Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 75679 

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 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 recently approved for marketing 

the human biologic product STELARA 

(ustekinumab). STELARA is indicated 

for treatment of adult patients with 

severe plaque psoriasis who are 

candidates for phototherapy or systemic 

therapy. Subsequent to this approval, 

the Patent and Trademark Office 

received a patent term restoration 

application for STELARA (U.S. Patent 

No. 6,902,734 and 7,166,285) from 

Centocor Ortho Biotech Inc., and the 

Patent and Trademark Office requested 

FDA’s assistance in determining the 

patents’ eligibility for patent term 

restoration. In a letter dated March 24, 

2010, FDA advised the Patent and 

Trademark Office that this human 

biological product had undergone a 

regulatory review period and that the 

approval of STELARA 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 

STELARA is 3,165 days. Of this time, 

2,498 days occurred during the testing 

phase of the regulatory review period, 

while 667 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: January 27, 2001. The 

applicant claims December 28, 2000 as 

the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was January 27, 2001, 

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): November 29, 2007. FDA 

has verified the applicant’s claim that 

the biologics license application (BLA) 

for STELARA (BLA 125261/0) was 

initially submitted on November 29, 

2007. 

3. The date the application was 

approved: September 25, 2009. FDA has 

verified the applicant’s claim that BLA 

125261/0 was approved on September 

25, 2009. 

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 425 or 510 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) either 

electronic or written comments and ask 

for a redetermination by February 4, 

2011. 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 June 6, 2011. 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. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: October 22, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–30512 Filed 12–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0584] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; BESIVANCE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

BESIVANCE 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 electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

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 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 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 


jdjones on DSK8KYBLC1PROD with NOTICES
75680 Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 

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 BESIVANCE 

(besifloxacin hydrochloride). 

BESIVANCE is indicated for treatment 

of bacterial conjunctivitis. Subsequent 

to this approval, the Patent and 

Trademark Office received a patent term 

restoration application for BESIVANCE 

(U.S. Patent No. 5,447,926) from Bausch 

& Lomb 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 May 10, 2010, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of BESIVANCE 

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 

BESIVANCE is 2,271 days. Of this time, 

1,910 days occurred during the testing 

phase of the regulatory review period, 

while 361 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 FD&C Act) (21 

U.S.C. 355(i)) became effective: March 

12, 2003. FDA has verified the 

applicant’s claim that the date the 

investigational new drug application 

became effective was on March 12, 

2003. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: June 2, 2008. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

Besivance (NDA 22–308) was submitted 

on June 2, 2008. 

3. The date the application was 

approved: May 28, 2009. FDA has 

verified the applicant’s claim that NDA 

22–308 was approved on May 28, 2009. 

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 1,316 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) either 

electronic or written comments and ask 

for a redetermination by February 4, 

2011. 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 June 6, 2011. 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. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: October 22, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–30510 Filed 12–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Oncologic Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Oncologic Drugs 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on February 9, 2011, from 8 a.m. 

to 12:30 p.m. 

Location: FDA White Oak Campus, 

Building 31 Conference Center, the 

Great Room (rm. 1503), 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002. Information regarding 

special accommodations due to a 

disability, visitor parking and 

transportation may be accessed at: 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘White Oak Conference Center 

Parking and Transportation Information 

for FDA Advisory Committee Meetings.’’ 

Please note that visitors to the White 

Oak Campus must have a valid driver’s 

license or other picture ID, and must 

enter through Building 1. 

Contact Person: Nicole Vesely, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301 847–8533, e-mail: 

Nicole.vesely@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512542. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the Agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 


jdjones on DSK8KYBLC1PROD with NOTICES