81 FR 21574 - Determination of Regulatory Review Period for Purposes of Patent Extension; APTIOM
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 70 (April 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 70 (April 12, 2016)
| Page Range | 21574-21576 | |
| FR Document | 2016-08334 |
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)] [Notices] [Pages 21574-21576] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08334] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2337] Determination of Regulatory Review Period for Purposes of Patent Extension; APTIOM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for APTIOM 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 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. [[Page 21575]] 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-2337 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; APTIOM.'' 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 the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human 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 APTIOM (eslicarbazepine acetate). APTIOM is indicated as an adjunctive treatment of partial-onset seizures. Subsequent to this approval, the USPTO received a patent term restoration application for APTIOM (U.S. Patent No. 5,753,646) from BIAL-PORTELA & CA, S.A., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of APTIOM 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 APTIOM is 2,517 days. Of this time, 832 days occurred during the testing phase of the regulatory review period, while 1,685 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: December 20, 2006. FDA has verified the BIAL-PORTELA & CA, S.A. claim that December 20, 2006, is the date the investigational new drug application became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: March 30, 2009. [[Page 21576]] The applicant claims March 29, 2009 as the date the NDA for APTIOM was initially submitted. However, FDA records indicate that NDA 22-416 was submitted on March 30, 2009. 3. The date the application was approved: November 8, 2013. FDA has verified the applicant's claim that NDA 22-416 was approved on November 8, 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 1,826 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. 2016-08334 Filed 4-11-16; 8:45 am] BILLING CODE P
![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.
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![21576 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
The applicant claims March 29, 2009 as guidance for industry entitled ‘‘Safety • Mail/Hand delivery/Courier (for
the date the NDA for APTIOM was Considerations for Product Design to written/paper submissions): Division of
initially submitted. However, FDA Minimize Medication Errors.’’ The Dockets Management (HFA–305), Food
records indicate that NDA 22–416 was guidance is intended for sponsors of and Drug Administration, 5630 Fishers
submitted on March 30, 2009. investigational new drug applications Lane, Rm. 1061, Rockville, MD 20852.
3. The date the application was (INDs); applicants of new drug • For written/paper comments
approved: November 8, 2013. FDA has applications (NDAs), biologics licensing submitted to the Division of Dockets
verified the applicant’s claim that NDA applications (BLAs), and abbreviated Management, FDA will post your
22–416 was approved on November 8, new drug applications (ANDAs); and comment, as well as any attachments,
2013. manufacturers of prescription drugs except for information submitted,
This determination of the regulatory marketed without an approved marked and identified, as confidential,
review period establishes the maximum application or over-the-counter (OTC) if submitted as detailed in
potential length of a patent extension. monograph drugs. This guidance ‘‘Instructions.’’
However, the USPTO applies several provides sponsors, applicants, and Instructions: All submissions received
statutory limitations in its calculations manufacturers with a set of principles to must include the Docket No. FDA–
of the actual period for patent extension. consider while developing drug 2012–D–1005 for ‘‘Safety Considerations
In its application for patent extension, products using a systems approach to for Product Design to Minimize
this applicant seeks 1,826 days of patent minimize medication errors relating to Medication Errors.’’ Received comments
term extension. product design and container closure will be placed in the docket and, except
design. The recommendations in this for those submitted as ‘‘Confidential
III. Petitions Submissions,’’ publicly viewable at
guidance document are intended to
Anyone with knowledge that any of provide best practices on how to http://www.regulations.gov or at the
the dates as published are incorrect may improve the drug product and container Division of Dockets Management
submit either electronic or written closure design for all prescription and between 9 a.m. and 4 p.m., Monday
comments and ask for a redetermination nonprescription drug products. This through Friday.
(see DATES). Furthermore, any guidance also provides examples of • Confidential Submissions—To
interested person may petition FDA for product designs that resulted in submit a comment with confidential
a determination regarding whether the postmarketing error. information that you do not wish to be
applicant for extension acted with due DATES: Submit either electronic or made publicly available, submit your
diligence during the regulatory review written comments on Agency guidances comments only as a written/paper
period. To meet its burden, the petition at any time. submission. You should submit two
must be timely (see DATES) and contain copies total. One copy will include the
ADDRESSES: You may submit comments
sufficient facts to merit an FDA information you claim to be confidential
as follows:
investigation. (See H. Rept. 857, part 1, with a heading or cover note that states
98th Cong., 2d sess., pp. 41–42, 1984.) Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Petitions should be in the format Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
specified in 21 CFR 10.30. following way: Agency will review this copy, including
Submit petitions electronically to • Federal eRulemaking Portal:http:// the claimed confidential information, in
http://www.regulations.gov at Docket www.regulations.gov. Follow the its consideration of comments. The
No. FDA–2013–S–0610. Submit written instructions for submitting comments. second copy, which will have the
petitions (two copies are required) to the Comments submitted electronically, claimed confidential information
Division of Dockets Management (HFA– including attachments, to http:// redacted/blacked out, will be available
305), Food and Drug Administration, www.regulations.gov will be posted to for public viewing and posted on http://
5630 Fishers Lane, Rm. 1061, Rockville, the docket unchanged. Because your www.regulations.gov. Submit both
MD 20852. comment will be made public, you are copies to the Division of Dockets
Dated: April 6, 2016. solely responsible for ensuring that your Management. If you do not wish your
comment does not include any name and contact information to be
Leslie Kux,
confidential information that you or a made publicly available, you can
Associate Commissioner for Policy. provide this information on the cover
third party may not wish to be posted,
[FR Doc. 2016–08334 Filed 4–11–16; 8:45 am] sheet and not in the body of your
such as medical information, your or
BILLING CODE P
anyone else’s Social Security number, or comments and you must identify this
confidential business information, such information as ‘‘confidential.’’ Any
as a manufacturing process. Please note information marked as ‘‘confidential’’
DEPARTMENT OF HEALTH AND will not be disclosed except in
HUMAN SERVICES that if you include your name, contact
information, or other information that accordance with 21 CFR 10.20 and other
Food and Drug Administration identifies you in the body of your applicable disclosure law. For more
comments, that information will be information about FDA’s posting of
[Docket No. FDA–2012–D–1005] posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access
Safety Considerations for Product the information at: http://www.fda.gov/
with confidential information that you
Design To Minimize Medication Errors; regulatoryinformation/dockets/
asabaliauskas on DSK3SPTVN1PROD with NOTICES
do not wish to be made available to the
Guidance for Industry; Availability default.htm.
public, submit the comment as a
AGENCY: Food and Drug Administration, written/paper submission and in the Docket: For access to the docket to
HHS. manner detailed (see ‘‘Written/Paper read background documents or the
ACTION: Notice. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to http://
SUMMARY: The Food and Drug Written/Paper Submissions www.regulations.gov and insert the
Administration (FDA or the Agency) is Submit written/paper submissions as docket number, found in brackets in the
announcing the availability of a follows: heading of this document, into the
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Document Created: 2016-04-12 00:46:57
Document Modified: 2016-04-12 00:46:57
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 21574 |
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