Newsletter 03 - June 2019


The pharmaceutical industry saga

The launch of a drug by a pharmaceutical laboratory, from the initial tests to the point of sale, is an obstacle race and does not always have a happy ending. According to the recent study “New therapies, new payment methods and technological convergence”, sponsored by Interfarma, an institutional partner of the Brazilian Intellectual Property Association (ABPI), only one among 5,000 to 10,000 investigational new drugs (INDs – new molecules in the early stages of research) are able to overcome all stages – basic research, molecule discovery, preclinical trials, clinical research (Phases I, II and III) and regulatory approval – only to reach the market. Millions and sometimes billions of dollars are invested in this process.

Since there is no guarantee of success in pharmaceutical R&D, a product that reaches the end of the line, that is, reaches the stage of commercialization, could yield huge profits. Nevertheless, a drug that does not translate into marketable medication (the vast majority) generates damage often of equal amount, because the investment is not recovered.

Because of the risk in pharmaceutical R&D, patent protection is a first-rate asset for research companies. But it does not prevent an eventual failure in clinical trials, with often deleterious consequences for young companies, which can have major losses. “In the list of the main failures of 2016, there are six promising molecules whose failure has resulted in a decline of more than 60% in the value of the companies involved; six other molecules resulted in the dismissal of 60% of employees. Sometimes, organizations simply go bankrupt in face of the negative results of their research lines or clinical trials”, the Interfarma study points out.

Panel discussion in the Congress – The path taken by a drug under the intellectual property view will be discussed in the panel “From the test tube to the shelf: the pharmaceutical industry saga”, one of the highlights of ABPI’s XXXIX International Congress on Intellectual Property in August. Participants confirmed for this panel are Craig Tucker, Patent Counsel at Eli Lilly and Company; Frederico de Masi, Senior Bioinformatics Project Manager at Intomics A/S; and Ricardo Luiz Sichel, Solicitor at the BPTO. The moderator of the panel will be attorney Anderson Ribeiro, of Kasznar Leonardos Intellectual Property Office.