Determination of Regulatory Review Period for Purposes of Patent Extension; LANTUS, 30595-30596 [E7-10632]

Download as PDF hsrobinson on PROD1PC76 with NOTICES Federal Register / Vol. 72, No. 105 / Friday, June 1, 2007 / Notices 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 recently approved for marketing the animal drug product ZILMAX (zilpaterol hydrochloride). ZILMAX is indicated for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for ZILMAX (U.S. Patent No. 4,900,735) from Intervet International B.V., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated March 5, 2007, FDA advised the Patent and Trademark Office that this animal drug product had undergone a regulatory review period and that the approval of ZILMAX represented the first permitted commercial marketing or use of the product. Shortly 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 ZILMAX is 4,720 days. Of this time, 4,674 days occurred during the testing phase of the regulatory review period, while 46 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 512(j) of the act involving this animal drug product became effective: September 9, 1993. FDA has verified the applicant’s claim that the date the investigational new animal drug application (INAD) became effective was on September 9, 1993. 2. The date the application was initially submitted with respect to the animal drug product under section 512(b) of the act: June 26, 2006. FDA has verified the applicant’s claim that the new animal drug application (NADA) for ZILMAX (NADA 141–258) was initially submitted on June 26, 2006. 3. The date the application was approved: August 10, 2006. FDA has verified the applicant’s claim that VerDate Aug<31>2005 18:10 May 31, 2007 Jkt 211001 NADA 141–258 was approved on August 10, 2006. 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 5 years of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by July 31, 2007. 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 28, 2007. 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. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 7, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7–10602 Filed 5–31–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007E–0011] Determination of Regulatory Review Period for Purposes of Patent Extension; LANTUS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for LANTUS and is publishing this notice of that determination as required by law. FDA has made the determination PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 30595 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 written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD–007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 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 human drug product 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 approved for marketing the human drug product LANTUS (insulin glargine [rDNA origin]). LANTUS is indicated for once-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the E:\FR\FM\01JNN1.SGM 01JNN1 hsrobinson on PROD1PC76 with NOTICES 30596 Federal Register / Vol. 72, No. 105 / Friday, June 1, 2007 / Notices control of hyperglycemia. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for LANTUS (U.S. Patent No. 5,101,013) from Hoechst 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 January 26, 2007, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of LANTUS represented the first permitted commercial marketing or use of the product. Shortly 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 LANTUS is 1,591 days. Of this time, 1,227 days occurred during the testing phase of the regulatory review period, while 364 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 act) (21 U.S.C. 355(i)) became effective: December 14, 1995. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on December 14, 1995. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: April 23, 1999. FDA has verified the applicant’s claim that the new drug application (NDA) for LANTUS (NDA 21–081) was initially submitted on April 23, 1999. 3. The date the application was approved: April 20, 2000. FDA has verified the applicant’s claim that NDA 21–081 was approved on April 20, 2000. 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 976 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) written or electronic comments and ask for a redetermination by July 31, 2007. 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 VerDate Aug<31>2005 18:10 May 31, 2007 Jkt 211001 November 28, 2007. 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. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 7, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7–10632 Filed 5–31–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E–0259] Determination of Regulatory Review Period for Purposes of Patent Extension; X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM 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 medical device. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD–007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 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 medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. 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 (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 medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA recently approved for marketing the medical device X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM. X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis (with x-ray, magnetic resonance imaging (MRI), and/or computerized tomography (CT) evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing). The X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM is indicated for those patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment. The X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels. Subsequent to this approval, the Patent and Trademark Office received a patent E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 72, Number 105 (Friday, June 1, 2007)]
[Notices]
[Pages 30595-30596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10632]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007E-0011]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for LANTUS 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 written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 human drug product 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 approved for marketing the human drug product LANTUS (insulin 
glargine [rDNA origin]). LANTUS is indicated for once-daily 
subcutaneous administration for the treatment of adult and pediatric 
patients with type 1 diabetes mellitus or adult patients with type 2 
diabetes mellitus who require basal (long-acting) insulin for the

[[Page 30596]]

control of hyperglycemia. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
LANTUS (U.S. Patent No. 5,101,013) from Hoechst 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 January 26, 2007, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of LANTUS represented the first permitted 
commercial marketing or use of the product. Shortly 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 
LANTUS is 1,591 days. Of this time, 1,227 days occurred during the 
testing phase of the regulatory review period, while 364 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 act) (21 U.S.C. 355(i)) became effective: 
December 14, 1995. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on 
December 14, 1995.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: April 23, 1999. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for LANTUS (NDA 21-081) was initially submitted on April 23, 
1999.
    3. The date the application was approved: April 20, 2000. FDA has 
verified the applicant's claim that NDA 21-081 was approved on April 
20, 2000.
    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 976 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) written or electronic comments and ask for a redetermination 
by July 31, 2007. 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 28, 
2007. 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.
    Comments and petitions should be submitted to the Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 7, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-10632 Filed 5-31-07; 8:45 am]
BILLING CODE 4160-01-S

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