81 FR 36929 - Determination of Regulatory Review Period for Purposes of Patent Extension; ELOCTATE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 110 (June 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 110 (June 8, 2016)
| Page Range | 36929-36931 | |
| FR Document | 2016-13521 |
[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)] [Notices] [Pages 36929-36931] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13521] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2014-E-2365, FDA-2014-E-2368, FDA-2014-E-2367, and FDA-2014-E-2366] Determination of Regulatory Review Period for Purposes of Patent Extension; ELOCTATE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ELOCTATE and is publishing this notice of that determination as required [[Page 36930]] by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim 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 August 8, 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 December 5, 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 Nos. FDA-2014-E-2365, FDA-2014-E-2368, FDA-2014-E-2367, and FDA-2014-E-2366 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; ELOCTATE.'' Received comments will be placed in the dockets 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 biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological 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 ELOCTATE (BDD-rFVIIIFc). ELOCTATE is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Subsequent to this approval, the USPTO received patent term restoration applications for ELOCTATE (U.S. Patent Nos. 7,348,004; 7,404,956; 7,862,820; and 8,329,182) from Biogen Idec Hemophilia Inc., and the USPTO requested FDA's assistance in [[Page 36931]] determining this patent's eligibility for patent term restoration. In a letter dated October 19, 2015, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of ELOCTATE 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 ELOCTATE is 1,695 days. Of this time, 1,239 days occurred during the testing phase of the regulatory review period, while 456 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: October 17, 2009. The applicant claims December 10, 2009, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was October 17, 2009, which was 30 days after FDA receipt of the IND. 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): March 8, 2013. The applicant claims March 7, 2013, as the date the biologics license application (BLA) for ELOCTATE (BLA 125487/0) was initially submitted. However, FDA records indicate that BLA 125487/0 was submitted on March 8, 2013. 3. The date the application was approved: June 6, 2014. FDA has verified the applicant's claim that BLA 125487/0 was approved on June 6, 2014. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,049 days, 740 days, 854 days, or 500 days, respectively, 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: June 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-13521 Filed 6-7-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices 36929
Management. If you do not wish your actual amount of extension that the 3. The date the application was
name and contact information to be Director of USPTO may award (for approved: March 28, 2014. FDA has
made publicly available, you can example, half the testing phase must be verified the applicant’s claim that BLA
provide this information on the cover subtracted as well as any time that may 125444/0 was approved on March 28,
sheet and not in the body of your have occurred before the patent was 2014.
comments and you must identify this issued), FDA’s determination of the This determination of the regulatory
information as ‘‘confidential.’’ Any length of a regulatory review period for review period establishes the maximum
information marked as ‘‘confidential’’ a human biological product will include potential length of a patent extension.
will not be disclosed except in all of the testing phase and approval However, the USPTO applies several
accordance with 21 CFR 10.20 and other phase as specified in 35 U.S.C. statutory limitations in its calculations
applicable disclosure law. For more 156(g)(1)(B). of the actual period for patent extension.
information about FDA’s posting of FDA has approved for marketing the In its applications for patent extension,
comments to public dockets, see 80 FR human biologic product ALPROLIX this applicant seeks 1,326 days, 465
56469, September 18, 2015, or access (Coagulation Factor IX (Recombinant), days, or 818, days, respectively, of
the information at: http://www.fda.gov/ Fc Fusion Protein). ALPROLIX is a patent term extension.
regulatoryinformation/dockets/ recombinant DNA derived, coagulation
Factor IX concentrate indicated in III. Petitions
default.htm.
Docket: For access to the docket to adults and children with hemophilia B Anyone with knowledge that any of
read background documents or the for control and prevention of bleeding the dates as published are incorrect may
electronic and written/paper comments episodes, perioperative management, submit either electronic or written
received, go to http:// and routine prophylaxis to prevent or comments and ask for a redetermination
www.regulations.gov and insert the reduce the frequency of bleeding (see DATES). Furthermore, any interested
docket number, found in brackets in the episodes. Subsequent to this approval, person may petition FDA for a
heading of this document, into the the USPTO received patent term determination regarding whether the
‘‘Search’’ box and follow the prompts restoration applications for ALPROLIX applicant for extension acted with due
and/or go to the Division of Dockets (U.S. Patent Nos. 7,348,004, 7,862,820, diligence during the regulatory review
Management, 5630 Fishers Lane, Rm. and 8,329,182) from Biogen Idec period. To meet its burden, the petition
1061, Rockville, MD 20852. Hemophilia Inc., and the USPTO must be timely (see DATES) and contain
requested FDA’s assistance in sufficient facts to merit an FDA
FOR FURTHER INFORMATION CONTACT:
determining the patents’ eligibility for investigation. (See H. Rept. 857, part 1,
Beverly Friedman, Office of Regulatory
patent term restoration. In a letter dated 98th Cong., 2d sess., pp. 41–42, 1984.)
