54994 Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Notices 

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 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 (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 

a 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 CYDECTIN 

(moxidectin). CYDECTIN is indicated 

for the treatment and control of certain 

internal and external parasites in cattle. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

CYDECTIN (U.S. Patent No. 4,916,154) 

from American Cyanamid Company, 

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 animal 

drug product had undergone a 

regulatory review period and that the 

approval of CYDECTIN 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 

CYDECTIN is 2,857 days. Of this time, 

2,841 days occurred during the testing 

phase of the regulatory review period, 

while 16 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 Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(j)) involving this animal drug 

product became effective: April 5, 1990. 

The applicant claims April 9, 1990, as 

the date the investigational new animal 

drug application (INAD) became 

effective. However, FDA records 

indicate that the date of FDA’s letter 

assigning a number to the INAD was 

April 5, 1990, which is considered to be 

the effective date for the INAD. 

2. The date the application was 

initially submitted with respect to the 

animal drug product under section 

512(b) of the act: January 13, 1998. The 

applicant claims August 8, 1995, as the 

date the new animal drug application 

(NADA) for CYDECTIN (NADA 141–

099) was initially submitted. The 

applicant claims this is the date it 

submitted the first component of NADA 

141–099, which was submitted in 

several modules. It is FDA’s position 

that the approval phase begins when the 

marketing application is complete. A 

review of FDA records reveals that the 

date of FDA’s official acknowledgement 

letter assigning a number to NADA 141–

099 was January 13, 1998, which is 

considered to be the initially submitted 

date for NADA 141–099. 

3. The date the application was 

approved: January 28, 1998. FDA has 

verified the applicant’s claim that 

NADA 141–099 was approved on 

January 28, 1998. 

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 1,754 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 November 20, 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 

March 19, 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 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: September 1, 2006. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 06–7800 Filed 9–19–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. 2006E–0023 and 2006E–0345] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; MYCAMINE—New Drug 

Application 21–754 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

MYCAMINE and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications 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 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 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Notices 54995 

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 MYCAMINE 

(mycafungin sodium). MYCAMINE is 

indicated for treatment of patients with 

esophageal candidiasis and prophylaxis 

of Candida infections in patients 

undergoing hematopoietic stem cell 

transplantation. Subsequent to this 

approval, the Patent and Trademark 

Office received patent term restoration 

applications for MYCAMINE (U.S. 

Patent Nos. 6,107,458 and 6,265,536) 

from Astellas Pharma, Inc., and the 

Patent and Trademark Office requested 

FDA’s assistance in determining these 

patents’ eligibility for patent term 

restoration. In a letter dated February 

24, 2006, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

MYCAMINE 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 

MYCAMINE is 2,546 days. Of this time, 

2,221 days occurred during the testing 

phase of the regulatory review period, 

while 325 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: March 29, 

1998. The applicant claims June 30, 

2003, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was March 29, 1998, 

which was 30 days after FDA receipt of 

the original IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: April 26, 2004. The 

applicant claims April 23, 2004, as the 

date the new drug application (NDA) for 

MYCAMINE (NDA 21–754) was initially 

submitted. However, FDA records 

indicate that NDA 21–754 was initially 

submitted on April 26, 2004. 

3. The date the application was 

approved: March 16, 2005. FDA has 

verified the applicant’s claim that NDA 

21–754 was approved on March 16, 

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 applications for patent extension, 

this applicant seeks 476 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 November 20, 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 

March 19, 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: September 11, 2006. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 06–7985 Filed 9–19–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0033] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; APTIVUS 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

APTIVUS 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 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 drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 


jlentini on PROD1PC65 with NOTICES