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European Patent Office confirms that dosage regimes are patentable

European Patent Office confirms that dosage regimes are patentable


The European Patent Office’s (EPO) Enlarged Board of Appeal (EBoA) has now issued its decision in case G2/08.




As well as confirming the previous practice of the EPO, which allowed a novel dosage regime to confer novelty on a 'second medical use' claim, the Board also ruled that the so-called 'Swiss' claim format for second and further medical indications is no longer to be considered allowable under the revised European Patent Convention (EPC 2000).




Under the EPC 2000 it is permitted to claim a new specific medical use of a known medicament in the form of a 'purpose limited' product claim (i.e. 'compound X for use in the treatment of disease Y').




As previously reported, the EBoA had been asked to consider whether a known medicament used to treat a particular illness can be patented for use in a different, new and inventive treatment of the same illness, and whether this was patentable if the only novel feature of the new treatment was a new dosage regime (which would define the amount and/or timing of administration of a particular medicament).




The EBoA decided that the answer to both of these questions was 'yes'.




This decision confirms that claims to novel dosage regimes are allowable before the EPO. This would be the case even if the compound in question were already known as a treatment for that particular disease. However, it would be necessary to show that the dosage regime is more than an arbitrary selection from a prior broader disclosure and provides a new technical effect, such as an improvement or advantage over the prior art.




The EBoA also considered the implications of EPC 2000 on second and further medical use claims more generally.




The so-called 'Swiss' claim format (i.e. 'use of compound X in the manufacture of a medicament for the treatment of disease Y') will no longer be acceptable before the EPO. Such claims must be in the 'EPC2000' format. A time limit of three months from the date of publication of the decision in the Official Journal of the EPO has been set for future applicants to comply. Pending and already granted applications will not be affected.