food, Drug, Fishers Lane, Rm. 1061, Rockville, MD date. and Cosmetic Act (21 U.S.C. 355(i)) 20852. became effective: December 19, 2008. Electronic Submissions Dated: February 13, 2018. FDA has verified the applicant’s claim Leslie Kux, Submit electronic comments in the that the date the investigational new following way: Associate Commissioner for Policy. • Federal eRulemaking Portal: drug application became effective was [FR Doc. 2018–03345 Filed 2–16–18; 8:45 am] https://www.regulations.gov. Follow the sradovich on DSK3GMQ082PROD with NOTICES on December 19, 2008. 2. The date the application was BILLING CODE 4164–01–P instructions for submitting comments. initially submitted with respect to the Comments submitted electronically, human biological product under section including attachments, to https:// 351 of the Public Health Service Act (42 www.regulations.gov will be posted to U.S.C. 262): December 2, 2014. The the docket unchanged. Because your applicant claims October 22, 2014, as comment will be made public, you are the date the biologics license solely responsible for ensuring that your VerDate Sep<11>2014 17:55 Feb 16, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\20FEN1.SGM 20FEN1


Document Created: 2018-02-17 02:29:23
Document Modified: 2018-02-17 02:29:23
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 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 20, 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 7191 
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