E8-28187. Questions Concerning Technology Transfer Practices at DOE Laboratories

AGENCY:

Department of Energy.

ACTION:

Notice of Inquiry; Technology transfer practices at Department of Energy (DOE) laboratories.

SUMMARY:

DOE hereby publishes the following questions concerning technology practices at DOE laboratories. Interested parties are requested to answer some or all of the questions at their discretion. In answering the questions parties are requested to identify whether they represent a large business (> 500 employees), a small business, a non-profit organization, a university, or other.

DATES:

Written comments are to be received at the address listed below no later than January 26, 2009.

ADDRESSES:

Comments may be submitted electronically at: [e-mail]; or by mail at: Office of the Assistant General Counsel for Technology Transfer and Intellectual Property, U.S. Department of Energy, 1000 Independence Ave., SW., Washington, DC 20585. ATTN: TECHNOLOGY TRANSFER QUESTIONS.

FOR FURTHER INFORMATION CONTACT:

Paul A. Gottlieb, Assistant General Counsel for Technology Transfer and Intellectual Property, U.S. Department of Energy, Forrestal Building, Room 6F-067, 1000 Independence Ave., SW., Washington, DC 20585; Telephone: [phone].

SUPPLEMENTARY INFORMATION:

Questions About DOE Laboratory Technology Transfer Seeking Input From All Parties Including Industry, Universities, Non-Profits and the General Public

As part of an ongoing review of technology partnering agreements at Department of Energy (DOE) laboratories and facilities, DOE solicits input from all parties including industry, universities, non-profits and the general public on the following questions related to technology partnering mechanisms utilized by DOE Laboratories and facilities:

1. Existing and Other Agreements (4 sub questions): The DOE labs currently offer CRADAs, WFO Agreements, and User Agreements, all briefly referenced below. The DOE Orders and model agreements for CRADAs, WFO and User Agreements can be found at http://www.gc.doe.gov/​lab_​partnering.htm. Questions for Comment: (i) What improvements to the existing transactions (e.g. CRADAs, WFOs, User Agreements, etc.) would you suggest that DOE consider? (ii) Are there terms and conditions that are troublesome and what steps might DOE take to streamline these agreements? (iii) Are there other types of research agreements or mechanisms that should be offered at DOE labs? (iv) How would such new agreement types or mechanisms be an improvement on or augment the existing agreements

2. Best Practices (2 sub questions) DOE is interested in improving the ways the laboratories collaborate, and improving the transfer and deployment of laboratory technologies into the marketplace. Question for Comment: (i) Are there other agency, industry, non-profit or university technology transfer “best practices” DOE should consider adopting? (ii) What are they and how would they improve DOE's current technology transfer program??

3. U.S. Competitiveness: (6 sub questions) Under Cooperative Research and Development Agreements (CRADAs) with DOE labs and under license agreements to lab inventions, the relevant statutes require that a “preference” be given to companies who agree to manufacture new inventions made under those agreements substantially in the U.S. As a matter of DOE policy, DOE has imposed a stricter standard than that required by statute under which every partner must agree to manufacture new technology substantially in the U.S. or make a legally binding commitment to provide an “alternate net benefit to the U.S. economy.” The DOE policy is more fully described in the DOE model CRADA at Article XXII and the guidance provided for that Article. This standard is also more stringent than the standard imposed under 35 U.S.C. Sec. 200 et seq. (“Bayh-Dole”) for funding agreements with Federal agencies. Bayh-Dole recipients may take ownership of new technologies without limitation on their own manufacture, but must agree not to assign or exclusively license those new technologies to other parties who do not agree to substantially manufacture in the U.S. DOE maintains its commitment to the U.S. economy, but is open to streamlining negotiation of the U.S. Competitiveness issue in view of the practical realities of a global economy. Questions for Comment: (i) What alternate approaches to addressing U.S. competitiveness would you suggest DOE consider? (ii) How would these alternatives help transactions/interface with DOE facilities? (iii) background: For example, one possible way to streamline this process is to forego a legally binding commitment from any partner that has a “substantial presence” in the U.S. This could be accomplished in a number of ways, such as where a partner indicates in writing that it or its intended suppliers will make best efforts to manufacture products resulting from the agreement in the U.S., and provides factually supported statements that it satisfies at least two of the following three factors: (1) The partner has or plans to have a manufacturing facility in the U.S. where its products resulting from the agreement will be manufactured; (2) more than half of the partner's assets are located in the U.S. or it derives more than half of its revenue or profits from the U.S.; and (3) significant design and development (other than the CRADA) will be done in the U.S. in an existing U.S. research facility. Another alternative would be to limit the legally binding commitment for substantially manufacturing in the U.S. to a specified number of years, e.g., 5 years. That would give the U.S. manufacturing facility a head start on sales (and setting up supply chains) before manufacturing might be moved offshore, as well provide some certain benefit to U.S. competitiveness. (iii) Would any of these three be a useful approach to industry to better streamline the process of the U.S. Competitiveness negotiation process? (iv) Does DOE's current implementation of U.S. Competitiveness have a negative impact on technology transfer? How? (v) Would approaches taken by other Federal Agencies with regard to U.S. Competitiveness in CRADAs be useful? If so, (vi) what are those approaches and how are they implemented?

