Amendment to Rules for Extension of Patent Term

DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. 941087-4287]

RIN 0651-AA52

Amendment to Rules for Extension of Patent Term

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Patent and Trademark Office (Office) proposes to amend the

rules directed to the extension of patent term to implement the

provisions of Public Law 103-179 (December 3, 1993) and to clarify the

requirements for eligibility. The proposed rules establish procedures

for the Commissioner to issue an interim extension of the term of a

patent where the original term would expire before a product covered by

the patent has received regulatory approval for commercial marketing or

use. The rules also are proposed to be amended to clarify that an

application for patent term extension must be based on regulatory

activities performed by the patent owner or its agent.

DATES: Written comments must be submitted on or before January 12,

1995. There will be no oral hearing.

ADDRESSES: Address written comments to Commissioner of Patents and

Trademarks, Washington, D.C. 20231 marked to the attention of Charles

E. Van Horn, Deputy Assistant Commissioner for Patent Policy and

Projects, or by FAX to (703) 305-8825.

FOR FURTHER INFORMATION CONTACT: Charles E. Van Horn by telephone at

(703) 305-9054 or Gerald A. Dost by telephone at (703) 305-9282 or by

mail addressed to Commissioner of Patents and Trademarks, Washington,

D.C. 20231 marked to the attention of Charles E. Van Horn, Deputy

Assistant Commissioner for Patent Policy and Projects, or by FAX to

(703) 305-8825.

SUPPLEMENTARY INFORMATION: Patent term extension has been available

under 35 U.S.C. 156 for patents that claim certain products that are

subject to regulatory review before being commercially marketed or

used. Prior to enactment of Public Law 103-179, eligibility for patent

term extension was dependent on regulatory approval of the product

before the original patent term expired. Public Law 103-179 has made it

possible, under appropriate circumstances, to obtain interim extensions

of patent term where the regulatory process is likely to extend beyond

the expiration of the patent term.

One purpose of the proposed rule change is to revise the present

regulations contained in 37 CFR Part 1, Subpart F, to include

provisions for interim extension of the patent term prior to regulatory

approval of the product that can now form the basis of patent term

extension. These proposed rules set forth procedures that govern the

content and submission of applications for an interim extension of a

patent term, and procedures governing the interim extension

determination and issuance of interim patent term extension

certificates by the Office.

Initial guidelines directed to the preparation and filing of

applications for interim extensions of patent terms as authorized by

Public Law 103-179 were published as ``Guidelines For Interim Extension

Under 35 U.S.C. 156(d)(5) of a Patent Term Prior To Regulatory Approval

of a Product For Commercial Marketing or Use--Public Law 103-179

(December 3, 1993)'' in the Official Gazette at 1159 Off. Gaz. Pat.

Office 12 (February 1, 1994). It is intended that those guidelines will

continue in effect until the promulgation of final rules based on the

proposed rulemaking.

It is important to keep in mind the distinction between an interim

patent term extension under Sec. 156(e)(2) and the interim patent term

extension provided for by Public Law 103-179 under Sec. 156(d)(5). The

former applies after regulatory approval has occurred and is addressed

in 37 CFR 1.706. Interim patent term extensions under Sec. 156(e)(2)

are not affected by the proposed changes to the rules. The latter

applies before regulatory approval has occurred and is addressed in 37

CFR 1.780 and 1.790.

The eligibility criteria for obtaining an interim extension under

Sec. 156(d)(5) are substantially the same as for obtaining patent term

extension under Sec. 156 after regulatory approval has occurred. Under

the provisions of Public Law 103-179, a patent owner or its agent may

submit an application for an interim patent term extension within six

months, but not later than 15 days, of the original expiration date of

the patent. At the time the application is submitted, the regulatory

review period must have advanced to the approval phase a defined in

Sec. 156(g), but must not have ended. For a new drug, for example, the

approval phase is defined in Sec. 156(g)(1)(B)(ii) as the period

beginning on the date a new drug application was initially submitted

for the new drug under section 505 of the Federal Food, Drug and

Cosmetic Act.

