80_FR_20299 80 FR 20227 - Determination of Regulatory Review Period for Purposes of Patent Extension; AUBAGIO-Patent No. 5,679,709

80 FR 20227 - Determination of Regulatory Review Period for Purposes of Patent Extension; AUBAGIO-Patent No. 5,679,709

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 72 (April 15, 2015)

Page Range20227-20227
FR Document2015-08615

The Food and Drug Administration (FDA) has determined the regulatory review period for AUBAGIO 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.

Federal Register, Volume 80 Issue 72 (Wednesday, April 15, 2015)
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Page 20227]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08615]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0688]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; AUBAGIO--Patent No. 5,679,709

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for AUBAGIO 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 AUBAGIO 
(teriflunomide). AUBAGIO is indicated for treatment of patients with 
relapsing forms of multiple sclerosis. Subsequent to this approval, the 
USPTO received a patent term restoration application for AUBAGIO (U.S. 
Patent No. 5,679,709) from sanofi-aventis Deutschland GMBH, and the 
USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated January 31, 
2014, FDA advised the USPTO that this human drug product had undergone 
a regulatory review period and that the approval of AUBAGIO represented 
the first permitted commercial marketing or use of the product. 
Thereafter, the USPTO requested that FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
AUBAGIO is 2,940 days. Of this time, 2,542 days occurred during the 
testing phase of the regulatory review period, while 398 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: August 27, 2004. FDA has verified the applicant's claim that 
the date the investigational new drug application became effective was 
on August 27, 2004.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: August 12, 
2011. FDA has verified the applicant's claim that the new drug 
application (NDA) for AUBAGIO (NDA 202992) was submitted on August 12, 
2011.
    3. The date the application was approved: September 12, 2012. FDA 
has verified the applicant's claim that NDA 202992 was approved on 
September 12, 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 5 years 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 15, 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 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 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08615 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P



                                                                           Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices                                                 20227

