The direct product of a Swiss-type claim is packaged and provided with instructions

In the appeal underlying the decision T 1673/11 (Treatment of Pompe's disease/GENZYME) of 20.10.2015, the patent had been granted with  a Swiss-type claim to a process of manufacture of a pharmaceutical product. The patentee wanted to change the claim category from a claim under the provisions of the EPC 1973 invoking the legal fiction according to G 5/83 to a claim under the provisions of Article 54(5) EPC 2000, i.e. to purpose-limited product claim and the question arose whether this extends the scope of protection.

Though the products covered by the claims may be identical from a pharmaceutical point of view, the difference lies in the packaging and information leaflet:

8. The respondent disagreed with the approach taken in decision T 1780/12 in as far as it was based on a comparison of the claim categories and the principle that a process claim was inherently narrower than a product claim. In the respondent's opinion, such an approach did not take into account the extension of protection by virtue of Article 64(2) EPC and the delimitation of the subject-matter claimed by the technical features. A purpose-limited process claim in the format of a Swiss-type claim was directed to a process of manufacture of a product. 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 manufacture could not be limiting on the product obtained by it. The medical use as limiting feature was the same whether the claim was drafted in the format of a Swiss-type claim or as a purpose-limited product claim in accordance with Article 54(5) EPC. As a consequence, the protection conferred by both types of claims was the same.  

9. The board does not agree. First, the comparison of the the protection conferred by the categories of claims in the patent before amendment with the protection conferred by the new category of claims introduced by amendment is in line with the test set out in decision G 2/88 (see point 5 above). Second, the protection conferred by a Swiss-type claim in accordance with decision G 5/83 and a purpose-limited product claim in accordance with Article 54(5) EPC 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 (see decision T 1635/09 of 27 October 2010, point 14.2).  

9.1 Claim 1 as granted is directed to the use of human acid alpha glucosidase in the 100 to 110 kD form in the manufacture of a medicament for the treatment of infantile Pompe's disease. Inasmuch as this use may be regarded as a manufacturing process, the claim would, pursuant to Article 64(2) EPC, confer protection on the product directly obtained thereby. The board judges that the product directly obtained is the manufactured medicament which contains as an active substance human acid alpha glucosidase in the 100 to 110 kD form and which is packaged and/or provided with instructions for use in the treatment of infantile Pompe's disease. Indeed, in a Swiss-type claim, the medicament is characterised by the functional feature of the specified therapeutic application. Contrary to the respondent's opinion, this implies limitations to the product directly obtained, although the manufacturing steps are characterised by the use of a defined compound only.

9.2 Claim 1 of the main request being drafted as a purpose-limited product claim, on the other hand, confers 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. Since the claim does not refer to a step of manufacture of a medicament, the product claimed, i.e. the human acid alpha glucosidase in the 100 to 110 kD form, is not limited to a manufactured medicament, packaged and/or with instructions for use in the treatment of infantile Pompe's disease.

9.3 It follows from the above that even if, by virtue of Article 64(2) EPC, the protection conferred by granted claim 1 extended to the product directly obtained by the manufacturing process referred to in said claim, the protection conferred by claim 1 of the main request is broader.

9.4 Nor can the board follow the appellant's argument that since the use limitation of the claims of the main request and of the granted claims was the same, their scope of protection was identical. The board takes 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 claim 1 of the main request when said medicament is being used for the treatment of infantile Pompe's disease. The protection conferred by granted claim 1 does not encompass such use.  

9.5 Consequently, claim 1 of the main request would amend the contested patent in such a way as to extend the protection it confers, contrary to Article 123(3) EPC.