Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 38659 

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 biological product 

RECOTHROM (Thrombin, topical 

(Recombinant)). RECOTHROM is 

indicated as an aid to hemostasis 

whenever oozing blood and minor 

bleeding from capillaries and small 

venules is accessible and control of 

bleeding by standard surgical 

techniques is ineffective or impractical. 

Subsequent to this approval, the Patent 

and Trademark Office received patent 

term restoration applications for 

RECOTHROM (U.S. Patent Nos. 

5,476,777, 5,502,034, and 5,527,692) 

from ZymoGenetics, Inc., and the Patent 

and Trademark Office requested FDA’s 

assistance in determining the patents’ 

eligibilities for patent term restoration. 

In a letter dated February 26, 2009, FDA 

advised the Patent and Trademark 

Office that this human biological 

product had undergone a regulatory 

review period and that the approval of 

RECOTHROM 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 

RECOTHROM is 1,511 days. Of this 

time, 1,115 days occurred during the 

testing phase of the regulatory review 

period, while 396 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: November 30, 

2003. FDA has verified the applicant’s 

claims that the date the investigational 

new drug application became effective 

was on November 30, 2003. 

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): December 18, 2006. FDA 

has verified the applicant’s claims that 

the biologics license application (BLA) 

for RECOTHROM (BLA 125248/0) was 

initially submitted on December 18, 

2006. 

3. The date the application was 

approved: January 17, 2008. FDA has 

verified the applicant’s claims that BLA 

125248/0 was approved on January 17, 

2008. 

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 952 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 October 5, 2009. 

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 

February 1, 2010. 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: June 8, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–18528 Filed 8–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–E–0551] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; XIENCE V EECSS 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for XIENCE 

V EECSS 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 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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

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 recently approved for marketing 

the medical device, XIENCE V EECSS. 

XIENCE V EECSS is indicated for 

improving coronary luminal diameter in 

patients with symptomatic heart disease 

due to de novo native coronary artery 

lesions (length = 28 millimeters (mm)) 

with reference vessel diameters of 2.5 

mm to 4.25 mm. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for XIENCE V EECSS (U.S. 

Patent No. 5,451,233) from Abbott 

Cardiovascular Systems, Inc., and the 

Patent and Trademark Office requested 

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38660 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated February 

18, 2009, FDA advised the Patent and 

Trademark Office that this medical 

device had undergone a regulatory 

review period and that the approval of 

XIENCE V EECSS 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 

XIENCE V EECSS is 1,157 days. Of this 

time, 759 days occurred during the 

testing phase of the regulatory review 

period, while 398 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: May 4, 2005. 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 on May 4, 2005. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the act (21 

U.S.C. 360e): June 1, 2007. The 

applicant claims the premarket approval 

application (PMA) XIENCE V EECSS 

(PMA 70015) was submitted in three 

modules and that Module 1 was initially 

submitted on July 14, 2006. The 

applicant claims July 14, 2006, as the 

date PMA 70015 was initially 

submitted. It is FDA’s position that the 

approval phase begins when the 

marketing application is complete. A 

review of FDA records indicates that 

PMA 70015 was submitted as a 

complete application on June 1, 2007, 

which is considered to be the initially 

submitted date for PMA 70015. 

3. The date the application was 

approved: July 2, 2008. FDA has verified 

the applicant’s claim that PMA 70015 

was approved on July 2, 2008. 

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 937 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 October 5, 2009. 

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 

February 1, 2010. 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: June 8, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–18530 Filed 8–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0020] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EOVIST 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for EOVIST 

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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

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 EOVIST 

(gadoxetate disodium). EOVIST is 

indicated for intravenous use in T1– 

weighted magnetic resonance imaging of 

the liver to detect and characterize 

lesions in adults with known or 

suspected focal liver disease. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for EOVIST 

(U.S. Patent No. 6,039,931) from Bayer 

Schering Pharma Aktiengesellschaft, 

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 26, 2009, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of EOVIST represented the 

first permitted commercial marketing or 

mstockstill on DSKH9S0YB1PROD with NOTICES