2010-9048. 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)).

DATES:

Written comments must be submitted on or before June 21, 2010.

ADDRESSES:

You may submit comments by any of the following methods:

• E-mail: [e-mail]. Include A0651-0020 comment@ in the subject line of the message.
• Fax: [phone], marked to the attention of Susan Fawcett.
• Mail: Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
• Federal Rulemaking Portal: http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Requests for additional information should be directed to Raul Tamayo, Legal Advisor, Office of Patent Legal Administration, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7728; or by e-mail to [e-mail].

SUPPLEMENTARY INFORMATION:

I. Abstract

The Federal Food, Drug, and Cosmetic Act at 35 U.S.C. 156 permits the United States Patent and Trademark Office (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 in order to restore the lost portion of the patent term is five years.

The USPTO may in some cases extend the term of an original patent due to certain delays in the prosecution of the patent application, including delays caused by interference proceedings, secrecy orders, or appellate review by the Board of Patent Appeals and Interferences or a Federal court in which the patent is issued pursuant to a decision reversing an adverse determination of patentability. 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, require the USPTO to notify the applicant of the patent term adjustment in the notice of allowance and give the applicant an opportunity to request reconsideration of the USPTO's patent term adjustment determination.

The USPTO may also reduce the amount of patent term adjustment granted if delays were caused by an applicant's failure to make a reasonable effort to respond within three months of the mailing date of a communication from the USPTO. Applicants may petition for reinstatement of a reduction in patent term adjustment with a showing that, in spite of all due care, the applicant was unable to respond to a communication from the USPTO within the three month period.

The USPTO administers 35 U.S.C. 154 and 156 through 37 CFR 1.701-1.791. These rules permit the public to submit applications to the USPTO to extend the term of a patent past its original expiration date, to request interim extensions and review of final eligibility decisions, and to withdraw an application requesting a patent term extension after it is submitted. Under 35 U.S.C. 156(d), an application for patent term extension must identify the approved product, the patent to be extended, and the claims included in the patent that cover the approved product, a method of using 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 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 the product receiving regulatory approval 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 an eligible patent for which an application for patent term extension has been submitted would expire before a certificate of extension is issued.

The information in this collection is used by the USPTO to consider whether an applicant is eligible for a patent term extension or reconsideration of a patent term adjustment and, if so, to determine the length of the patent term extension or adjustment.

II. Method of Collection

By mail, facsimile, hand delivery, or electronically to the USPTO. Electronic submissions are made through EFS-Web, the USPTO's online filing system for patent applications and related documents.

III. Data

OMB Number: 0651-0020.

Form Number(s): PTO/SB/131.

Type of Review: Revision of a currently approved collection.

Affected Public: Businesses or other for-profits; not-for-profit institutions.

Estimated Number of Respondents: 13,586 responses per year.

Estimated Time per Response: The USPTO estimates that it will take the public from 10 minutes (0.17 hours) to 25 hours, depending on the complexity of the situation, to gather the necessary information, prepare the appropriate documents, and submit the information in this collection to the USPTO.

Estimated Total Annual Respondent Burden Hours: 7,808 hours.

Estimated Total Annual Respondent Cost Burden: $2,537,600. The USPTO expects that the information in this collection will be prepared by attorneys. Using the professional rate of $325 per hour for attorneys in private firms, the USPTO estimates that the respondent cost burden for submitting the information in this collection will be $2,537,600 per year.

Item	Estimated time for response	Estimated annual responses	Estimated annual burden hours
Application to Extend Patent Term under 35 U.S.C. 156	25 hours	40	1,000
Request for Interim Extension under 35 U.S.C. 156(e)(2)	1 hour	1	1
Petition to Review Final Eligibility Decision under 37 CFR 1.750	25 hours	3	75
Initial Application for Interim Extension under 35 U.S.C. 156(d)(5)	20 hours	3	60
Subsequent Application for Interim Extension under 37 CFR 1.790	1 hour	1	1
Response to Requirement to Elect	1 hour	5	5
Response to Request to Identify Holder of Patent Term	2 hours	1	2
Declaration to Withdraw an Application to Extend Patent Term	2 hours	1	2
Petition for Reconsideration of Patent Term Adjustment Determination	3 hours	1,500	4,500
Petition for Reinstatement of Reduced Patent Term Adjustment	4 hours	30	120
Petition to Accord a Filing Date to an Application under 37 CFR 1.740 for Extension of a Patent Term	2 hours	1	2
Request for Recalculation of Patent Term Adjustment in View of Wyeth (PTO/SB/131)	10 minutes	12,000	2,040
Totals		13,586	7,808

Estimated Total Annual Non-hour Respondent Cost Burden: $360,416. There are no capital start-up or maintenance costs associated with this information collection. However, this collection does have annual (non-hour) costs in the form of filing fees, postage costs, and recordkeeping costs.

This collection has filing fees associated with the requirements for patent term extension and patent term adjustment. The USPTO estimates that the total filing fees associated with this collection will be $358,680 per year.

Item	Estimated annual responses	Fee amount	Estimated annual filing fees
Application to Extend Patent Term under 35 U.S.C. 156	40	$1,120.00	$44,800.00
Request for Interim Extension under 35 U.S.C. 156(e)(2)	1	0.00	0.00
Petition to Review Final Eligibility Decision under 37 CFR 1.750	3	0.00	0.00
Initial Application for Interim Extension under 35 U.S.C. 156(d)(5)	3	420.00	1,260.00
Subsequent Application for Interim Extension under 37 CFR 1.790	1	220.00	220.00
Response to Requirement to Elect	5	0.00	0.00
Response to Request to Identify Holder of Patent Term	1	0.00	0.00
Declaration to Withdraw an Application to Extend Patent Term	1	0.00	0.00
Petition for Reconsideration of Patent Term Adjustment Determination	1,500	200.00	300,000.00
Petition for Reinstatement of Reduced Patent Term Adjustment	30	400.00	12,000.00
Petition to Accord a Filing Date to an Application under 37 CFR 1.740 for Extension of a Patent Term	1	400.00	400.00
Request for Recalculation of Patent Term Adjustment in View of Wyeth (PTO/SB/131)	12,000	0.00	0.00
Totals	13,586		358,680.00

Customers may incur postage costs when submitting the information in this collection to the USPTO by mail. The USPTO expects that the Application to Extend Patent Term under 35 U.S.C. 156, the Initial Application for Interim Extension under 35 U.S.C. 156(d)(5), and approximately 7% of the other responses for this collection will be submitted by mail. The USPTO estimates that the average first-class postage cost for these 991 mailed submissions will be 44 cents each, for a total estimated postage cost of $436 per year.

When submitting the information in this collection to the USPTO electronically, the customer is strongly urged to retain a copy of the acknowledgment receipt as evidence that the submission was received by the USPTO on the date noted. The USPTO estimates that it will take 5 seconds (0.001 hours) to print and retain a copy of the acknowledgment receipt and that approximately 12,595 responses per year will be submitted electronically, for a total of approximately 13 hours per year for printing this receipt. Using the paraprofessional rate of $100 per hour, the USPTO estimates that the recordkeeping cost associated with this collection will be $1,300 per year.

The total non-hour respondent cost burden for this collection in the form of filing fees, postage costs, and recordkeeping costs is estimated to be $360,416 per year.

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, e.g., 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 also will become a matter of public record.

Dated: April 13, 2010.

Susan K. Fawcett,

Records Officer, USPTO, Office of the Chief Information Officer.