PROCUREMENT REGULATIONS 9-9.109-6 (i) Making the benefits of the energy research, development, and demonstration program widely available to the public in the shortest practicable time; (ii) Promoting the commercial utilization of such inventions; (iii) Encouraging participation by private persons in DOE's energy research, develop ment, and de:nonstration program; and (iv) Fostering competition and preventing undue market concentration or the creation or maintenance of other situations inconsistent with the antitrust laws. (2) If it is not possible to attain each of these objectives immediately and simultaneously for any one waiver determination, the Head of the Agency or designee will seek to reconcile these objectives in light of the overall purposes of the DOE patent policy which is governed by Section 152 of the Atomic Energy Act of 1954, as amended, and Section 9 of the Federal Nonnuclear Energy Research and Development Act of 1974. (3) Over time, however, the application of this waiver policy is expected to attain each of these objectives. In addition to the patent policies provided by legislation, and where not inconsistent therewith, the waiver determinations will also be guided by the revised Presidential Memorandum and Statement of Government Patent Policy issued August 23, 1971 (36 F.R. 16887-16892). (b) Advance waiver. In determining whether a waiver to the contractor at the time of contracting will best serve the interests of the United States and the general public, the Head of the Agency or designee shall, as a minimum, specifically include as considerations the following: (1) The extent to which the participation of the contractor will expedite the attainment of the purposes of the program; (2) The extent to which a waiver of all or any part of such rights in any or all fields of technology is needed to secure the participation of the particular contractor; (3) The extent to which the work to be performed under the contract is useful in the production or utilization of special nuclear material or atomic energy; (4) The extent to which the contractor's commercial position may expedite utilization of the research, development, and demonstration program results; (5) The extent to which the Government has contributed to the field of technology to be funded under the contract; (6) The purpose and nature of the contract, including the intended use of the results developed thereundér; (7) The extent to which the contractor has made or will make substantial investment of financial resources or technology developed at the contractor's private expense which will directly benefit the work to be performed under the contract; (8) The extent to which the field of technology to be funded under the contract has been developed at the contractor's private expense; (9) The extent to which the Government intends to further develop to the point of commercial utilization the results of the contract effort; (10) The extent to which the contract objectives are concerned with the public health, public safety, or public welfare; (11) The likely effect of the waiver on competition and market concentration; (12) In the case of a nonprofit educational institution, the extent to which such institution has a technology transfer capability and program approved by the Head of the Agency or designee as being consistent with the applicable policies of this section, and 9-9.109-6 U. S. DEPARTMENT OF ENERGY (13) The small business status of the contractor. (c) Waiver of identified inventions. In determining whether a waiver to the contractor or inventor of rights to an identified invention will best serve the interests of the United States and the general public, the Head of the Agency or designee shall, as a minimum, specifically include as considerations the following: (1) The extent to which such waiver is a reasonable and necessary incentive to call forth private risk capital for the development and commercialization of the invention; (2) The extent to which the plans, intentions, and ability of the contractor or inventor will obtain expeditious commercialization of such invention; (3) The extent to which the invention is useful in the production or utilization of special nuclear material or atomic energy; (4) The extent to which the Government has contributed to the field of technology of the invention; (5) The purpose and nature of the invention, including the anticipated use thereof; (6) The extent to which the contractor has made or will make substantial investment of financial resources or technology developed at the contractor's private expense which will directly benefit the commercialization of the inventor; (7) The extent to which the field of technology of the invention has been developed at the contractor's expense; (8) The extent to which the Government intends to further develop the invention to the point of commercial utilization; (9) The extent to which the invention is concerned with the public health, public safety, or public welfare; (10) The likely effect of the waiver on competition and market concentration; (11) In the case of a nonprofit educational institution, the extent to which such institution has a technology transfer capability and program approved by the Head of the Agency or designee as being consistent with the applicable policies of this section; and (12) The small business status of the contractor. (d) Procedures. (1) All waiver determinations shall be initiated by a written request providing the information set forth in paragraph (e). Such requests may be submitted by existing or potential contractors in the case of requests for an advance waiver and by contractors or employee-inventors in the case of requests for waiver for identified inventions. A request for an advance waiver may also be made for an identified invention which has already been conceived and which reasonably may be first actually reduced to practice in the course of or under a DOE contract. Such waiver requests must include a copy of the patent or patent application covering the identified invention. (2) A request for an advance waiver shall be submitted to the Contracting Officer or to contractors for their subcontractors at any time prior to execution of the contract or within thirty days thereafter, but should normally be submitted as part of the contract proposal. If the purpose, scope, or cost of the contract is substantially altered by modification or extension, a new waiver request will be required. Accordingly, in such instance, Patent Counsel should advise the Contracting Officer if the purpose, scope, cost, or other factors are so changed upon which the original waiver was granted as to require submission and approval of a new waiver request covering the proposed modification or extension. When advance waivers are granted. the rights set forth in paragraphs (b), (c) and (d) of the clause of $9-407-5(a) should be mode PROCUREMENT REGULATIONS fied to conform to the waiver granted. 