[Ip-health] US Mandatory Patent Licenses Under Section 308 of the Clean Air Act
George Willingmyre
George Willingmyre" <gtw@gtwassociates.com
Fri Nov 17 17:53:01 2006
Another very helpful post.
I shall enquire of some friends at EPA if this section has ever been used to
require a license
The FCC has a note w/r to securing RAND commitments from a holder of
essential patent to meet an FCC standard
http://www.gtwassociates.com/answers/fccipr.htm
3 F.C.C. 2d Excerpted from pages 26 and 27 FCC Report
FEDERAL COMMUNICATIONS COMMISSION
Washington, D.C., 20554 December 1961 PUBLIC Notice Revised
Patent Procedures of the Federal Communications Commission
The Federal Communications Commission announces that it is
strengthening its patent procedures to assure that the availability of
broadcast equipment and radio apparatus meeting performance standards
established by the Commission's rules and regulations will not be prejudiced
by unreasonable royalty or licensing policies of patent holders.
Essentially, the new procedure, which supplements existing patent procedures
of long standing, provides for enlarging the staffing order that the
Commission may keep currently abreast of all patents issued arid technical
developments, in the Communications field which may have an impact on
technical standards approved by the Commission in the various services.
Under the Communications Act of 1934, as amended (47 U. S. C. 303
(g)), the Commission is charged with the responsibility to "study" new
uses for radio, provide for experimental uses of frequencies, and generally
encourage; the larger and more, effective use of radio in the public
interest. In this connection the Commission promulgates technical
standards; for broadcasting and other radio communication services to
establish requirements which its licensees must meet in order to provide the
kind and quality of service desired. Such requirements may frequently be
met only by the use of patented equipment. Therefore, in promulgating these
technical standards and regulations, the Commission necessarily gives
consideration to the effect of patent rights upon the availability of
equipment that will meet the specified performance standards. In order to
determine how these rights are exercised, information relating to licensing
and royalty agreements is essential.
The Commission's patent policy for a number of years has been to
obtain patent information whenever it becomes relevant to a particular
proceeding. For example, the Commission utilized this method of obtaining
patent information from system proponents in recent rule-making proceedings
to establish standards to permit FM broadcast stations to transmit
stereophonic programs on a multiplex basis (docket 13506). In addition,
the Commission has required the principal common carriers, such as American
Telephone & Telegraph Co., International Telephone & Telegraph Co., Radio
Corp. of America, and Western Union to file semiannual patent reports.
These procedures will continue to be utilized.
In view of the rapid technological advances in the communications
field, the Commission has determined to augment its staff in order to
permit, a regularized, continuing, and current study of new technical
developments relevant to its jurisdiction. Patent Office publications and
records and technical journals will be studied and information of interest
will be compiled in the Commission's files. Copies of relevant patents as
issued will be secured. The Commission's staff will ascertain the
assignment or licensing arrangements for significant patents either by
examination of the Patent Office records or by direct inquiry to the
patentee, licensees, or assignees.
Whenever it appears that the patent structure is or may be such as to
indicate obstruction of the service to be provided under the technical
standards promulgated by the Commission, this fact will be brought to
the Commission's attention for early consideration and appropriate action.
Through these revised and strengthened procedures, the Commission
believes that it will be able to secure the information necessary to
protect fully the public interest in this all-important area.
George T. Willingmyre, P.E.
GTW Associates
1.301.421.4138
www.gtwassociates.com
----- Original Message -----
From: "James Love" <james.love@cptech.org>
To: "Ip-health" <ip-health@lists.essential.org>
Sent: Friday, November 17, 2006 3:40 PM
Subject: [Ip-health] US Mandatory Patent Licenses Under Section 308 of the
Clean Air Act
> http://www.epa.gov/docs/fedrgstr/EPA-AIR/1994/December/Day-30/
> pr-251.html
>
> Mandatory Patent Licenses Under Section 308 of the Clean Air Act
>
> [Federal Register: December 30, 1994]
> ENVIRONMENTAL PROTECTION AGENCY
> 40 CFR Part 95
> [FRL-5131-5]
>
> Mandatory Patent Licenses Under Section 308 of the Clean Air Act
>
> AGENCY: Environmental Protection Agency (EPA).
