Determination of Regulatory Review Period for Purposes of Patent Extension; TRADJENTA, 27316-27317 [2014-10945]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES 27316 Federal Register / Vol. 79, No. 92 / Tuesday, May 13, 2014 / Notices 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 animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal 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 an animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B). FDA has approved for marketing the animal drug product IMPROVEST (gonadotropin releasing factor analogdiptheria toxoid conjugate). IMPROVEST is indicated for the temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for IMPROVEST (U.S. Patent No. 7,534,441) from Pfizer Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated August 10, 2012, FDA advised the Patent and Trademark Office that this animal drug product had undergone a regulatory review period and that the approval of IMPROVEST represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that the FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for IMPROVEST is 2,555 days. Of this time, 2,498 days occurred during the testing phase of the regulatory review period, while 57 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: March VerDate Mar<15>2010 19:27 May 12, 2014 Jkt 232001 25, 2004. The applicant claims July 18, 2005, as the date the investigational new animal drug application (INAD) became effective. However, FDA records indicate that the INAD effective date was March 25, 2004, which was the received date of the first submission containing a Notice of Claimed Investigational Exemption for a new animal drug. 2. The date the application was initially submitted with respect to the animal drug product under section 512 of the FD&C Act (21 U.S.C. 360b): January 25, 2011. The applicant claims January 24, 2011, as the date the new animal drug application (NADA) for IMPROVEST (NADA 141–322) was initially submitted. However, FDA records indicate that January 24, 2011, was the correspondence date of the cover letter for NADA 141–322 and the application was received by FDA on January 25, 2011. 3. The date the application was approved: March 22, 2011. FDA has verified the applicant’s claim that NADA 141–322 was approved on March 22, 2011. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the 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 366 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 July 14, 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 November 10, 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, two copies are required. A petition submitted electronically must be submitted to https:// www.regulations.gov, Docket No. FDA– PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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: May 7, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–10951 Filed 5–12–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–E–0160] Determination of Regulatory Review Period for Purposes of Patent Extension; TRADJENTA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for TRADJENTA 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 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 https:// www.regulations.gov at Docket No. FDA–2013–S–0610. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, 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 SUMMARY: E:\FR\FM\13MYN1.SGM 13MYN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 92 / Tuesday, May 13, 2014 / Notices 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 has approved for marketing the human drug product TRADJENTA (linagliptin). TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for TRADJENTA (U.S. Patent No. 7,407,955) from Boehringer Ingelheim Pharma GmbH & Co. KGA, 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 TRADJENTA 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 TRADJENTA is 2,051 days. Of this time, 1,746 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: September 21, 2005. FDA has verified VerDate Mar<15>2010 19:27 May 12, 2014 Jkt 232001 the applicant’s claim that the date the investigational new drug application became effective was on September 21, 2005. 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 2, 2010. FDA has verified the applicant’s claim that the new drug application (NDA) for TRADJENTA (NDA 201–280) was submitted on July 2, 2010. 3. The date the application was approved: May 2, 2011. FDA has verified the applicant’s claim that NDA 201–280 was approved on May 2, 2011. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the 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 629 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 July 14, 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 November 10, 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, two copies are required. 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: May 8, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–10945 Filed 5–12–14; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 27317 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Advisory Council on Blood Stem Cell Transplantation. Date and Time: May 29, 2014, 10:00 a.m. to 4:00 p.m. (Eastern Standard Time). Place: The meeting will be via audio conference call and Adobe Connect Pro. Status: The meeting will be open to the public. Purpose: Pursuant to Public Law 109– 129, 42 U.S.C. 274k (section 379 of the Public Health Service Act, as amended), the Advisory Council on Blood Stem Cell Transplantation (ACBSCT) advises the Secretary of the Department of Health and Human Services and the Administrator, Health Resources and Services Administration on matters related to the activities of the C.W. Bill Young Cell Transplantation Program (Program) and the National Cord Blood Inventory Program. Agenda: The Council will hear reports from ACBSCT Work Groups including: Cord Blood Thawing and Washing; Access to Transplantation; and Advancing Hematopoietic Stem Cell Transplantation for Hemoglobinopathies. The Council also will hear presentations and discussions on topics including: Accreditation; Adverse Event Reporting; and Unmet Need. Agenda items are subject to changes as priorities indicate. After Council discussions, members of the public will have an opportunity to provide comments. Because of the Council’s full agenda and the time frame in which to cover the agenda topics, public comment will be limited. All public comments will be included in the record of the ACBSCT meeting. Meeting summary notes will be posted on the Program Web site at https:// bloodcell.transplant.hrsa.gov/ABOUT/ Advisory_Council/. The draft meeting agenda will be posted on www.blsmeetings.net/ ACBSCT. Those participating in this meeting should register by visiting www.blsmeetings.net/ACBSCT. The deadline to register for this meeting is Wednesday, May 28, 2014. For all logistical questions and concerns, please contact Anita Allen, Seamon Corporation, by calling (301) 658–3442 E:\FR\FM\13MYN1.SGM 13MYN1

Agencies

[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Pages 27316-27317]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10945]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0160]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for TRADJENTA 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 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 https://www.regulations.gov at Docket 
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of 
Management, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, 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

[[Page 27317]]

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 has approved for marketing the human drug product TRADJENTA 
(linagliptin). TRADJENTA is indicated as an adjunct to diet and 
exercise to improve glycemic control in adults with type 2 diabetes 
mellitus. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for TRADJENTA (U.S. 
Patent No. 7,407,955) from Boehringer Ingelheim Pharma GmbH & Co. KGA, 
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 TRADJENTA 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 
TRADJENTA is 2,051 days. Of this time, 1,746 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: September 21, 2005. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on September 21, 2005.
    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 2, 
2010. FDA has verified the applicant's claim that the new drug 
application (NDA) for TRADJENTA (NDA 201-280) was submitted on July 2, 
2010.
    3. The date the application was approved: May 2, 2011. FDA has 
verified the applicant's claim that NDA 201-280 was approved on May 2, 
2011.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the 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 629 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 July 14, 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 November 10, 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, two copies 
are required. 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: May 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10945 Filed 5-12-14; 8:45 am]
BILLING CODE 4160-01-P
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