A presentation given at a 5 days intensive training for practitioners/professionals in Pharma Law & Policy (CSU), 13 – 17 August 2012, 9, at the University of Copenhagen, Frederiksberg Campus.

One of the most controversial topics in pharmaceutical and biomedical patent law relates to the question of whether patent protection should be available for specific diagnostic methods and dosage regimes, which is related to the patentability of 2nd and further medical indications. Recent high profile decisions from Europe and the U.S. have provided some guidance on this issue but many problems still remain. This presentation will first focus on the most recent EPO decisions addressing this crucial issue and discuss their ramifications for theory and practice. Recent US developments are addressed in the following session.