New decisions on second medical use claims
and the language of European patent applications
The Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) has issued two decisions providing clarification on points of European practice.
The first decision, G2/08, confirms that protection for a new medical treatment using a known substance is possible under the EPC2000 law that came into force in December 2007, even when the substance is already known for use in a different treatment regime for the same illness. The protection of so-called “second medical uses” should apply to any specific use of the substance in a therapeutic method, provided this use is not known and is inventive.
Essentially, if a method of treatment using a known substance would be patentable were it not for the exclusion from patentability of methods of treatment, then a claim to the substance for this new use should be permitted. This includes situations where the novel and inventive feature is a new dosage regime. This is consistent with the UK Court of Appeal decision in Actavis UK Ltd v Merck & Co Inc.
The EBA also found that the “Swiss type” claim language used for second medical use
claims prior to EPC2000 was no longer acceptable. This claim language, covering use of
a substance in the manufacture of a medicament for the treatment of a specified
therapeutic application, was developed by case law due to a lack of statute in this area. The fact that EPC2000 fills the gap in the statute means that the case law is no longer
required. Accordingly, inventions in this field must use the language permitted by Article
54(5) EPC, namely claiming the substance for use in the specific treatment. However, the
EBA indicated that this bar on Swiss type claim language would not have retroactive
effect. Instead, it would only affect patent applications having an earliest date (priority
date or filing date) three months or more after the date of publication of G2/08 in the
Official Journal.
The second case, G4/08, rules out the possibility of switching the official language of the proceedings for European patent applications. Specifically, the EBA has stated that for a European regional phase application where the PCT application was published in an EPO official language (English, French or German) the European application has this language, by default, as the official language of the proceedings. This language cannot be changed by providing a translation into a different EPO language on filing, nor can it be changed on request, even if all parties agree.
This decision is not unexpected; the rule that had specifically allowed the language of the proceedings to be switched was deleted from EPO law in 1991. However, rules remain that allow the applicant to correspond in any of the languages of the EPO and to use any of the languages of the EPO at oral proceedings. Therefore the main effect of the ruling is that the specification, and any subsequent amendments, must be in the language of the proceedings, and that the EPO will issue its communications in that official language.
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