Table 1c. Comparison between the requirements for market authorization and patentability in Europe.

Art 26 Directive 2001/83/EC	Art 52 (1) EPC
The marketing authorisation shall be refused if (...) it proves that: (a) the medicinal product is harmful in the normal conditions of use, or (b) that its therapeutic efficacy is lacking or is insufficiently substantiated by the applicant, or (c) that its qualitative and quantitative composition is not as declared	(1) European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application.