80 FR 19671 - Determination of Regulatory Review Period for Purposes of Patent Extension; ELVITEGRAVIR
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 70 (April 13, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 70 (April 13, 2015)
| Page Range | 19671-19672 | |
| FR Document | 2015-08362 |
[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)] [Notices] [Pages 19671-19672] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08362] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-E-0475] Determination of Regulatory Review Period for Purposes of Patent Extension; ELVITEGRAVIR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ELVITEGRAVIR (as a component of STRIBILD) 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. ADDRESSES: Submit electronic comments to http://www.regulations.gov. Submit written petitions (two copies are required) and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900. SUPPLEMENTARY INFORMATION: 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 ELVITEGRAVIR (as a component of STRIBILD (cobicistat/emtricitabine/ELVITEGRAVIR/ tenofovir disoproxil fumarate)). STRIBILD is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive. Subsequent to this approval, the USPTO received a patent term restoration application for ELVITEGRAVIR (as a component of STRIBILD) (U.S. Patent No. 7,176,220) from Japan Tobacco Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 10, 2013, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of STRIBILD represented the first permitted commercial marketing or use of the ELVITEGRAVIR product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for ELVITEGRAVIR (as a component of STRIBILD) is 2,666 days. Of this time, 2,360 days occurred during the testing phase of the regulatory review period, while 306 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: May 12, 2005. The applicant claims May 18, 2005, as the date the investigational new drug application (IND) for ELVITEGRAVIR became effective. However, FDA records indicate that the IND effective date was May 12, 2005, which was the date the IND sponsor was notified that clinical trials may proceed. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: October 27, 2011. The applicant claims October 26, 2011, as the date the new drug application (NDA) for STRIBILD (NDA 203-100) was initially submitted. However, FDA records indicate that NDA 203-100 was submitted on October 27, 2011. 3. The date the application was approved: August 27, 2012. FDA has verified the applicant's claim that NDA 203-100 was approved on August 27, 2012. 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 1,021 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by June 12, 2015. 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 13, 2015. To meet its burden, the petition must 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. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written or electronic [[Page 19672]] petitions. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. If you submit a written petition, two copies are required. A petition submitted electronically must be submitted to http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-08362 Filed 4-10-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 19671
approved under OMB control number Silver Spring, MD 20993, 301–796– FDA determine the product’s regulatory
0910–0756. 7900. review period.
FDA has determined that the
V. Comments SUPPLEMENTARY INFORMATION: The Drug applicable regulatory review period for
Interested persons may submit either Price Competition and Patent Term ELVITEGRAVIR (as a component of
electronic comments regarding this Restoration Act of 1984 (Pub. L. 98–417) STRIBILD) is 2,666 days. Of this time,
document to http://www.regulations.gov and the Generic Animal Drug and Patent 2,360 days occurred during the testing
or written comments to the Division of Term Restoration Act (Pub. L. 100–670) phase of the regulatory review period,
Dockets Management (see ADDRESSES). It generally provide that a patent may be while 306 days occurred during the
is only necessary to send one set of extended for a period of up to 5 years approval phase. These periods of time
comments. Identify comments with the so long as the patented item (human were derived from the following dates:
docket number found in brackets in the drug product, animal drug product, 1. The date an exemption under
heading of this document. Received medical device, food additive, or color section 505(i) of the Federal Food, Drug,
comments may be seen in the Division additive) was subject to regulatory and Cosmetic Act (the FD&C Act) (21
of Dockets Management between 9 a.m. review by FDA before the item was U.S.C. 355(i)) became effective: May 12,
and 4 p.m., Monday through Friday, and marketed. Under these acts, a product’s 2005. The applicant claims May 18,
will be posted to the docket at http:// regulatory review period forms the basis 2005, as the date the investigational new
www.regulations.gov. for determining the amount of extension drug application (IND) for
an applicant may receive. ELVITEGRAVIR became effective.
Dated: April 7, 2015.
A regulatory review period consists of However, FDA records indicate that the
Leslie Kux, IND effective date was May 12, 2005,
Associate Commissioner for Policy.
two periods of time: A testing phase and
an approval phase. For human drug which was the date the IND sponsor was
[FR Doc. 2015–08364 Filed 4–10–15; 8:45 am] notified that clinical trials may proceed.
products, the testing phase begins when
BILLING CODE 4164–01–P
the exemption to permit the clinical 2. The date the application was
investigations of the drug becomes initially submitted with respect to the
effective and runs until the approval human drug product under section
DEPARTMENT OF HEALTH AND 505(b) of the FD&C Act: October 27,
phase begins. The approval phase starts
HUMAN SERVICES 2011. The applicant claims October 26,
with the initial submission of an
application to market the human drug 2011, as the date the new drug
Food and Drug Administration application (NDA) for STRIBILD (NDA
product and continues until FDA grants
[Docket No. FDA–2013–E–0475] permission to market the drug product. 203–100) was initially submitted.
