ARTICLEReflections on the Science and Law of Structural Biology, Genomics, and Drug Development
Helen M. Berman*
Rochelle C. Dreyfuss**
53 UCLA L. Rev. 871
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The Patent Act is now over a half-century old, and many observers have become concerned that it is not responsive to the needs of emerging industries or to the changing landscape of science. In this Article, we look at this issue in the context of the life sciences and examine how patent doctrine has reacted as the fields of proteomics, genomics, and structural biology have advanced. We find many missteps along what we call the subject matter-inventiveness-scope-exemption trajectory. Patents now protect subject matter such as genes and proteins. These advances no longer represent particularly difficult scientific challenges. But because this subject matter lies far upstream, the patents on these advances have strong potential to block drug development. Although attempts have been made to narrow the scope of upstream patents to permit competitive pharmaceutical research, patentees have fought back with new claiming strategies and with new arguments for curtailing use of their inventions for experimental purposes. In this Article, we argue that a more realistic appraisal of the underlying science is needed, one that takes account of the automation of early stage research and recognizes that the place for patenting is downstream—when long, convoluted, and risky creative efforts are made to convert genetic and proteomic knowledge into viable commercial products. Pushing patents downstream is not only more defensible from the perspective of the underlying science, it is also desirable socially, for it would increase public access to the fundamental building blocks of scientific knowledge and allow competitive basic research to flourish.
* The Board of Governors Professor of Chemistry and Chemical Biology, Rutgers University; Director, Protein Data Bank, Research Collaboratory for Structural Bioinformatics.
** The Pauline Newman Professor of Law, New York University School of Law.
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