81_FR_21643 81 FR 21573 - Determination of Regulatory Review Period for Purposes of Patent Extension; APOQUEL

81 FR 21573 - Determination of Regulatory Review Period for Purposes of Patent Extension; APOQUEL

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 70 (April 12, 2016)

Page Range21573-21574
FR Document2016-08333

The Food and Drug Administration (FDA) has determined the regulatory review period for APOQUEL 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 U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

Federal Register, Volume 81 Issue 70 (Tuesday, April 12, 2016) 
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21573-21574]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08333]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-1222]


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

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 APOQUEL 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 U.S. 
Patent and Trademark Office (USPTO), Department of Commerce, for the 
extension of a patent which claims that animal 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 June 
13, 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 October 11, 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 No. 
FDA-2014-E-1222 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; APOQUEL.'' 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 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

[[Page 21574]]

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 animal drug products, the 
testing phase begins on the earlier date when either a major 
environmental effects test was initiated for the drug or when an 
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the animal 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 an animal 
drug product will include all of the testing phase and approval phase 
as specified in 35 U.S.C. 156(g)(4)(B).
    FDA has approved for marketing the animal drug product APOQUEL 
(oclacitinib). APOQUEL is indicated for control of pruritus associated 
with allergic dermatitis and control of atopic dermatitis in dogs at 
least 12 months of age. Subsequent to this approval, the USPTO received 
a patent term restoration application for APOQUEL (U.S. Patent No. 
6,890,929) from Pfizer Inc., and the USPTO requested FDA's assistance 
in determining this patent's eligibility for patent term restoration. 
In a letter dated May 11, 2015, FDA advised the USPTO that this animal 
drug product had undergone a regulatory review period and that the 
approval of APOQUEL 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 
APOQUEL is 2,226 days. Of this time, 2,172 days occurred during the 
testing phase of the regulatory review period, while 54 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: April 12, 2007. FDA has verified the applicant's claim that 
the date the investigational new animal drug application (INAD) became 
effective was on April 12, 2007.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512 of the FD&C Act (21 U.S.C. 
360b): March 22, 2013. FDA has verified the applicant's claim that the 
new animal drug application (NADA) for APOQUEL (NADA 141-345) was 
submitted on March 22, 2013.
    3. The date the application was approved: May 14, 2013. FDA has 
verified the applicant's claim that NADA 141-345 was approved on May 
14, 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 application for patent extension, 
this applicant seeks 1,139 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, 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: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08333 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices 21573 Chemistry, regarding Review of DEPARTMENT OF HEALTH AND do not wish to be made available to the Carbadox Metabolism (September 7, HUMAN SERVICES public, submit the comment as a 1994). written/paper submission and in the 16. FDA, Freedom of Information (FOI) Food and Drug Administration manner detailed (see ‘‘Written/Paper Summary, NADA 041–061, MECADOX Submissions’’ and ‘‘Instructions’’). [Docket No. FDA–2014–E–1222] 10 (carbadox) Type A medicated article, supplemental approval October 5, 1998. Written/Paper Submissions Determination of Regulatory Review Available at http://www.fda.gov/ Period for Purposes of Patent Submit written/paper submissions as AnimalVeterinary/Products/ Extension; APOQUEL follows: ApprovedAnimalDrugProducts/ • Mail/Hand delivery/Courier (for FOIADrugSummaries/ucm064223.htm AGENCY: Food and Drug Administration, written/paper submissions): Division of (accessed on March 19, 2016). HHS. Dockets Management (HFA–305), Food 17. FDA, Freedom of Information (FOI) ACTION: Notice. and Drug Administration, 5630 Fishers Summary, NADA 141–211, MECADOX Lane, Rm. 1061, Rockville, MD 20852. 10 (carbadox) and TERRAMYCIN 50, SUMMARY: The Food and Drug • For written/paper comments 100, or 200 (oxytetracycline) in Type C Administration (FDA) has determined submitted to the Division of Dockets medicated feed, original approval July the regulatory review period for Management, FDA will post your 21, 2004. Available at http:// APOQUEL and is publishing this notice comment, as well as any attachments, www.fda.gov/downloads/ of that determination as required by except for information submitted, AnimalVeterinary/Products/ law. FDA has made the determination marked and identified, as confidential, ApprovedAnimalDrugProducts/ because of the submission of an if submitted as detailed in FOIADrugSummaries/ucm118005.pdf application to the Director of U.S. Patent ‘‘Instructions.’’ (accessed on March 19, 2016). and Trademark Office (USPTO), Instructions: All submissions received 18. Codex Alimentarius Commission, Department of Commerce, for the must include the Docket No. FDA– Twenty-Eighth Session, Headquarters, extension of a patent which claims that 2014–E–1222 for ‘‘Determination of Food and Agriculture Organization, animal drug product. Regulatory Review Period for Purposes Rome, Italy, 2005. DATES: Anyone with knowledge that any of Patent Extension; APOQUEL.’’ 19. FDA, CVM Guidance for Industry (GFI) of the dates as published (in the Received comments will be placed in #205, VICH GL 46, ‘‘Studies to Evaluate SUPPLEMENTARY INFORMATION section) are the docket and, except for those the Metabolism and Residue Kinetics of incorrect may submit either electronic submitted as ‘‘Confidential Veterinary Drugs in Food-Producing or written comments and ask for a Submissions,’’ publicly viewable at Animals: Metabolism Study to redetermination by June 13, 2016. http://www.regulations.gov or at the Determine the Quantity and Identify the Furthermore, any interested person may Division of Dockets Management Nature of Residues (MRK),’’ September petition FDA for a determination between 9 a.m. and 4 p.m., Monday 15, 2011. Available at http:// regarding whether the applicant for through Friday. www.fda.gov/downloads/ extension acted with due diligence • Confidential Submissions—To AnimalVeterinary/ during the regulatory review period by submit a comment with confidential GuidanceComplianceEnforcement/ October 11, 2016. See ‘‘Petitions’’ in the information that you do not wish to be GuidanceforIndustry/UCM207939.pdf made publicly available, submit your SUPPLEMENTARY INFORMATION section for (accessed on March 19, 2016). comments only as a written/paper more information. 20. MacIntosh, A.I., G. Lauriault, and G.A. submission. You should submit two ADDRESSES: You may submit comments Neville, ‘‘Liquid Chromatographic copies total. One copy will include the Monitoring of the Depletion of Carbadox as follows: information you claim to be confidential and its Metabolite Desoxycarbadox in Electronic Submissions with a heading or cover note that states Swine Tissues,’’ Journal—Association of ‘‘THIS DOCUMENT CONTAINS Submit electronic comments in the Official Analytical Chemists, 68:665–71, CONFIDENTIAL INFORMATION.’’ The 1985. following way: • Federal eRulemaking Portal: http:// Agency will review this copy, including 21. FDA, CVM Guidance for Industry (GFI) www.regulations.gov. Follow the the claimed confidential information, in #208, VICH GL 49, ‘‘Studies to Evaluate instructions for submitting comments. its consideration of comments. The the Metabolism and Residue Kinetics of Comments submitted electronically, second copy, which will have the Veterinary Drugs in Food-Producing Animals: Validation of Analytical including attachments, to http:// claimed confidential information Methods Used in Residue Depletion www.regulations.gov will be posted to redacted/blacked out, will be available Studies,’’ September 15, 2011. Available the docket unchanged. Because your for public viewing and posted on http:// at http://www.fda.gov/downloads/ comment will be made public, you are www.regulations.gov. Submit both AnimalVeterinary/ solely responsible for ensuring that your copies to the Division of Dockets GuidanceComplianceEnforcement/ comment does not include any Management. If you do not wish your GuidanceforIndustry/UCM207942.pdf confidential information that you or a name and contact information to be (accessed on March 19, 2016). third party may not wish to be posted, made publicly available, you can 22. FDA, Memorandum to the File, such as medical information, your or provide this information on the cover Claycamp, H. G., Verification and anyone else’s Social Security number, or sheet and not in the body of your confidential business information, such comments and you must identify this asabaliauskas on DSK3SPTVN1PROD with NOTICES Extension of the 2003 JECFA Carbadox Monograph Analyses, July 29, 2012. as a manufacturing process. Please note information as ‘‘confidential.’’ Any that if you include your name, contact information marked as ‘‘confidential’’ Dated: April 6, 2016. information, or other information that will not be disclosed except in Tracey Forfa, accordance with 21 CFR 10.20 and other identifies you in the body of your Acting Director, Center for Veterinary comments, that information will be applicable disclosure law. For more Medicine. posted on http://www.regulations.gov. information about FDA’s posting of [FR Doc. 2016–08327 Filed 4–8–16; 11:15 am] • If you want to submit a comment comments to public dockets, see 80 FR BILLING CODE 4164–01–P with confidential information that you 56469, September 18, 2015, or access VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\12APN1.SGM 12APN1