The content of the application for interim extension is proposed to

be the same as for an application for patent term extension following

regulatory review, with certain modifications necessitated by the

circumstances. For example, the application for interim term extension

will not be required to contain information about regulatory approval

since that event has not occurred. A fee is proposed for each interim

extension application filed before regulatory approval occurs--$400.00

for the initial application for interim extension and $200.00 for each

supplementary application for interim extension.

The processing of an application for interim patent term extension

under Pub. L. No. 103-179 will not require transmission of a copy of

the application to the regulatory agency. However, it is contemplated

that the Office will consult with the regulatory agency, as it has been

doing for the past 10 years under Sec. 156, on the question of

eligibility for patent term extension.

If the patent is eligible for extension but for the fact that it is

still under regulatory review, the Office can extend the patent term is

one-year increments not to exceed five years from the expiration date.

Any such extension would terminate 60 days after market approval.

Before the 60-day period expires, the patentee could submit an

application for patent term extension, supplying any additional

information necessary to obtain any additional extension available

under Sec. 156.

The interim extension of patent term available under Sec. 156(d)(5)

cannot exceed the extension from the original patent term that would be

available after regulatory approval. Thus, for example, a patent that

was subject to the two-year extension limitation of Sec. 156(g)(6)(C),

could not obtain interim extension beyond two years from the original

patent term expiration date. However, after an interim extension under

Sec. 156(d)(5) has been granted, the amount of patent term extension

available after regulatory review is controlled by either

Sec. 156(d)(5) or Sec. 156(g)(6) (A) or (B). In no case would the

extension go beyond five years from the original expiration date of the

patent. However, for those situations falling under Sec. 156(g)(6)(C),

where regulatory approval occurs within the two-year period after the

original expiration date of the patent, the extension after approval is

measured from the date on which the product receives permission for

commercial marketing or use. Sec. 156(d)(5)(E)(ii).

Review of recent applications for patent term extension has

revealed that the provisions of 37 CFR 1.785(c) may be read as being

inconsistent with 35 U.S.C. 156. The statute requires that an

application for patent term extension be filed by the patent owner or

its agent. 35 U.S.C. 156(d)(1). The statute further requires under

Sec. 156(d)(1)(D) a description of the activities undertaken by the

applicant (i.e., the patent owner or its agent) during the regulatory

review period, and specifies in Sec. 156(d)(2)(B)(i) that the lack of

due diligence by the applicant during the regulatory review period may

be taken into account. Given these statutory requirements, the Office

has held that in order to be eligible for patent term extension, the

patent owner or its agent must have undertaken the activities that lead

to regulatory approval. If a patent owner has not been involved, either

directly or indirectly, in the regulatory review process, that patent

owner has not lost any effective patent life since it never invested

time and resources necessary to obtain approval for commercial

marketing or use. Accordingly, to the extent that Sec. 1.785 could be

interpreted to permit a patent owner to obtain a patent term extension

where neither the patent owner nor its agent were responsible for

activities leading to regulatory approval, it was misleading and

contrary to both the letter and intent of Sec. 156.

Discussion of Specific Rules

Section 1.750, if amended as proposed, would be changed to also

provide for an eligibility determination which will be made on

applications for interim extension filed in compliance with Sec. 1.790.

The section is further modified to limit the mailing of a notice of a

final determination to applications filed in compliance with Sec. 1.740

after the regulatory approval process is complete.

Section 1.760, if amended as proposed, would have the title recite

that the section is directed to requests for interim extensions of

patent term under 35 U.S.C. 156(e)(2), to distinguish it from interim

extensions available under Pub. Law No. 103-179, proposed to be

addressed in Sec. 1.780.

