Determination of Regulatory Review Period for Purposes of Patent Extension; VAPRISOL, 14819-14820 [E7-5737]

Download as PDF jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Notices 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–7), 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 biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological 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 biological product and continues until FDA grants permission to market the biological 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 biological 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 biological product RETEVASE (reteplase). RETEVASE is indicated in the management of acute myocardial infarction (AMI) in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for RETEVASE (U.S. Patent No. 5,223,256) from Boehringer VerDate Aug<31>2005 17:20 Mar 28, 2007 Jkt 211001 Mannheim GmbH, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated February 6, 1997, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of RETEVASE represented the first permitted commercial marketing or use of the product. On September 14, 2006, 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 RETEVASE is 1,919 days. Of this time, 1,430 days occurred during the testing phase of the regulatory review period, while 489 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 (21 U.S.C. 355(i)) became effective: August 1, 1991. The applicant claims July 1, 1991, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was August 1, 1991, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): June 30, 1995. FDA has verified the applicant’s claim that the product license application (PLA) for Retevase (PLA 95–1167) was initially submitted on June 30, 1995. The PLA was renumbered as biologics license application (BLA) 103632/0. 3. The date the application was approved: October 30, 1996. The applicant claims October 29, 1996, as the date the PLA was approved. However, FDA records indicate that PLA 95–1167 (BLA 103632/0) was approved on October 30, 1996. 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 123 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 29, 2007. Furthermore, any interested person may PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 14819 petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 25, 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: March 12, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7–5736 Filed 3–28–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E–0354] Determination of Regulatory Review Period for Purposes of Patent Extension; VAPRISOL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for VAPRISOL 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 that 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–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–2041. E:\FR\FM\29MRN1.SGM 29MRN1 14820 Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Notices 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 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 VAPRISOL (conivaptan hydrochloride). VAPRISOL is indicated for treatment of euvolemic hyponatremia in hospitalized patients. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for VAPRISOL (U.S. Patent No. 5,723,606) from Astellas Pharma, 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 September 5, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of VAPRISOL 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 VAPRISOL is 2,796 days. Of this time, jlentini on PROD1PC65 with NOTICES SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 17:20 Mar 28, 2007 Jkt 211001 2,096 days occurred during the testing phase of the regulatory review period, while 700 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: May 6, 1998. FDA has verified the applicant’s claim that the date the Investigational New Drug application became effective was on May 6, 1998. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: January 30, 2004. FDA has verified the applicant’s claim that the new drug application (NDA) for VAPRISOL (NDA 21–697) was initially submitted on January 30, 2004. 3. The date the application was approved: December 29, 2005. FDA has verified the applicant’s claim that NDA 21–697 was approved on December 29, 2005. 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 1,745 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 29, 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 September 25, 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. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Dated: March 12, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7–5737 Filed 3–28–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003N–0312] Meeting to Present Work-in-Progress on a Method for Ranking Feed Contaminants According to the Relative Risks They Pose to Animal and Public Health; Part 2: Exposure Scoring for Feed Contaminants; Public Meeting AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing the following public meeting: ‘‘Meeting to Present Work-in-Progress on a Method for Ranking Feed Contaminants According to the Relative Risks They Pose to Animal and Public Health; Part 2: Exposure Scoring for Feed Contaminants.’’ The topic to be discussed will present work-in-progress on a method for ranking animal feed contaminants by their relative risks to animal and human health. The relative risk posed by feed contaminants to animal and human health consists of two components, namely, health consequence scoring and exposure scoring. At a meeting held in September 2006, the agency presented its current thinking on health consequence scoring. At this public meeting, the agency will describe the methods it plans to use to develop animal and human exposure scoring for chemical, physical, and microbiological feed contaminants. At a subsequent public meeting, FDA will present information on its relative riskranking model and how the health consequence scoring and exposure scoring will be combined to determine the relative risks of contaminants in feed. Date and Time: The public meeting will be held on May 22, 2007, from 9 a.m. to 4 p.m. Location: The public meeting will be held at the Holiday Inn, 2 Mongomery Village Ave., Gaithersburg, MD 20879. Contact: For general information: Zoe Gill, Center for Veterinary Medicine (HFV–226), Food and Drug Administration, 7519 Standish Pl., E:\FR\FM\29MRN1.SGM 29MRN1

Agencies

[Federal Register Volume 72, Number 60 (Thursday, March 29, 2007)]
[Notices]
[Pages 14819-14820]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5737]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0354]


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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the 
regulatory review period for VAPRISOL 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 
that 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-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

[[Page 14820]]


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 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 VAPRISOL 
(conivaptan hydrochloride). VAPRISOL is indicated for treatment of 
euvolemic hyponatremia in hospitalized patients. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for VAPRISOL (U.S. Patent No. 5,723,606) from 
Astellas Pharma, 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 September 5, 2006, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of VAPRISOL 
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 
VAPRISOL is 2,796 days. Of this time, 2,096 days occurred during the 
testing phase of the regulatory review period, while 700 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: 
May 6, 1998. FDA has verified the applicant's claim that the date the 
Investigational New Drug application became effective was on May 6, 
1998.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: January 30, 
2004. FDA has verified the applicant's claim that the new drug 
application (NDA) for VAPRISOL (NDA 21-697) was initially submitted on 
January 30, 2004.
    3. The date the application was approved: December 29, 2005. FDA 
has verified the applicant's claim that NDA 21-697 was approved on 
December 29, 2005.
    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 1,745 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 29, 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 September 25, 
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: March 12, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-5737 Filed 3-28-07; 8:45 am]
BILLING CODE 4160-01-S

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