T 847/07 – Try And See?

Claim 1 of the patent as granted (and of the main request) read as follows:

1. A pharmaceutical formulation suitable for subcutaneous, intramuscular or intradermal administration, comprising highly purified recombinant coagulation factor VIII in a concentration of at least 1000 IU/ml.

The claim having been found to lack novelty, an amended claim 1 was filed during oral proceedings before the Board:

1. A pharmaceutical formulation which has a volume of 0.1 to 2 ml and is suitable for subcutaneous, intramuscular or intradermal administration, comprising highly purified recombinant coagulation factor VIII in a concentration of at least 1000 IU/ml.

This amendment provided novelty over prior art disclosing an intravenous administration of the coagulation factor. The following is an extract from the discussion of inventive step:

[68] The board has considered whether or not the skilled person faced with the disclosure in document D8 would be in a “try and see” situation.

The board in decision T 1599/06 [20.2] comes to the conclusion that the “try and see” approach has been applied in the assessment of inventive step in situations where, in view of the prior art, the skilled person had clearly envisaged a group of compounds or a compound and then could determine by routine tests whether or not such compound(s) had the desired effect.

[69] It follows however from the observations above that highly purified factor VIII had not been identified as a candidate for an administration route other than the intravenous one, i.e. it was never envisaged for injection volumes in the range of 0.1 to 2 ml.

Consequently, applying the rationale of the decisions which have used the “try and see” approach as summarised by the board in decision T 1599/06, the board concludes that in the present case the skilled person is not in a “try and see” situation in the light of the disclosure in document D8.

[70] Finally, in the board’s view, it is questionable whether the skilled person would adopt a “try and see” attitude at all in cases such as the present one where extensive in vivo animal and ultimately human testing would be necessary in order to determine whether or not a compound has a certain property.

To read the whole decision, please click here.