9-9.109-6 (3) A request for waiver (other than advance waivers) for an identified invention shall be submitted to the Patent Counsel (with notification by Patent Counsel to the Contracting Officer) at the time the invention is reported to DOE, or not later than nine months after conception or first actual reduction to practice, whichever occurs first, or such longer period as may be authorized by the Patent Counsel (with notification by Patent Counsel to the Contracting Officer) for good cause shown in writing by the contractor or inventor. (4) All requests for waiver received by DOE or its contractors will be forwarded promptly to the Patent Counsel assisting the procuring activity, together with any reference or supporting documents provided by the requestor and any documents or comments provided by the staff of the activity. If the request for waiver appears to contain insufficient information, the Patent Counsel may seek additional information from the requestor to supplement the request and may also seek additional information from other sources. The Patent Counsel will thoroughly analyze the request in view of each of the objectives and considerations set forth in this §9-9.109-6 and shall also consider the overall rights obtained by the Government in the patent, copyright, and data clauses of the contract. Where it appears that a lesser part of the rights of the United States than requested would be more appropriate in view of the policies set forth in this §9-9.109-6, the Patent Counsel should attempt to negotiate a compromise acceptable to both the requestor and DOE. (5) The Patent Counsel will prepare and recommend a statement of considerations setting forth the rationale for either accepting or rejecting the waiver request. While the statement need not make specific findings as to each and every consideration of paragraph (b) or (c) of this section, it will cover those that raise significant issues and those that are decisive, and it will explain the basis for the recommmended determination. There may be occasions when the application of the various considerations in (b) or (c) of this section to a particular case could cause conflicting results, and in those instances the differences will be reconciled giving due regard to the overall policies set forth in this §9-9.109-6. Field Patent Counsel will coordinate actions on advance waivers with the Chief Counsel of the field procuring activity concerned as required by local procedures. (6) The statement shall be forwarded to the Assistant General Counsel for Patents to serve as a recommended basis for the waiver determination. The Assistant General Counsel for Patents will also obtain comments from the appropriate DOE program organization to assist the Head of the Agency or designee in the waiver determination. In situations where time does not permit a delay in contract negotiations for the preparation and mailing of a full written statement, field Patent Counsel may submit a recommendation on the waiver verbally to the Assistant General Counsel for Patents and request a verbal determination from the Head of the Agency or designee. Such action shall be promptly confirmed in writing. (7) In making waiver determinations, the Head of the Agency or designee shall objectively review all requests for waiver in view of the objectives and considerations set forth in this §9-9.109-6. If this determination and the rationale therefor is not accurately reflected in the recommended statement of considerations, a new statement shall be prepared. (8) Where the request for advance waiver has not been approved prior to the effective date of the contract and the terms and conditions of the waiver have thus not been made a part of the contract, the Contracting Officer shall promptly notify the requestor by letter of the determination of the Head of the Agency or designee, and the basis therefor. If the advance waiver is approved, the letter shall state the scope, terms, and conditions of such waiver. Where the terms and conditions of an approved advance waiver have not been made a part of the contract, the letter shall inform the requestor that the advance waiver shall be effective (i) as of the effective date of the contract for an advance waiver of inventions identified, i.e., conceived prior to the effective date of the contract, or (ii) as of the date the invention is reported with an election by the contractor to retain rights therein, i.e.. for an invention conceived or first actually reduced to practice after the effective date of the contract; provided a copy of 52-476 - 80-9 9-9.109-6 U. S. DEPARTMENT OF ENERGY the letter is signed and returned to the Contracting Officer by the requestor acknowledging the acceptance of the scope, terms and conditions of the advance waiver. After acceptance by the contractor of an advance waiver, the Contracting Officer shall cause a unilateral no-cost modification to be made to the contract incorporating the terms and conditions of the waiver in lieu of previous patent provisions. Whenever a requested determination has been denied, the requestor may, within thirty days, request reconsideration. Such a request shall include any additional facts and rationale not previously submitted which support the request. Requests for reconsideration shall be submitted and processed in accordance with the procedures set forth in this paragraph (d). (e) Content of waiver requests. (1) All requests for waiver shall include the following information (Forms for submitting requests for advance and identified waivers indicating the necessary information may be obtained from the