Although only a portion of a regulatory However, FDA records indicate that
Determination of Regulatory Review NDA 203–100 was submitted on
review period may count toward the
Period for Purposes of Patent October 27, 2011.
actual amount of extension that the
Extension; ELVITEGRAVIR 3. The date the application was
Director of USPTO may award (for
approved: August 27, 2012. FDA has
AGENCY: Food and Drug Administration, example, half the testing phase must be
verified the applicant’s claim that NDA
HHS. subtracted as well as any time that may
203–100 was approved on August 27,
ACTION: Notice. have occurred before the patent was
2012.
issued), FDA’s determination of the This determination of the regulatory
SUMMARY: The Food and Drug length of a regulatory review period for review period establishes the maximum
Administration (FDA) has determined a human drug product will include all potential length of a patent extension.
the regulatory review period for of the testing phase and approval phase However, the USPTO applies several
ELVITEGRAVIR (as a component of as specified in 35 U.S.C. 156(g)(1)(B). statutory limitations in its calculations
STRIBILD) and is publishing this notice FDA has approved for marketing the of the actual period for patent extension.
of that determination as required by human drug product ELVITEGRAVIR In its application for patent extension,
law. FDA has made the determination (as a component of STRIBILD this applicant seeks 1,021 days of patent
because of the submission of an (cobicistat/emtricitabine/ term extension.
application to the Director of the U.S. ELVITEGRAVIR/tenofovir disoproxil Anyone with knowledge that any of
Patent and Trademark Office (USPTO), fumarate)). STRIBILD is indicated as a the dates as published are incorrect may
Department of Commerce, for the complete regimen for the treatment of submit to the Division of Dockets
extension of a patent which claims that HIV–1 infection in adults who are Management (see ADDRESSES) either
human drug product. antiretroviral treatment-naive. electronic or written comments and ask
ADDRESSES: Submit electronic Subsequent to this approval, the USPTO for a redetermination by June 12, 2015.
comments to http:// received a patent term restoration Furthermore, any interested person may
www.regulations.gov. Submit written application for ELVITEGRAVIR (as a petition FDA for a determination
petitions (two copies are required) and component of STRIBILD) (U.S. Patent regarding whether the applicant for
written comments to the Division of No. 7,176,220) from Japan Tobacco Inc., extension acted with due diligence
Dockets Management (HFA–305), Food and the USPTO requested FDA’s during the regulatory review period by
and Drug Administration, 5630 Fishers assistance in determining this patent’s October 13, 2015. To meet its burden,
Lane, Rm. 1061, Rockville, MD 20852. eligibility for patent term restoration. In the petition must contain sufficient facts
Submit petitions electronically to http://
mstockstill on DSK4VPTVN1PROD with NOTICES
a letter dated July 10, 2013, FDA to merit an FDA investigation. (See H.
www.regulations.gov at Docket No. advised the USPTO that this human Rept. 857, part 1, 98th Cong., 2d sess.,
FDA–2013–S–0610. drug product had undergone a pp. 41–42, 1984.) Petitions should be in
FOR FURTHER INFORMATION CONTACT: regulatory review period and that the the format specified in 21 CFR 10.30.
Beverly Friedman, Office of approval of STRIBILD represented the Interested persons may submit to the
Management, Food and Drug first permitted commercial marketing or Division of Dockets Management (see
Administration, 10001 New Hampshire use of the ELVITEGRAVIR product. ADDRESSES) electronic or written
Ave., Hillandale Campus, Rm. 3180, Thereafter, the USPTO requested that comments and written or electronic
VerDate Sep<11>2014 18:02 Apr 10, 2015 Jkt 235001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1](https://thefederalregister.org/doc/80_FR_19741/page/1.svg)
![19672 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices
petitions. It is only necessary to send ADDRESSES: An electronic copy of the Agency considers postmarket data as
one set of comments. Identify comments guidance document is available for part of the benefit-risk framework
with the docket number found in download from the Internet. See the described in FDA’s guidance ‘‘Factors to
brackets in the heading of this SUPPLEMENTARY INFORMATION section for Consider When Making Benefit-Risk
document. If you submit a written information on electronic access to the Determinations in Medical Device
petition, two copies are required. A guidance. Submit written requests for a Premarket Approval and De Novo
petition submitted electronically must single hard copy of the guidance Classifications,’’ issued on March 28,
be submitted to http:// document entitled ‘‘Balancing 2012. This guidance provides a resource
www.regulations.gov, Docket No. FDA– Premarket and Postmarket Data for industry and FDA staff on how FDA
2013–S–0610. Comments and petitions Collection for Devices Subject to determines when it is appropriate for a
that have not been made publicly Premarket Approval’’ to the Office of the sponsor of a PMA to collect some data
available on http://www.regulations.gov Center Director, Guidance and Policy (clinical or non-clinical) in the
may be viewed in the Division of Development, Center for Devices and postmarket setting, rather than
Dockets Management between 9 a.m. Radiological Health, Food and Drug premarket.
and 4 p.m., Monday through Friday. Administration, 10903 New Hampshire A draft of this guidance was made
Ave., Bldg. 66, Rm. 5431, Silver Spring, available in the Federal Register on
Dated: April 7, 2015.
