Biotechnology is the trend in the development of medicines. Biological products represent the spearhead of biomedical research and currently offer the most effective means of treating a wide variety of diseases and medical conditions that currently have no other way of being treated. Biological drugs are medicines made from living organisms, living cells, through complex manufacturing processes, to the extreme that is often said “in biological, the process is the product.” These molecules are more structurally complex and more sensitive to changes in their environment. The process for its manufacture requires a strict control and monitoring of the production conditions and even packaging. Given the characteristics of biologics, it is not possible to speak of “generics”, as is the case with chemical synthesis products. What there may be are similar products, hence the expression “biosimilar”, that is, a biological product that is similar to an innovative biological product (the reference product). Do the traditional patentability requirements apply to biological medicines? Are there limitations to its patentability? Is the data protection results of the research and development process available to biologists? In regulatory matters, what are the States applying to qualify and approve the entry of a “biosimilar”? What is the difference between a biosimilar product and an interchangeable biological product? What aspects should an intellectual property lawyer consider regarding the protection of biologics and regarding access to the biosimilars market?
Speakers will take us on a tour of the intellectual property and regulatory aspects of biologics, based on a reference to the fascinating world of biomedicines.