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Dosage Regimes - EPO Enlarged Board issues decision

The Enlarged Board of Appeal of the European Patent Office has issued its decision in case G 2/08, clarifying the law on second medical use claims. Under the current law, it is permitted to claim a new specific medical use of a known medicament, in the form of a ‘purpose limited’ product claim (ie ‘compound X for use in the treatment of disease Y…’).

In G2/08 the Enlarged Board was asked to consider whether such a ‘new use’ is patentable if it consists of a new treatment of an old illness (ie an illness previously treated with that medicament) and specifically, whether this was the case if the only novel feature of the new treatment was a new dosage regime.

The Board decided that the answer to these questions was ‘yes’ and added that “…there is no reason to give to a feature consisting in a new dosage regime of a known medicament a different treatment than the one given to any other specific use acknowledged in the case law”.

Such dosage regime claims are therefore allowable but also must be considered to be selection inventions. Hence, these claims must provide a technical effect (such as an improvement or advantage) over the general disclosure to meet the requirements of novelty and inventive step.

In the past, prior to the coming into force (in December 2007) of the 2000 revision of the European Patent Convention (EPC2000), it was customary to obtain protection for new medical uses of known compounds by means of so-called “Swiss” claims (“Use of compound X in the manufacture of a medicament for the treatment of disease Y”). Even though other forms of claim are now available, many applicants have continued to include Swiss-type claims in their applications. That practice will need to change in the future. The Enlarged Board indicated in its decision that the acceptance of claims of that type is no longer justified, and that they should not be permitted in future European patents. The Enlarged Board has set a cut-off date, three months after publication of its decision in the Official Journal of the EPO (which has not yet occurred). Swiss-type claims will not be permitted in European patent applications filed (or with priority dates) after that date.

25 February 2010

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