[Federal Register Volume 60, Number 92 (Friday, May 12, 1995)]
[Rules and Regulations]
[Pages 25615-25619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11787]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 1
[Docket No. 950411099-5099-01]
RIN 0651-AA52
Amendment to Rules for Extension of Patent Term
AGENCY: Patent and Trademark Office, Commerce.
ACTION: Final rule.
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SUMMARY: The Patent and Trademark Office (Office) is revising the rules
directed to the extension of patent term to implement the provisions of
Pub. L. 103-179, section 5; 107 Stat. 2040 codified at 35 U.S.C.
156(d)(5) and to clarify the requirements for eligibility. The amended
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 amended rules also clarify that an
application for patent term extension must be based on regulatory
activities performed by the patent owner or its agent.
EFFECTIVE DATE: July 11, 1995.
FOR FURTHER INFORMATION CONTACT:
Gerald A. Dost by telephone at (703) 305-9285 or by mail addressed to
Commissioner of Patents and Trademarks, Washington, DC 20231 marked to
the attention of Mr. Dost, Office of the Deputy Assistant Commissioner
for Patent Policy and Projects, or by FAX to (703) 308-6916.
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 35 U.S.C. 156(d)(5), eligibility for patent
term extension was dependent on regulatory approval of the product
before the original patent term expired. 35 U.S.C. 156(d)(5) 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 amended rules 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
[[Page 25616]] extension. The amended 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.
The initial guidelines directed to the preparation and filing of
applications for interim extensions of patent terms as authorized by 35
U.S.C. 156(d)(5), 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). The Final Rule supplements these initial
guidelines. To the extent that they conflict with the interim
guidelines, the Final Rule governs.
It is important to keep in mind the distinction between an interim
patent term extension under section 156(e)(2) and the interim patent
term extension provided for by 35 U.S.C. 156(d)(5), under section
156(d)(5). The former applies after regulatory approval has occurred
and is addressed in 37 CFR 1.760. Interim patent term extensions under
section 156(e)(2) are not affected by the amendments 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
section 156(d)(5) are substantially the same as for obtaining patent
term extension under section 156 after regulatory approval has
occurred. Under the provisions of 35 U.S.C. 156(d)(5), 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 as defined in section 156(g), but must not have ended.
For a new drug, for example, the approval phase is defined in section
156(g)(1)(B)(ii) as the period beginning on the date a new drug
application was initially submitted for the new drug under Sec. 505 of
the Federal Food, Drug and Cosmetic Act.
The content of the application for interim extension is 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 required 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 35 U.S.C. 156(d)(5), 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 section 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 in
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 section 156.
The interim extension of patent term available under section
156(d)(5) cannot exceed the extension from the original patent that
would be available after regulatory approval. Thus, for example, a
patent that was subject to the two-year extension limitation of section
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 section 156(d)(5) has been granted, the amount of
patent term extension available after regulatory review is controlled
by either section 156(d)(5) or section 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 section
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. Section 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 further 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
section 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 section 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 37 CFR 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 section 156.
A notice of proposed rulemaking relating to Amendment to Rules for
Extension of Patent Term was published in the Federal Register, 59 FR
56015, (November 10, 1994) and in the Official Gazette, 1169 Off. Gaz.
Pat. Office 33 (December 13, 1994). A sole comment was received in
response to this notice, but no change has been made in the text of the
proposed amendments and additions to the rules.
The comment was directed to the proposed amendment to 37 CFR
1.785(c) when taken in light of 35 U.S.C. 156. The comment suggested
that the party in interest before the regulatory agency (e.g., the Food
and Drug Administration) should be the party to obtain a patent term
extension, whether that party is the patent owner or licensee, and
regardless of any ``agency'' relationship which may exist between the
two with respect to such regulatory proceedings. This may be
accomplished, it was argued, by construing the term ``applicant'' in 35
U.S.C. 156(d)(1)(D) and (d)(2)(B)(i) to mean the ``applicant for
regulatory approval.''
In response, it is clear that under 35 U.S.C. 156(a)(3) and (d)(1),
the ``applicant'' for the patent term extension shall be either the
``owner of record of the patent'' or the party which may be construed
to be ``its agent,'' which requirement is repeated in 35 U.S.C.
156(d)(5)(A) and (d)(5)(C) with regard to interim extensions. Indeed,
to hold otherwise in the manner suggested in the comment would violate
the plain meaning of 35 U.S.C. 156(c)(1), which requires that the
patent term extension [[Page 25617]] period be reduced by the time that
the ``applicant for patent extension did not act with due diligence
during such period of the regulatory review period.'' This section not
only cites 35 U.S.C. 156(d)(2)(B) but also is consistent with the
required description of activities undertaken during the applicable
regulatory period set forth in 35 U.S.C. 156(d)(1)(D). The statute thus
specifically requires that the application for patent term extension
contain a description of the activities performed by the patent owner
or its agent before the regulatory agency with regard to such
proceedings, 35 U.S.C. 156(d)(1)(D), and further specifies that the
lack of due diligence by the patent owner or its agent during the
regulatory review period may be taken into account, 35 U.S.C. 156(c)(1)
and (d)(2)(B)(i).