Section 1.765(a) if amended as proposed, would change the phrase

(two occurrences) ``the Office of the Secretary'' to read ``the Office

or the Secretary.'' The change provides that the applicant has a duty

of disclosure to both the Patent and Trademark Office and the Secretary

of Health and Human Services or the Secretary of Agriculture.

Section 1.780, if amended as proposed, would provide that a

certificate of interim extension under 35 U.S.C. 156(d)(5) will be

issued to the applicant. Section 1.780 would also provide for

notification of the issuance of the certificate of interim extension

under 35 U.S.C. Sec. 156(d)(5), including the identity of the product

currently under regulatory review, to be published in the Federal

Register.

Section 1.785, if amended as proposed, would require the applicant

for extension, i.e., the patent owner or its agent, to also have been

the marketing applicant who obtained regulatory approval of the product

for commercial marketing or use. While regulatory approval can be

obtained by a party other than the patent owner, that other party must

have been an agent of the patent owner when obtaining the regulatory

approval in order for the patent owner to be eligible to apply for

extension of the patent term.

Section 1.790, if added as proposed, would provide for one or more

interim extensions for periods of up to one year for patents where the

applicable regulatory review period described in paragraph (1)(B)(ii),

(2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii) of section 156(g)

that began for the patented product may extend beyond the expiration of

the patent term in effect.

Paragraph (a) of proposed Sec. 1790 defines the time periods in

which the initial interim extension application and each subsequent

interim extension application must be filed in the Office. In no event

will interim extensions be granted under proposed Sec. 1.790 for a

period of extension longer than that to which the applicant would be

entitled to under 35 U.S.C. 156(c).

Paragraph (b) of proposed Sec. 1.790 would establish that the

content requirements of the initial interim extension applications are

substantially the same as the content requirements for a formal

application for extension of patent term under Sec. 1.740 and a

complete application under Sec. 1.741, except that the content

requirements relate to a product currently undergoing regulatory

review. In other words, the interim extension applications contain

information available to the patent owner or its agent at the time the

application is filed.

Paragraph (c) of proposed Sec. 1.790 permits each interim extension

application after the initial interim extension application to be

limited to a request for a subsequent interim extension along with a

statement that the regulatory review period has not been completed and

any materials or information required under Secs. 1.740 and 1.741 not

present in the preceding interim extension application.

Section Sec. 1.795, if added as proposed, would provide that any

interim extension granted under 35 U.S.C. 156(d)(5) terminates at the

end of the 60-day period beginning on the date on which the product

involved receives permission for commercial marketing or use. If within

that 60-day period the patent owner or its agent files additional

information required under 35 U.S.C. 156(d)(1) not contained in the

applications for interim extension, the patent shall be further

extended in accordance with the provisions of 35 U.S.C. 156.

Other Considerations

The proposed rule changes are in conformity with the requirements

of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., E.O. 12612,

and the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq. The

proposed rule changes have been determined to be not significant for

the purposes of E.O. 12866.

The General Counsel of the Department of Commerce has certified to

the Chief Counsel for Advocacy, Small Business Administration, that the

proposed rule changes will not have a significant economic impact on a

substantial number of small entities (Regulatory Flexibility Act, 5

U.S.C. 605(b)), because the proposed rules would affect only a very

small number of patents eligible for interim patent term extension.

The Office has also determined that this notice has no federalism

implications affecting the relationship between the National Government

and the States as outlined in E.O. 12612.

These rule changes will impose no substantial additional burden

under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq. The

paperwork burden imposed by adherence to the patent term extension

rules is currently approved by the Office of Management and Budget

under Control Number 0651-0020. Comments relating to this requirement

should be directed to the Office of Information and Regulatory Affairs

of OMB, Attention: Desk Officer for Commerce, Patent and Trademark

Office.

List of Subjects in 37 CFR Part 1

Administrative practice and procedure, Authority delegations

(government agencies), Conflict of interest, Courts, Inventions and

patents, Lawyers.

