15322 Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices 

documents in the docket at http:// 

www.regulations.gov. 

References 

The following references are on 

display in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20857, under 

Docket No. FDA–2010–P–0176 and may 

be seen by interested persons between 9 

a.m. and 4 p.m., Monday through 

Friday. 

1. Letter from Christy Foreman, FDA, 

CDRH, to Ken Charak, Ethicon EndoSurgery, Inc., containing the order 

denying approval of the PMA for the 

SEDASYS system, October 26, 2010. 

2. Charter Medical Devices Advisory 

Committee; Charter Amendment, 

Medical Devices Advisory Committee; 

FDA; July 15, 2008, http://www.fda.gov/ 

AdvisoryCommittees/Committees

MeetingMaterials/MedicalDevices/

MedicalDevicesAdvisoryCommittee/

ucm124098.htm. 

3. ‘‘Resolving Scientific Disputes 

Concerning the Regulation of Medical 

Devices, A Guide To Use of the Medical 

Devices Dispute Resolution Panel; Final 

Guidance for Industry and FDA’’ FDA, 

CDRH; July 2, 2001, http://www.fda.gov/ 

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/

default.htm. 

Dated: March 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6520 Filed 3–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0400] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; VPRIV 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for VPRIV 

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 

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 VPRIV 

(velaglucerase alfa). VPRIV is indicated 

for long-term enzyme replacement 

therapy for pediatric and adult patients 

with type 1 Gaucher Disease. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for VPRIV 

(U.S. Patent No. 7,138,262) from Shire 

Human Genetic Therapies, 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 September 

30, 2010, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

VPRIV 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 

VPRIV is 2,221 days. Of this time, 2,041 

days occurred during the testing phase 

of the regulatory review period, while 

180 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: January 

30, 2004. The applicant claims May 20, 

2004, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was January 30, 2004, 

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 FD&C Act: August 31, 

2009. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for VPRIV (NDA 22–575) was 

initially submitted on August 31, 2009. 

3. The date the application was 

approved: February 26, 2010. FDA has 

verified the applicant’s claim that NDA 

22–575 was approved on February 26, 

2010. 

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 687 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 May 20, 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 

September 19, 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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 54 / Monday, March 21, 2011 / Notices 15323 

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 

http://www.regulations.gov may be 

viewed in the Division of Dockets 

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

Monday through Friday. 

Dated: February 14, 2011. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2011–6514 Filed 3–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0241] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ATRYN 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for ATRYN 

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 biological 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 

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 ATRYN 

(antithrombin (recombinant)). ATRYN is 

indicated for the prevention of perioperative and peri-partum 

thromboembolic events in hereditary 

antithrombin deficient patients. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for ATRYN 

(U.S. Patent No. 6,441,145) from GTC 

Biotherapeutics, 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 February 17, 2010, FDA 

advised the Patent and Trademark 

Office that this human biological 

product had undergone a regulatory 

review period and that the approval of 

ATRYN represented the first permitted 

commercial marketing or use of the 

recombinant 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 

ATRYN is 4,468 days. Of this time, 

4,285 days occurred during the testing 

phase of the regulatory review period, 

while 183 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: November 15, 1996. 

The applicant claims November 14, 

1996, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was November 15, 

1996, 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): August 8, 2008. The 

applicant claims January 31, 2008, as 

the date the biologics license 

application (BLA) for ATRYN (BLA 

125284) was initially submitted. 

However, FDA records indicate that 

BLA 125284 was submitted on August 

8, 2008. 

3. The date the application was 

approved: February 6, 2009. FDA has 

verified the applicant’s claim that BLA 

125284 was approved on February 6, 

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 1,243 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 May 20, 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 

September 19, 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 

mstockstill on DSKH9S0YB1PROD with NOTICES