> ACTION: Final rule.
>
>
> SUMMARY: On occasion, a party attempting to comply with a standard of
> the Clean Air Act [CAA] may be unable to meet the standard without
> resort to a patented technology. CAA section 308 provides a mechanism
> by which such a non-complying party may obtain a patent license where
> it has been unsuccessful in its attempts to obtain a license on its
> own. Under CAA section 308, the United States may require the owner of
> the patented technology to grant the non-complying party a patent
> license in exchange for a reasonable royalty if the patented technology
> is necessary to meet the requirements in certain sections of the CAA.
> The North American Free Trade Agreement (NAFTA) imposes certain
> limits on the ability of the United States to force patent owners to
> grant licenses under their patents. Section 104(b) of the North
> American Free Trade Implementation Act requires EPA to issue a
> regulation conforming CAA section 308 with the mandatory patent
> licensing restrictions found in NAFTA article 1709(10).
> EPA is issuing this rule to ensure that EPA's implementation of CAA
> section 308 conforms with the requirements of NAFTA article 1709(10).
> The rule establishes the policies and procedures EPA will follow prior
> to applying to the Attorney General for a mandatory license under a
> patent covering a technology necessary to enable compliance with the
> new stationary sources standards, hazardous air pollutants standards,
> or motor vehicle emission standards of the CAA.
>
>
> EFFECTIVE DATE: January 30, 1995.
>
>
> ADDRESSES: Materials relevant to this rulemaking are contained in EPA
> Air Docket No. A-94-51: Environmental Protection Agency, 401 M Street,
> SW., Washington, DC 20460. The Air and Radiation Docket and Information
> Center is located in room M-1500, Waterside Mall (Ground Floor)
> Environmental Protection Agency, 401 M Street, SW., Washington, DC
> 20460. Dockets may be inspected from 9 a.m. to 4 p.m., Monday through
> Friday, except Federal holidays. A reasonable fee may be charged for
> copying docket materials.
>
>
> FOR FURTHER INFORMATION CONTACT: Thomas Gorman, Patent Counsel (Mail
> Code 2379), Office of General Counsel, U.S. Environmental Protection
> Agency, 401 M Street SW., Washington, DC 20460. Phone: (202) 260-1339.
>
>
> SUPPLEMENTARY INFORMATION:
>
>
> I. Authority
>
>
> This rule is promulgated under the authority of CAA section 308, as
> amended, 42 U.S.C. 7608, and the North American Free Trade Agreement
> Implementation Act, Public Law No. 103-182, section 104, 107 Stat.
> 2057, 2064 (1993).
>
>
> II. Background
>
>
> Section 308 of the Clean Air Act provides for mandatory licensing
> of patented technologies needed to meet certain CAA requirements. Under
> section 308, the United States can require the owner of a patented
> technology that is necessary to enable another party's compliance with
> certain limitations of the Clean Air Act to permit the other party to
> practice the patented technology in exchange for a reasonable royalty
> set by a Federal court. In order to compel the licensing of a patent
> under section 308, the EPA Administrator must ask the Attorney General
> to certify to a Federal district court that the following conditions
> are satisfied:
> (a) The patent must be necessary for compliance with the standards
> of the CAA sections 111, 112 or 202;
> (b) The patent right must be actively in use or intended for public
> or commercial use and not otherwise reasonably available;
> (c) No reasonable alternatives to licensing the patent can exist
> for meeting the specified CAA standards; and
> (d) Failure to license the patent may cause reduced competition or
> monopoly conditions in any area of trade.