For the reasons given in the preamble and pursuant to the authority

granted to the Commissioner of Patents and Trademarks by 35 U.S.C. 6

and 156, the Office proposes to amend Title 37 of the Code of Federal

Regulations as set forth below:

It is proposed to amend 37 CFR Part 1, Subparts A and F, as follows

wherein removals are indicated by brackets and additions by arrows:

PART 1--RULES OF PRACTICE IN PATENT CASES

1. (a) An authority citation for 37 CFR Part 1, subpart A would be

added to read as follows:

Authority: 35 U.S.C. 6, unless otherwise noted.

1. (b) The authority citation for 37 CFR Part 1, subpart F would

continue to read as follows:

Authority: 35 U.S.C. 6 and 156.

2. Section 1.20 is proposed to be amended by revising paragraph (j)

to read as follows:

Sec. 1.20 Post-issuance fees.

* * * * *

(j) For filing an application for extension of the term of a patent

>(1) Application for extension under Sec. 1.740(2) Initial application for interim extension under Sec. 1.790--

$400.00

(3) Subsequent application for interim extension under Sec. 1.790--

$200.00 or Sec. 1.790In an application for extension filed in compliance

with Sec. 1.740,a Sec. under 35 U.S.C.

Sec. 156(e)(2) or or or certificate of

interim extension under 35 U.S.C. 156(d)(5)Notification of the issuance of the

certificate of interim extension under 35 U.S.C. 156(d)(5), including

the identity of the product currently under regulatory review, will be

published in the Official Gazette of the Patent and Trademark Office

and in the Federal Register.(h) patents are term

the patent owner or its agent Sec. 1.790 Interim extension of patent term under 35 U.S.C.

156(d)(5).

(a) An owner of record of a patent or its agent who reasonably

expects that the applicable regulatory review period described in

paragraph (1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii)

of subsection (g) of 35 U.S.C. 156 that began for a product that is the

subject of such patent may extend beyond the expiration of the patent

term in effect may submit one or more applications for interim

extensions for periods of up to one year each. The initial application

for interim extension must be filed during the period beginning 6

months and ending 15 days before the patent term is due to expire. Each

subsequent application for interim extension must be filed during the

period beginning 60 days before and ending 30 days before the

expiration of the preceding interim extension. In no event will the

interim extensions granted under this section be longer than the

maximum period of extension to which the applicant would be entitled

under 35 U.S.C. 156(c).

(b) A complete application for interim extension under this section

shall include all of the information required for a formal application

under Sec. 1.740 and a complete application under Sec. 1.741. Sections

(a)(1), (a)(2), (a)(4), and (a)(6) through (a)(17) of Sec. 1.740 and

Sec. 1.741 shall be read in the context of a product currently

undergoing regulatory review. Paragraphs (a)(3) and (a)(5) of

Sec. 1.740 are not applicable to an application for interim extension

under this section.

(c) The content of each subsequent interim extension application

may be limited to a request for a subsequent interim extension along

with a statement that the regulatory review period has not been

completed and any materials or information required under Sec. 1.740

and Sec. 1.741 not present in the preceding interim extension

application.Sec. 1.791 Termination of interim extension granted prior to

regulatory approval of a product for commercial marketing or use.

Any interim extension granted under 35 U.S.C. 156(d)(5) terminates

at the end of the 60-day period beginning on the date on which the

product involved receives permission for commercial marketing or use.

If within that 60-day period the patent owner or its agent files an

application for extension under Sec. 1.740 and Sec. 1.741 including any

additional information required under 35 U.S.C. 156(d)(1) not contained

in the application for interim extension, the patent shall be further

extended in accordance with the provisions of 35 U.S.C. 156.<

Dated: November 2, 1994.

Bruce A. Lehman,

Assistant Secretary of Commerce and Commissioner of Patents and

Trademarks.

[FR Doc. 94-27881 Filed 11-9-94; 8:45 am]

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