Determination of Regulatory Review Period for Purposes of Patent Extension; Porcine Circovirus Vaccine, Type 1-Type 2 Chimera, Killed Virus, Mycoplasma Hyopneumoniae Bacterin, 53099-53100 [2019-21677]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 84, Number 193 (Friday, October 4, 2019)]
[Notices]
[Pages 53099-53100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21677]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0039]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Porcine Circovirus Vaccine, Type 1-Type 2 Chimera, Killed 
Virus, Mycoplasma Hyopneumoniae Bacterin

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has determined the regulatory review period for 
Porcine Circovirus Vaccine, Type 1-Type 2 Chimera, Killed Virus, 
Mycoplasma Hyopneumoniae Bacterin 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 for 
Patents, 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 November 4, 
2019. We will consider all due diligence petitions that we receive on 
or before April 1, 2020.

ADDRESSES: You may submit revision requests and due diligence petitions 
by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0039.
     Postal Mail/Commercial Delivery: Please send your request 
or petition to Docket No. APHIS-2019-0039, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, 
Riverdale, MD 20737-1238.
    A copy of the regulatory review period determination and any 
revision requests or due diligence petitions that we receive on this 
determination may be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0039 or in our reading room, which 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) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Barbara J. Sheppard, Senior Staff 
Veterinary Medical Officer, Center for Veterinary Biologics, Policy, 
Evaluation, and Licensing, VS, APHIS, USDA, 1920 Dayton Avenue, P.O. 
Box 844, Ames, IA 50010; (515) 337-6100.

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 the U.S. 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 U.S. 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 53100]]

may count toward the actual amount of extension that the Commissioner 
for Patents 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 Porcine Circovirus Vaccine, Type 1-Type 2 Chimera, Killed 
Virus, Mycoplasma Hyopneumoniae Bacterin. Subsequent to this approval, 
the U.S. Patent and Trademark Office received a patent term restoration 
application for Porcine Circovirus Vaccine, Type 1-Type 2 Chimera, 
Killed Virus, Mycoplasma Hyopneumoniae Bacterin (U.S. Patent No. 
9,585,951) from Zoetis, Inc., and the U.S. Patent and Trademark Office 
requested APHIS' assistance in determining this patent's eligibility 
for patent term restoration. In a letter dated November 1, 2018, APHIS 
advised the U.S. Patent and Trademark Office that this veterinary 
biologic had undergone a regulatory review period and that the approval 
of Porcine Circovirus Vaccine, Type 1-Type 2 Chimera, Killed Virus, 
Mycoplasma Hyopneumoniae Bacterin represented the first permitted 
commercial licensing or use of the product. Subsequently, the U.S. 
Patent and Trademark Office requested that APHIS determine the 
product's regulatory review period.
    APHIS has determined that the applicable regulatory review period 
for Porcine Circovirus Vaccine, Type 1-Type 2 Chimera, Killed Virus, 
Mycoplasma Hyopneumoniae Bacterin is 1,376 days. Of this time, 0 days 
occurred during the testing phase of the regulatory review period, and 
1,376 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: April 28, 2014. APHIS has 
verified the applicant's claim that the application was initially 
submitted on April 28, 2014.
    2. The date the license was issued: February 1, 2018. APHIS has 
verified the applicant's claim that the license for the commercial 
marketing of the vaccine was issued on February 1, 2018.
    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 1,376 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; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 30th day of September 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-21677 Filed 10-3-19; 8:45 am]
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