Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices 14121 

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 ONYX LES. ONYX 

LES is indicated for presurgical 

embolization of brain arteriovenous 

malformations. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for ONYX LES (U.S. Patent 

No. 5,667,767) from Micro Therapeutics, 

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 

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 

ONYX LES 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 

ONYX LES is 1,682 days. Of this time, 

825 days occurred during the testing 

phase of the regulatory review period, 

while 857 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 14, 2000. 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 14, 2000. 

2. The date the application was 

initially submitted with respect to the 

device under section 515 of the act (21 

U.S.C. 360e): March 18, 2003. The 

applicant claims March 12, 2003, as the 

date the premarket approval application 

(PMA) for ONYX LES (PMA P030004) 

was initially submitted. However, FDA 

records indicate that PMA P030004 was 

submitted on March 18, 2003. 

3. The date the application was 

approved: July 21, 2005. FDA has 

verified the applicant’s claim that PMA 

P030004 was approved on July 21, 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 1,271 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates are published is incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by May 25, 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 24, 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. E7–5444 Filed 3–23–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0478] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; NOVOLOG 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

NOVOLOG 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 NOVOLOG 

(insulin aspart (rDNA origin)). 

NOVOLOG is indicated for the 

treatment of adult patients with diabetes 

mellitus, for the control of 

hyperglycemia. Subsequent to this 


cprice-sewell on PROD1PC66 with NOTICES
14122 Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for NOVOLOG (U.S. Patent 

No. 5,618,913) from Novo Nordisk A/S, 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

December 12, 2006, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of NOVOLOG 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 

NOVOLOG is 1,776 days. Of this time, 

1,145 days occurred during the testing 

phase of the regulatory review period, 

while 631 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: July 30, 1995. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on July 30, 1995. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: September 16, 1998. 

The applicant claims September 15, 

1998, as the date the new drug 

application (NDA) for NOVOLOG (NDA 

20–986) was initially submitted. 

However, FDA records indicate that 

NDA 20–986 was submitted on 

September 16, 1998. 

3. The date the application was 

approved: June 7, 2000. FDA has 

verified the applicant’s claim that NDA 

20–986 was approved on June 7, 2000. 

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 59 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 25, 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 24, 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. E7–5445 Filed 3–23–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005E–0259] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EMTRIVA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

EMTRIVA 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 EMTRIVA 

(emtricitabine). EMTRIVA is indicated, 

in combination with other antiretroviral 

agents, for the treatment of HIV–1 

infection in adults. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for EMTRIVA (U.S. Patent 

No. 5,914,331) from Emory University, 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

July 8, 2005, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of EMTRIVA 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 

EMTRIVA is 2,114 days. Of this time, 

1,811 days occurred during the testing 

phase of the regulatory review period, 

while 303 days occurred during the 


cprice-sewell on PROD1PC66 with NOTICES