Abstract

The use of genetic information to design and guide therapies and to develop novel diagnostic procedures creates important patent issues. Patents on human gene sequences have likely helped stimulate the introduction of new biologics; however, their role and that of patents on genotype-phenotype correlations in diagnostic testing is highly controversial. Genotype-phenotype associations are at the heart of personalized medicine. The intellectual property rules by which these biologic relationships are governed have profound implications for the growth of individualized medicine.

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