Personalised Medicine: Incentives from Exclusivities Provided by IP and Regulatory Law (Munich Studies on Innovation and Competition, 22)

“It is commonly held that the limited market of Personalised Medicine (PM) undermines the relevance of patent protection, given the limited returns on investment.However, contrary to initial assumptions, this study finds that PM markets are not per se unattractive financially because of their size.While each application market may be characterised by a smaller consumer base, this does not represent the entire scale of the market.The same substance may be utilised for a multitude of applications, encompassing both personalised and conventional drugs.In addition, factors such as the added value of more efficient and targeted treatments and cost reduction of clinical trials also enhance PM’s appeal.Despite the absence of any substantial challenges to the patentability of PM drugs and diagnostics in Europe, the enforcement of these rights against infringement is notably challenging.The uncertain enforcement environment has been shown to encourage strategic behavior from both patent holders