一覧に戻る Dosage Regimen

In its recently published Decision G 2/08 the Enlarged Board of Appeal of the EPO has established the first jurisprudence of the EPO with regard to the second medical use of a known medicament as stipulated in Art. 54(5) EPC, which has been newly introduced into the EPC when the EPC2000 came into effect. The above Decision of the Enlarged Board of Appeal has been eagerly awaited by patent professionals in the field of pharmacology in Europe. In the above Decision the Enlarged Board of Appeal of the EPO has ruled out the following:

1) If the use of a medicament for the treatment of a particular illness is known, the EPC does not exclude the patenting of a medicament for the therapy of the same illness by a different treatment. In particular, it is outlined in the above Decision that one or more steps pertaining by their nature to a novel and non-obvious therapeutic method for using the medicament are sufficient for providing patentability to the new therapeutic use of said medicament. Accordingly, the “specific use” of a medicament in a method of treatment the patentability of which is stipulated in Art. 54(5) EPC is not only considered to be the use in a treatment of a different illness, but also a use in a different treatment of a known illness.

2) The above patenting is also not excluded where a dosage regimen is the only feature claimed which is not comprised in the state of the art, provided that said dosage regimen is novel and inventive. One aspect for assessing novelty and inventive step can be for example the application of the rules developed by the EPO for assessing novelty and inventive step of a selection invention. In particular, it will be assessed whether a new technical effect is caused by the proposed dosage regimen.

3) The second medical use may no longer be claimed in the form of the so-called Swiss-type claim. The above prohibition of the so-called Swiss-type claim applies to all patent applications which are filed after three months after the publication of the above Decision in the Official Journal of the EPO.

As a consequence of the above, it is now possible to obtain patent protection in Europe for a new and inventive method step in a claimed use of a medicament for treating an illness, like e.g. a dosage regimen, although the treatment of said illness with said medicament is already known from the prior art. In this context, it has to be kept in mind that a method of treatment per se is not patentable under the EPC, but a use of a medicament for the treatment of an illness.

Download the full text of the decision G 2/08 “dosage regimen” of the Enlarged Board of Appeal of the EPO under:

http://www.mueller-bore.de/tl_files/Decisions_EPO/Dosage_Regimen.pdf

Should you have any questions, please feel free to contact lenhard@mueller-bore.de

download Pdf