[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.                                                                                         
                                                                                 -------------------------------
    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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