4. The Intellectual Property Rights disposition in Work For Others (WFO) Agreements: (4 sub questions) Under WFO Agreements with DOE labs, the sponsor may access highly specialized or unique DOE facilities, services, or technical expertise. The sponsor pays the full cost of the research with non-federal funds, and, with very limited exceptions may elect ownership in any new inventions by lab employees. Those new inventions are subject to a Government use license, March-In Rights, and U.S. preference provisions in licensing of the patent rights. In addition, at many laboratories the sponsor may mark all newly generated data as proprietary. The current DOE model provides that the sponsor retains title to lab inventions because the sponsor pays full cost and bears all of the risk. On the other hand, one might argue that the laboratory contractor should own the IP it develops because it would allow the laboratory to better ensure full utilization of the intellectual property for the benefit of the public and provide additional benefits to inventors through laboratory royalty sharing policies. If the laboratory owns such inventions, as is the norm under sponsored research at most universities, it could also provide free use of the inventions to non-profit research organizations and universities. As a matter of general policy, the latter position is reflected in the provisions in Bayh-Dole when government funding is involved. One proposal aimed at satisfying both sides of the issue is to modify the terms and conditions of DOE's WFO Agreements so that the labs may retain title to lab employee inventions but grant the sponsor a nonexclusive, royalty-free, non-transferrable, non-sublicensable worldwide license in a field of use with no requirements concerning U.S. manufacture, no Government use license where the Government is not a likely user of the technology, and no March-In Rights. In addition, the sponsor would be offered the opportunity to negotiate an exclusive license in a field of use for reasonable compensation and consideration of U.S. competitiveness. Question for Comment: (i) How would these proposed changes affect the attractiveness of WFO Agreements? (ii) What other options do you recommend for DOE to consider? (iii) What is the desirable disposition of IP rights that would stimulate working with a DOE laboratory or facility? (iv) Do the Government reserved license in Sponsor inventions, March-In Rights, and U.S. preference clauses pose any problems for a successful project?

5. Negotiable or Non-negotiable User Agreements: (3 sub questions) DOE labs also offer User Facility Agreements under which parties may gain access to designated unique lab equipment and facilities to perform their own experiments. Under the Non-proprietary User Agreement, which is aimed primarily at non-commercial, basic science research, a user may access lab equipment/facilities and may collaborate with lab scientists in carrying out its research. The user and the lab share the costs of the research by each absorbing their own costs, the lab and the user may elect to retain ownership of their respective new inventions, and the research data is made publicly available. The Proprietary User Agreement permits the sponsor to conduct proprietary research using unique lab equipment/facilities. In this case, the user pays the full cost of the research, and the user retains ownership of research data and inventions. User Agreements have been used successfully at labs for over 25 years. Typically User Agreements have relatively short durations, their terms and conditions are non-negotiable, and labs are authorized to enter into the agreements without additional DOE approval. As such, execution takes relatively little time. The most recent changes to these agreements permit some terms and conditions to be negotiable, but changes require DOE approval. These new Interim User Agreements and the class patent waivers to which they are attached can be found at http://www.gc.doe.gov/​1002.htm. Comments are solicited on the terms of these agreements. Question for Comments: (i) Do you think these new DOE-wide standardized User Agreement formats which allow for some negotiation will promote more timely placement of User Agreements? (ii) Should DOE allow some negotiability of the terms or utilize agreements that are non-negotiable? (iii) Please describe the pros and cons of each approach.

6. Are there any other issues, concerns, or experiences that could make working with DOE laboratories and facilities more effective and efficient.

Disclaimer

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. In accordance with FAR 15.202(e) responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI. Respondents should not include any confidential information in any information they furnish. Responses to the RFI will not be returned. Respondents will not be notified of the result of the review.

Issued in Washington, DC, on November 20, 2008.

Devon Streit,

Office of Science.