Determination of Regulatory Review Period for Purposes of Patent Extension; DALIRESP, 3831-3832 [2014-01306]

Download as PDF Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: January 17, 2014. Leslie Kux, Assistant Commissioner for Policy. Dated: January 17, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–01312 Filed 1–22–14; 8:45 am] [FR Doc. 2014–01298 Filed 1–22–14; 8:45 am] BILLING CODE 4160–01–P BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2014–N–0001] [Docket No. FDA–2012–E–0456] Science Board to the Food and Drug Administration; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: AGENCY: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. This meeting was announced in the Federal Register of January 9, 2014 (79 FR 1645). The amendment is being made to reflect a change in the Date and Time and the Agenda portions of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Martha Monser, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4286, Silver Spring, MD 20993, 301– 796–4627, martha.monser@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). Please call the information line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of January 9, 2014, FDA announced that a meeting of the Science Board to the Food and Drug Administration would be held on February 5, 2014. 1. On page 1645, in the second column, the Date and Time portion of the document is changed to read as follows: Date and time: The meeting will be held on February 5, 2014, from approximately 8:30 a.m. until 1 p.m. 2. On page 1645, in the second column, under Agenda, in the first paragraph, after the third sentence, the following sentence is added to read as follows: The Office of Women’s Health (OWH) will seek input from the Board on the development of the OWH Research Roadmap. sroberts on DSK5SPTVN1PROD with NOTICES 21:50 Jan 22, 2014 Food and Drug Administration, HHS. SUMMARY: VerDate Mar<15>2010 Determination of Regulatory Review Period for Purposes of Patent Extension; DALIRESP Jkt 232001 ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for DALIRESP 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written petitions (two copies are necessary) 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 https://www.regulations.gov at Docket No. FDA 2013–S–0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993–0002, 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 SUMMARY: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 3831 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 Patents and Trademarks 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 recently approved for marketing the human drug product DALIRESP (roflumilast). DALIRESP is indicated as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Subsequent to this approval, the U.S. Patent and Trademark Office received a patent term restoration application for DALIRESP (U.S. Patent No. 5,712,298) from Nycomed GmbH, and the U.S. Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated August 7, 2012, FDA advised the U.S. Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of DALIRESP represented the first permitted commercial marketing or use of the product. Thereafter, the U.S. Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for DALIRESP is 4,237 days. Of this time, 3,645 days occurred during the testing phase of the regulatory review period, while 592 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: July 26, 1999. The applicant claims December 19, 1999, as the date the investigational E:\FR\FM\23JAN1.SGM 23JAN1 sroberts on DSK5SPTVN1PROD with NOTICES 3832 Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices new drug application (IND) became effective. However, FDA records indicate that the IND effective date was July 26, 1999, when clinical trials were allowed to 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: July 17, 2009. FDA has verified the applicant’s claim that the new drug application (NDA) for DALIRESP (NDA 22–522) was submitted on July 17, 2009. 3. The date the application was approved: February 28, 2011. FDA has verified the applicant’s claim that NDA 22–522 was approved on February 28, 2011. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,826 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 March 24, 2014. 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 July 22, 2014. 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, you must submit two copies of the written petition. A petition submitted electronically must be submitted to https:// www.regulations.gov, Docket No. FDA 2013–S–0610. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VerDate Mar<15>2010 21:50 Jan 22, 2014 Jkt 232001 Dated: January 16, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–01306 Filed 1–22–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–E–0760] Determination of Regulatory Review Period for Purposes of Patent Extension; GADAVIST AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for GADAVIST 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written petitions (two copies are necessary) 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 https://www.regulations.gov at Docket No. FDA 2013–S–0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6284, Silver Spring, MD 20993–0002, 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 SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 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 Patents and Trademarks 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 recently approved for marketing the human drug product GADAVIST (gadobutrol). GADAVIST is indicated for intravenous use in diagnostic magnetic resonance imaging in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for GADAVIST (U.S. Patent No. 5,980,864) from Bayer Schering Pharma Aktiengesellschaft and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated July 10, 2012, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of GADAVIST represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for GADAVIST is 4,269 days. Of this time, 3,964 days occurred during the testing phase of the regulatory review period, while 305 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: July 8, 1999. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on July 8, 1999. E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3831-3832]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01306]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0456]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; DALIRESP

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for DALIRESP 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 Patents 
and Trademarks, Department of Commerce, for the extension of a patent 
which claims that human drug product.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written petitions (two copies are necessary) 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 https://www.regulations.gov at Docket 
No. FDA 2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of 
Management, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6284, Silver Spring, MD 20993-0002, 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 Patents and 
Trademarks 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 recently approved for marketing the human drug product DALIRESP 
(roflumilast). DALIRESP is indicated as a treatment to reduce the risk 
of chronic obstructive pulmonary disease (COPD) exacerbations in 
patients with severe COPD associated with chronic bronchitis and a 
history of exacerbations. Subsequent to this approval, the U.S. Patent 
and Trademark Office received a patent term restoration application for 
DALIRESP (U.S. Patent No. 5,712,298) from Nycomed GmbH, and the U.S. 
Patent and Trademark Office requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In a letter 
dated August 7, 2012, FDA advised the U.S. Patent and Trademark Office 
that this human drug product had undergone a regulatory review period 
and that the approval of DALIRESP represented the first permitted 
commercial marketing or use of the product. Thereafter, the U.S. Patent 
and Trademark Office requested that FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
DALIRESP is 4,237 days. Of this time, 3,645 days occurred during the 
testing phase of the regulatory review period, while 592 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: July 26, 1999. The applicant claims December 19, 1999, as 
the date the investigational

[[Page 3832]]

new drug application (IND) became effective. However, FDA records 
indicate that the IND effective date was July 26, 1999, when clinical 
trials were allowed to 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: July 17, 
2009. FDA has verified the applicant's claim that the new drug 
application (NDA) for DALIRESP (NDA 22-522) was submitted on July 17, 
2009.
    3. The date the application was approved: February 28, 2011. FDA 
has verified the applicant's claim that NDA 22-522 was approved on 
February 28, 2011.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In its 
application for patent extension, this applicant seeks 1,826 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 March 24, 2014. 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 July 22, 2014. 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, you must 
submit two copies of the written petition. A petition submitted 
electronically must be submitted to https://www.regulations.gov, Docket 
No. FDA 2013-S-0610. Comments and petitions that have not been made 
publicly available on https://www.regulations.gov may be viewed in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01306 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P

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