[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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