81 FR 65656 - Determination of Regulatory Review Period for Purposes of Patent Extension; MYALEPT
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 185 (September 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 185 (September 23, 2016)
| Page Range | 65656-65658 | |
| FR Document | 2016-22935 |
[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)] [Notices] [Pages 65656-65658] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22935] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2014-E-2360 and FDA-2014-E-2361] Determination of Regulatory Review Period for Purposes of Patent Extension; MYALEPT AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for MYALEPT 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 November 22, 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 March 22, 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: 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, [[Page 65657]] if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket Nos. FDA-2014-E-2360 and FDA-2014-E-2361 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; MYALEPT.'' 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 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 MYALEPT (metreleptin). MYALEPT is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Subsequent to this approval, the USPTO received two patent term restoration applications for MYALEPT (U.S. Patent No. 6,001,968 from The Rockefeller University, and U.S. Patent No. 7,183,254 from Amgen, Inc.; The Board of Regents, The University of Texas System; and the Secretary, United States Department of Health and Human Services, National Institutes of Health). The USPTO requested FDA's assistance in determining these patents' eligibility for patent term restoration. The USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated October 22, 2015, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of MYALEPT 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 MYALEPT is 6,509 days. Of this time, 6,174 days occurred during the testing phase of the regulatory review period, while 335 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: May 2, 1996. The applicants claim June 19, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the first IND effective date was May 2, 1996, 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 27, 2013. FDA has verified the applicants' claims that the biologics license application (BLA) for MYALEPT (BLA 125-390) was initially submitted on March 27, 2013. 3. The date the application was approved: February 24, 2014. FDA has verified the applicant's claim that BLA 125-390 was approved on February 24, 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 the applications for patent extension, the applicants each seek 1,206 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 [[Page 65658]] 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: September 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22935 Filed 9-22-16; 8:45 am] BILLING CODE 4164-01-P
![65656 Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices
have occurred before the patent was 3. The date the application was application to the Director of the U.S.
issued), FDA’s determination of the approved: October 22, 2012. FDA has Patent and Trademark Office (USPTO),
length of a regulatory review period for verified the applicant’s claim that NDA Department of Commerce, for the
a human drug product will include all 202834 was approved on October 22, extension of a patent which claims that
of the testing phase and approval phase 2012. human biological product.
as specified in 35 U.S.C. 156(g)(1)(B). This determination of the regulatory DATES: Anyone with knowledge that any
FDA has approved for marketing the review period establishes the maximum of the dates as published (see the
human drug product FYCOMPA potential length of a patent extension. SUPPLEMENTARY INFORMATION section) are
(perampanel). FYCOMPA is indicated as However, the USPTO applies several incorrect may submit either electronic
adjunctive therapy for the treatment of statutory limitations in its calculations or written comments and ask for a
partial-onset seizures with or without of the actual period for patent extension. redetermination by November 22, 2016.
secondarily generalized seizures in In its application for patent extension, Furthermore, any interested person may
patients with epilepsy aged 12 years and this applicant seeks 1,549 days of patent petition FDA for a determination
older. Subsequent to this approval, the term extension. regarding whether the applicant for
USPTO received a patent term extension acted with due diligence
restoration application for FYCOMPA III. Petitions
during the regulatory review period by
(U.S. Patent No. 6,949,571) from Eisai Anyone with knowledge that any of
March 22, 2017. See ‘‘Petitions’’ in the
R&D Management Co., Ltd., and the the dates as published are incorrect may
SUPPLEMENTARY INFORMATION section for
USPTO requested FDA’s assistance in submit either electronic or written
more information.
determining this patent’s eligibility for comments and ask for a redetermination
patent term restoration. In a letter dated (see DATES). Furthermore, any interested ADDRESSES: You may submit comments
March 26, 2014, FDA advised the person may petition FDA for a as follows:
USPTO that this human drug product determination regarding whether the Electronic Submissions
had undergone a regulatory review applicant for extension acted with due
period and that the approval of diligence during the regulatory review Submit electronic comments in the
FYCOMPA represented the first period. To meet its burden, the petition following way:
permitted commercial marketing or use must be timely (see DATES) and contain • Federal eRulemaking Portal: http://
of the product. Thereafter, the USPTO sufficient facts to merit an FDA www.regulations.gov. Follow the
requested that FDA determine the investigation. (See H. Rept. 857, part 1, instructions for submitting comments.
product’s regulatory review period. 98th Cong., 2d sess., pp. 41–42, 1984.) Comments submitted electronically,
Petitions should be in the format including attachments, to http://
II. Determination of Regulatory Review www.regulations.gov will be posted to
Period specified in 21 CFR 10.30.
