In short, it is reasonable to hypothesize that to the extent they arise at all, intellectual property complications will be greater in research involving at least some of these pathways than in genomic and proteomic research in general.

Methods

In consultation with USPTO supervising examiners in technology center “1600” (biotechnology), committee staff developed search algorithms for each of the categories of patents (see Appendix C). These searches were run on the patent claims field to obtain the number of U.S. patents and assignees, assignee countries, inventor countries, application years, and ultimate assignees over the period from January 1, 1995, to February 1, 2005. An independent search using the same algorithms for the same period was made subsequently by staff of the Georgetown University project. The numbers of patents found in the two sets of searches corresponded very closely but not exactly. In addition to U.S.-assigned patents, the searches included published U.S. patent applications and, for comparison, patents and applications issued by the European Patent Office (EPO). The “software,” “database,” and “algorithm” categories were limited to patent classification 435 (chemistry: molecular biology and microbiology). Table 4-1 summarizes the results. Especially for the “software” and “algorithm” categories, the class restriction may limit the results, because biologically related patents may have been placed in other patent classifications. It was not possible with the re-

TABLE 4-1 Issued U.S. and European Patents and Patent Applications in Selected Categories of Biotechnology Inventions, 1995-2005

Category

U.S.

Granted

U.S.

Application

EPO

Granted

EPO

Application

Genes and gene regulation

6,145

7,105

1,327

1,153

Haplotype/SNPs

1,482

2,292

266

293

Gene expression profiling

7,428

16,983

2,635

3,043

Protein structure

39

230

28

31

Protein-protein interactions

6,964

12,845

3,590

2,066

Modified animals

652

2,767

177

334

Software

60

209

11

28

Algorithms

91

325

64

113

Databases

1,466

3,765

A

A

EGF pathway

765

1,045

212

166

CTLA4 pathway

63

149

19

19

NF-kB pathway

94

206

42

81

NOTE: A = No biological class restriction is available for this category.



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