Dosage Regimen Claims Deemed Patentable by EPO Board of Appeal

In August 2005, a Technical Board of Appeal of the European Patent Office (EPO) issued a decision allowing a dosage regimen claim to be patentable. The decision related to a patent application for a novel dosage regimen of insulin-like growth factor-I (IGF-I).

The patent claim was a second medical use claim or “Swiss claim” which takes the form “use of substance X in the preparation of a medicament for the treatment of disease Y”. The contentious claim was for:

“Use of IGF-I in the preparation of a medicament...[for] the treatment of a chronic disorder...wherein the administration pattern of the medicament comprises...[a cyclic on/off dosage regimen]”.

Under the European Patent Convention, methods of treatment of the human body are excluded from patentability as not being industrially applicable. The EPO, in coming to this decision, has decided that this claim does not relate to a method of treatment.

This is not, however, the first time that the EPO has had to decide on the patentability of a dosage regimen. In 2002, for example, an Opposition Division of the EPO revoked a patent for the anti-cancer drug Taxol. The claimed dosage regimen consisted of a 3 hour infusion of Taxol rather than the previously known 24 hour infusion. This had the effect of reducing neutropenia. The patent claim in this case was for:

“Use of Taxol...for manufacturing a medicamentation...for the administration of...taxol over a period of about 3 hours or less as a means for treating cancer and simultaneously reducing neutropenia”.

The Opposition Division decided that this claim did not relate to a method of treatment and was allowable. The patent was revoked, however, for lack of novelty instead.

The UK part of the European patent for Taxol was also revoked in the UK Court of Appeal. However, the UK Court considered that the claims did relate to a method of treatment and revoked the patent on grounds of lack of industrial applicability as well as lack of novelty.

In a similar case, an Opposition Division of the EPO revoked a patent for the drug Alendronate. This patent also claimed a dosage regimen in which the drug was given in a 70mg single dose once a week rather than the previously known 10mg daily dose. The patent claim was for:

“Use of alendronic acid...for the manufacture of a medicament for treating osteoporosis...adapted for oral administration in a unit dosage form...about 70mg of alendronic acid...according to a continuous schedule...dosing interval of once weekly”.

The Opposition Division considered this related to a method of treatment and revoked the patent on grounds of lack of industrial applicability and lack of inventive step.The UK Court of Appeal, bound by the Taxol case, also revoked the UK part of the European patent. They considered the claims related to a method of treatment and revoked the patent on grounds of lack of industrial applicability and lack of inventive step.

In this latest decision of the EPO (T1020/03), a Technical Board of Appeal, having reviewed the decisions of the Opposition Division and the UK Court of Appeal on Taxol and Alendronate, concluded that there was no reason why dosage regimens were not patentable as long as they were new and inventive. The decision stated that “any use to which Article 52(4) EPC first sentence applies in circumstances where the composition has already been suggested for some therapeutic use, allows a second medical use claim to the preparation of the composition for that second medical use, irrespective of in what detail that use was specified, subject to the use being novel and inventive.” The Board considered that such claims were directed at the manufacture of the medicament intended for a particular use rather than at the method of treatment per se. This decision is significant as it raises doubt as to the EPO’s position on this type of claim. Hopefully, the Enlarged Board of Appeal will consider this area and provide further guidance. In any event, this decision appears to be a step in the right direction for inventions relating to novel dosage regimens.

Even if the EPO begins to follow T1020/03, such dosage regimen claims are unlikely to be enforceable in the UK due to the previous Taxol and Alendronate UK decisions. The UK position is unlikely to change unless it is reviewed by the House of Lords in an appeal from the Court of Appeal. Such an appeal is unforeseen at present. The presence of Jacob, L. J. in the Court of Appeal may have an impact on the chances of such an appeal since it is clear from his comments in the High Court decision on Alendronate that he had misgivings as to the precedent set in the earlier Taxol case. The only other potential for change lies with the introduction of the EPC 2000, which should come into force in about two years and which slightly changes the law with regard to these types of claims.

So, do dosage regimen claims relate to a method of treatment? When a marketing authorisation is sought for a drug, a dosage regimen is specified. Accordingly, the dosage regimen may be regarded as an intrinsic aspect of the marketed product for most of the uses to which the product will be put. This seems to tie in with the decision of the EPO to consider dosage regimen claims as being directed to the manufacture of the final marketed medicinal product and not at the method of treatment. However, it is yet to be seen whether this will become official EPO policy, or whether the position of the UK Courts will alter to provide the appropriate enforceability.

Justin Wilson and Adrian Tombling
Life Sciences and Chemistry Group
London Office