# Amendment to Rules for Extension of Patent Term

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URL: https://www.frixlaw.com/law-library/documents/fr%3A94-27881

## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** November 10, 1994

## Text

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]
BILLING CODE 3510-16-M

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-27881. Public record. Not legal advice.