Saturday, 22 December 2012

T 1545/08 – Try And See

As we have seen in the preceding post, the Board was bound by a preceding Board decision and could only examine whether the invention involved an inventive step. The opponents launched an impressive firework of objections, one of which was that the skilled person would have adopted a “try and see” attitude.

[92] As a fifth line of argument [opponent 3] asserts that the skilled person would have at least adopted a “try and see” attitude towards the use of interferon and ribavirin for treating naïve patients having an HCV 1 genotype infection, a viral load of greater than 2 million copies per ml of serum for a period of 40 to 50 weeks and hence an inventive step was not present.

[93] In decision T 1599/06 [20.2] the board observed 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. In decision T 293/07 [37] the board considered that the testing of humans could not be considered to represent known routine tests and accordingly the skilled person was not in a “try and see” situation. Also in decision T 847/07 [70] the board considered it questionable whether the skilled person would adopt a “try and see” attitude at all in cases where human testing would be necessary in order to determine whether or not a compound has a certain property.

[94] In the present case, it can be taken from document OD2 that neither cell culture nor animal models of HCV were available one year before the priority date of the patent. In fact document OD2 states […] that
“[u]nfortunately, cell culture systems and animal models of HCV replication are yet to be developed and the lack of simple in vitro and in vivo systems for evaluating antiviral agents for effects on HCV replication makes it necessary to investigate agents of promise in humans with this disease.”
No evidence is before the board that at the priority date this situation had changed. It follows that the effect of the combination had to be tested in humans. In line with established case law […] the board concludes that the skilled person was not in a “try and see” situation.

Should you wish to download the whole decision, just click here.

The file wrapper can be found here.