Intellectual Property Strategies for Pharmaceutical Development

This report provides an introduction to the intellectual property strategies involved in the development of pharmaceuticals from the discovery of an NCE, through to its launch, with details and advice on the appropriate decisions and actions. The report also deals with the different types of inventions that may occur.

According to Tufts University in 2003, a new chemical entity (NCE) costs on average US$897 million to develop, including cost of post-approval research (rising from US$803 M in 2001). An NCE can often be copied very easily once it is on the market.

Lesser, but still considerable costs apply to the development of new forms of an NCE, and to new formulations and uses of existing NCEs. To justify such investments the research-based industry, including those who develop new formulations and uses, needs exclusive rights for a reasonable period. This exclusivity allows the investors to recoup their costs, and, if they are lucky, the costs of their failed developments. If they are very lucky and skillful they may make a considerable amount of money.