개요로 돌아 The Second Medical Use of a Known Medicament as Stipulated in Art. 54(5) EPC

In its decision T 1319/04 (OJ EPO 2009, 36), a Technical Board of Appeal of the European Patent Office (EPO) referred questions to the Enlarged Board of Appeal of the EPO regarding the second medical use of a known medicament as stipulated in Art. 54(5) EPC. Art. 54(5) EPC has been newly introduced into the EPC when the EPC2000 came into effect. This referral to the Enlarged Board of Appeal has the case number G 2/08 and will be the first jurisprudence of the EPO with regard to Art. 54(5) EPC. The referred questions will be discussed in oral proceedings scheduled for November, 5, 2009. The decision of the Enlarged Board of Appeal is eagerly awaited by patent professionals in the field of pharmacology in Europe. The most relevant questions referred to the Enlarged Board of Appeal are as follows:

Can a medicament, which is known for the treatment of a specific disease, be patented for a novel and inventive manner of treatment of the same disease? If the answer is yes, can the patentability be established by a new and inventive dosage regimen?

In the recent past, several decisions by the Technical Boards of Appeal have taken different views on the assessment of the issue as to whether a new and inventive dosage regimen can establish the patentability of a second medical use claim under the EPC. The patentability of a second medical use, where the target group to be treated is different (T 19/86, OJ EPO 1989, 25), the technical effect is different (T 290/86, OJ EPO 1992, 414) or the mode of administration is different (T 51/93, not published), has been acknowledged. However, there are numerous decisions by the Technical Boards of Appeal which stipulate that a new and inventive dosage regimen cannot be regarded as providing patentability for a second medical use. In the decision T 1020/03 (OJ EPO 2007, 204), the decisions cited above were discussed in detail, and the Board concluded that said decisions are not in conformity with the decision G 1/83 (OJ EPO, 1985, 60) of the Enlarged Board of Appeal. In the decision G 1/83 the Enlarged Board of Appeal set out the conditions for the protection of a second medical use under the EPC. Accordingly, in the decision T 1020/03 a new and inventive dosage regimen is considered to provide patentability to a second medical use. In view of the above, the Technical Board of Appeal responsible for T 1319/04 came to the conclusion that an important point of law arose which has to be decided by the Enlarged Board of Appeal of the EPO.

Additionally, the Enlarged Board of Appeal has outlined in its communication dated September 15, 2009, in preparation for the oral proceedings that it will comment in detail on the changes in the law brought by the revision of the EPC concerning a second medical use of a known medicament. This is of particular relevance for the patenting of inventions in the field of pharmacology, since only meager guidance is provided by the regulations of the EPC regarding the interpretation of the new Art. 54(5) EPC so far.

Download the full text of the decision T 1319/04 “Allowability of Dosage Regimen” of the BoA of the EPO under:

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

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