80 FR 20228 - Determination of Regulatory Review Period for Purposes of Patent Extension; AUBAGIO-Patent No. 6,794,410
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 72 (April 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 72 (April 15, 2015)
| Page Range | 20228-20228 | |
| FR Document | 2015-08616 |
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)] [Notices] [Page 20228] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08616] [[Page 20228]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-E-0687] Determination of Regulatory Review Period for Purposes of Patent Extension; AUBAGIO--Patent No. 6,794,410 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. 6,794,410) from Aventis Pharmaceuticals Inc., 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 1,625 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 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. 2015-08616 Filed 4-14-15; 8:45 am] BILLING CODE 4164-01-P
![20228 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices
DEPARTMENT OF HEALTH AND phase begins. The approval phase starts This determination of the regulatory
HUMAN SERVICES with the initial submission of an review period establishes the maximum
application to market the human drug potential length of a patent extension.
Food and Drug Administration product and continues until FDA grants However, the USPTO applies several
[Docket No. FDA–2013–E–0687] 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 1,625 days of patent
Extension; AUBAGIO—Patent No. Director of USPTO may award (for term extension.
6,794,410 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 petition FDA for a determination
FDA has approved for marketing the
AUBAGIO and is publishing this notice regarding whether the applicant for
human drug product AUBAGIO
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 October 13, 2015. To meet its burden,
application to the Director of the U.S.
to this approval, the USPTO received a the petition must contain sufficient facts
Patent and Trademark Office (USPTO),
patent term restoration application for to merit an FDA investigation. (See H.
Department of Commerce, for the
AUBAGIO (U.S. Patent No. 6,794,410) Rept. 857, part 1, 98th Cong., 2d sess.,
extension of a patent which claims that
from Aventis Pharmaceuticals Inc., and pp. 41–42, 1984.) Petitions should be in
human drug product.
the USPTO requested FDA’s assistance the format specified in 21 CFR 10.30.
ADDRESSES: Submit electronic in determining this patent’s eligibility
comments to http:// for patent term restoration. In a letter Interested persons may submit to the
www.regulations.gov. Submit written dated January 31, 2014, FDA advised Division of Dockets Management (see
petitions (two copies are required) and the USPTO that this human drug ADDRESSES) electronic or written
written comments to the Division of product had undergone a regulatory comments and written or electronic
Dockets Management (HFA–305), Food review period and that the approval of petitions. It is only necessary to send
and Drug Administration, 5630 Fishers AUBAGIO represented the first one set of comments. Identify comments
Lane, Rm. 1061, Rockville, MD 20852. permitted commercial marketing or use with the docket number found in
Submit petitions electronically to http:// of the product. Thereafter, the USPTO brackets in the heading of this
www.regulations.gov at Docket No. requested that FDA determine the document. If you submit a written
FDA–2013–S–0610. 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 be submitted to http://
Management, Food and Drug AUBAGIO is 2,940 days. Of this time, www.regulations.gov, Docket No. FDA–
Administration, 10001 New Hampshire 2,542 days occurred during the testing 2013–S–0610. Comments and petitions
Ave., Hillandale Campus, Rm. 3180, phase of the regulatory review period, that have not been made publicly
Silver Spring, MD 20993, 301–796– while 398 days occurred during the available on http://www.regulations.gov
7900. approval phase. These periods of time may be viewed in the Division of
SUPPLEMENTARY INFORMATION: The Drug were derived from the following dates: Dockets Management between 9 a.m.
Price Competition and Patent Term 1. The date an exemption under and 4 p.m., Monday through Friday.
Restoration Act of 1984 (Pub. L. 98–417) section 505(i) of the Federal Food, Drug,
Dated: April 8, 2015.
and the Generic Animal Drug and Patent and Cosmetic Act (the FD&C Act) (21
Term Restoration Act (Pub. L. 100–670) U.S.C. 355(i)) became effective: August Leslie Kux,
generally provide that a patent may be 27, 2004. FDA has verified the Associate Commissioner for Policy.
extended for a period of up to 5 years applicant’s claim that the date the [FR Doc. 2015–08616 Filed 4–14–15; 8:45 am]
so long as the patented item (human investigational new drug application BILLING CODE 4164–01–P
drug product, animal drug product, became effective was on August 27,
medical device, food additive, or color 2004.
additive) was subject to regulatory 2. The date the application was
review by FDA before the item was initially submitted with respect to the
marketed. Under these acts, a product’s human drug product under section
regulatory review period forms the basis 505(b) of the FD&C Act: August 12,
for determining the amount of extension 2011. FDA has verified the applicant’s
an applicant may receive. claim that the new drug application
tkelley on DSK3SPTVN1PROD with NOTICES
A regulatory review period consists of (NDA) for AUBAGIO (NDA 202992) was
two periods of time: A testing phase and submitted on August 12, 2011.
an approval phase. For human drug 3. The date the application was
products, the testing phase begins when approved: September 12, 2012. FDA has
the exemption to permit the clinical verified the applicant’s claim that NDA
investigations of the drug becomes 202992 was approved on September 12,
effective and runs until the approval 2012.
VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 9990 E:\FR\FM\15APN1.SGM 15APN1](https://thefederalregister.org/doc/80_FR_20300/page/1.svg)
Document Created: 2015-12-18 11:13:01
Document Modified: 2015-12-18 11:13:01
| 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 20228 |
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