Contracting Officer or Patent Counsel): (i) The requestor's identification, business address, and, if represented by Counsel, the Counsel's name and address; (ii) An identification of the pertinent contract or proposed contract and a copy of the contract statement of work or a nonproprietary statement which fully describes the proposed work to be performed; (iii) The nature and extent of waiver requested; (iv) A full and detailed statement of facts, to the extent known by or available to the requestor, directed to each of the considerations set forth in paragraph (b) or (c) of this section, as applicable, and a statement applying such facts and considerations to the policies set forth in paragraph (a) of this section. It is important that this submission be tailored to the unique aspects of each request for waiver, and be as complete as feasible; and statement: (v) The signature of the requestor or authorized representative with the following The facts set forth in this request for waiver are within the knowledge of the (2) Requests for waiver, for identified inventions shall include, in addition to items (1)(i) to (v) above: (i) The full names of all inventors; (ii) A statement of whether a patent application has been filed on the invention, together with a copy of such application if filed or, if not filed, a complete description of the invention; (iii) If a patent application has not been filed, any information which may indicate a potential statutory bar to the patenting of the invention under 35 USC 102 or a statement that no such bar is known to exist; and (iv) Where the requestor is the inventor, written authorization from the applicable contractor or subcontractor permitting the inventor to request a waiver. (3) Subject to DOE regulations, requirements, and restrictions on the treatment of proprietary and classified information, all material submitted in requests for waiver or in support thereof will be made available to the public after a determination on the waiver request has been made, regardless of whether a waiver is granted. Accordingly, requests for waiver should not contain information or data that the requestor is not willing to have made public. If proprietary or classified information is needed to make the waiver determination, such information shall not be submitted unless specifically requested by the Patent Counsel. (D) Record of waiver determinations. PROCUREMENT REGULATIONS 9-9.109-6 The Assistant General Counsel for Patents shall maintain and periodically update a publicly available record of waiver determinations. (g) Waiver situations and types of waivers. (1) The various factual situations which are appropriate for waivers cannot be categorized precisely inasmuch as the appropriateness of a waiver will depend upon the manner in which the considerations set forth in paragraph (b) or paragraph (c) of this section relate to the facts and circumstances surrounding the particular contracting situation or the particular invention in order to best achieve the objectives set forth in paragraph (a) of this section. However, some examples where waivers might be appropriate are in the following: (i) Cost-sharing contracts; (ii) Situations in which DOE is providing increased funding to a specific ongoing privately-sponsored research, development, or demonstration project; (iii) Situations involving the private use of Government facilities where the contractor is funding all or a part of such costs; (iv) Situations in which the equities of the contractor are so substantial in relation to that of the Government that the waiver is necessary to obtain the participation of the contractor; and (v) Situations involving contracts with small business concerning their privately developed technology. (2) As stated in paragraph (a) of this section, waivers may be granted as to all or any part of the rights of the United States to an invention except for certain rights as set forth in paragraph (i) in this section. Accordingly, the waiver of all patent rights that are inherent to an invention, rather than part of the rights, will not necessarily be appropriate. The scope of the waiver will depend upon the relationship of the contractual situation or identified invention to the considerations set forth in paragraph (b) or (c) in order to best achieve the objectives set forth in paragraph (a) of this section. For example, waivers may be restricted to a particular field of use in which the contractor has substantial equities or a commercial position, or restricted to those uses that are not the primary object of the contract effort. Waivers may also be limited to particular geographical locations, may be made effective only for a specified duration of time, or may require the contractor to license others at reduced royalties in consideration of the Government's contribution to the research, development, or demonstration effort. (3) In advance waivers of identified inventions, the invention will be deemed to be a subject invention and the waiver will be considered as being effective as of the effective date of the contract. This will be true regardless of whether the identified invention had been first actually reduced to practice prior to the time of contracting or would be reduced to practice under the contract. A purpose of such waivers is to clarify and definitize the rights of the parties to such inventions when the facts surrounding the first actual reduction to practice prior to or during the contract are or will be difficult to establish. (h) Waivers to educational institutions. (1) Except to the extent that a nonprofit educational institution may be engaged as a contractor operating a Government-owned facility or undertaking other special contracts, the following considerations apply to granting of advance and identified waivers to educational institutions having an approved technology transfer program capability. To obtain approval of a technology transfer program, an educational institution shall forward its request to DOE as provided in paragraph (2) below. (2) A nonprofit educational institution desiring to obtain approval of its technology transfer program and acceptability shall provide the agency with the following information: (i) General information concerning the institution, including: |