Submit petitions electronically to the docket unchanged. Because your
FDA has determined that the http://www.regulations.gov at Docket comment will be made public, you are
applicable regulatory review period for No. FDA–2013–S–0610. Submit written solely responsible for ensuring that your
FYCOMPA is 3,274 days. Of this time, petitions (two copies are required) to the comment does not include any
2,968 days occurred during the testing Division of Dockets Management (HFA– confidential information that you or a
phase of the regulatory review period, 305), Food and Drug Administration, third party may not wish to be posted,
while 306 days occurred during the 5630 Fishers Lane, Rm. 1061, Rockville, such as medical information, your or
approval phase. These periods of time MD 20852. anyone else’s Social Security number, or
were derived from the following dates: confidential business information, such
1. The date an exemption under Dated: September 19, 2016. as a manufacturing process. Please note
section 505(i) of the Federal Food, Drug, Leslie Kux, that if you include your name, contact
and Cosmetic Act (the FD&C Act) (21 Associate Commissioner for Policy. information, or other information that
U.S.C. 355(i)) became effective: [FR Doc. 2016–22933 Filed 9–22–16; 8:45 am] identifies you in the body of your
November 7, 2003. FDA has verified the BILLING CODE 4164–01–P comments, that information will be
Eisai R&D Management Co., Ltd. claim posted on http://www.regulations.gov.
that November 7, 2003, is the date the • If you want to submit a comment
investigational new drug application DEPARTMENT OF HEALTH AND with confidential information that you
became effective. HUMAN SERVICES do not wish to be made available to the
2. The date the application was public, submit the comment as a
initially submitted with respect to the Food and Drug Administration
written/paper submission and in the
human drug product under section [Docket Nos. FDA–2014–E–2360 and FDA– manner detailed (see ‘‘Written/Paper
505(b) of the FD&C Act: December 22, 2014–E–2361] Submissions’’ and ‘‘Instructions’’).
2011. The applicant claims May 25,
2011, as the date that the new drug Determination of Regulatory Review Written/Paper Submissions
application (NDA) for Fycompa (NDA Period for Purposes of Patent Submit written/paper submissions as
202834) was initially submitted. Extension; MYALEPT follows:
However, FDA records indicate that AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
NDA 202834, received May 25, 2011, HHS. written/paper submissions): Division of
was not sufficiently complete to permit ACTION: Notice. Dockets Management (HFA–305), Food
a substantive review. FDA refused to file and Drug Administration, 5630 Fishers
sradovich on DSK3GMQ082PROD with NOTICES
this application and notified the SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
applicant of this fact by letter dated July Administration (FDA) has determined • For written/paper comments
21, 2011. The completed NDA was then the regulatory review period for submitted to the Division of Dockets
submitted on December 22, 2011, which MYALEPT and is publishing this notice Management, FDA will post your
is considered to be the date that the of that determination as required by comment, as well as any attachments,
NDA was initially submitted within the law. FDA has made the determination except for information submitted,
meaning of 35 U.S.C. 156(g)(B)(ii). because of the submission of an marked and identified, as confidential,
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![65658 Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices
sufficient facts to merit an FDA 741–8138 (301–443–0572 in the notify interested persons regarding their
investigation. (See H. Rept. 857, part 1, Washington, DC area). A notice in the request to speak by November 14, 2016.
98th Cong., 2d sess., pp. 41–42, 1984.) Federal Register about last minute Persons attending FDA’s advisory
Petitions should be in the format modifications that impact a previously committee meetings are advised that the
specified in 21 CFR 10.30. announced advisory committee meeting Agency is not responsible for providing
Submit petitions electronically to cannot always be published quickly access to electrical outlets.
http://www.regulations.gov at Docket enough to provide timely notice. FDA welcomes the attendance of the
No. FDA–2013–S–0610. Submit written Therefore, you should always check the public at its advisory committee
petitions (two copies are required) to the Agency’s Web site at http:// meetings and will make every effort to
Division of Dockets Management (HFA– www.fda.gov/AdvisoryCommittees/ accommodate persons with disabilities.
305), Food and Drug Administration, default.htm and scroll down to the If you require accommodations due to a
5630 Fishers Lane, Rm. 1061, Rockville, appropriate advisory committee meeting disability, please contact Kalyani Bhatt
MD 20852. link, or call the advisory committee at least 7 days in advance of the
Dated: September 19, 2016. information line to learn about possible meeting.
