My speech described how the pharma & biotech sector is challenged by new ground-breaking regulatory legislation and a significant activity in the courts dealing with the ongoing struggle between innovative drug companies and generic companies, and a fierce policy debate about the right balance for enhancing innovation and access to medicine. In addition my speech pointed out that the many scientific advances cause a constant change of the rules of the game in the industry. The innovative activity in the pharmaceutical sector will presumably increasingly focus on the development of biologics and personalized medicine. I argued that this shift will be accompanied by transformations of "closed up" company-internal R&D strategies, into a system with increased outsourcing of R&D activities and a growing co-operation of "Big Pharma" with smaller “Biotech” start-ups or public entities, such as PPPs with universities. While it can be expected that alternative forms of IPR protection, such as trade secrets and regulatory exclusivities, as well as new models of enhancing open innovation will gain in importance in the course of this so-called pharmaceutical paradigm shift, patents will presumably still play an important role for biopharmaceutical R&D and technology transfer. Accordingly, the design of the patent system and the optimal application of the basic patentability criteria to i.a. DNA- and protein related technology remains an important factor which requires careful analysis.