20228 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–E–0687] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; AUBAGIO—Patent No. 

6,794,410 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

AUBAGIO 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 the U.S. 

Patent and Trademark Office (USPTO), 

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 (two copies are required) and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Submit petitions electronically to http:// 

www.regulations.gov at Docket No. 

FDA–2013–S–0610. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of 

Management, Food and Drug 

Administration, 10001 New Hampshire 

Ave., Hillandale Campus, Rm. 3180, 

Silver Spring, MD 20993, 301–796– 

7900. 

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 USPTO 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 has approved for marketing the 

human drug product AUBAGIO 

(teriflunomide). AUBAGIO is indicated 

for treatment of patients with relapsing 

forms of multiple sclerosis. Subsequent 

to this approval, the USPTO received a 

patent term restoration application for 

AUBAGIO (U.S. Patent No. 6,794,410) 

from Aventis Pharmaceuticals Inc., and 

the USPTO requested FDA’s assistance 

in determining this patent’s eligibility 

for patent term restoration. In a letter 

dated January 31, 2014, FDA advised 

the USPTO that this human drug 

product had undergone a regulatory 

review period and that the approval of 

AUBAGIO represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

requested that FDA determine the 

product’s regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

AUBAGIO is 2,940 days. Of this time, 

2,542 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 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

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

27, 2004. FDA has verified the 

applicant’s claim that the date the 

investigational new drug application 

became effective was on August 27, 

2004. 

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 12, 

2011. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for AUBAGIO (NDA 202992) was 

submitted on August 12, 2011. 

3. The date the application was 

approved: September 12, 2012. FDA has 

verified the applicant’s claim that NDA 

202992 was approved on September 12, 

2012. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,625 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 June 15, 2015. 

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 

October 13, 2015. 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 or electronic 

petitions. It is only necessary to send 

one set of comments. Identify comments 

with the docket number found in 

brackets in the heading of this 

document. If you submit a written 

petition, two copies are required. A 

petition submitted electronically must 

be submitted to http://

www.regulations.gov, Docket No. FDA– 

2013–S–0610. 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: April 8, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08616 Filed 4–14–15; 8:45 am] 

BILLING CODE 4164–01–P 


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