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Authors

W. Lesser

Abstract

The Myriad Genetics decision has rekindled the product of nature debate. This article analyzes legal decisions spanning the past century for products ranging from plants to man-made elements, which in sum provide guidance to the patentability of genes. The product of nature argument it is concluded confuses rather than clarifies patentability considerations. Patentability in the evaluated cases as well as for genes can be resolved more precisely under the utility, non-obviousness, disclosure, and enablement patentability requirements without a need for any additional judicially-created stipulation. As regards genes, there is an additional dimension for consideration which in the case law and scientific literature is referred to as "information," although the two groups do not use the term equivalently. Decisions involving complex compositions of matter cannot be treated the same way as simple chemical substances. This article argues that the information dimension of genes is an enablement and patent scope, not a patentable subject matter, issue. The appropriate scope will emerge over time as the science of genomics advances. In the interim it is proposed that the allowed scope err on the side of too limited rather than too broad.

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