Adalimumab protection trough patents of invention: a comparison of the strategies adopted by the American, Brazilian and European Patent Offices

Abstract

Introduction: Biological drugs displayed an exponential development in recent years. Monoclonal antibodies (mAbs), in particular, have proved to be one of the main categories of these drugs, incorporating several innovations in their production. In order to protect these innovative products, patent protection has been widely used by companies, from startups to multinationals. However, although allowing the return of investments in the R&D of new drugs, patent protection creates an exploitation monopoly which leads to an increase of costs by national health systems. According to the Brazilian Ministry of Health, biological drugs represent 40% of the costs with drugs, but only 2% of the total drugs volume. These high costs may be due to the exceptions admitted by the sole paragraph of article 40 of the Brazilian Patent Statute, which allows the extension of the patent term if the examination takes more than 10 years, and to the Brazilian Patent Office delay in finishing the examination, the socalled backlog. Therefore, the identification of common points in patent examination among several patent offices could reduce the examination time and, ultimately, the backlog.