FIGURE 4-8 Patent Class 536/23.1 (DNA/RNA fragments) application pendency by quarter, 1997-2002. NOTE: Pendency is calculated based on original file date and issue date for all issued patents in Class 536/23.1. Overall pendency is calculated by USPTO and also includes an estimate of the time from filing date to abandonment of the application. A = Utility and written description guidelines implemented.

The committee staff analysis also looked at the inventor and assignee country for the patents in each of the categories. The United States leads the world in both inventors and assignees, holding 65 to 80 percent of the worldwide patent share, followed by the United Kingdom, France, Germany, Japan, and Canada. Other active countries are Israel and the Netherlands. For the U.S.-granted patents and pending U.S. applications, the top assignees were all in the United States—sometimes by a factor of 15 or more. Additionally, the United States is the top inventor country, but by a smaller margin. Figures 4-9 through 4-12 show these data for the DNA-related categories, the protein-related categories, tools, and the three pathways.

In the United States, the institutions constituting the University of California have been active patentees across all categories, with a combined patenting frequency at the level of a commercial entity. Categories that developed more recently (software, databases, and gene expression profiling) typically are dominated by biotechnology firms. The protein structure category has been led by pharmaceutical companies because of its proximity to drug discovery, while universities have been dominant in the modified animals category. NIH (through the



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