21574 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices the information at: http://www.fda.gov/ (oclacitinib). APOQUEL is indicated for (see DATES). Furthermore, any interested regulatoryinformation/dockets/ control of pruritus associated with person may petition FDA for a default.htm. allergic dermatitis and control of atopic determination regarding whether the Docket: For access to the docket to dermatitis in dogs at least 12 months of applicant for extension acted with due read background documents or the age. Subsequent to this approval, the diligence during the regulatory review electronic and written/paper comments USPTO received a patent term period. To meet its burden, the petition received, go to http:// restoration application for APOQUEL must be timely (see DATES) and contain www.regulations.gov and insert the (U.S. Patent No. 6,890,929) from Pfizer sufficient facts to merit an FDA docket number, found in brackets in the Inc., and the USPTO requested FDA’s investigation. (See H. Rept. 857, part 1, heading of this document, into the assistance in determining this patent’s 98th Cong., 2d sess., pp. 41–42, 1984.) ‘‘Search’’ box and follow the prompts eligibility for patent term restoration. In Petitions should be in the format and/or go to the Division of Dockets a letter dated May 11, 2015, FDA specified in 21 CFR 10.30. Management, 5630 Fishers Lane, Rm. advised the USPTO that this animal Submit petitions electronically to 1061, Rockville, MD 20852. drug product had undergone a http://www.regulations.gov at Docket FOR FURTHER INFORMATION CONTACT: regulatory review period and that the No. FDA–2013–S–0610. Submit written Beverly Friedman, Office of Regulatory approval of APOQUEL represented the petitions (two copies are required) to the Policy, Food and Drug Administration, first permitted commercial marketing or Division of Dockets Management (HFA– 10903 New Hampshire Ave., Bldg. 51, use of the product. Thereafter, the 305), Food and Drug Administration, Rm. 6250, Silver Spring, MD 20993, USPTO requested that FDA determine 5630 Fishers Lane, rm. 1061, Rockville, 301–796–3600. the product’s regulatory review period. MD 20852. SUPPLEMENTARY INFORMATION: Dated: April 6, 2016. II. Determination of Regulatory Review I. Background Period Leslie Kux, The Drug Price Competition and FDA has determined that the Associate Commissioner for Policy. Patent Term Restoration Act of 1984 applicable regulatory review period for [FR Doc. 2016–08333 Filed 4–11–16; 8:45 am] (Pub. L. 98–417) and the Generic APOQUEL is 2,226 days. Of this time, BILLING CODE 4164–01–P Animal Drug and Patent Term 2,172 days occurred during the testing Restoration Act (Pub. L. 100–670) phase of the regulatory review period, generally provide that a patent may be while 54 days occurred during the DEPARTMENT OF HEALTH AND extended for a period of up to 5 years approval phase. These periods of time HUMAN SERVICES so long as the patented item (human were derived from the following dates: drug product, animal drug product, 1. The date an exemption under Food and Drug Administration medical device, food additive, or color section 505(i) of the Federal Food, Drug, additive) was subject to regulatory and Cosmetic Act (the FD&C Act) (21 [Docket No. FDA–2014–E–2337] review by FDA before the item was U.S.C. 355(i)) became effective: April marketed. Under these acts, a product’s 12, 2007. FDA has verified the Determination of Regulatory Review regulatory review period forms the basis applicant’s claim that the date the Period for Purposes of Patent for determining the amount of extension investigational new animal drug Extension; APTIOM an applicant may receive. application (INAD) became effective AGENCY: Food and Drug Administration, A regulatory review period consists of was on April 12, 2007. HHS. two periods of time: A testing phase and 2. The date the application was an approval phase. For animal drug initially submitted with respect to the ACTION: Notice. products, the testing phase begins on animal drug product under section 512 SUMMARY: The Food and Drug the earlier date when either a major of the FD&C Act (21 U.S.C. 360b): March Administration (FDA) has determined environmental effects test was initiated 22, 2013. FDA has verified the the regulatory review period for for the drug or when an exemption applicant’s claim that the new animal APTIOM and is publishing this notice of under section 512(j) of the Federal Food, drug application (NADA) for APOQUEL that determination as required by law. Drug, and Cosmetic Act (the FD&C Act) (NADA 141–345) was submitted on FDA has made the determination (21 U.S.C. 360b(j)) became effective and March 22, 2013. because of the submission of an runs until the approval phase begins. 3. The date the application was application to the Director of the U.S. The approval phase starts with the approved: May 14, 2013. FDA has Patent and Trademark Office (USPTO), initial submission of an application to verified the applicant’s claim that Department of Commerce, for the market the animal drug product and NADA 141–345 was approved on May continues until FDA grants permission extension of a patent which claims that 14, 2013. to market the drug product. Although This determination of the regulatory human drug product. only a portion of a regulatory review review period establishes the maximum DATES: Anyone with knowledge that any period may count toward the actual potential length of a patent extension. of the dates as published (in the amount of extension that the Director of However, the USPTO applies several SUPPLEMENTARY INFORMATION section) are USPTO may award (for example, half statutory limitations in its calculations incorrect may submit either electronic the testing phase must be subtracted as of the actual period for patent extension. or written comments and ask for a redetermination by June 13, 2016. asabaliauskas on DSK3SPTVN1PROD with NOTICES well as any time that may have occurred In its application for patent extension, before the patent was issued), FDA’s this applicant seeks 1,139 days of patent Furthermore, any interested person may determination of the length of a term extension. petition FDA for a determination regulatory review period for an animal regarding whether the applicant for drug product will include all of the III. Petitions extension acted with due diligence testing phase and approval phase as Anyone with knowledge that any of during the regulatory review period by specified in 35 U.S.C. 156(g)(4)(B). the dates as published are incorrect may October 11, 2016. See ‘‘Petitions’’ in the FDA has approved for marketing the submit either electronic or written SUPPLEMENTARY INFORMATION section for animal drug product APOQUEL comments and ask for a redetermination more information. VerDate Sep<11>2014 17:18 Apr 11, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\12APN1.SGM 12APN1


Document Created: 2016-04-12 00:46:26
Document Modified: 2016-04-12 00:46:26
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 June 13, 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 October 11, 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 21573 
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