01-9080. Patent Term Extension

ACTION:

Proposed collection; comment request.

SUMMARY:

The United States Patent and Trademark Office (USPTO), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity 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 USPTO in the performance of its statutory functions of processing applications for patent term extension as required by the Federal Food, Drug and Cosmetic Act, 35 U.S.C. 156, and processing requests for reconsideration or reinstatement of any patent term adjustment under 35 U.S.C. 154(b).

DATES:

Written comments must be submitted on or before June 11, 2001.

ADDRESSES:

Direct all written comments to Susan K. Brown, Records Officer, Office of Data Management, Data Administration Division, USPTO, Suite 310, 2231 Crystal Drive, Washington, DC 20231; by telephone [phone]; by e-mail at [e-mail]; or by facsimile at 703-308-7407.

FOR FURTHER INFORMATION CONTACT:

Requests for additional information should be directed to the attention of Karin L. Tyson, Office of Patent Legal Administration, United States Patent and Trademark Office, Washington, DC 20231; by telephone at 703-306-3159; or by facsimile transmission to 703-872-9411.

SUPPLEMENTARY INFORMATION:

I. Abstract

The United States Patent and Trademark Office (USPTO), together with the Secretary of Health and Human Services and the Department of Agriculture, administers the Federal Food, Drug and Cosmetic Act, 35 U.S.C. 156. This Act permits the USPTO to restore the patent term lost due to certain types of regulatory review by the Federal 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.

Under 35 U.S.C. 156(d), an application for patent term extension must identify the approved product, the patent to be extended, 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. 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.

The statute (35 U.S.C. 156) requires the USPTO to extend the term of various patents past their original expiration dates, to grant interim extensions, to review applications for patent term extension and final eligibility decisions, to obtain additional information from the public that might influence the extension of the patent term, and to withdraw an application for a patent term extension.

The USPTO administers 35 U.S.C. 156 through 37 CFR 1.705-1.791. These rules permit the public to submit applications to the USPTO to extend the term of a patent past its original expiration date; to petition for reviews of informal extensions of applications, final eligibility decisions, and interim extensions; and to withdraw an application requesting a patent term extension after it is submitted.

The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended if the term of the patent has not expired before an application is submitted. The Federal Food, Drug and Cosmetic Act requires that an application for patent term extension be filed with the USPTO within 60 days of a product (approved product) that was subject to regulatory review receiving permission for commercial marketing or use from the Federal Food and Drug Administration or the Department of Agriculture.

Under 35 U.S.C. 156(e), 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), and which is eligible for extension, would expire before a certificate of extension is issued.

The patent term provisions of 35 U.S.C. 154(b), as amended by Title IV, subtitle D of the “Intellectual Property and Communications Omnibus Reform Act of 1999,” requires the USPTO to notify the applicant of the patent term adjustment in the notice of allowance, and gives the applicant an opportunity to request reconsideration of the USPTO's patent term adjustment determination and to request reinstatement of a reduction in patent term adjustment.

The information supplied to the USPTO by an applicant requesting reconsideration of a USPTO patent term adjustment determination under 35 U.S.C. 154(b) is used by the USPTO to determine whether the USPTO's determination of patent term adjustment under 35 U.S.C. 154(b) is correct, and to determine whether the applicant is entitled to reinstatement of reduced patent term adjustment.

The subsequent application for interim extension under 37 CFR 1.790 is part of the initial application for interim extension and has been reported as such in previous submissions of this collection. Because we are now reporting filing fees as part of the nonhour respondent cost burden, it became necessary to separate out this requirement as the filing fees are different for the two requirements.

The information supplied to the USPTO by an applicant seeking a patent term extension under 35 U.S.C. 156 and a patent term adjustment under 35 U.S.C. 154(b) is used by the USPTO, the Department of Health and Human Services, and the Department of Agriculture to determine the eligibility of a patent for extension and to determine the period of any such extension.

