[Federal Register Volume 63, Number 108 (Friday, June 5, 1998)]
[Notices]
[Pages 30732-30733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14946]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Patent Term Extension
ACTION: Proposed collection; comment request.
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SUMMARY: The Department of Commerce (DOC), as part of its continuing
effort to reduce paperwork and respondent burden, invites the general
public and other Federal agencies to comment on the continuing
information collection, as required by the Paperwork Reduction Act of
1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), and by the Patent
and Trademark Office (Office) in the performance of its statutory
functions of processing applications for patent term extension as
required by the Hatch-Waxman Act, 35 U.S.C. 156.
DATES: Written comments must be submitted on or before August 4, 1998.
ADDRESSES: Direct all written comments to Linda Engelmeier,
Departmental Forms Clearance Officer, Department of Commerce, Room
5327, 14th and Constitution Avenue, NW, Washington, DC 20230.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to the attention of Karin L. Tyson, at the Special
Program Law Office, Office of the Deputy Assistant Commissioner for
Patent Policy and Projects, Washington DC 20231, by telephone at (703)
305-9285 or by facsimile transmission to (703) 308-6916.
SUPPLEMENTARY INFORMATION:
I. Abstract
The Patent and Trademark Office (Office), together with the
Secretary of Health and Human Services and the Department of
Agriculture administers the Hatch-Waxman Act, e.g. 35 U.S.C. 156. This
Act permits the Office to restore the patent term lost due to certain
types of regulatory review by the Food and Drug Administration or the
Department of Agriculture. Only patents for drug products, medical
devices, food additives, and color additives are eligible for
extension. The maximum length that a patent may be extended (the
maximum of patent term that may be restored) is five years.
The Hatch-Waxman Act requires that an application for patent term
extension be filed with the Office within 60 days of a product
(approved product) that was subject to regulatory review receiving
permission for commercial marketing or use from the Food and Drug
Administration or the Department of Agriculture. Under 35 U.S.C.
156(d)(1), an application for patent term extension must identify the
approved product, the patent to be extended, and the claims of the
patent that claim the approved product, a method of use of the approved
product, or a method of manufacturing the approved product. It must
also set forth sufficient information for the Commissioner of the
Patent and Trademark Office to determine the eligibility of the patent
for extension and to enable the Commissioner and the Secretary of
Health and Human Services or the Department of Agriculture to determine
the length of extension. In addition, the application for patent term
extension must provide a brief description of the activities undertaken
by the applicant during the regulatory review period with respect to
the approved product and the significant dates of these activities. If
the information supplied is not sufficient for the Commissioner to
determine the eligibility of the patent for extension, the rights that
will be derived from the extension, or the period of extension, the
Commissioner may regard the application as informal and the applicant
may provide a response, addressing any deficiencies. In addition, the
Commissioner may require additional information; for example, to
identify the holder of the regulatory approval or to elect a single
patent for extension. An applicant may file a written declaration of
withdrawal of an application for patent term extension. If a patent is
finally determined not to be eligible for patent term extension, an
applicant for patent term extension may request reconsideration of this
decision.
Under 35 U.S.C. 156(d)(5), an interim extension for a patent may be
granted if the regulatory review of a product is in the approval phase
(i.e., the regulatory review period referenced in 35 U.S.C.
156(d)(5)(A) has begun), but the approval phase is expected to extend
beyond the original expiration date of the patent. An application for
interim extension is required to be filed in the period beginning six
months and ending fifteen days before the term of the patent is set to
expire. An application for interim extension must identify the product
subject to regulatory review, the Federal Statute which requires its
review, the patent for which interim extension is sought, including
each claim of the patent which claims the product under regulatory
review or a method of using or manufacturing the product, and
information to enable the Commissioner to determine eligibility for
extension under 35 U.S.C. 156(a)(1), (a)(2) and (a)(3). In addition, an
application for interim extension must provide a brief description of
the activities undertaken by the applicant during the applicable
regulatory review period to date and the significant dates applicable
to such activities. If the information supplied is not sufficient for
the Commissioner to determine the eligibility of the patent for interim
extension or the rights that will be derived from the interim
extension, the Commissioner may regard the application as informal and
the applicant may provide a response, addressing any deficiencies. In
addition, the Commissioner may require additional information.
Under 35 U.S.C. 156(e)(2), an interim extension may be granted if
the term of a patent for which an application for patent term extension
has been submitted under 35 U.S.C. 156(d)(1), and which is eligible for
extension, would expire before a certificate of extension is issued.
[[Page 30733]]
II. Method of Collection
By mail, facsimile transmission, or hand carried to the Patent and
Trademark Office.
III. Data
OMB Number: 0651-0020.
Type of Review: Renewal with change.
Affected Public: Individuals or households, businesses or other
for-profit, not-for-profit institutions, farms, state, local or tribal
governments, and the Federal Government.
Estimated Number of Respondents: 57.
Estimated Time Per Response: It is estimated to take the public 20
to 25 hours to complete an application for patent term extension under
35 U.S.C. 156(d)(1), an application for interim patent term extension
under 35 U.S.C. 156(d)(5), or to petition for review of a final
eligibility decision. In addition, it is estimated to take the public 1
to 2 hours to file a request for an interim extension under 35 U.S.C.
156(e)(2), to respond to a requirement for additional information, and
to file a written declaration of withdrawal. There are no forms
associated with this information collection.
Estimated Total Annual Respondent Burden Hours: 1,302 hours per
year.
Estimated Total Annual Respondent Cost Burden: $227,850 per year.
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Estimated time Estimated Estimated
Title of form Form Nos. for response annual burden annual
(hours) hours responses
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Application to Extend Patent Term No Forms Associated..... 25 1,250 50
under 35 U.S.C. 156(d)(1).
Request for Interim Extension under 35 No Forms Associated..... 1 1 1
U.S.C. 156(e)(2).
Petition to Review Final Eligibility No Forms Associated..... 25 25 1
Decision.
Application for Interim Extension No Forms Associated..... 20 20 1
under 35 U.S.C. 156(d)(5).
Response to Requirement to Elect...... No Forms Associated..... 1 2 2
Response to Request to Identify Holder No Forms Associated..... 2 2 1
of Regulatory Approval.
Declaration to Withdraw an Application No Forms Associated..... 2 2 1
To Extend Patent Term.
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Totals............................ ........................ .............. 1,302 57
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IV. Request for Comments
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden
(including hours and cost) of the proposed collection of information;
(c) ways to enhance the quality, utility, and clarity of the
information to be collected; and (d) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques or other forms of information
technology.
Comments submitted in response to this notice will be summarized or
included in the request for OMB approval of this information
collection; they will also become a matter of public record.
Dated: June 1, 1998.
Linda Engelmeier,
Departmental Forms Clearance Officer, Office of Management and
Organization.
[FR Doc. 98-14946 Filed 6-4-98; 8:45 am]
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