ABSTRACT

This chapter presents some case studies on the development of drugs for pharmaceutical use coming from university research in which both the patent availability and the use of experimental animals and pilot studies in patients were very important and actually necessary. It provides some example of how complicated the patent system can be and how sometimes it can go to excesses. The patent system is totally different from the scientific literature in the sense that, when there is a challenge, it will end up in court, with lawyers. The advent of biotechnology and recombinant DNA technology made it possible to make human tissue-type plasminogen activator (t-PA) — which normally is only present in our body in an extremely low concentration — at very high production yields so that it could be used for thrombolytic treatment. Thrombolytic treatment means the treatment of a heart attack aiming at dissolving the blood clot.