[Federal Register Volume 59, Number 217 (Thursday, November 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27881]


[[Page Unknown]]

[Federal Register: November 10, 1994]


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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<[(Sec. 1.740)]--
$1,000.00
>(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 proposed to be 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< [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 [37 
CFR]> Sec. <1.136.
    4. In Sec. 1.760, the heading is proposed to be revised to read as 
follows:


Sec. 1.760  Interim extension of patent term > under 35 U.S.C. 
Sec. 156(e)(2)<.

    5. Section 1.765(a) is proposed to be 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 [of] > 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 [of] > or < the Secretary would consider it 
important in determinations to be made in the patent term extension 
proceeding.
    6. Section 1.780 is proposed to be 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)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 proposed to be 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 period.

    (a) Only one patent may be extended for a regulatory review period 
for any product (Sec. 1.720[(g)]>(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 [applications or] 
> 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 [--
    (1) The applicant for extension] > the patent owner or its agent < 
is the holder of the regulatory approval granted with respect to the 
regulatory review period [, or
    (2) The holder of the regulatory approval granted with respect to 
the regulatory review period is not an applicant and the applicant for 
extension holds express and exclusive authorization from the holder of 
the regulatory approval to rely upon the regulatory review period as 
the basis for the application for extension, or
    (3) The holder of the regulatory approval granted with respect to 
the regulatory review period is not an applicant and no applicant for 
extension holds an express and exclusive authorization from the holder 
of the regulatory approval to rely upon the regulatory review period as 
the basis for the application for extension and the application is for 
extension of the patent having the earliest date of issuance of those 
patents for which extension is sought based upon the same 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 [or express and exclusive authorization from 
the holder of the regulatory approval to rely on the regulatory review 
period for extension]. 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 [and is not expressly and 
exclusively authorized by the holder of the regulatory approval to seek 
the extension being sought].
    (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 proposed to be 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) 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.<
    9. Section 1.791 is proposed to be 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: November 2, 1994.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 94-27881 Filed 11-9-94; 8:45 am]
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