EPO Enlarged Board of Appeal Decision in G2/08 (“Kos”) – Dosage regimen claims

02 March 2010

Gerry Kamstra

In its decision of 19 February 2010, the European Patent Office (EPO) Enlarged Board of Appeal (EBA) interpreted the scope of Article 54(5) of the 2000 revision to the European Patent Convention (EPC 2000, which entered into force on 13 December 2007) as not excluding the patentability of a medicament already known for use in the treatment of an illness where the patent sought relates to the medicament’s use in a different treatment by therapy of the same illness. It also held that so-called Swiss-type claims, which it said only had a temporary “praetorian” function in filling a lacuna in the 1973 text of the EPC, are no longer available – the effect of this part of the decision is not retrospective (so granted patents and applications filed at the EPO, or with a priority date, earlier than three months after publication of the decision in the Official Journal of the EPO will not be affected).

The European patent application was filed originally by Kos Life Sciences, Inc (now Abbott Respiratory LLC) and the claim considered by the EBA is as follows: “The use of nicotinic acid or a compound metabolised to nicotinic acid by the body selected from a group consisting of [named chemicals] for the manufacture of a sustained release medicament for use in the treatment by oral administration once per day prior to sleep, of hyperlipidaemia characterised in that the medicament does not comprise in admixture [disclaimed composition]” (the key features being emphasised in italics). The prior art disclosed the use of nicotinic acid for the manufacture of a sustained release medicament for use in the treatment of hyperlipidaemia by oral administration. The claim is in so-called Swiss form and uses the “fiction” of a novel manufacturing method to get round twin obstacles under EPC 1973, Art. 54(5) of which only allowed claims to the first medical use of a known compound and Art. 52(4) of which prohibited claims to methods of treatment on the grounds of lack of industrial applicability – here the additional problem of lack of novelty and inventive step is sought to be overcome by the additional use of a specific dosage regimen, “once per day prior to sleep”.  The EPO Examining Division objected to the latter feature as it arguably reflects a medical activity, so that too would be contrary to Art. 52(4) EPC 1973.  The Technical Board of Appeal considered that, given the changes in EPC 2000, the permissibility of so-called “dosage regimen” claims, and indeed the previously permissible Swiss claim format, should be reviewed by the EBA having regard to the new rules set out in Arts. 53(c), 54(4) and 54(5) EPC 2000.

The EBA considered the replacement of Art. 52(4) EPC 1973 by Art. 53(c) EPC 2000.  Whereas Art. 52(4) EPC 1973 provided that methods of treatment should not be regarded as susceptible of industrial application, the EBA noted that this basis of exclusion was no longer justified and for that reason Art. 53(c) EPC simply states that patents shall not be granted in respect of methods of treatment.  It then went on to consider Art. 54(4) EPC 2000, which replaces Art. 54(5) EPC 1973, and concluded that no fundamental change was intended as they both provide that, in relation to novelty, the use of any substance or composition in the state of the art in a method excluded by old Art. 52(4)/new Art. 53(c) shall not be excluded from patentability provided the method (i.e. as opposed to the substance or composition) is not in the state of the art (so a new use in a method of treatment can confer patentability). Thus first medical uses of old compounds were, and are, permitted. 

The EBA then went on to consider Art. 54(5) EPC 2000 which, as it said, now expressly allows further patent protection of substances or compositions already known as medicines, provided their use in a method excluded by Art. 53(c) EPC 2000 is a “specific use” which is not in the state of the art. As the EBA also pointed out, Art. 54(5) EPC 2000 fills in the lacuna left by EPC 1973 which required the gap left in relation to further medical uses to be “filled in a praetorian way” by so-called Swiss claims (under EBA decision G 5/83, as EPC 1973 prima facie did not allow further medical use claims).  The principal question before the EBA therefore was whether the term “specific use” should be construed broadly, so as to encompass inter alia dosage regimens, or narrowly. The EBA concluded that there is only one sensible way of construing the requirement underlying the specificity of the use, namely merely by contrast to the generic broad protection conferred on first medical use under Art. 54(4) EPC 2000. Thus, the new use allowed under Art.54(5) EPC 2000 need not be the treatment of another disease.