J.D., 1985, Catholic University. Deputy Director, Office of Technology Transfer, National Institutes of Health.

J.D., 1989, University of Virginia. Senior Attorney, NIH Legal Advisor's Office, Office of the General Counsel, Department of Health and Human Services.

The opinions expressed herein are personal and do not reflect the position of the National Institutes of Health or the Department of Health and Human Services.

1. 35 U.S.C. 200-212 (1994).

2. Pub. L. No. 96-480 (1980) (current version at 15 U.S.C. 3701-3717) (authorizing federal laboratories to, inter alia, enter into cooperative research and development agreements, and collect and retain royalites under patent license agreements).

3. Grantees and contractors are treated identically under the Bayh-Dole Act. See 35 U.S.C. 201(c) (1994). Thus, for simplicity's sake, this Essay will use the term "funding recipient" for both types of award.

4. For example, at the National Institutes of Health, 990 licensed technologies generated approximately $40 million in fiscal year 1998. See NIH Office of Technology Transfer, GAO Report RCED-99-173-Technology Transfer: Number and Characteristics of Inventions Licensed by Six Federal Agencies 33-34 (June 1999), available at <http://www.nih.gov/od/ott/rc99173.pdf>. Many products, including new research tools, diagnostics, vaccines, and therapeutics, are on the market and benefitting the public as a result of NIH's technology transfer program. See id.

5. For a discussion of the history of government patent policy with respect to technology transfer, see, for example, Rebecca S. Eisenberg, Symposium on Regulating Innovation: Public Research and Private Development: Patents and Technology Transfer in Government-Sponsored Research, 82 VA. L. REV. 1663 (1996). For a review of the historical patent policies of various federal agencies, see Ralph C. Nash and Leonard Rawicz, George Washington University, Government Contracts, Monograph No. 10, Patents and Technical Data 74-78 (1983).

6. See 45 C.F.R. 8.1(a) (1996) ("Inventions and Patents (General)"), made obsolete and superseded by the Bayh-Dole Act and implementing regulations. See 61 Fed. Reg. 54743, 54743-44 (Oct. 22, 1996).

7. 45 C.F.R. 8.1(a) (1996). Contracts for research were similarly handled. See 45 C.F.R. 8.6 (1996).

8. Of the more than 28,000 patents in the government's patent portfolio obtained from its funding recipients, only 4% were successfully licensed. See S. REP. NO. 96-480, at 2 (1979).

9. In 1983, President Reagan issued a memorandum instructing all federal agencies, to the extent not prohibited by law, to grant all recipients the same right to their inventions as the Bayh-Dole Act provided small businesses and non-profit institutions. Memorandum to the Heads of Executive Departments and Agencies: Government Patent Policy, Pub. Papers 252 (Feb. 18, 1983). This was subsequently acknowledged in law. See 35 U.S.C. 210(c) (1994).

10. Funding recipients do not obtain title to inventions, however, when the government makes a determination of "exceptional circumstances" and under other circumstances set forth at 35 U.S.C. 202(a) (1994).

11. See 35 U.S.C. 200 (stating that the policy objectives of the Bayh-Dole Act include ensuring that "inventions ... are used in a manner to promote free competition and enterprise" and promoting "the commercialization and public availability of inventions made in the United States by United States industry and labor").

12. See id. (stating that the Act seeks "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"); see also 35 U.S.C. 202 (1994).

13. A "subject invention" means any invention of the funding recipient conceived or first actually reduced to practice in performance of work under the funding agreement. See 35 U.S.C. 201(e) (1994).

14. See 35 U.S.C. 202(c)(1) (1994). Regulations implementing this portion of the Act are set forth at 37 C.F.R. Part 401.

15. See 35 U.S.C. 202(c)(2) (1994).

16. See 35 U.S.C. 202(c)(3) (1994).

17. See 35 U.S.C. 202(c)(1)-(3) (1994).

18. See 35 U.S.C. 202(c)(4) (1994). Specifically, "[w]ith respect to any invention in which the contractor elects rights, the Federal agency shall have 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...." Id.

19. 35 U.S.C. 203(1) (1994).

20. 35 U.S.C. 203(1)(a)-(d) (1994).

21. See S. REP. NO. 96-480, at 34 (1979) ("'March-in' is intended as a remedy to be invoked by the Government and a private cause of action is not created in competitors or other outside parties, although it is expected that in most cases complaints from third-parties will be the basis for the initiation of agency action.").

22. Stem cell separation is the process of isolating and purifying a certain type of blood cell, the stem cell, from the bone marrow or peripheral blood. Purified stem cells are infused into a patient during bone marrow transplantation as a means of helping the patient regenerate the patient's blood supply after cancer chemotherapy or radiation therapy. Newer means of stem cell separation, such as the antibody/device process at issue in the present case, allow such efficient purification that they are also being studied for their potential ability to prevent metastatic recurrences by screening out the microscopic cancer cells that typically remain with older isolation methods.

23. See Johns Hopkins Univ. v. CellPro, 978 F. Supp. 184, 184 (D. Del. 1997).

24. Letter from Lloyd N. Cutler and former Senator Birch Bayh, attorneys for CellPro, to Donna Shalala, Secretary, U.S. Department of Health and Human Services 13 (Mar. 3, 1997) (on file with authors) [hereinafter Petition].

25. The CellPro Ceprate SC device was approved for use in the United States by the U.S. Food and Drug Administration in December 1996. See Petition, supra note