The main characteristic of PM is the tailoring of the treatment for certain patient (sub)groups based on predisposition – biomarkers’ status of an individual. A biomarker is involved in new drug candidate discovery and drug development, diagnostics, and evidence generation as well as for drug or therapy determination. With biomarkers’ exploitation patients can be stratified into groups regarding their susceptibility to or diagnoses of disease, and the reaction to the drug or to therapy. The application of PM pharmaceuticals will go in tandem with precision tests that work as tailoring tool. Tests will be data dependent and thus will make this field of Life Sciences data intensive.
The overarching issue of bunch of legal aspects is whether incentives de lege lata that are provided as exclusivity rights can incentivise investing in PM research and development.
It has been alleged that PM pharmaceuticals’ markets are reduced in comparison with traditional medicines’ markets. How do exclusivity rights such as patents function for PM in such circumstances?
Although it is axiomatic that pharmaceutical market cannot function without the intervention of granting exclusivity rights which has the function of first, creating the market for inherently non-exclusive goods, and, second, providing the rights holder with an advanced market position vis a vis its competitors thereby being able to exclude imitation competition and consequently to obtain for limited time maximized profits, it might lead to two intertwined inherent issues which both threat with market failure. The traditional incentive - patent protection - might not be suitable for PM pharmaceuticals as markets are anyways smaller. In this situation, patent exclusivity alone might not effectively provide a perspective of return on investment and thereby might lead to underinvestment. To make PM pharmaceutical business economically feasible, the price for the PM would essentially grow which in case of extremes might lead to other market failure caused by excessive pricing. Due to the reduced size of PM pharmaceuticals’ markets, PM innovators tend to obtain exclusivity rights for each possible innovation all drug development steps.There where patent protection is rather weak or difficult to obtain, other exclusivities such as trade secrets or regulatory exclusivities play a significant role. The thesis addresses the question of what protection de lege lata in Europe offers for these PM innovations. The central research object is exclusivity rights – patents, trade secrets and regulatory law exclusivities (data and market exclusivities), and their implications on PM inventions.
The exclusivity right systems are compared in terms of eligibility, scope of protection and rights granted (effect of ius excludendi).
The question whether this protection is sufficient is analysed within the purposes underlying each of the exclusivity providing system.
The task is to systematically analyse and explain features common and different of those tree types of protection regimes and the effects on incentives for investing in R&D of PM.