IP Cases & Articles

Scope of second medical use claims: T1673/11

In this case a European Patent Office (EPO) Board of Appeal considered whether there is any extension of the protection conferred by a patent, under the provisions of Article 123(3) EPC, where an amendment only concerns a change in format of a claim from a Swiss-type use claim to an EPC 2000 medical use claim pursuant to Article 54(5) EPC.

Granted claim 1 of European patent No. EP1137762B to Genzyme Corporation was a Swiss-type second medical use claim and read: "The use of human acid glucosidase in the manufacture of a medicament for the treatment of infantile Pompe's disease, wherein the human acid alpha glucosidase is in the 100 to 110 kD form, wherein the medicament is to be administered intravenously, and wherein the treatment is to be continued for at least 4 weeks."

Two oppositions were filed against the patent, and in its interlocutory decision, the Opposition Division decided that the following claim in EPC 2000 format met the requirements of the EPC: "Human acid alpha glucosidase in the 100 to 110 kD form, for use in the treatment of infantile Pompe's disease, wherein the human acid alpha glucosidase is to be administered intravenously, and wherein the treatment is to be continued for at least 4 weeks."

Following an appeal against the decision of the opposition division by an opponent, the Board of Appeal considered whether the amendment to change the format of the claim from a Swiss-type claim to an EPC 2000 second medical use claim was allowable under Article 123(3) EPC.

The patentee argued that a purpose-limited process claim in the format of a Swiss-type claim was directed to a process of manufacture. According to Article 64(2) EPC the protection conferred by such a process extended to the products directly obtained. Because the manufacturing process in a Swiss-type claim was not limited by any technical feature, the patentee argued that manufacture could not be limiting on the product obtained by it. The Board of Appeal disagreed.

The Board of Appeal considered that the protection conferred by a purpose-limited process Swiss-type claim and an EPC 2000 purpose-limited product claim is not the same even if, for the sake of argument, it is accepted that Article 64(2) EPC is to be taken into account when assessing the extent of protection conferred by a Swiss-type claim.

The Board of Appeal judged that the product directly obtained in the Swiss-type claim is the manufactured medicament which contains as an active substance human acid alpha glucosidase in the alpha 100 to 110 kD form and which is packaged and/or provided with instructions for use in the treatment of infantile Pompe's disease. The Board of Appeal went on to say that in a Swiss-type claim, the medicament is characterised by the functional feature of the specified therapeutic application and that this implies limitations to the product directly obtained.

In contrast, the purpose-limited product EPC 2000 claim was viewed as conferring protection on the human acid alpha glucosidase in the 100 to 110 kD form, whenever it is being used for the treatment of infantile Pompe's disease. The board said that since the claim does not refer to a step of manufacture of a medicament, the product claimed is not limited to a manufactured medicament, packaged and/or with instructions for use in the treatment of infantile Pompe's disease.

The Board of Appeal also took the position that, for example, a medicament containing human acid alpha glucosidase in the 100 to 110 kD form packaged and provided with instructions for the use in a treatment other than that of infantile Pompe's disease is encompassed by the scope of the EPC 2000 claim, whereas the protection conferred by the granted Swiss-type claim does not encompass such use.

In view of the above, the Board of Appeal decided that the EPC 2000 claim was not allowable under Article 123(3) EPC. The patent was revoked as all requests on file contained EPC 2000 claims. A request for the referral of the issue to the Enlarged Board of Appeal was refused.

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