> Upon certification of the above conditions to a Federal district
> court by the Attorney General, the court may then order the patent
> holder to license the patent under terms and conditions determined by
> the court after a hearing.
> Chapter 17 of the NAFTA addresses intellectual property issues
> generally and article 1709 addresses patents specifically. NAFTA
> article 1709 promotes the availability of patent protection for a broad
> range of inventions and also limits the scope of permissible violations
> of patent rights. The latter function is performed by paragraph 10 of
> article 1709, which sets conditions for violating a patent holder's
> right to decide the conditions for practice of the holder's patent.
> NAFTA Article 1709(10) sets specific conditions that must be met by
> the compulsory patent licensing statutes of any member country. The
> conditions are as follows:
> (a) Authorization of each compulsory license of a patent must be
> considered on the individual merits;
> (b) Any proposed compulsory licensee already must have made efforts
> to obtain authorization from the patent holder;
> (c) The scope and duration of an authorized compulsory patent
> license must be limited;
> (d) An authorized compulsory patent license must be non-exclusive;
> (e) An authorized compulsory patent license must be non-assignable;
> (f) An authorized compulsory patent license must be predominantly
> for supply of the domestic market;
> (g) The authorization of the compulsory patent license must be
> terminable when the circumstances that led to the authorization cease
> to exist;
> (h) Patent holders must be paid adequate compensation;
> (i) Authorization decisions must be subject to judicial or other
> independent review;
> (j) Compensation rates must be subject to judicial or other
> independent review;
> (k) When an authorized compulsory use is necessary to remedy a
> practice determined after judicial or administrative process to be
> anti-competitive, a member country is allowed greater latitude in
> applying conditions (a)-(j), including noncompliance with conditions
> (b) and (f); and
> (l) Authorization of the use of a patent in order to permit
> exploitation of another patent shall not be granted except as a remedy
> for an adjudicated violation of laws directed against anti-competitive
> practices.
> No direct conflict exists between NAFTA article 1709(10) and CAA
> section 308. However, section 308 does not address a number of the
> NAFTA conditions. The following rule establishes the policies and
> procedures that EPA will follow before applying to the Attorney
> General, pursuant to CAA section 308, for a mandatory license under a
> patent covering a technology necessary to enable compliance with CAA
> sections 111, 112 or 202. The procedures in the rule ensure that EPA's
> implementation of CAA section 308 will conform to article 1709(10) of
> the NAFTA.
> Section 95.1 of the rule sets forth definitions of a number of
> terms used in the rule. Section 95.2 identifies who is entitled to
> petition the EPA for a mandatory patent license under section 308 and
> the required contents of such petitions. Section 95.3 identifies
> findings that EPA will have to make prior to making application to the
> Attorney General for a mandatory patent license under CAA section 308.
> These findings reflect the requirements of CAA section 308 and NAFTA
> Article 1709(10). Section 95.4 of the rule sets forth certain
> limitations that will be included in all mandatory patent licenses for
> which EPA makes application to the Attorney General under CAA section
> 308. These limitations are in accord with the requirements of CAA
> section 308 and NAFTA article 1709(10).
> EPA published this rule in a notice of proposed rulemaking
> published on August 29, 1994 (59 FR 44390). EPA received three comments
> in response to the notice of proposed rulemaking. Each of the three
> comments expressed the concern that the proposed rule might be used to
> require mandatory licensing of patented products or processes that are
> only marginally related to reducing air pollution. Each comment
> suggested that the language of the proposed rule should be amended to
> state that mandatory patent licenses under CAA section 308 may be
> required only for patents relating to air pollution control.
