Patenting Proteomics

The Human Genome Project revealed that the human organism contains far fewer genes than proteins. The fact that approximately 33,000 genes encode more than 200,000 thousands proteins invalidated the long-held assumption that one gene encodes a single protein. Further studies demonstrated that even small structural variations in the “proteome” defined as the total set of proteins expressed in a given cell at a given time – such as posttranslational or interactive modifications – could have an enormous impact on the physiology of the entire cell.

The aim of this study is to provide a comparative assessment of legal issues at the nexus between intellectual property rights and a central area of modern biotechnology, proteomics. More specifically, the study discusses the patentability of proteomic patent claims, and the scope of protection of biotechnological inventions in the post-genomic, or proteomic, era. How do patent law institutions currently treat proteomic inventions, and how would they treat the range of inventions that can be expected to materialize in the not so distant future? Do broad gene patents hinder further research? How did the patent system react when it became clear that knowledge about a protein’s structure may prove to be much more important to the development of medical treatments than knowledge about the encoding gene? Analyzing these and further questions, this study delivers important insights into the mechanisms the different patent systems provide and their flexibility in dealing with novel issues.

Martina Schuster received a doctorate in comparative patent law from Ludwig-Maximilians-University Munich and an LL.M. from The George Washington University, Washington, D.C. She currently works as an associate in Frankfurt, Germany.