Determination of Regulatory Review Period for Purposes of Patent Extension; CRESTOR, 13407-13408 [E6-3641]

Download as PDF sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 71, No. 50 / Wednesday, March 15, 2006 / Notices appropriately treated with follicle stimulating hormones as part of an assisted reproductive technology program such as in vitro fertilization and embryo transfer. Ovidrel is also indicated for the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for OVIDREL (U.S. Patent No. 4,840,896) from Genzyme Corp., 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 8, 2005, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of OVIDREL 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 OVIDREL is 1,787 days. Of this time, 1,485 days occurred during the testing phase of the regulatory review period, while 302 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: November 1, 1995. The applicant claims October 2, 1995, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 1, 1995, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the act: November 24, 1999. The applicant claims November 23, 1999, as the date the new drug application (NDA) for OVIDREL (NDA 21–149) was initially submitted. However, FDA records indicate that NDA 21–149 was submitted on November 24, 1999. 3. The date the application was approved: September 20, 2000. FDA has verified the applicant’s claim that NDA 21–149 was approved on September 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. VerDate Aug<31>2005 17:27 Mar 14, 2006 Jkt 208001 In its application for patent extension, this applicant seeks 1,054 days 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 May 15, 2006. 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 September 11, 2006. 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 are to 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: February 13, 2006. Jane Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6–3640 Filed 3–14–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004E–0039] Determination of Regulatory Review Period for Purposes of Patent Extension; CRESTOR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for CRESTOR 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 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 13407 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: Claudia V. Grillo, Office of Regulatory Policy (HFD–013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–453–6681. 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 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 CRESTOR (rosuvastatin calcium). CRESTOR is indicated in the following ways: (1) As an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Type IIa and IIb); (2) as an adjunct to diet for the treatment of patients with elevated serum TG levels (Frederickson Type IV); and (3) to reduce LDL-C, total-C, and ApoB in patients with homozygous E:\FR\FM\15MRN1.SGM 15MRN1 sroberts on PROD1PC70 with NOTICES 13408 Federal Register / Vol. 71, No. 50 / Wednesday, March 15, 2006 / Notices familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for CRESTOR (U.S. Patent No. RE37,314) from Shionogi Seiyaku Kabushiki Kaisha, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated April 6, 2004, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of CRESTOR 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 CRESTOR is 1,831 days. Of this time, 1,053 days occurred during the testing phase of the regulatory review period, while 778 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: August 9, 1998. FDA has verified the applicant’s claim that the date the Investigational New Drug application (IND) became effective was on August 9, 1998. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the act: June 26, 2001. FDA has verified the applicant’s claim that the new drug application (NDA) for CRESTOR (NDA 21–366) was initially submitted on June 26, 2001. 3. The date the application was approved: August 12, 2003. FDA has verified the applicant’s claim that NDA 21–366 was approved on August 12, 2003. 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 1,304 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 May 15, 2006. Furthermore, any interested person may VerDate Aug<31>2005 17:27 Mar 14, 2006 Jkt 208001 petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 11, 2006. 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: February 13, 2006. Jane Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6–3641 Filed 3–14–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003E–0146] (formerly 03E– 0146) Determination of Regulatory Review Period for Purposes of Patent Extension; RELPAX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for RELPAX 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: Claudia V. Grillo, Office of Regulatory Policy (HFD–013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–453–6681. PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 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 RELPAX (eletriptan hydrobromide). RELPAX is indicated for the acute treatment of migraine, with or without aura, in adults. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for RELPAX (U.S. Patent No. 5,545,644) 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 April 6, 2004, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of RELPAX 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 RELPAX is 2,829 days. Of this time, 1,307 days occurred during the testing SUPPLEMENTARY INFORMATION: E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 71, Number 50 (Wednesday, March 15, 2006)]
[Notices]
[Pages 13407-13408]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3641]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004E-0039]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for CRESTOR 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: Claudia V. Grillo, Office of 
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 240-453-6681.

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 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 CRESTOR 
(rosuvastatin calcium). CRESTOR is indicated in the following ways: (1) 
As an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-
C, and TG levels and to increase HDL-C in patients with primary 
hypercholesterolemia (heterozygous familial and nonfamilial) and mixed 
dyslipidemia (Frederickson Type IIa and IIb); (2) as an adjunct to diet 
for the treatment of patients with elevated serum TG levels 
(Frederickson Type IV); and (3) to reduce LDL-C, total-C, and ApoB in 
patients with homozygous

[[Page 13408]]

familial hypercholesterolemia as an adjunct to other lipid-lowering 
treatments (e.g., LDL apheresis) or if such treatments are unavailable. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for CRESTOR (U.S. Patent No. 
RE37,314) from Shionogi Seiyaku Kabushiki Kaisha, and the Patent and 
Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
April 6, 2004, FDA advised the Patent and Trademark Office that this 
human drug product had undergone a regulatory review period and that 
the approval of CRESTOR 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 
CRESTOR is 1,831 days. Of this time, 1,053 days occurred during the 
testing phase of the regulatory review period, while 778 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: 
August 9, 1998. FDA has verified the applicant's claim that the date 
the Investigational New Drug application (IND) became effective was on 
August 9, 1998.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505 of the act: June 26, 2001. FDA 
has verified the applicant's claim that the new drug application (NDA) 
for CRESTOR (NDA 21-366) was initially submitted on June 26, 2001.
    3. The date the application was approved: August 12, 2003. FDA has 
verified the applicant's claim that NDA 21-366 was approved on August 
12, 2003.
    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 1,304 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 May 15, 2006. 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 September 11, 
2006. 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: February 13, 2006.
Jane Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-3641 Filed 3-14-06; 8:45 am]
BILLING CODE 4160-01-S

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