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. The ongoing debate over the patent eligibility of inter alia isolated DNA, diagnostic methods and dosage regimes has in the last years resulted in a series of seminal decisions by the US Supreme Court, such as Bilski v. Kappos , Mayo v. Prometheus, and most recently AMP v. USPTO (Myriad). Seminal decision have also been rendered by the European Patent Office and national courts. This presentation will discuss the most recent U.S. case-law developments concerning these crucial issues and compare them to similar developments and case law from Europe.