The claims in the pharmaceutical patent – Peculiarities and exceptions


European and Italian Patent and Trademark Attorney, Litapat

IP documentation specialist, Litapat

Speaking about medical and pharmaceutical patents, it is first of all important to specify what is patentable (and what is not) in the European Union.

According to the Article 53(c) of the EPC-European Patent Convention (1) (“Exceptions to patentability”), it is not allowed to patent “methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body”.

There is an analogous provision in the Italian legislation, at article 45(4) of the CPI-Industrial Property Code (2).

Products and processes not excluded from patentability pursuant to Article 53(c), must comply with the provision of Article 54 (4) and (5) EPC (“Novelty”) in order to be granted as a patent. It’s not excluded from the patentability “(4) (…) any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art” and “(5) (…) any substance or composition referred to in paragraph 4 for any specific use in a method ref ... ...