> This rule is not intended to limit the technologies for which
> mandatory patent licenses may be sought under CAA section 308 more than
> is already provided in CAA section 308. That is, the technology must be
> necessary to enable compliance with CAA section 111 (new stationary
> sources standards), section 112 (hazardous air pollutants), or section
> 202 (motor vehicle emission standards). However, EPA notes that under
> the rule, the EPA Administrator may apply to the Attorney General for a
> mandatory patent license pursuant to CAA section 308 only after
> expressly finding that the patented technology is not otherwise
> reasonably available, and that there are no other reasonable
> alternatives for accomplishing compliance with CAA section 111, 112 or
> 202. These requirements help ensure that a mandatory patent license
> will not be ordered pursuant to this rule where the patent is only
> marginally related to meeting the standards of the CAA.
>
>
> III. Procedural Requirements
>
>
> A. Review Under Executive Order 12866
>
>
> Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the
> EPA must determine whether the regulatory action is ``significant'' and
> therefore subject to review by the Office of Management and Budget
> (OMB), and the requirements of the Executive Order. The Order defines
> ``significant regulatory action'' as one that is likely to result in a
> rule that may: (1) Have an annual effect on the economy of $100 million
> or more or adversely affect in a material way the economy, a sector of
> the economy, productivity, competition, jobs, the environment, public
> health or safety, or State, local, or tribal governments or
> communities; (2) create a serious inconsistency or otherwise interfere
> with an action taken or planned by another agency; (3) materially alter
> the budgetary impact of entitlements, grants, user fees, or loan
> programs, or the rights and obligations of recipients thereof; or (4)
> raise novel legal or policy issues arising out of legal mandates, the
> President's priorities, or the principles set forth in the Executive
> Order.
> Pursuant to the terms of Executive Order 12866, it has been
> determined that this rule is not ``significant'' because none of the
> listed criteria apply to this action. Consequently, this action was not
> submitted to OMB for review under Executive Order 12866.
>
>
> B. Review Under the Regulatory Flexibility Act
>
>
> This rule was reviewed under the Regulatory Flexibility Act of
> 1980, Pub. L. 96-354, which requires preparation of a regulatory
> flexibility analysis for any rule which is likely to have significant
> economic impact on a substantial number of small entities. Pursuant to
> section 605(b) of the Regulatory Flexibility Act, 5 U.S.C. 605(b), EPA
> certifies that this rule will not have a significant economic impact on
> a substantial number of small entities. The rule codifies the existing
> procedures for application of CAA section 308 and imposes no new
> impacts on large or small entities. Therefore, no regulatory
> flexibility analyses has been prepared.
>
>
> D. Review Under the Paperwork Reduction Act
>
>
> The information collection requirements in this rule have been
> submitted to the Office of Management and Budget (OMB) under the
> requirements of the Paperwork Reduction Act, 44 U.S.C. 3501, et seq. An
> Information Collection document has been prepared by EPA (ICR No.
> 1714.01), and a copy may be obtained from Sandy Farmer, Information
> Policy Branch, EPA Mail Code 2136, 401 M Street SW., Washington, DC
> 20460, or by calling (202) 260-2740.
> The public reporting burden for this collection of information
> would be a one-time burden for each petitioner. The burden was
> estimated on the basis of the number of hours needed to complete a
> single petition, along with the associated cost.
> Completing a petition was estimated to require 21 hours at a cost
> of $1482. This includes time for reviewing instructions, gathering
> materials supporting the patent license, identifying other interested
> parties, and composition of a statement of facts upon which the
> petition is based. EPA received no comments regarding this information
> collection requirement. ICR No. 1714.01 was approved by OMB, Control
> Number 2060-0307, on October 3, 1994. Unless renewed, ICR No. 1714.01
> will expire on October 31, 1997.
>
>
> List of Subjects in 40 CFR Part 95
>
>
> Environmental protection, Administrative practice and procedure,
> Air pollution control, Inventions and patents, Patent licensing, North
> American Free Trade Agreement (NAFTA), Reporting and recordkeeping
> requirements.
>
>
> Dated: December 23, 1994.
> Carol M. Browner,
> Administrator.
