Determination of Regulatory Review Period for Purposes of Patent Extensions: NAHVAX Mareks Disease Vaccine

Federal Register: July 27, 2009 (Volume 74, Number 142)

Notices

Page 37000-37001

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr27jy09-25

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

Docket No. APHIS-2009-0056

Determination of Regulatory Review Period for Purposes of Patent

Extension; NAHVAX[supreg] Marek's Disease Vaccine

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public that the Animal and Plant Health

Inspection Service has determined the regulatory review period for

NAHVAX[supreg] Marek's Disease Vaccine and is publishing this notice of that determination as required by law. We have made this determination in response to the submission of an application to the Commissioner of

Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that veterinary biologic.

DATES: We will consider all requests for revision of the regulatory review period determination that we receive on or before August 26, 2009. We will consider all due diligence petitions that we receive on or before January 25, 2010.

ADDRESSES: You may submit revision requests and due diligence petitions by either of the following methods:

Federal eRulemaking Portal: Go to http:// www.regulations.gov/fdmspublic/component/ main?main=DocketDetail&d=APHIS-2009-0056 to submit or view revision requests and due diligence petitions and to view supporting and related materials available electronically.

Postal Mail/Commercial Delivery: Please send two copies of your request or petition to Docket No. APHIS-2009-0056, Regulatory

Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road,

Unit 118, Riverdale, MD 20737-1238. Please state that your revision request or due diligence petition refers to Docket No. APHIS-2009-0056.

Reading Room: A copy of the regulatory review period determination and any revision requests or due diligence petitions that we receive on this determination are available for public inspection in our reading room. The reading room is located in room 1141 of the USDA South

Building, 14th Street and Independence Avenue SW., Washington, DC.

Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through

Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader,

Operational Support Section, Center for Veterinary Biologics, Policy

Evaluation and Licensing, VS, APHIS, 4700 River Road, Unit 148,

Riverdale, MD 20737-1231; phone (301) 734-8245; fax (301) 734-4314.

For information concerning the regulatory review period determination contact Dr. Patricia L. Foley, Center for Veterinary

Biologics, Policy Evaluation and Licensing, VS, APHIS, 510 South 17th

Street, Suite 104, Ames, IA 50010; phone (515) 232-5785, fax (515) 232- 7120.

SUPPLEMENTARY INFORMATION: The provisions of 35 U.S.C. 156, ''

Extension of patent term,'' provide, generally, that a patent for a product may be extended for a period of up to 5 years as long as the patent claims a product that, among other things, was subject to a regulatory review period before its commercial marketing or use. (The term ``product'' is defined in that section as ``a drug product''

which includes veterinary biological products

or ``any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act.'') A product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

The regulations in 9 CFR part 124, ``Patent Term Restoration''

(referred to below as the regulations), set forth procedures and requirements for the Animal and Plant Health Inspection Service's

(APHIS) review of applications for the extension of the term of certain patents for veterinary biological products pursuant to 35 U.S.C. 156.

As identified in the regulations, the responsibilities of APHIS include:

Assisting Patent and Trademark Office of the U.S.

Department of Commerce in determining eligibility for patent term restoration;

Determining the length of a product's regulatory review period;

If petitioned, reviewing and ruling on due diligence challenges to APHIS' regulatory review period determinations; and

Conducting hearings to review initial APHIS findings on due diligence challenges.

The regulations are designed to be used in conjunction with regulations issued by the Patent and Trademark Office concerning patent term extension, which may be found at 37 CFR 1.710 through 1.791.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For veterinary biologics, the testing phase begins on the date the authorization to prepare an experimental veterinary biologic became effective and runs until the approval phase begins. The approval phase begins on the date an application for a license was initially submitted for approval and ends on the date such license was issued. Although only a portion of a regulatory review period

Page 37001

may count toward the actual amount of extension that the Commissioner of Patents and Trademarks may award, APHIS' determination of the length of a regulatory review period for a veterinary biologic will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(5)(B).

APHIS recently licensed for production and marketing the veterinary biologic NAHVAX[supreg] Marek's Disease Vaccine. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for NAHVAX[supreg] Marek's Disease Vaccine

(U.S. Patent No. 5, 965, 138) from Schering Plough Animal Health

Corporation, and the Patent and Trademark Office requested APHIS' assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 2, 2009, APHIS advised the

Patent and Trademark Office that this veterinary biologic had undergone a regulatory review period and that the approval of NAHVAX[supreg]

Marek's Disease Vaccine (Marek's Disease Vaccine, Serotypes 1 & 3, Live

Herpesvirus Chimera) represented the first permitted commercial licensing or use of the product. Subsequently, the Patent and Trademark

Office requested that APHIS determine the product's regulatory review period.

APHIS has determined that the applicable regulatory review period for NAHVAX[supreg] Marek's Disease Vaccine is 1,539 days. Of this time, 0 days occurred during the testing phase of the regulatory review period, and 1,539 days occurred during the approval phase. These periods were derived from the following dates: 1. The date the application for a license was initially submitted for approval under the Virus-Serum-Toxin Act: July 14, 2004. APHIS has verified the applicant's claim that the application was initially submitted on July 14, 2004. 2. The date the license was issued: September 29, 2008. APHIS has verified the applicant's claim that the license for the commercial marketing of the vaccine was issued on September 29, 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 1,539 days of patent term extension.

Section 124.22 of the regulations provides that any interested person may request a revision of the regulatory review period determination within 30 days of the date of this notice (see DATES above). The request must specify the following:

The identity of the product;

The identity of the applicant for patent term restoration;

The docket number of this notice; and

The basis for the request for revision, including any documentary evidence.

Further, under Sec. 124.30 of the regulations, any interested person may file a petition with APHIS, no later than 180 days after the date of this notice (see DATES above), alleging that a license applicant did not act with due diligence in seeking APHIS approval of the product during the regulatory review period. The filing, format, and content of a petition must be as described in the regulations in

``Subpart D-Due Diligence Petitions'' (Sec. Sec. 124.30 through 124.33).

Authority: 35 U.S.C. 156.

Done in Washington, DC, this 21st day of July 2009.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

FR Doc. E9-17795 Filed 7-24-09; 8:45 am

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