19 February 2010

G 2/08 EPO Case Law Update: EPO Enlarged Board of Appeal Liberalises Law on Second Medical Use Claims: Dosage Regimes Patentable

Garreth Duncan

The EPO’s Enlarged Board of Appeal has just issued an important decision in case G 2/08 clarifying the law on second medical use claims.

The Enlarged Board has decided that, when it is already known to use a medicament to treat a particular illness, Article 54(5) of the European Patent Convention does not exclude from patentability this medicament for use in a different treatment of the same illness. This decision is expected to liberalise the law on second medical uses, as the Enlarged Board has confirmed that it is not necessary for the treatment to be directed to a different illness to confer novelty on the second medical use claim.

In particular, the Enlarged Board has decided that this ruling also applies to second medical use claims where the only novel feature relates to a dosage regime. This confirms that claims to dosage regimes (which define the amount and/or frequency of administration of a particular medicament) are allowable before the EPO. Examples of dosage regime claims include the following: 

• “Substance X for use in the treatment of disease Y, wherein substance X is administered every morning for a 10 day period”.
• “Substance X for use in the treatment of disease Y, wherein substance X is administered at a dosage of 50 to 100 mg/day”.

Such claims would be allowable under the Enlarged Board ruling even if substance X is already known in general terms for treating of disease Y. However, as such claims would be considered a selection invention over this general disclosure, the Enlarged Board has indicated that these claims must comply with the existing requirements of Boards of Appeal case law for selection inventions. In particular, it will be necessary for the dosage regime defined in the claim to provide a technical effect (such as an improvement or advantage) over the general disclosure to meet the requirements of novelty and inventive step.

The Enlarged Board has also indicated that the Swiss-form claim (“Use of substance X in the manufacture of a medicament for the treatment of disease Y”) will no longer be acceptable for second medical use claims before the EPO. The Enlarged Board has set a 3-month time limit from publication of the decision for applicants to comply with this ruling: for applications filed after this time, second medical use claims will be required to use the new format (“Substance X for use in treating disease Y”) introduced by EPC2000. However, this decision does not have retroactive effect, so Swiss-form claims will continue to be acceptable for applications filed before this time period expires.

A more detailed report of the case will follow in the next D Young & Co patent newsletter.