Second and further medical use claims provide companies and patent lawyers with interesting opportunities, as Caroline Pallard explains.
Under Article 54(5) of the European Patent Convention (EPC) 2000, known substances or compositions are deemed novel provided they are for any specific use in a medical method provided that such use is not comprised in the state of the art (ie, second or further medical use) (this is derived from Article 54 EPC 1973).
In 1983, the Enlarged Board of Appeal (G5/83) defined the way to formulate a second or further medical use of a substance or composition for the manufacture of a medicament for any “specified new and inventive therapeutic application”, based on Article 54 EPC 1973. Since then, case law decisions have primarily dealt with new diseases or conditions defining such second or further medical use.
In 2010, the Enlarged Board of Appeal (G02/08), redefined the way to formulate a second or further medical use of a substance or composition from Article 54(5) EPC 2000 and emphasised that “any specific use in a therapeutic method” as stated in Article 54(5) EPC 2000 could potentially be considered as a second or further medical use of a substance or composition, provided that such use was not comprised in the state of the art, thereby opening up the possibility to protect “any such specific use in a therapeutic method” as long as it meets all other EPC requirements.
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Medical use claims, EPC 2000, second medical use, fulvestrant, Enlarged Board of Appeal