In addition to the constraints of the statutory language, the
comment fails to identify any justification for granting a term
extension on a patent where the patent owner has not, either directly
or indirectly, incurred either the significant costs associated with
regulatory approval or any delay in the commercial marketing of a
product. Since the patent term extension provisions of section 156 are
intended to be remedial in nature, providing a patent term extension to
a patent owner who has not been harmed by the delay and costs
associated with regulatory approval of a product would provide an
unintended benefit to such a patent owner. In addition, providing a
patent term extension to a patent owner that did not participate in the
regulatory review process could also frustrate an important purpose of
the statute, that is, to encourage companies to make the significant
investment necessary to obtain regulatory approval and distribute the
pharmaceutical product to the public rather than placing a non-
participating patent owner in a position to keep the product off the
market during the extended term, to the detriment of the party that
made the significant investment necessary to obtain regulatory
approval.
Accordingly, not only does the plain language of the statute
prohibit the statutory interpretation suggested in the comment, but
also the purpose of the statute would not be fulfilled by construing
``applicant'' to mean the applicant for regulatory review.
Discussion of Specific Rules
Section 1.750 is being amended, as proposed, to 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 1.750 is being amended, as proposed, to require that 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 in
from interim extensions available under 35 U.S.C. 156(d)(5), addressed
in Sec. 1.780.
Section 1.765(a) is being amended, as proposed, to 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 is being amended, as proposed, to provide that a
certificate of interim extension under 35 U.S.C. 156(d)(5) will be
issued to the applicant. Section 1.780 also provides for 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, to be published in the Federal Register.
Section 1.785 is being amended, as proposed, to 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 is being added, as proposed, to 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 35
U.S.C. 156(g) that began for the patented product may extend beyond the
expiration of the patent term in effect.
Paragraph (a) of added Sec. 1.790 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 added Sec. 1.790 establishes that the content
requirements for 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 added 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 1.795 is being added, as proposed, to 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
These rule changes are in conformity with the requirements of the
Regulatory Flexibility Act, 5 U.S.C. 601 et seq., Executive Order
12612, and the Paperwork Reduction Act of 1980, 44 U.S.C. 35091 et seq.
The Assistant General Counsel for Legislation and Regulation of the
Department of Commerce has certified to the Chief Counsel for Advocacy,
Small Business Administration, that these rules 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 rules would
affect only a very small number of patents eligible for interim patent
term extension.
The Patent and Trademark Office has also determined that this
notice has no Federalism implications affecting the relationship
between the National Government and the States as outlined in Executive
Order 12612.
These rule changes contain collection of information requirements
subject to [[Page 25618]] the Paperwork Reduction Act of 1980, 44
U.S.C. 35 U.S.C. 156(d)(5) 3501 et seq., which have previously been
approved by the Office of Management and Budget under Control Number
0651-0020. The public reporting burden for this collection of
information for Petition Extension is estimated to average 60 hours
each, including the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing the collections of information. Send comments regarding
this burden estimate, or any other aspect of this collection of
information, including suggestions for reducing the burden, to Gerald
A. Dost, Office of the Deputy Assistant Commissioner for Patent Policy
and Projects, Box DAC, Washington, DC 20231, and to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20503 (ATTN: Paperwork Reduction Act Projects 0651-
0020).
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 set forth, the preamble, part 1 of title 37 of the
Code of Federal Regulations is amended to read as follows:
PART 1--RULES OF PRACTICE IN PATENT CASES
1. The authority citation for 37 CFR part 1, subparts A and F
continues to read as follows:
Authority: 35 U.S.C. 6, unless otherwise noted.
2. Section 1.20 is 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............. $1,030.00
(2) Initial application for interim extension under Sec.
1.790..................................................... 400.00
(3) Subsequent application for interim extension under Sec.
1.790..................................................... 200.00
3. Section 1.750 is revised to read as follows:
Sec. 1.750 Determination of eligibility for extension of patent term.
A determination as to whether a patent is eligible for extension
may be made by the Commissioner solely on the basis of the
representations contained in the application for extension filed in
compliance with Sec. 1.740 or Sec. 1.790. This determination may be
delegated to appropriate Patent and Trademark Office officials and may
be made at any time before the certificate of extension is issued. The
Commissioner or other appropriate officials may require from applicant
further information or make such independent inquiries as desired
before a final determination is made on whether a patent is eligible
for extension. In an application for extension filed in compliance with
Sec. 1.740, a notice will be mailed to applicant containing the
determination as to the eligibility of the patent for extension and the
period of time of the extension, if any. This notice shall constitute
the final determination as to the eligibility and any period of
extension of the patent. A single request for reconsideration of a
final determination may be made if filed by the applicant within such
time as may be set in the notice of final determination or, if no time
is set, within one month from the date of the final determination. The
time periods set forth herein are subject to the provisions of
Sec. 1.136.
4. In Sec. 1.760, the heading is revised to read as follows:
Sec. 1.760 Interim extension of patent term under 35 U.S.C.
156(e)(2).
5. Section 1.765(a) is revised to read as follows:
Sec. 1.765 Duty of disclosure in patent term extension proceedings.
(a) A duty of candor and good faith toward the Patent and Trademark
Office and the Secretary of Health and Human Services or the Secretary
of Agriculture rests on the patent owner or its agent, on each attorney
or agent who represents the patent owner and on every other individual
who is substantively involved on behalf of the patent owner in a patent
term extension proceeding. All such individuals who are aware, or
become aware, of material information adverse to a determination of
entitlement to the extension sought, which has not been previously made
of record in the patent term extension proceeding must bring such
information to the attention of the Office or the Secretary, as
appropriate, in accordance with paragraph (b) of this section, as soon
as it is practical to do so after the individual becomes aware of the
information. Information is material where there is a substantial
likelihood that the Office or the Secretary would consider it important
in determinations to be made in the patent term extension proceeding.
6. Section 1.780 is revised to read as follows:
Sec. 1.780 Certificate of extension of patent term.
If a determination is made pursuant to Sec. 1.750 that a patent is
eligible for extension and that the term of the patent is to be
extended, a certificate of extension, under seal, or certificate of
interim extension under 35 U.S.C. 156(d)(5) will be issued to the
applicant for the extension of the patent term. Such certificate will
be recorded in the official file of the patent and will be considered
as part of the original patent. Notification of the issuance of the
certificate of extension will be published in the Official Gazette of
the Patent and Trademark Office. 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. No certificate of extension will be issued
if the term of the patent cannot be extended, even though the patent is
otherwise determined to be eligible for extension. In such situations
the final determination made pursuant to Sec. 1.750 will indicate that
no certificate will issue.
7. Section 1.785 is revised to read as follows:
Sec. 1.785 Multiple applications for extension of term of the same
patent or of different patents for the same regulatory review period
for a product.
(a) Only one patent may be extended for a regulatory review period
for any product (Sec. 1.720(h)). If more than one application for
extension of the same patent is filed, the certificate of extension of
patent term, if appropriate, will be issued based upon the first filed
application for extension.
(b) If more than one application for extension is filed by a single
applicant which seeks the extension of the term of two or more patents
based upon the same regulatory review period, and the patents are
otherwise eligible for extension pursuant to the requirements of this
subpart, in the absence of an election by the applicant, the
certificate of extension of patent term, if appropriate, will be issued
upon the application for extension of the patent term having the
earliest date of issuance [[Page 25619]] of those patents for which
extension is sought.
(c) If an application for extension is filed which seeks the
extension of the term of a patent based upon the same regulatory review
period as that relied upon in one or more applications for extension
pursuant to the requirements of this subpart, the certificate of
extension of patent term will be issued on the application only if the
patent owner or its agent is the holder of the regulatory approval
granted with respect to the regulatory review period.
(d) An application for extension shall be considered complete and
formal regardless of whether it contains the identification of the
holder of the regulatory approval granted with respect to the
regulatory review period. When an application contains such
information, or is amended to contain such information, it will be
considered in determining whether an application is eligible for an
extension under this section. A request may be made of any applicant to
supply such information within a non-extendable period of not less than
one (1) month whenever multiple applications for extension of more than
one patent are received and rely upon the same regulatory review
period. Failure to provide such information within the period for
response set shall be regarded as conclusively establishing that the
applicant is not the holder of the regulatory approval.
(e) Determinations made under this section shall be included in the
notice of final determination of eligibility for extension of the
patent term pursuant to Sec. 1.750 and shall be regarded as part of
that determination.
8. Section 1.790 is added to read as follows:
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) 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)-(a)(17) of Sec. 1.740 and Sec. 1.741
shall be read in the context of a product currently undergoing
regulatory review. Sections (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 along with any materials or information required under
Sec. 1.740 and Sec. 1.741 that are not present in the preceding interim
extension application.
9. Section 1.791 is added to read as follows:
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: May 8, 1995.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and
Trademarks.
[FR Doc. 95-11787 Filed 5-11-95; 8:45 am]
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