8182 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 

claim that the date the investigational 

new drug application became effective 

was on January 19, 1997. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: September 29, 2004. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

BARACLUDE (NDA 21–797) was 

initially submitted on September 29, 

2004. 

3. The date the application was 

approved: March 29, 2005. FDA has 

verified the applicant’s claim that NDA 

21–797 was approved on March 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 1,587 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 April 24, 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 

August 22, 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: January 25, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–3042 Filed 2–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. 2004E–0300, 2004E–0301, 

2004E–0302, 2004E–0303, 2004E–0304, 

2004E–0306, 2004E–0426, and 2006E–0206] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; S8 OVER–THE–WIRE 

SYSTEM 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for S8 

OVER–THE–WIRE SYSTEM 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 

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 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 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 approved for marketing the 

medical device, S8 OVER–THE–WIRE 

SYSTEM. S8 OVER–THE–WIRE 

SYSTEM is indicated for improving 

coronary luminal diameter in patients 

with symptomatic ischemic heart 

disease due to discrete de novo or 

restenotic lesions with reference vessel 

diameters of 3.0—4.0 mm and = 30 mm 

in length using direct stenting or 

predilatation. Subsequent to this 

approval, the Patent and Trademark 

Office received patent term restoration 

applications for S8 OVER–THE–WIRE 

SYSTEM (U.S. Patent Nos. 5,292,331; 

5,800,509; 5,836,965; 5,879,382; 

5,891,190; 6,159,229; 6,309,402; and 

6,344,053) from Medtronic Vascular, 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining the patents’ eligibilities for 

patent term restoration. In letters dated 

February 24, 2006, and June 14, 2006, 

FDA advised the Patent and Trademark 

Office that this medical device had 

undergone a regulatory review period 

and that the approval of S8 OVER–THE–

WIRE SYSTEM 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 

S8 OVER–THE–WIRE SYSTEM is 652 

days. Of this time, 477 days occurred 

during the testing phase of the 

regulatory review period, while 175 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

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

360j(g)) involving this device became 

effective: December 20, 2001. FDA has 

verified the applicant’s claim that the 

date the investigational device 

exemption (IDE) required under section 

520(g) of the act for human tests to begin 

became effective December 20, 2001. 

2. The date the application was 

initially submitted with respect to the 

device under section 515 of the act (21 

U.S.C. 360e): April 10, 2003. The 


cprice-sewell on PROD1PC61 with NOTICES
Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 8183 

applicant claims April 9, 2003, as the 

date the premarket approval application 

(PMA) for S8 OVER–THE–WIRE 

SYSTEM (PMA P030009) was initially 

submitted. However, FDA records 

indicate that PMA P030009 was 

submitted on April 10, 2003. 

3. The date the application was 

approved: October 1, 2003. FDA has 

verified the applicant’s claim that PMA 

P030009 was approved on October 1, 

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 applications for patent extension, 

this applicant seeks 413 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 April 24, 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 

August 22, 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: January 25, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–3127 Filed 2–22–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0355] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; AMITIZA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

AMITIZA 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 

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 recently approved for marketing 

the human drug product AMITIZA 

(lubiprostone). AMITIZA is indicated 

for the treatment of chronic idiopathic 

constipation in the adult population. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

AMITIZA (U.S. Patent No. 5,284,858) 

from Sucampo AG, 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 AMITIZA 

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 

AMITIZA is 2,197 days. Of this time, 

1,890 days occurred during the testing 

phase of the regulatory review period, 

while 307 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: January 28, 

2000. The applicant claims January 29, 

2000, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was January 28, 2000, 

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(b) of the act: March 31, 2005. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

AMITIZA (NDA 21–908) was initially 

submitted on March 31, 2005. 

3. The date the application was 

approved: January 31, 2006. FDA has 

verified the applicant’s claim that NDA 

21–908 was approved on January 31, 

2006. 

This determination of the regulatory 

review period establishes the maximum 


cprice-sewell on PROD1PC61 with NOTICES