Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 45865 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: November 17, 2005. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) 

21–911 for BANZEL was initially 

submitted on November 17, 2005. 

3. The date the application was 

approved: November 14, 2008. FDA has 

verified the applicant’s claim that NDA 

21–911 was approved on November 14, 

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 819 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 November 3, 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 

March 3, 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 23, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–21428 Filed 9–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–E–0568] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; TALENT ABDOMINAL 

STENT GRAFT SYSTEM 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

TALENT ABDOMINAL STENT GRAFT 

SYSTEM 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, TALENT 

ABDOMINAL STENT GRAFT SYSTEM. 

The TALENT ABDOMINAL STENT 

GRAFT SYSTEM is indicated for the 

endovascular treatment of abdominal 

aortic aneurysms with or without iliac 

involvement having: Iliac/femoral 

access vessel morphology that is 

compatible with vascular access 

techniques, devices, and/or accessories; 

a proximal aortic neck length of ≥ 10 

millimeters (mm); proximal aortic neck 

angulation ≤ 60° distal iliac artery 

fixation length of ≥ 15 mm; an aortic 

neck diameter of 18 to 32 mm and iliac 

artery diameters of 8 to 22 mm; and 

vessel morphology suitable for 

endovascular repair. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for TALENT ABDOMINAL 

STENT GRAFT SYSTEM (U.S. Patent 

No. 6,306,141) from Medtronic, 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 18, 2009, FDA advised the 

Patent and Trademark Office that this 

medical device had undergone a 

regulatory review period and that the 

approval of TALENT ABDOMINAL 

STENT GRAFT SYSTEM 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 

TALENT ABDOMINAL STENT GRAFT 

SYSTEM is 4,024 days. Of this time, 

3,843 days occurred during the testing 

phase of the regulatory review period, 

while 181 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: April 11, 1997. FDA has 

verified the applicant’s claim that the 

date the investigational device 

exemption (IDE) required under section 


srobinson on DSKHWCL6B1PROD with NOTICES
45866 Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 

520(g) of the act for human tests to begin 

became effective April 11, 1997. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the act (21 

U.S.C. 360e): October 18, 2007. FDA has 

verified the applicant’s claim that the 

premarket approval application (PMA) 

for TALENT ABDOMINAL STENT 

GRAFT SYSTEM (PMA P070027) was 

initially submitted October 18, 2007. 

3. The date the application was 

approved: April 15, 2008. FDA has 

verified the applicant’s claim that PMA 

P070027 was approved on April 15, 

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 1,183 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 November 3, 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 

March 3, 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. E9–21424 Filed 9–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Antigenic Chimeric Tick-Borne 

Encephalitis Virus/Dengue Virus Type 4 

Recombinant Viruses 

Description of Technology: The tickborne encephalitis virus (TBEV) 

complex is a group of viruses that can 

cause severe neutrotropic disease and 

up to thirty percent (30%) mortality. 

While these viruses can be found in 

many parts of the world, the largest 

impact of the disease occurs in Europe 

and Russia, where approximately 

fourteen thousand (14,000) hospitalized 

TBEV cases occur annually. TBEV is in 

the family Flaviviridae, genus flavivirus 

and is composed of a positive-sense 

single stranded RNA genome that 

contains 5′ and 3′ non-coding regions 

and a single open reading frame 

encoding ten (10) proteins. At present, 

a vaccine or FDA approved antiviral 

therapy is not available. 

The inventors have previously 

developed a WNV/Dengue4Delta30 

antigenic chimeric virus as a live 

attenuated virus vaccine candidate that 

contains the WNV premembrane and 

envelope (prM and E) proteins on a 

dengue virus type 4 (DEN4) genetic 

background with a thirty nucleotide 

deletion (Delta30) in the DEN4 3′-UTR. 

Using a similar strategy, the inventors 

have generated an antigenic chimeric 

virus, TBEV/DEN4Delta30. This 

chimeric virus also contains attenuating 

mutations within the E and 

nonstructural NS5 proteins. Preclinical 

testing results with the derived virus 

indicate that chimerization of TBEV 

with DEN4Delta30 and introduction of 

the attenuating mutations decreased 

neuroinvasiveness and neurovirulence 

in mice. The TBEV/DEN4delta30 

vaccine candidate was safe, 

immunogenic, and provided protection 

in monkeys against challenge with TBE 

viruses. 

This application claims live 

attenuated chimeric TBEV/DEN4Delta30 

vaccine compositions. Also claimed are 

methods of treating or preventing TBEV 

infection in a mammalian host, methods 

of producing a subunit vaccine 

composition, isolated polynucleotides 

comprising a nucleotide sequence 

encoding a TBEV immunogen, methods 

for detecting TBEV infection in a 

biological sample and infectious 

chimeric TBEV. 

Applications: Development of TickBorne Encephalitis Virus vaccines, 

therapeutics and diagnostics. 

Advantages: Live attenuated chimeric 

vaccine, known regulatory pathway, 

potential for lasting immunity with 

fewer doses. 

Development Status: Vaccine 

candidates have been synthesized and 

preclinical studies have been 

performed. 

Inventors: Alexander G. Pletnev, 

Amber R. Engel, Brian R. Murphy 

(NIAID). 

Patent Status: U.S. Provisional 

Application No. 61/181,982 filed 28 

May 2009 (HHS Reference No. E–078– 

2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301–435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID is seeking statements of 

capability or interest from parties 

interested in collaborative research in 

preclinical study of the long-term 

immunity induced by the TBEV/DEN4 

vaccine candidate against highly 

virulent TBE viruses and in the clinical 

trials of this vaccine in humans. Please 

contact Michael Piziali, NIAID Office of 

Technology Development, at 301–496– 

2644 for more information. 

Monoclonal Antibodies That React 

With the Capsule of Bacillus 

anthracis 

Description of Technology: Bacillus 

anthracis is the causative agent of 

anthrax and is surrounded by a 


srobinson on DSKHWCL6B1PROD with NOTICES