Policy, Food and Drug Administration,
May 11, 2015, FDA advised the USPTO Petitions should be in the format
10903 New Hampshire Ave., Bldg. 51, that this human biological product had
Rm. 6250, Silver Spring, MD 20993, specified in 21 CFR 10.30.
undergone a regulatory review period Submit petitions electronically to
301–796–3600. and that the approval of ALPROLIX http://www.regulations.gov at Docket
SUPPLEMENTARY INFORMATION: represented the first permitted No. FDA–2013–S–0610. Submit written
I. Background commercial marketing or use of the petitions (two copies are required) to the
product. Thereafter, the USPTO Division of Dockets Management (HFA–
The Drug Price Competition and requested that FDA determine the 305), Food and Drug Administration,
Patent Term Restoration Act of 1984 product’s regulatory review period. 5630 Fishers Lane, Rm. 1061, Rockville,
(Pub. L. 98–417) and the Generic MD 20852.
Animal Drug and Patent Term II. Determination of Regulatory Review
Restoration Act (Pub. L. 100–670) Period Dated: June 2, 2016.
generally provide that a patent may be FDA has determined that the Leslie Kux,
extended for a period of up to 5 years applicable regulatory review period for Associate Commissioner for Policy.
so long as the patented item (human ALPROLIX is 2,223 days. Of this time, [FR Doc. 2016–13526 Filed 6–7–16; 8:45 am]
drug product, animal drug product, 1,767 days occurred during the testing BILLING CODE 4164–01–P
medical device, food additive, or color phase of the regulatory review period,
additive) was subject to regulatory while 456 days occurred during the
review by FDA before the item was approval phase. These periods of time DEPARTMENT OF HEALTH AND
marketed. Under these acts, a product’s were derived from the following dates: HUMAN SERVICES
regulatory review period forms the basis 1. The date an exemption under
for determining the amount of extension section 505(i) of the Federal Food, Drug, Food and Drug Administration
an applicant may receive. and Cosmetic Act (21 U.S.C. 355(i)) [Docket Nos. FDA–2014–E–2365, FDA–
A regulatory review period consists of became effective: February 27, 2008. 2014–E–2368, FDA–2014–E–2367, and FDA–
two periods of time: A testing phase and FDA has verified the applicant’s claim 2014–E–2366]
an approval phase. For human that the date the investigational new
biological products, the testing phase drug application (IND) became effective Determination of Regulatory Review
begins when the exemption to permit was on February 27, 2008. Period for Purposes of Patent
the clinical investigations of the 2. The date the application was Extension; ELOCTATE
biological becomes effective and runs initially submitted with respect to the AGENCY: Food and Drug Administration,
until the approval phase begins. The human biological product under section
mstockstill on DSK3G9T082PROD with NOTICES
HHS.
approval phase starts with the initial 351 of the Public Health Service Act (42 ACTION: Notice.
submission of an application to market U.S.C. 262): December 28, 2012. FDA
the human biological product and has verified the applicant’s claim that SUMMARY: The Food and Drug
continues until FDA grants permission the biologics license application (BLA) Administration (FDA) has determined
to market the biological product. for ALPROLIX (BLA 125444/0) was the regulatory review period for
Although only a portion of a regulatory initially submitted on December 28, ELOCTATE and is publishing this
review period may count toward the 2012. notice of that determination as required
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![Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices 36931
determining this patent’s eligibility for period. To meet its burden, the petition appropriation levels for these programs;
patent term restoration. In a letter dated must be timely (see DATES) and contain and b) review ways that behavioral
October 19, 2015, FDA advised the sufficient facts to merit an FDA health content could be integrated into
USPTO that this human biological investigation. (See H. Rept. 857, part 1, primary care education and training.
product had undergone a regulatory 98th Cong., 2d sess., pp. 41–42, 1984.) The Committee has identified that
review period and that the approval of Petitions should be in the format integrating behavioral health services
ELOCTATE represented the first specified in 21 CFR 10.30. into primary care settings offers a
permitted commercial marketing or use Submit petitions electronically to promising, viable, and efficient way of
of the product. Thereafter, the USPTO http://www.regulations.gov at Docket ensuring that people have access to
requested that FDA determine the No. FDA–2013–S–0610. Submit written needed behavioral health services. The
product’s regulatory review period. petitions (two copies are required) to the ACTPCMD’s reports are submitted to
Division of Dockets Management (HFA– the Secretary of the Department of
II. Determination of Regulatory Review
305), Food and Drug Administration,
Period Health and Human Services; the
5630 Fishers Lane, Rm. 1061, Rockville,
FDA has determined that the Committee on Health, Education, Labor,
MD 20852.
