Patent Term Extension

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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