until 1991 when it began accelerating, peaking at 4,500 in 2001. The number of issued patents declined sharply in 2002 and again in 2003 and 2004 (Figure 4-1).

A more refined analysis has been done using bioinformatics methods to compare nucleotide sequences claimed in U.S. patents to the human genome (Jensen and Murray, 2005). This analysis shows that approximately 20 percent of human genes (4,382 of the 23,685 genes currently in the public databank) are explicitly claimed, not merely disclosed, in issued U.S. patents owned by 1,156 different assignees. A number of genes, including BRCA1, are subjects of multiple patents asserting rights to various gene uses and manifestations. In a few cases, single patents claim multiple genes, usually as probes on a DNA microarray. None of these circumstances is by itself indicative of a “thicket” or “blocking” problem absent information on patent claims, licensing, and corporate relationships.

Large numbers of applications for patents with such claims are still pending, some of them since the early 1990s. Many of these can be retrieved from the database, because USPTO began publication of most 18-month-old applications in March 2001; but there are two reasons why the precise number for each year cannot be ascertained. First, under the American Inventors Protection Act of 1999, an application can be withheld from publication if the filer agrees not to seek a patent on her or his invention outside the United States. In biotechnology and organic chemistry the “withholding” rate was about 6 percent through 2002 (NRC, 2004). Second and more important, USPTO has not been systematic about publishing applications after 18 months of filing. For example, applications filed in 2001 and 2002 continue to appear for the first time in the database in 2005.3

Approximately 5,000, or 15 percent, of the issued patents in the Georgetown database are managed by universities, led by the University of California, the largest patent holder in the field overall. The dominance of the University of California is somewhat misleading, however, because the number is a compilation of the patenting activity of 10 major research institutions, including the University of California at San Francisco, the University of California at Berkeley, and the University of California at San Diego. More than 800 are assigned to the U.S. government. The government also has an “interest” in as many as 60 percent of the patents held by the leading academic patenting institutions, meaning that they derived from federally funded research.4 The majority of patents are held by U.S.-based biotechnology and pharmaceutical companies. Figure 4-2 shows the 30 largest holders of DNA-based U.S. patents.

3  

The Georgetown University investigators observed this when recently adding pending DNA patent applications to their database.

4  

A federal grantee is supposed to disclose in a patent application the government’s “interest” in the invention, but it is doubtful that this rule is followed consistently. Thus, the 60 percent figure for university genomic inventions may in fact be on the low side.



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