OTT, Beltsville Area www.ba.ars.usda.gov/techt/ Harry Danforth or Sherry A. Cohen Bldg. 003, Rm. 208, BARC-W 504-6421 504-6001 FAX Danforthh@ba.ars.usda.gov Cohens@ba.ars.usda.gov www.ba.ars.usda.gov/techt/

ARS is Increasingly Being Asked to Demonstrate the Positive Impact of our Programs

Federal Technology Transfer Acts of 1986 and 1996 To help translate research results into practical products To give taxpayers a return on their investment in research To promote economic competitiveness and job creation

Philosophy of Technology Transfer U.S. Company ARS Mission Interests Area Ripe for Technology Transfer Not all Successful Technology Transfer Uses Formal Mechanisms

How is Technology Transferred?

Types of Formal Agreements Confidentiality Agreement Material Transfer Agreement (MTA) Cooperative Research and Development Agreement (CRADA) Trust Fund Cooperative Agreements Memorandum of Understanding (MOU) Patents – License Agreement

Confidentiality Agreement Used only when contemplating entering into a CRADA, MOU or License Agreement. Otherwise, do not disclose or receive confidential information. Can be one way or two way Protects patent rights Do not sign non-standard confidentiality agreements without first checking with the Technology Transfer Coordinator (TTC). Can be signed by any permanent ARS scientist. Provide copy of executed agreement to TTC.

Material Transfer Agreement Used when transferring materials which may be or will be or are patented. Do not sign non-standard MTAs without first checking with TTC. Signed by scientist, RL and then sent to TTC for signature and transmittal to cooperator. TTC will let you know when it is OK to send/receive materials. Example (transfer of cell lines to a U.S. company for production of viral pesticides.)

Develop a CRADA When: A joint research effort with a non-Federal, U.S. partner has the possibility of contributing to a commercial product. A partner requires limited confidentiality and or exclusivity. Negotiations are between TTC and cooperator, not scientist and cooperator. Watch out for sensitive issues.

Examples of Sensitive Issues Creation of transgenic food or feed organisms by genetic engineering (human-directed splicing, altering, deletion, antisense reassembly, or other asexual recombining of DNA or RNA, including subsequent activities to regenerate whole transgenic organisms from cells or tissues, or to transfer genetically-engineered DNA from one organism to another to enhance its potential utility). Cloning of animals by somatic cell nuclear transfer. Herbicide-resistant crop plant research. Antibiotic/Antimicrobial Resistance.

Cooperative Research and Development Agreement (CRADA) Benefits to Firms: First right to Exclusive License Access to ARS Confidentiality Benefits to ARS: Results-Oriented Research Identification of Licensee Resources (For the Project)

CRADA Negotiations Firms May Provide ARS May Provide Any of the Above Expertise Materials Equipment Employees Money Facilities ARS May Provide Any of the Above Except Money

Trust Fund Cooperative Agreements Multiple agreements can be used with multiple partners for same project. Involves funding to ARS from Cooperator. No confidentiality provisions (with exceptions). No right to negotiate an exclusive license.

Memorandum of Understanding Used for collaborative research or evaluation No money changes hands No confidentiality (with exceptions) No rights to exclusive license

Proprietary Information or Intellectual Property (IP) Confidentiality Always Remember Proprietary Information or Intellectual Property (IP)

PATENTING GUIDELINES ARS Can Patent Cooperator Can Patent Can be individually or jointly owned

CALL THE PATENT ADVISOR FIRST!! INVENTOR GUIDELINES CALL THE PATENT ADVISOR FIRST!! Janelle Graeter 504-5676

INVENTOR GUIDELINES 1. Use Permanently bound Research Notebooks. 2. Critical Dates in Patent Law to Avoid Loss of Patent Rights: a. Protection Intellectual Property - invention reporting, confidential agreements, CRADA’s. b. Invention Report’s (IR) to Patent Advisor (PA) ASAP. c. Report publication of invention to PA ASAP. d. Foreign patents must be filed before publication. e. Avoid disclosing inventive concepts in abstracts, CRIS reports and interpretative summaries.

INVENTOR GUIDELINES 3. Conduct Thorough Search Before Writing IR. 4. Provide Advice to PA-talk to the PA. 5. Assist the PA in Prosecution of the Patent: a. Review and comment on patent office actions. 6. Plant Variety Protection Certificates Considerations - Associate Deputy Administrator from Plant Sciences 7. General Information on PVPC Obtained from: Commissioner, Plant Variety Protection Office, AMS, NAL Building, Beltsville, MD 20705. Tel. No. 504-5518 or visit their website at www.ams.usda.gov/science/pvp.htm

ARS Patent Committee Evaluation Criteria The Patent Committee meets every 3 to 4 months and recommends whether invention disclosures on the docket should be accepted for patent application preparation, deferred, or suspended. If there is a patent….

License Agreements Negotiated by Licensing Coordinator or TTC only Exclusive agreements require publication in Federal Register, except for CRADA inventions. Scientist receives incentive award: First $2,000 plus 25% thereafter of all license revenue exclusive of reimbursed fees.

For All Formal Agreements Negotiations of language and scope of the agreement are almost always necessary to protect ARS’ rights and policies. Flexibility, compromise and communication within the guidelines and policies of OTT is necessary to develop successful agreements. “Compromise, if not the spice of life, is its solidity.”

Questions ? www.ba.ars.usda.gov/techt/