Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Notices 14819 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

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 

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 

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 http:// 

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. 


jlentini on PROD1PC65 with NOTICES
14820 Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Notices 

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 

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. 

ACTION: Notice of public meeting; 

request for comments. 

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., 


jlentini on PROD1PC65 with NOTICES