Abstract

Personalized Medicine Patents – Opportunities and Challenges

Claudia Meinken, European Patent Attorney, Patents and Trademarks for Life Sciences

The overview will cover the patentability of biomarkers, diagnostics and tailored therapy, which are central building blocks of personalized medicine. While the focus will be on the situation in Europe, a brief overview will also be given on the US situation after some recent decisions of the US Supreme Court. Further, upcoming challenges such as the patentability of in vivo diagnostics and “big data” will be touched. The second part of the presentation will address issues of enforcement of personalized medicine patents, with a focus on most recent case law in Germany, Great Britain and the Netherlands. In particular the questions, who might be sued if a second medical use patent is infringed and how such patents can successfully be enforced so far, although being of importance, have rarely been addressed. These are complex issues, because in contrast to other fields of technology, inventions relating to pharmaceuticals are exploited in a highly regulated market and the patented technology is used by a private person in need of the best treatment.