T 1592/11 - Medical method

EPO T 1592/11

For the decision, click here. 

Key points

• The claim at issue was for "a method of dispensing a dose of medicament from [...] an injection device". The Board finds this to be an unallowable medical method (G 1/07), because it encompasses the step of administering insulin or an insulin-type medicament to a human body (as mentioned in the description). 
• The Board finds that in such case, there is no scope for arguing that the exception of T 245/87 applies that the method is without any functional link between the claimed method and the effects produced by the device on the body (G 1/07, Reasons 4.3.2)
• The proprietor tried adding as disclaimer "the medicament is not administered to a human or animal body". The Board finds this to contravene Art. 84 because "a medicament is a substance used in therapy a method of dispensing a dose of medicament primarily implies that the medicament is administered to a human or animal body. To define that it is not appears to be an oxymoron".

Summary of Facts and Submissions

Claim 3 of auxiliary request XIII reads as follows:

"3. A method of dispensing a dose of medicament from a medicament cartridge within an injection device according to any of claims 1 or 2 comprising the steps of causing the drive mechanism (42) to act on the bung (48) at a first speed; and causing the drive mechanism (42) to act on the bung (48) at a second speed thereafter, wherein the first speed is faster than the second speed."

Note: Claim 1 of auxiliary request IA reads as follows (amendments to claim 1 of the main request are highlighted by the Board):

"1. An injection device for injection of a medicament from a medicament cartridge, the medicament cartridge (40) having a bung (48) displaceable within the medicament cartridge (40) to cause the medicament to be expelled from the medicament cartridge (40), the injection device comprising a drive mechanism (42) for selectively acting on the bung (48) to dispense the medicament from the medicament cartridge (40) and an electronic control unit for controlling operation of the drive mechanism (42) in which the drive mechanism (42) under the control of the electronic control unit initially acts at a first speed and at a second speed thereafter, [deleted: characterized in that] wherein the second speed is slower than the first speed, wherein the drive mechanism (42) is adapted to deliver more output force when operated at the second speed."

Reasons for the Decision

6. Auxiliary request XIII

6.1 Independent claim 3 is directed to "a method of dispensing a dose of medicament from [...] an injection device". The Board questioned the allowability of such a method under Article 53(c) EPC in its communication attached to the summons to oral proceedings. An objection under this ground had already been examined during the oral proceedings before the Opposition Division (paragraphs 5 to 8 of the minutes of oral proceedings).

6.2 By definition, a medicament is a substance used in therapy. Paragraph [0002] of the patent makes it clear moreover that the claimed method encompasses the step of administering insulin or an insulin-type medicament to a human body. Consequently, the claimed method which comprises (or, at least, encompasses) such a step is deemed to be a method of treatment by therapy under Article 53(c) EPC (G 1/07, point 3.2.5 of the Reasons).

The respondent-proprietor's argument that the claimed method did not necessarily encompass the step of administering a medicament to a human body, but could instead be used during a priming operation of the device in which a small amount of a medicament is dispensed without administering it to a human or animal body (as explained in paragraph [0025] of the patent), is hence irrelevant.

6.3 Since the claim comprises (or encompasses) the therapeutic step of dispensing a dose of medicament to the human body, respondent-proprietor's further assertion that the present method claims were only concerned with the operation of a device without any functional link between the claimed method and the effects produced by the device on the body (G 1/07, Reasons 4.3.2; T 245/87, Reasons 5.2) is not accepted by the Board either. There is no room to question the existence of such a link when the therapeutic step is comprised (or encompassed) by the claim. The present claim is explicitly directed to "a method of dispensing a dose of a medicament", rather than to the operation of a device as in T 245/87.

6.4 Consequently, the method of claim 3 of auxiliary request XIII is a method for treatment by therapy within the meaning of Article 53(c) EPC and therefore excepted from patentability.

7. Auxiliary request XIIIi

7.1 Independent claim 3 of this request defines "a method of dispensing a dose of medicament from [...] an injection device" including the disclaimer that "the medicament is not administered to a human or animal body".

7.2 Since a medicament is a substance used in therapy a method of dispensing a dose of medicament primarily implies that the medicament is administered to a human or animal body. To define that it is not appears to be an oxymoron. As such, the definition is unclear and not allowable under Article 84 EPC.

7.3 The respondent-proprietor argued that the patent specification included an example of a method of dispensing a medicament without any therapeutic effect. The disclosed example was a priming operation in which a small amount of medicament was ejected with the needle pointing upwards, without any medicament being administered to a human or animal body (paragraph [0025] of the patent).

The Board considers, however, that the disclosure of the priming operation of the device gives no support for defining it in other terms, particularly not in terms of the mentioned disclaimer. There is hence no support in the description for defining the priming of the device as a method of dispensing a dose of medicament from an injection device wherein "the medicament is not administered to a human or animal body".

7.4 For the above reasons, claim 3 of auxiliary request XIIIi is not considered to be allowable under Article 84 EPC.