>
>
> Title 40, Code of Federal Regulations, is amended by adding part 95
> as follows:
>
>
> PART 95-MANDATORY PATENT LICENSES
>
>
> Sec.
> 95.1 Definitions.
> 95.2 Petition for mandatory license.
> 95.3 Findings prior to application to Attorney General.
> 95.4 Limitations on mandatory licenses.
>
>
> Authority: 42 U.S.C. 7609; Sec. 104, Pub. L. 103-182, 107 Stat.
> 2057, 2064.
>
>
>
> Sec. 95.1 Definitions.
>
>
> (a) As used in this part, all terms not defined in this section
> shall have the meaning given them by the Act.
> (b) Act means the Clean Air Act, as amended (42 U.S.C. Secs. 7401-
> 7671).
> (c) Agency means the Environmental Protection Agency.
> (d) Administrator means the Administrator of the Environmental
> Protection Agency.
>
>
>
> Sec. 95.2 Petition for mandatory license.
>
>
> (a) Any party required to comply with sections 111, 112 or 202 of
> the Act (42 U.S.C. 7411, 7412 or 7521) may petition to the
> Administrator for a mandatory patent license pursuant to section 308 of
> the Act (42 U.S.C. 7608), under a patent that the petitioner maintains
> is necessary to enable the petitioner to comply with Sections 111, 112
> or 202 of the Act.
> (b)(1) Each petition shall be signed by the petitioner and shall
> state the petitioner's name and address. If the petitioner is a
> corporation, the petition shall be signed by an authorized officer of
> the corporation, and the petition shall indicate the state of
> incorporation. Where the petitioner elects to be represented by
> counsel, a signed notice to that effect shall be included with the
> petition at the time of filing.
> (2) Each petition shall include a copy of the patent under which a
> mandatory patent license is sought. The petition shall identify all
> current owners of the patent and shall include a copy of all assignment
> documents relevant to the patent that are available from the United
> States Patent and Trademark Office.
> (3) Each petition must identify any person whose interest the
> petitioner believes may be affected by the grant of the license to
> which the petition is directed.
> (4) Each petition must contain a concise statement of all of the
> essential facts upon which it is based. No particular form of statement
> is required. Each petition shall be verified by the petitioner or by
> the person having the best knowledge of such facts. In the case of
> facts stated on information and belief, the source of such information
> and grounds of belief shall be given. The statement of facts shall
> include the following:
> (i) An identification of the provisions of the Act and/or
> regulations thereunder that the petitioner maintains petitioner will be
> able to comply with if the petitioner is granted the patent license
> that is the subject of the petition;
> (ii) An identification of the nature and purpose of the
> petitioner's intended use of the patent license;
> (iii) An explanation of the relationship between the patented
> technology and the activities to which petitioner proposes to apply the
> patented technology, including an estimate of the effect on such
> activities stemming from the grant or denial of the patent license;
> (iv) A summary of facts demonstrating that the patent under which a
> mandatory patent license is sought is being used or is intended for
> public or commercial use;
> (v) An explanation of why a mandatory patent license is necessary
> for the petitioner to comply with the requirements of sections 111, 112
> or 202 of the Act, and why the patented technology is not otherwise
> available;
> (vi) An explanation of why there are no other reasonable
> alternatives for accomplishing compliance with sections 111, 112 or 202
> of the Act;
> (vii) An explanation of why the unavailability of a mandatory
> patent license may result in a substantial lessening of competition or
> a tendency to create a monopoly in any line of commerce in any section
> of the United States;
> (viii) A summary of efforts made by the petitioner to obtain a
> patent license from the owner of the patent, including the terms and
> conditions of any patent license proposed by petitioner to the patent
> owner; and
> (ix) The terms, if any, on which the owner of the patent has
> proposed to grant the petitioner a patent license.
> (5) Each petition shall include a proposed patent license that
> states all of the terms and conditions that the petitioner proposes for
> the patent license.
