Is a dosage regime patentable?


Annelise Holme

In a decision of February 19, 2010, the Enlarged Board of Appeal interpreted the scope of Article 54(5) of the revised European Patent Convention (EPC), which entered into force on December 13, 2007.

The board concluded that the article does not prevent patenting a medicine used for treating a condition as long as the treatment differs from the existing option by providing a new mode of administration, such as where a dosage regime is the only feature claimed that is not disclosed in the state of the art.

However, irrespective of this decision, the French Court of First Instance in Paris held on September 28, 2010 that a dosage regime is effectively a method of treatment and is, as such, excluded from patentability in view of Article 53 (c) of EPC 2000.

This particular case related to the French part of Merck & Co. Ltd’s patent, filed in October 1994, which claimed “[t]he use of finasteride for the preparation of a medicament for oral administration for the treatment [of] androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg”.

EPC, dosage