MD 20993–0002 or to the Office of April 23, 2014, and the comment period
Leslie Kux, closed July 22, 2014. Changes between
Communication, Outreach and
Associate Commissioner for Policy. the draft and final versions of this
Development, Center for Biologics
[FR Doc. 2015–08362 Filed 4–10–15; 8:45 am]
Evaluation and Research, Food and guidance include an increased focus on
BILLING CODE 4164–01–P Drug Administration, 10903 New patient outcomes and additional
Hampshire Ave., Bldg. 71, Rm. 3128, examples to help industry better
Silver Spring, MD 20993–0002. Send understand when it may be appropriate
DEPARTMENT OF HEALTH AND to shift data collection from the
one self-addressed adhesive label to
HUMAN SERVICES premarket to postmarket setting. The
assist that office in processing your
request. final guidance also recognizes the
Food and Drug Administration potential for use of registry data to
Submit electronic comments on the
[Docket No. FDA–2014–D–0090] guidance to http://www.regulations.gov. satisfy post-approval study
Submit written comments to the requirements.
Balancing Premarket and Postmarket Division of Dockets Management (HFA–
Data Collection for Devices Subject to II. Significance of Guidance
305), Food and Drug Administration,
Premarket Approval; Guidance for This guidance is being issued
5630 Fishers Lane, Rm. 1061, Rockville,
Industry and Food and Drug consistent with FDA’s good guidance
MD 20852. Identify comments with the
Administration Staff; Availability practices regulation (21 CFR 10.115).
docket number found in brackets in the The guidance represents the Agency’s
AGENCY: Food and Drug Administration, heading of this document. current thinking on balancing premarket
HHS. FOR FURTHER INFORMATION CONTACT: and postmarket data collection for
ACTION: Notice. Aaron Josephson, Center for Devices devices subject to premarket approval. It
and Radiological Health, Food and Drug does not create or confer any rights for
SUMMARY: The Food and Drug Administration, 10903 New Hampshire or on any person and does not operate
Administration (FDA) is announcing the Ave., Bldg. 66, Rm. 5449, Silver Spring, to bind FDA or the public. An
availability of the guidance entitled MD 20993–0002, 301–796–5178; or alternative approach may be used if
‘‘Balancing Premarket and Postmarket Stephen Ripley, Center for Biologics such approach satisfies the
Data Collection for Devices Subject to Evaluation and Research, Food and requirements of the applicable statute
Premarket Approval.’’ This guidance Drug Administration, 10903 New and regulations.
clarifies FDA’s current policy on Hampshire Ave., Bldg. 71, Rm. 7301,
balancing premarket and postmarket Silver Spring, MD 20993–0002. III. Electronic Access
data collection during the Agency’s SUPPLEMENTARY INFORMATION: Persons interested in obtaining a copy
review of premarket approval of the guidance may do so by
applications (PMA). Specifically, this I. Background downloading an electronic copy from
guidance outlines how FDA considers FDA has long applied postmarket the Internet. A search capability for all
the role of postmarket information in controls as a way to reduce premarket Center for Devices and Radiological
determining the appropriate type and data collection, where appropriate, Health guidance documents is available
amount of data that should be collected while assuring that the statutory at http://www.fda.gov/MedicalDevices/
in the premarket setting to support standard for approval of reasonable DeviceRegulationandGuidance/
premarket approval, while still meeting assurance of safety and effectiveness is GuidanceDocuments/default.htm.
the statutory standard of safety and still met. The right balance of premarket Guidance documents are also available
effectiveness. FDA believes this and postmarket data collection at http://www.regulations.gov or from
guidance will improve patient access to facilitates timely patient access to CBER at http://www.fda.gov/Biologics
safe and effective medical devices that important new technology without BloodVaccines/GuidanceCompliance
are important to public health by undermining patient safety. RegulatoryInformation/default.htm.
improving the predictability,
mstockstill on DSK4VPTVN1PROD with NOTICES
In this guidance, FDA describes Persons unable to download an
consistency, transparency, and existing statutory requirements under electronic copy of ‘‘Balancing Premarket
efficiency of the premarket process. the Federal Food, Drug, and Cosmetic and Postmarket Data Collection for
DATES: Submit either electronic or Act, its implementing regulations, and Devices Subject to Premarket Approval’’
written comments on this guidance at FDA policies that support the policy on may send an email request to CDRH-
any time. General comments on Agency balancing premarket and postmarket Guidance@fda.hhs.gov to receive an
guidance documents are welcome at any data collection during review of PMAs. electronic copy of the document. Please
time. In addition, FDA clarifies how the use the document number 1833 to
VerDate Sep<11>2014 18:02 Apr 10, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\13APN1.SGM 13APN1](https://thefederalregister.org/doc/80_FR_19741/page/2.svg)
Document Created: 2015-12-18 11:22:31
Document Modified: 2015-12-18 11:22:31
| 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. | |
| Contact | Beverly Friedman, Office of Management, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900. | |
| FR Citation | 80 FR 19671 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR