PLEASE NOTE: This course has had a change of code - up to and including 2009 it was PHPH9128.

The aim of PHAR9128 is to provide insight into the integration of the various processes involved in the development of new drugs, starting with some lead compounds and progressing through a series of Go / No-Go decisions until a small number of candidate drugs remain that seem worth progressing to market. The decisions that determine Go or No-Go in drug development are a complex mixture of scientific, legal, cultural, budgetary, and commercial factors. Enormous investments are made in drug development and strategies are important to protect and capitalise on that investment. There are, however, limits to that protection which allow for early market entry of generic medicines.

Patent law is an enormously technical and complex subject. It is a mixture of ‘state of the art’ science and innovation in technological fields such as structural chemistry, analytical chemistry, formulation chemistry, molecular biology, and gene technology combined with a body of legal principles developed over many years of litigation and legislation to define and set the limits of a claimed invention. Its purpose is to provide certainty to the owner of a patent during the ‘monopoly period’ to allow the patentee sufficient time to recoup its initial investment and at the same time to provide certainty to competitors to know precisely the limits around a particular invention and hence when they are permitted to enter the market with competitor products.

Note: This course is compulsory for programmes 7370, 5504 and 9060.