ABSTRACT

This chapter considers the National Institutes of Health (NIH) patents for deoxyribonucleic acid (DNA) sequences because, though unsuccessful, they indicate an increasing trend in biotechnology to file patents of obscure utility. The NIH controversy has been useful in drawing attention to a number of vital issues. Partial and complete human complementary DNA (cDNA) and genomic sequences correspond to particular expressed sequence tags. The NIH application contained claims not only to the partial cDNA sequences as isolated molecules but also to longer sequences that incorporate the partial cDNAs. The patent application filed by J. Ventor and Mark D. Adams was a sweeping one, broadly encompassing cDNA sequencing of the human genome. NIH’s claim that its patenting of cDNA sequences would stimulate greater investment by the private industry in developing the gene products was contradicted by the Pharmaceutical Manufacturers Association as well as two biotechnology trade groups that have since merged the Industrial Biotechnology Association and the Association of Biotechnology Companies.