82 FR 2378 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADYNOVATE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 5 (January 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 5 (January 9, 2017)
| Page Range | 2378-2380 | |
| FR Document | 2017-00095 |
[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)] [Notices] [Pages 2378-2380] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00095] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-1196 and FDA-2016-E-1197] Determination of Regulatory Review Period for Purposes of Patent Extension; ADYNOVATE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ADYNOVATE 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 March 10, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for [[Page 2379]] extension acted with due diligence during the regulatory review period by July 10, 2017. 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: 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): 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 Nos. FDA-2016-E-1196 and FDA-2016-E-1197 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; ADYNOVATE.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://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 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 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 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 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 ADYNOVATE (antihemophilic factor (recombinant), PEGylated). ADYNOVATE is indicated in adolescent and adult patients (12 years and older) with Hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes, and routine prophylaxis to reduce the frequency of bleeding episodes. Subsequent to this approval, the USPTO received patent term restoration applications for ADYNOVATE (U.S. Patent Nos. 7,199,223 and 8,247,536) from Nektar Therapeutics, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of ADYNOVATE 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 ADYNOVATE is 1,061 days. Of this time, 707 days occurred during the testing phase of the regulatory review period, while 354 days occurred during the approval phase. These periods of [[Page 2380]] 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, 2012. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on December 19, 2012. 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): November 25, 2014. FDA has verified the applicant's claim that the biologics license application (BLA) for ADYNOVATE (BLA 125566) was initially submitted on November 25, 2014. 3. The date the application was approved: November 13, 2015. FDA has verified the applicant's claim that BLA 125566 was approved on November 13, 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 708 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 https://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: January 3, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00095 Filed 1-6-17; 8:45 am] BILLING CODE 4164-01-P
![2380 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices
time were derived from the following DEPARTMENT OF HEALTH AND do not wish to be made available to the
dates: HUMAN SERVICES public, submit the comment as a
1. The date an exemption under written/paper submission and in the
Food and Drug Administration manner detailed (see ‘‘Written/Paper
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i)) [Docket No. FDA–2016–E–1198] Submissions’’ and ‘‘Instructions’’).
became effective: December 19, 2012. Written/Paper Submissions
FDA has verified the applicant’s claim Determination of Regulatory Review
Period for Purposes of Patent Submit written/paper submissions as
that the date the investigational new follows:
drug application became effective was Extension; EMPLICITI
• Mail/Hand delivery/Courier (for
on December 19, 2012. AGENCY: Food and Drug Administration, written/paper submissions): Division of
2. The date the application was HHS. Dockets Management (HFA–305), Food
initially submitted with respect to the ACTION: Notice. and Drug Administration, 5630 Fishers
human biological product under section Lane, Rm. 1061, Rockville, MD 20852.
351 of the Public Health Service Act (42 SUMMARY: The Food and Drug • For written/paper comments
U.S.C. 262): November 25, 2014. FDA Administration (FDA) has determined submitted to the Division of Dockets
has verified the applicant’s claim that the regulatory review period for Management, FDA will post your
EMPLICITI and is publishing this notice comment, as well as any attachments,
the biologics license application (BLA)
of that determination as required by except for information submitted,
for ADYNOVATE (BLA 125566) was
law. FDA has made the determination marked and identified, as confidential,
initially submitted on November 25,
because of the submission of an if submitted as detailed in
2014.
application to the Director of the U.S. ‘‘Instructions.’’
3. The date the application was Patent and Trademark Office (USPTO), Instructions: All submissions received
approved: November 13, 2015. FDA has Department of Commerce, for the must include the Docket No. FDA–
verified the applicant’s claim that BLA extension of a patent which claims that 2016–E–1198 for ‘‘Determination of
125566 was approved on November 13, human biological product. Regulatory Review Period for Purposes
2015. DATES: Anyone with knowledge that any of Patent Extension; EMPLICITI.’’
This determination of the regulatory of the dates as published (see the Received comments will be placed in
review period establishes the maximum SUPPLEMENTARY INFORMATION section) are the docket and, except for those
potential length of a patent extension. incorrect may submit either electronic submitted as ‘‘Confidential
However, the USPTO applies several or written comments and ask for a Submissions,’’ publicly viewable at
statutory limitations in its calculations redetermination by March 10, 2017. https://www.regulations.gov or at the
of the actual period for patent extension. Furthermore, any interested person may Division of Dockets Management
In its application for patent extension, petition FDA for a determination between 9 a.m. and 4 p.m., Monday
this applicant seeks 708 days of patent regarding whether the applicant for through Friday.
term extension. extension acted with due diligence • Confidential Submissions—To
during the regulatory review period by submit a comment with confidential
III. Petitions July 10, 2017. See ‘‘Petitions’’ in the information that you do not wish to be
SUPPLEMENTARY INFORMATION section for made publicly available, submit your
Anyone with knowledge that any of comments only as a written/paper
the dates as published are incorrect may more information.
ADDRESSES: You may submit comments submission. You should submit two
submit either electronic or written copies total. One copy will include the
comments and ask for a redetermination as follows:
information you claim to be confidential
(see DATES). Furthermore, any interested Electronic Submissions with a heading or cover note that states
person may petition FDA for a ‘‘THIS DOCUMENT CONTAINS
Submit electronic comments in the
determination regarding whether the CONFIDENTIAL INFORMATION.’’ The
following way:
applicant for extension acted with due • Federal eRulemaking Portal: Agency will review this copy, including
diligence during the regulatory review https://www.regulations.gov. Follow the the claimed confidential information, in
period. To meet its burden, the petition instructions for submitting comments. its consideration of comments. The
must be timely (see DATES) and contain Comments submitted electronically, second copy, which will have the
sufficient facts to merit an FDA including attachments, to https:// claimed confidential information
investigation. (See H. Rept. 857, part 1, www.regulations.gov will be posted to redacted/blacked out, will be available
98th Cong., 2d sess., pp. 41–42, 1984.) the docket unchanged. Because your for public viewing and posted on
Petitions should be in the format comment will be made public, you are https://www.regulations.gov. Submit
specified in 21 CFR 10.30. solely responsible for ensuring that your both copies to the Division of Dockets
Submit petitions electronically to comment does not include any Management. If you do not wish your
https://www.regulations.gov at Docket confidential information that you or a name and contact information to be
No. FDA–2013–S–0610. Submit written third party may not wish to be posted, made publicly available, you can
petitions (two copies are required) to the such as medical information, your or provide this information on the cover
Division of Dockets Management (HFA– anyone else’s Social Security number, or sheet and not in the body of your
305), Food and Drug Administration, confidential business information, such comments and you must identify this
5630 Fishers Lane, Rm. 1061, Rockville, information as ‘‘confidential.’’ Any
sradovich on DSK3GMQ082PROD with NOTICES
as a manufacturing process. Please note
MD 20852. that if you include your name, contact information marked as ‘‘confidential’’
Dated: January 3, 2017. information, or other information that will not be disclosed except in
identifies you in the body of your accordance with 21 CFR 10.20 and other
Leslie Kux,
comments, that information will be applicable disclosure law. For more
Associate Commissioner for Policy. posted on https://www.regulations.gov. information about FDA’s posting of
[FR Doc. 2017–00095 Filed 1–6–17; 8:45 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
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Document Created: 2018-10-24 11:11:13
Document Modified: 2018-10-24 11:11:13
| 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by March 10, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 10, 2017. 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 | 82 FR 2378 |
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