applicable regulatory review period for and Pensions of the Senate; and the
Dated: June 2, 2016. Committee on Energy and Commerce of
ELOCTATE is 1,695 days. Of this time,
1,239 days occurred during the testing Leslie Kux, the House of Representatives. The
phase of the regulatory review period, Associate Commissioner for Policy. ACTPCMD agenda will be available 2
while 456 days occurred during the [FR Doc. 2016–13521 Filed 6–7–16; 8:45 am] days prior to the meeting on the HRSA
approval phase. These periods of time BILLING CODE 4164–01–P Web site at http://www.hrsa.gov/
were derived from the following dates: advisorycommittees/bhpradvisory/
1. The date an exemption under actpcmd/index.html.
section 505(i) of the Federal Food, Drug, DEPARTMENT OF HEALTH AND
HUMAN SERVICES SUPPLEMENTARY INFORMATION: Requests
and Cosmetic Act (21 U.S.C. 355(i))
became effective: October 17, 2009. The to make oral comments or provide
applicant claims December 10, 2009, as Health Resources and Service written comments to the ACTPCMD
the date the investigational new drug Administration should be sent to Dr. Joan Weiss,
application (IND) became effective. Designated Federal Official, using the
Advisory Committee on Training in address and phone number below.
However, FDA records indicate that the Primary Care Medicine and Dentistry;
IND effective date was October 17, 2009, Individuals who plan to make oral
Notice of Meeting comments or provide written comments
which was 30 days after FDA receipt of
the IND. In accordance with section 10(a)(2) of to the ACTPCMD should notify Dr.
2. The date the application was the Federal Advisory Committee Act Weiss at least 3 days prior to the
initially submitted with respect to the (Pub. L. 92–463), notice is hereby given meeting, using the address or phone
human biological product under section of the following meeting: number below. Members of the public
351 of the Public Health Service Act (42 Name: Advisory Committee on will have the opportunity to provide
U.S.C. 262): March 8, 2013. The Training in Primary Care Medicine and comments. Individuals who plan to
applicant claims March 7, 2013, as the Dentistry (ACTPCMD). attend and need special assistance, such
date the biologics license application Dates and Times: June 28, 2016 (Day as sign language interpretation or other
(BLA) for ELOCTATE (BLA 125487/0) 1—8:30 a.m.–5:00 p.m., EST), June 29, reasonable accommodations, should
was initially submitted. However, FDA 2016 (Day 2—8:30 a.m.–5:00 p.m., EST). notify Dr. Weiss at least 10 days prior
records indicate that BLA 125487/0 was Place: In-Person Meeting with to the meeting.
submitted on March 8, 2013. Webinar/Conference Call Component,
3. The date the application was 5600 Fishers Lane, Room 5E29, • The conference call-in number is 1–
approved: June 6, 2014. FDA has Rockville, MD 20857. 800–619–2521. The passcode is
verified the applicant’s claim that BLA Status: The meeting will be open to 9271697.
125487/0 was approved on June 6, 2014. the public. • The webinar link is https://hrsa.
This determination of the regulatory Purpose: The ACTPCMD provides connectsolutions.com/actpcmd.
review period establishes the maximum advice and recommendations on a broad
Contact: Anyone requesting
potential length of a patent extension. range of issues relating to grant
information regarding the ACTPCMD
However, the USPTO applies several programs authorized by title VII, part C,
sections 747 and 748 of the Public should contact Dr. Joan Weiss,
statutory limitations in its calculations
Health Service Act (PHSA). During the Designated Federal Official within the
of the actual period for patent extension.
June 28–29, 2016 meeting, the Bureau of Health Workforce, Health
In its application for patent extension,
Committee will discuss the topic for the Resources and Services Administration,
this applicant seeks 1,049 days, 740
14th report which is divided into two in one of three ways: (1) Send a request
days, 854 days, or 500 days,
respectively, of patent term extension. areas: a) Review of Primary Care to the following address: Dr. Joan Weiss,
Medicine and Dentistry Programs under Designated Federal Official, Bureau of
III. Petitions title VII, part C of the PHSA and b) the Health Workforce, Health Resources and
Anyone with knowledge that any of ways to integrate behavioral health Services Administration, 5600 Fishers
the dates as published are incorrect may content into primary care medicine and Lane, Room 15N39, Rockville, Maryland
mstockstill on DSK3G9T082PROD with NOTICES
submit either electronic or written dentistry training programs. 20857; (2) call (301) 443–0430; or (3)
comments and ask for a redetermination Agenda: The purpose of the Advisory send an email to jweiss@hrsa.gov.
(see DATES). Furthermore, any interested Committee meeting is two-fold: a)
Jason Bennett,
person may petition FDA for a Review the activities under sections 747
determination regarding whether the and 748, part C of title VII of the PHS Director, Division of the Executive Secretariat.
applicant for extension acted with due Act including performance measures, [FR Doc. 2016–13523 Filed 6–7–16; 8:45 am]
diligence during the regulatory review longitudinal evaluations, and BILLING CODE 4165–15–P
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Document Created: 2016-06-08 03:10:44
Document Modified: 2016-06-08 03:10:44
| 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 August 8, 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 December 5, 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 36929 |
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