Contact

RESOURCES

Medical use

Devices

8.181 Claims to a medical device are allowed on the condition that it is novel and inventive. However, it is not possible to claim the first or second medical use of devices. Contrary to substances or compositions in Section 16(3) and Section 14(7) of the Patents Act, which can derive novelty from a novel use in a therapeutic method, there is no equivalent provision in the Patents Act for medical devices. As such, when the device per se is known, the use of the device in relation to a new medical indication would not render the claim novel. “Swiss-type” claims relating to a new use of known surgical apparatus were disallowed in T 775/97 EXPANDABLE GRAFTS/Surgical device [2002] EPOR 24, T 227/91 CODMAN/Second surgical use OJEPO 1994, 491, and in National Research & Development Corporation’s Application BL O/117/85.

8.182 In T 2003/08 EDWARDS LIFESCIENCES, a “Swiss-type” claim relating to the use of a substance in the manufacture of a column for removing immunoglobulin from the blood ex vivo before re-infusing the blood back to the patient was allowed. The claim in question reads:

“Use of a specific ligand for human immunoglobulin in the manufacture of a column having said ligand coupled thereto for the treatment of a patient suffering from dilated cardiomyopathy, said treatment comprising passing plasma of the patient over the column under conditions which effect the binding of said specific ligand to immunoglobulin in the patient’s plasma, thereby removing a significant portion of the immunoglobulin from the patient’s plasma, and reinfusing the plasma to the patient.”

In this decision, several factors were recognised: namely the blood was in a closed circuit connected with the body and thus was considered as a part of the body; the column and ligand were brought into contact with a part of the body, namely blood, and hence was regarded as administered to the patient’s body; the ligand was consumed during use and hence was regarded as a chemical entity; and lastly, the column was not instrumental in achieving the therapeutic effect and thus was regarded as merely a carrier for the ligand. Hence, it was held that the means for achieving the treatment lies in that of the ligand and not the column that holds it. Since the ligand was undeniably a chemical entity, it was also considered a substance or composition. As such, the invention herein lies not in the device (column) per se but in the compound (ligand) and thus, the “Swiss-type” claim was allowed.