Biotechnology

In response to a congressional request, GAO examined the Patent and Trademark Office's (PTO) backlog of unprocessed biotechnology patent applications, focusing on: (1) PTO efforts to streamline the backlog; (2) the level of technical scrutiny required for biotechnology applications compared to other applications; (3) PTO ability to attract and retain qualified examiners; (4) the waiting period for biotechnology applications compared with that for other applications; (5) causes of biotechnology patent application delays; and (6) whether foreign applicants attempted to overwhelm the patent system with applications.

GAO found that: (1) PTO implemented accelerated examination procedures to reduce its backlog of biotechnology patent applications; (2) PTO estimated that it would take approximately 4 years to reduce its backlog because it lacked experienced examiners to process the applications; (3) biotechnology applications required much more technical scrutiny than other patent applications; (4) patent examiners spent about 15 percent more time processing biotechnology applications than other applications; (5) PTO obtained special engineering pay rates and hiring authority to correct prior delays in hiring patent examiners, and in 1988 assigned 26 percent of its personnel to process biotechnology applications; (6) applicants for biotechnology patents experienced longer waiting periods than other applicants; (7) PTO more quickly processed patent applications in such areas as biotechnology equipment because of few backlogs; and (8) there was no evidence that foreign patent applicants deliberately overwhelmed or intentionally undermined the system with applications.