Erythropoietin: From a Biosimilar to Innovative Products Protected by Industrial Property Assets

Abstract

Aim: EPO (erythropoietin) is a hormone that stimulates the erythropoiesis and is mainly produced by the kidneys. In the early 1990s among the emerging biotech drugs, the recombinant human EPO (rhEPO) was the best-selling product worldwide, reaching nearly three billion dollars annually. The CIM (center of molecular immunology) produced and sold the rhEPO as commercial strategy to recover the investment made in its new facilities. This work summarizes the inventions that protect the innovative products developed by three Cuban institutions, starting from rhEPO, and the industrial property strategy followed by them. Methods: The information was obtained from the United States Patent, Trademark Office (USPTO) database, Patentscope, Espacenet, patent databases of Center for Pharmaceutical Research and Drug Development (CIDEM) and Cuban Industrial Property Office. Conclusions: The manufacturing process of CIM's EPO has its own patent family. From a manufacturing by product an innovative formulation protected by patent was obtained. There is a patent family around the nasal formulation and it continues enlarging. From a biosimilar pharmaceutical innovative products impacting on human health have been obtained.