II. Method of Collection

By mail, facsimile, or hand carried to the USPTO when the applicant or agent files an application for a patent term extension with the USPTO, submits papers during the prosecution of the application, files a Petition for Reconsideration of Patent Term Adjustment Determination, files a Petition for Reinstatement of Patent Term Adjustment, or related papers during processing of a patent application.

III. Data

OMB Number: 0651-0020.

Type of Review: Revision of a currently approved collection.

Affected Public: Individuals or households; business or other for-profit; not-for-profit institutions; farms; the Federal Government; and state, local or tribal governments.

Estimated Number of Respondents: 26,858 responses per year.

Estimated Time Per Response: The USPTO estimates that it will take the public anywhere from one to 25 hours, depending upon the complexity of the situation, to gather, prepare, and submit the applications, petitions, and various requests associated with the patent term and interim extensions, review of eligibility decisions, requirement to elect, requests to identify holders of regulatory approval, declarations to withdraw an application, petitions for reconsideration of a patent term adjustment determination, and petitions for reinstatement of reduced patent term adjustment with a showing that the applicant was unable to respond within three months in spite of all due care. There are no forms associated with this information collection.

Estimated Total Annual Respondent Burden Hours: 30,903 hours per year.

Estimated Total Annual Respondent Cost Burden: Using the professional hourly rate of $175 per hour for associate attorneys in private firms, the USPTO estimates $5,408,025 per year for salary costs associated with respondents.

Item	Estimated time for response (in hours)	Estimated annual burden hours	Estimated annual responses
Application to Extend Patent Term under 35 U.S.C. 156	25	1,250	50
Request for Interim Extension under 35 U.S.C. 156(e)(2)	1	1	1
Petition to Review Final Eligibility Decision	25	25	1
Initial Application for Interim Extension under 35 U.S.C. 156(d)(5)	20	20	1
Subsequent Application for Interim Extension under 37 CFR 1.790	1 D1	1
Response to Requirement to Elect	1	2	2
Response to Request to Identify Holder of Regulatory Approval	2	2	1
Declaration to Withdraw an Application to Extend Patent Term	2	2	1
Petition for Reconsideration of Patent Term Adjustment Determination (35 U.S.C. 154(b))	1	24,000	24,000
Petition for Reinstatement of Reduced Patent Term Adjustment (35 U.S.C. 154(b))	2	5,600	2,800
Totals		30,903	26,858

Estimated Total Annual Nonhour Respondent Cost Burden: $5,976,770. (There are no capitol start-up or maintenance costs associated with this information collection.)

There is annual nonhour cost burden in the way of filing fees associated with this collection. The filing fees related to this collection are considered part of the nonhour cost burden of the collection. Following is a chart listing these filing fees/nonhour cost burden. A zero means that there is no fee associated with that requirement. The total annual filing fees/nonhour cost burden is $5,976,770.

Item	Responses (a)	Filing fees ($)* (b)	Total non-hour cost burden (a) × (b)
Application to Extend Patent Term under 35 U.S.C. 156(d)(1)	50	$1,120	$56,000
Request for Interim Extension under 35 U.S.C. 156(e)(2)	1	0	0
Petition to Review Final Eligibility Decision	1	130	130
Initial Application for Interim Extension under 35 U.S.C. 156(d)(5)	1	420	420
Subsequent Application for Interim Extension under 37 CFR 1.790	1	220	220
Response to Requirement to Elect	2	0	0
Response to Request to Identify Holder of Regulatory Approval	1	0	0
Declaration to Withdraw an Application to Extend Patent Term	1	0	0
Petition for Reconsideration of Patent Term Adjustment Determination (35 U.S.C. 154(b))	24,000	200	4,800,000
Petition for Reinstatement of Reduced Patent Term Adjustment (35 U.S.C. 154(b))	2,800	400	1,120,000
Totals	26,858	2,490	5,976,770
* Note: All fees listed are based on per class filing.

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: April 3, 2001.

Susan K. Brown,

Records Officer, USPTO, Office of Data Management, Data Administration Division.