ABSTRACT
Generally, society has been repugnant at the idea of patenting human genes and synthesized recombinant nucleic acids and biospecimens in biomedical research. Indeed, the evidence that genes are embedded with information and are shared by other family members seems to galvanize societal rejection of patenting them. As Deegan pointed out, a gene patent is an intellectual property, which gives the patent holder the right to exclude others from making, using, selling, or importing an invention for a period of time…. 1 Should genes therefore be patented? Whose intellectual property—the specimen donor's, families’, physician's, or the researcher's? Most importantly, what are the implications of the law on patenting of genes or genomic materials to pharmacogenomic and PM? The debates seem to hinge on certain significant legal questions: are genes products of nature or are genes human inventions? An affirmation of the former means that within patent jurisprudence, cDNAs may not be patent eligible while the later implies the patentability of genes because they are human inventions in view of Section 101 of the Patent Act. The third question is on the extent to which a researcher could claim property ownership on another person's genomic materials and biodata. Since patent laws in the United States have evolved, it is important therefore to explore how these laws are applicable in current jurisprudence and their significance for the advancement of PM, most especially the post-Myriad implications.
