Medical Use Claims: EPC 2000 and its Impact on Prosecution and Enforcement

Patents, economic monopolies granted for a limited period of time, are generally considered by the world wide industry as an important tool for returning investments into new technologies to further develop them up to a level on which society can profit from them. Such patents are also particularly important in the pharmaceutical area. It is currently understood that the development of a pharmaceutical until its introduction into the market costs about $1.7 billion. Thus, it is straight forward that optimization of medical care strongly depends on the patentability of research based technical contributions in the pharmaceutical area. In this context, it should also be mentioned that 99.9% of the tentatively useful pharmacologically active compounds for which there has been proof of concept eventually fail. The average success rate of those compounds that make it into clinical trials is only 11%. This continuous searching for the needle in the haystack makes it a challenging task to operate a pharmaceutical company steadily on a profitable level, something that tends to be forgotten in academic debates about patenting pharmaceutical inventions.

In the United States, in Japan and in the contracting states of the European Patent Convention it is customary practice to grant compound protection for lower molecular weight organic compounds, proteins and antibodies, to mention a few. This even applies to Germany, France and Italy after the amendment of their national Patent Acts in light of Directive 98/44/EC of the European Parliament and of the Council of July 6, 1989 on the Legal Protection of Biotechnological inventions. Examples of successful drugs based on lower molecular weight organic compounds are Clodronate and Ibandronate (for osteoporosis), Atorvastatin and Symv-astatin (fat metabolism disorders) and Olanzapine (schizophrenia). Examples of successful drugs based on recombinant proteins are Somatotropin (human growth hormone for GH deficiencies), Epoetin (erythropoietin for anemia) and Filgastin/ Lenograstim (G-CSF for recovery from neutropenia). Finally, examples of successful drugs based on antibodies developed relying on genetic engineering are Hercep-tin (metasstatic breast cancer), Avastin (colorectal cancer) and Mylotarg (acute myeloid leukemia).