1. Intellectual Property And Data Rights Issues Domestic & Global Perspectives Bayh-Dole act -- rights in data Henry N. Wixon Chief Counsel National Institute of Standards and Technology

2. The bayh-dole act “It is the policy and objective of the Congress... “to encourage maximum participation of small business firms in federally supported research and development efforts... “to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inventions...” 35 USC § 200

3. Bayh-Dole Highlights A “Contractor” (nonprofit organization (such as a university) or a small business) has the right to elect (within a reasonable time) to retain title to any “subject invention” made under federally funded R&D (e.g., grants, contracts, cooperative agreements). Under “exceptional circumstances when it is determined by the agency that restriction or elimination of the right to retain title to any subject invention will better promote the policy and objectives of this chapter” an agency may limit the presumption that ownership will vest in the Contractor. A Contractor may assign or obtain rights in joint inventions made with federal employees. An inventor may obtain ownership rights from the Contractor or from a federal agency. The Contractor must commit to commercialization within a predetermined, agreed upon, time frame.

4. Bayh-Dole Highlights The government retains “a nonexclusive, nontransferable, irrevocable, paid- up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world....” The government also retains “march-in rights,” which allow the federal agency to require the Contractor (whether it owns the title or has an exclusive license) to “grant a nonexclusive, partially exclusive, or exclusive license in any field of use to a responsible applicant or applicants....” (with compensation) or to grant such a license itself under certain circumstances. To trigger march-in rights, the agency must determine that the Contractor has not made efforts to commercialize within an agreed upon time frame, or that march-in “is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor....” To date, no agency has ever exercised march-in rights.

5. Bayh-Dole Highlights A Contractor must report an invention to the funding agency within 2 months from the date it is reported to the Contractor by the inventor. A Contractor must make an election of rights within 2 years from the date it is reported to the agency (may request additional time). A Contractor must file a patent application within 1 year of making an election. The patent application must include a government rights statement.

6. Bayh-Dole Summed Up The Bayh-Dole Act underpins an SBIR awardee’s ability to commercialize inventions made with federal funding. Bayh-Dole creates a presumption of ownership by the federally funded non-profit or small business, and of a non-exclusive right of the government to practice. A number of clocks start ticking for the SBIR awardee - including the obligation to disclose inventions, elect to retain title, file an application, and report on commercialization progress – failure to satisfy these can result in loss of rights. The over-arching objective is to achieve practical application of government-funded research for the benefit of the public.

7. Rights in data FAR Subpart 27.4 - Rights in Data and Copyrights Contract Clauses –Rights in Data - General (52.227-14) –Rights in Data - Special Works (52.227-17) –Rights in Data - SBIR Program (52.227-20) Agency-specific FAR Supplements

8. Rights in Data - SBIR Program SBIR contractors may assert copyright without prior approval of the Contracting Officer –unless there is specific contract language to the contrary If claim to copyright is made –Government gets same license as it receives under the FAR general data rights clause Additional restrictions on Government use of “SBIR Data” may apply where –SBIR data are: data first produced in performance of an SBIR contract, not generally known, not already available to the Government, and not made available to others without an obligation of confidentiality

9. Rights in Data General Clause - Government’s Right in Contractor Copyrighted Work When copyright asserted –Contractor must place copyright notice and acknowledgment of government sponsorship (w/ contract number) on the data when delivered to the Government, when published, and when deposited for registration with Copyright Office –Government agrees not to remove contractor’s copyright notice Copyright notice should be included on all Government reproductions of data –If no copyright notice is placed on the work Government obtains unlimited rights –Otherwise, Government obtains a license to the work

10. Rights in Data General Clause - Government’s Right in Contractor Copyrighted Work “Government Purpose License,” provides right to –Reproduce, prepare derivative works, distribute copies to the public, and perform and display publicly, by or on behalf of the Government –Examples of permissible use under Government Purpose License use the work within the Government without restriction release the work outside the Government for governmental purposes, e.g., for performance of a government contract authorize persons to whom release has been made to exercise license rights on behalf of the government

11. Rights in Data - SBIR Program When SBIR Data are delivered to the Government with “SBIR Rights Notice” provided in the clause –Government may use SBIR data for government purposes only –Cannot disclose the data outside the Government for a specified period of time (usually 4 years) restriction intended to provide incentives for development or commercialization of technology by the private partner If not marked with “SBIR Rights Notice” –No additional restrictions on Government’s use

12. Rights in Data General Clause - Government’s Unlimited Rights Unless contractor asserts claim to copyright, Government has unlimited rights –In all data first produced in the performance of a contract, and –In all data delivered under a contract unless provided otherwise in the contract (e.g., limited rights data)

13. Rights in Data General Clause - Government’s Unlimited Rights Government’s unlimited rights include –Right to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform and display publicly, in any manner and for any purpose, and to have or permit others to do so –Examples of permissible use may provide data to another contractor may distribute data to the general public may post data to a public web site

14. Thank you! Henry N. Wixon Chief Counsel National Institute of Standards and Technology