United States to a global harmonization treaty could bring improvements in the patent protections offered by foreign countries for U.S. applicants seeking patents abroad; and (3) there would be a decrease in the complexities, time frame, and resources now associated with procedures devoted purely to determining who invented the product first.

To offset the potential disadvantages of a first-to-file system, the commission endorsed the change with three conditions: (1) the establishment of a provisional application procedure to expedite early filing at a reduced cost; (2) a grace period during which public disclosure of an invention would not affect patentability if an application is filed within 12 months of disclosure; and (3) "a third party who uses or makes substantial preparation for the use of invention before the filing date of an application on which patent is granted to another, has a right to continue to use the product under certain conditions" (Advisory Commission on Patent Law Reform, 1992, p. 21).

Other commission recommendations included extending the general patent term from 17 to 20 years (from the filing date) and that PTO funding should be maintained at a level that equips it to generally support an 18-month pendency period (Advisory Commission on Patent Law Reform, 1992).

Over the past decade, the PTO has had to face sharply increasing numbers of biotechnology patent applications. From 1983 to 1988, the number of biotechnology applications rose 20 percent (applications in all other areas rose an average of 2.9 percent). To deal with this major influx, the PTO established an examining unit specifically for biotechnology in 1989. However, recent congressional reports reveal that the pendency period for biotechnology patent applications remains longer than that for any other technology (average pendency is 36.1 months for biotechnology patents compared with an average of 21 months for all other patents issued). Applications specifically related to immunology have an average pendency period of 44.1 months (Office of Technology Assessment, 1991). Nevertheless, it is important to note that patents (even those relating to biotechnology) are granted faster in the United States than in any major examining office in world, and by a significant amount of time (Office of Technology Assessment, 1991).

The reasons behind the backlog include the fact that the level of scientific scrutiny required to process an application for a biotechnology patent far exceeds that required for patents in most other areas. In addition,

FRONT MATTER (R1-R16)

1 Executive Summary (1-18)

2 Why a Children's Vaccine Initiative (19-35)

3 Resources and Infrastructure (36-65)

4 Vaccine Demand and Supply (66-97)

5 Investing in New and Improved Vaccines (98-108)

6 Stages of Vaccine Development (109-127)

7 A Strategy to Enhance U.S. Participation in the Children's Vaccine Initiative (128-146)

Appendix A: Relevant Intellectual Property Rights Law (147-159)

Appendix B: National Vaccine Injury Compensation Program (160-163)

Appendix C: Regulatory Aspects of Vaccine Development, Manufacture, and Distribution (164-169)

Appendix D: Strategies for Achieving Full U.S. Participation in the Children's Vaccine Initiative (170-183)

Appendix E: Public Health Service Act (1944) (184-188)

Appendix F: National Vaccine Program Legislation (189-192)

Appendix G: Immunization Schedules (193-195)

Appendix H: Historical Record of Vaccine Product License Holders in the United States (196-204)

Appendix I: Working Group Participants (205-209)

Appendix J: Committee and Staff Biographies (210-219)

Appendix K: Acronyms (220-221)