                                                Dated: April 9, 2015.                                 for determining the amount of extension               claim that the new drug application
                                              Kathy Greenlee,                                         an applicant may receive.                             (NDA) for AUBAGIO (NDA 202992) was
                                              Administrator and Assistant Secretary for                  A regulatory review period consists of             submitted on August 12, 2011.
                                              Aging.                                                  two periods of time: A testing phase and
                                                                                                                                                              3. The date the application was
                                              [FR Doc. 2015–08654 Filed 4–14–15; 8:45 am]             an approval phase. For human drug
                                                                                                      products, the testing phase begins when               approved: September 12, 2012. FDA has
                                              BILLING CODE 4154–01–P                                                                                        verified the applicant’s claim that NDA
                                                                                                      the exemption to permit the clinical
                                                                                                      investigations of the drug becomes                    202992 was approved on September 12,
                                                                                                      effective and runs until the approval                 2012.
                                              DEPARTMENT OF HEALTH AND
                                              HUMAN SERVICES                                          phase begins. The approval phase starts                 This determination of the regulatory
                                                                                                      with the initial submission of an                     review period establishes the maximum
                                              Food and Drug Administration                            application to market the human drug                  potential length of a patent extension.
                                                                                                      product and continues until FDA grants                However, the USPTO applies several
                                              [Docket No. FDA–2013–E–0688]                            permission to market the drug product.                statutory limitations in its calculations
                                                                                                      Although only a portion of a regulatory               of the actual period for patent extension.
                                              Determination of Regulatory Review                      review period may count toward the                    In its application for patent extension,
                                              Period for Purposes of Patent                           actual amount of extension that the                   this applicant seeks 5 years of patent
                                              Extension; AUBAGIO—Patent No.                           Director of USPTO may award (for                      term extension.
                                              5,679,709                                               example, half the testing phase must be
                                                                                                      subtracted as well as any time that may                 Anyone with knowledge that any of
                                              AGENCY:    Food and Drug Administration,                have occurred before the patent was                   the dates as published are incorrect may
                                              HHS.                                                    issued), FDA’s determination of the                   submit to the Division of Dockets
                                              ACTION:   Notice.                                       length of a regulatory review period for              Management (see ADDRESSES) either
                                                                                                      a human drug product will include all                 electronic or written comments and ask
                                              SUMMARY:   The Food and Drug                            of the testing phase and approval phase               for a redetermination by June 15, 2015.
                                              Administration (FDA) has determined                     as specified in 35 U.S.C. 156(g)(1)(B).               Furthermore, any interested person may
                                              the regulatory review period for                           FDA has approved for marketing the                 petition FDA for a determination
                                              AUBAGIO and is publishing this notice                   human drug product AUBAGIO                            regarding whether the applicant for
                                              of that determination as required by                    (teriflunomide). AUBAGIO is indicated                 extension acted with due diligence
                                              law. FDA has made the determination                     for treatment of patients with relapsing              during the regulatory review period by
                                              because of the submission of an                         forms of multiple sclerosis. Subsequent
                                              application to the Director of the U.S.                                                                       October 13, 2015. To meet its burden,
                                                                                                      to this approval, the USPTO received a
                                              Patent and Trademark Office (USPTO),                                                                          the petition must contain sufficient facts
                                                                                                      patent term restoration application for
                                              Department of Commerce, for the                                                                               to merit an FDA investigation. (See H.
                                                                                                      AUBAGIO (U.S. Patent No. 5,679,709)
                                              extension of a patent which claims that                 from sanofi-aventis Deutschland GMBH,                 Rept. 857, part 1, 98th Cong., 2d sess.,
                                              human drug product.                                     and the USPTO requested FDA’s                         pp. 41–42, 1984.) Petitions should be in
                                              ADDRESSES: Submit electronic                            assistance in determining this patent’s               the format specified in 21 CFR 10.30.
                                              comments to http://                                     eligibility for patent term restoration. In             Interested persons may submit to the
                                              www.regulations.gov. Submit written                     a letter dated January 31, 2014, FDA                  Division of Dockets Management (see
                                              petitions (two copies are required) and                 advised the USPTO that this human                     ADDRESSES) electronic or written
                                              written comments to the Division of                     drug product had undergone a                          comments and written or electronic
                                              Dockets Management (HFA–305), Food                      regulatory review period and that the                 petitions. It is only necessary to send
                                              and Drug Administration, 5630 Fishers                   approval of AUBAGIO represented the                   one set of comments. Identify comments
                                              Lane, Rm. 1061, Rockville, MD 20852.                    first permitted commercial marketing or               with the docket number found in
                                              Submit petitions electronically to http://              use of the product. Thereafter, the                   brackets in the heading of this
                                              www.regulations.gov at Docket No.                       USPTO requested that FDA determine                    document. If you submit a written
                                              FDA–2013–S–0610.                                        the product’s regulatory review period.               petition, two copies are required. A
                                              FOR FURTHER INFORMATION CONTACT:
                                                                                                         FDA has determined that the
                                                                                                                                                            petition submitted electronically must
                                              Beverly Friedman, Office of                             applicable regulatory review period for
                                                                                                      AUBAGIO is 2,940 days. Of this time,                  be submitted to http://
                                              Management, Food and Drug                                                                                     www.regulations.gov, Docket No. FDA–
                                              Administration, 10001 New Hampshire                     2,542 days occurred during the testing
                                                                                                      phase of the regulatory review period,                2013–S–0610.
                                              Ave., Hillandale Campus Rm. 3180,
                                                                                                      while 398 days occurred during the                      Comments and petitions that have not
                                              Silver Spring, MD 20993, 301–796–
                                              7900.                                                   approval phase. These periods of time                 been made publicly available on http://
                                                                                                      were derived from the following dates:                www.regulations.gov may be viewed in
                                              SUPPLEMENTARY INFORMATION:     The Drug                    1. The date an exemption under                     the Division of Dockets Management
                                              Price Competition and Patent Term                       section 505(i) of the Federal Food, Drug,             between 9 a.m. and 4 p.m., Monday
                                              Restoration Act of 1984 (Pub. L. 98–417)                and Cosmetic Act (the FD&C Act) (21                   through Friday.
                                              and the Generic Animal Drug and Patent                  U.S.C. 355(i)) became effective: August
                                              Term Restoration Act (Pub. L. 100–670)                  27, 2004. FDA has verified the                          Dated: April 8, 2015.
                                              generally provide that a patent may be                  applicant’s claim that the date the                   Leslie Kux,
                                              extended for a period of up to 5 years                  investigational new drug application                  Associate Commissioner for Policy.
tkelley on DSK3SPTVN1PROD with NOTICES




                                              so long as the patented item (human                     became effective was on August 27,                    [FR Doc. 2015–08615 Filed 4–14–15; 8:45 am]
                                              drug product, animal drug product,                      2004.                                                 BILLING CODE 4164–01–P
                                              medical device, food additive, or color                    2. The date the application was
                                              additive) was subject to regulatory                     initially submitted with respect to the
                                              review by FDA before the item was                       human drug product under section
                                              marketed. Under these acts, a product’s                 505(b) of the FD&C Act: August 12,
                                              regulatory review period forms the basis                2011. FDA has verified the applicant’s


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Document Created: 2015-12-18 11:13:19
Document Modified: 2015-12-18 11:13:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactBeverly Friedman, Office of Management, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Campus Rm. 3180, Silver Spring, MD 20993, 301-796-7900.
FR Citation80 FR 20227 

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