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.
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,    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, D.C. 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 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    156(e)(2) and the interim patent term
extension provided for by 35 U.S.C. 156(d)(5), under    156(d)(5). The
former applies after regulatory approval has occurred and is addressed in
37 CFR 1.760. Interim patent term extensions under    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
156(d)(5) are substantially the same as for obtaining patent term
extension under    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    156(g), but must not
have ended. For a new drug, for example, the approval phase is defined in
  156(g)(1)(B)(ii) as the period beginning on the date a new drug
application was initially submitted for the new drug under    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    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    156.
   The interim extension of patent term available under    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    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    156(d)(5)
has been granted, the amount of patent term extension available after
regulatory review is controlled by either    156(d)(5) or    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    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.    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    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    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    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 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 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    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    1.790. The section is further
modified to limit the mailing of a notice of a final determination to
applications filed in compliance with    1.740 after the regulatory
approval process is complete.
   Section 1.760 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 it from interim
extensions available under 35 U.S.C. 156(d)(5), addressed in    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    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    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    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    1.740 and a complete
application under    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    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      1.740 and 1.741 not present in the
preceding interim extension application.
   Section    1.791 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. 3501 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 Govemment and the States as outlined in Executive Order 12612.
   These rule changes contain collection of information requirements
subject to 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, D.C.
20231, and to the Office of Information and Regulatory Affairs, Office of
Management and Budget, Washington, D.C. 20503 (ATTN: Paperwork Reduction
Act Projects 0651-0020).

List of Subjects in 37 CFR Part 1

   Administrative practice and procedure, Authority delegations (govemment
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 C.F.R. 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:

   1.20 Post-issuance fees.

* * * * *

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

   (1) Application for extension under
   1.740          $1,030.00
   (2) Initial application for interim extension under
   1.790          $400.00
   (3) Subsequent application for interim extension under    1.790
 $200.00

3. Section 1.750 is revised to read as follows:

   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
1.740 or    1.790. This determination may he 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    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    1.136.

4. In    1.760, the heading is revised to read as follows:

   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:

   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:

   1.780 Certificate of extension of patent term

   If a determination is made pursuant to    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
1.750 will indicate that no certificate will issue.

7. Section 1.785 is revised to read as follows:

   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    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 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    1.750 and shall be regarded as part of that
determination.

8. Section 1.790 is added to read as follows:

   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    1.740 and a complete application under    1.741. Sections (a)(1),
(a)(2), (a)(4), and (a)(6) - (a)(17) of    1.740 and    1.741 shall be
read in the context of a product currently undergoing regulatory review.
Sections (a)(3) and (a)(5) of    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    1.740 and    1.741
that are not present in the preceding interim extension application.

9. Section 1.791 is added to read as follows:

   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    1.740 and    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.

* * * * *

May 8, 1995                                                     BRUCE A. LEHMAN
                                                Assistant Secretary of Commerce
                                     and Commissioner of Patents and Trademarks