Leslie Kux, modifications before coming to the FDA is committed to the orderly
Associate Commissioner for Policy. meeting. conduct of its advisory committee
SUPPLEMENTARY INFORMATION:
meetings. Please visit our Web site at
[FR Doc. 2016–22935 Filed 9–22–16; 8:45 am]
Agenda: The committee will discuss http://www.fda.gov/
BILLING CODE 4164–01–P
appropriate clinical trial design features, AdvisoryCommittees/
including acceptable endpoints for AboutAdvisoryCommittees/
DEPARTMENT OF HEALTH AND demonstrating clinical benefit, for drugs ucm111462.htm for procedures on
HUMAN SERVICES intended to treat secondary public conduct during advisory
hypogonadism while preserving or committee meetings.
Food and Drug Administration improving testicular function, including Notice of this meeting is given under
spermatogenesis. the Federal Advisory Committee Act (5
[Docket No. FDA–2016–N–0001] U.S.C. app. 2).
FDA intends to make background
Bone, Reproductive and Urologic material available to the public no later Dated: September 20, 2016.
Drugs Advisory Committee; Notice of than 2 business days before the meeting. Janice M. Soreth,
Meeting If FDA is unable to post the background Acting Associate Commissioner, Special
material on its Web site prior to the Medical Programs.
AGENCY: Food and Drug Administration, meeting, the background material will [FR Doc. 2016–22925 Filed 9–22–16; 8:45 am]
HHS. be made publicly available at the BILLING CODE 4164–01–P
ACTION: Notice. location of the advisory committee
SUMMARY: The Food and Drug meeting, and the background material
Administration (FDA) announces a will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
forthcoming public advisory committee the meeting. Background material is HUMAN SERVICES
meeting of the Bone, Reproductive and available at http://www.fda.gov/
AdvisoryCommittees/Calendar/ Food and Drug Administration
Urologic Drugs Advisory Committee.
The general function of the committee is default.htm. Scroll down to the [Docket Nos. FDA–2012–E–1231; FDA–
to provide advice and recommendations appropriate advisory committee meeting 2012–E–1232; and FDA–2012–E–1247]
to the Agency on FDA’s regulatory link.
issues. The meeting will be open to the Procedure: Interested persons may Determination of Regulatory Review
public. present data, information, or views, Period for Purposes of Patent
orally or in writing, on issues pending Extension; BELVIQ
DATES: The meeting will be held on
before the committee. Written
December 6, 2016, from 8 a.m. to 5 p.m. submissions may be made to the contact AGENCY: Food and Drug Administration,
ADDRESSES: Tommy Douglas Conference person on or before November 21, 2016. HHS.
Center, 10000 New Hampshire Ave., Oral presentations from the public will ACTION: Notice.
Silver Spring, MD 20903. The be scheduled between approximately 1
conference center’s telephone number is p.m. and 2 p.m. Those individuals SUMMARY: The Food and Drug
240–645–4000. Answers to commonly interested in making formal oral Administration (FDA) has determined
asked questions including information presentations should notify the contact the regulatory review period for BELVIQ
regarding accommodations due to a person and submit a brief statement of and is publishing this notice of that
disability, visitor parking, and the general nature of the evidence or determination as required by law. FDA
transportation may be accessed at: arguments they wish to present, the has made the determination because of
http://www.fda.gov/ names and addresses of proposed the submission of applications to the
AdvisoryCommittees/ participants, and an indication of the Director of the U.S. Patent and
AboutAdvisoryCommittees/ approximate time requested to make Trademark Office (USPTO), Department
ucm408555.htm. their presentation on or before of Commerce, for the extension of a
FOR FURTHER INFORMATION CONTACT: November 10, 2016. Time allotted for patent which claims that human drug
Kalyani Bhatt, Center for Drug each presentation may be limited. If the product.
sradovich on DSK3GMQ082PROD with NOTICES
Evaluation and Research, Food and number of registrants requesting to DATES: Anyone with knowledge that any
Drug Administration, 10903 New speak is greater than can be reasonably of the dates as published (in the
Hampshire Ave., Bldg. 31, Rm. 2417, accommodated during the scheduled SUPPLEMENTARY INFORMATION section) are
Silver Spring, MD 20993–0002, 301– open public hearing session, FDA may incorrect may submit either electronic
796–9001, Fax: 301–847–8533, email: conduct a lottery to determine the or written comments and ask for a
BRUDAC@fda.hhs.gov, or FDA Advisory speakers for the scheduled open public redetermination by November 22, 2016.
Committee Information Line, 1–800– hearing session. The contact person will Furthermore, any interested person may
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Document Created: 2016-09-23 01:43:44
Document Modified: 2016-09-23 01:43:44
| 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 November 22, 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 March 22, 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 | 81 FR 65656 |
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