> (6) Petitions shall be addressed to the Assistant Administrator for
> Air and Radiation, Mail Code 6101, U.S. Environmental Protection
> Agency, Washington, DC 20460.
> (c) Petitions that do not include all of the information required
> in paragraph (b) of this section shall be returned to the petitioner.
> The petitioner may supplement the petition and resubmit the petition.
> (d) If the Administrator, or the Administrator's designee, finds
> that the criteria in Sec. 95.3 are not met, or otherwise decides to
> deny the petition, a denial of the petition shall be sent to the
> petitioner, along with an explanation of the reasons for the denial.
> (e) If the Administrator, or the Administrator's designee, finds
> that the criteria in Sec. 95.3 are met and decides to apply to the
> Attorney General for a patent license under section 308 of the Act,
> notice of such application shall be given to the petitioner, along with
> a copy of the application sent to the Attorney General.
>
>
>
> Sec. 95.3 Findings prior to application to Attorney General.
>
>
> The Administrator, or the Administrator's designee, may apply to
> the Attorney General for a mandatory patent license pursuant to section
> 308 of the Act (42 U.S.C. 7608) either in response to a petition under
> Sec. 95.2 or on the Administrator's or designee's own initiative, only
> after expressly finding that each one of the following mandatory
> criteria is met:
> (a) The application is for a patent license covering no more than
> one patent;
> (b) The party to whom the proposed patent license is to be granted
> has presented the Administrator or designee with evidence that such
> party has made reasonable efforts to obtain a patent license from the
> patent owner with terms similar to the license terms to be proposed in
> the application to the Attorney General;
> (c) The patent under which a patent license is sought in the
> application to the Attorney General is being used or is intended for
> public or commercial use;
> (d) The mandatory patent license is necessary for a party to comply
> with the requirements of sections 111, 112 or 202 of the Act (42 U.S.C.
> 7411, 7412 or 7521);
> (e) The patented technology is not otherwise reasonably available,
> and there are no other reasonable alternatives for accomplishing
> compliance with sections 111, 112 or 202 of the Act (42 U.S.C. 7411,
> 7412 or 7521); and
> (f) The unavailability of a mandatory patent license may result in
> a substantial lessening of competition or a tendency to create a
> monopoly in any line of commerce in any section of the United States.
>
>
>
> Sec. 95.4 Limitations on mandatory licenses
>
>
> (a) If the Administrator, or the Administrator's designee, decides
> to apply to the Attorney General for a mandatory patent license in
> accordance with Sec. 95.3, the application shall include a proposed
> patent license with the following limitations:
> (1) The scope and duration of the patent license shall be limited
> to that necessary to permit the proposed licensee to comply with the
> requirements the Act;
> (2) The patent license shall be nonexclusive;
> (3) The patent license shall be non-assignable, except with that
> part of the enterprise or goodwill that enjoys the license;
> (4) The patent license shall be for use of the licensed technology
> in the United States only;
> (5) The patent license shall extend only to those uses necessary to
> enable the licensee to comply with sections 111, 112 or 202 of the Act
> (42 U.S.C. 7411, 7412 or 7521);
> (6) The patent license shall provide for termination, subject to
> adequate protections of the legitimate interests of the licensed party,
> when the circumstances that made the compulsory patent license
> necessary cease to exist and are unlikely to recur; and
> (7) The patent license shall provide for adequate remuneration that
> takes into account the economic value of the license.
> (b) The Administrator, or the Administrator's designee, may decide
> as appropriate to include additional conditions, terms or limitations
> on the scope of the patent license for which application is made to the
> Attorney General.
>
>
> [FR Doc. 94-32268 Filed 12-29-94; 8:45 am]
> BILLING CODE 6560-50-P
>
>
> ---------------------------------
> James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
> tel. +1.202.332.2670 / mobile +1.202.361.3040
>
> "If everyone thinks the same: No one thinks." Bill Walton"
>
>
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