One area in which European patent law lacks clarity is how far a commercial product placed on the market becomes part of the state of the art. Whilst it might be relatively simple to analyse the structure of and then reproduce a small chemical molecule, the situation is more difficult when the product placed on the market is more complex (such as a large biomolecule) or when the product is some kind of blend. Is Coca Cola® state of the art as no-one can exactly reproduce it?
G1/92 confirmed that a chemical compound which is placed on the market is state of the art insofar as it can be analysed and reproduced. There is no particular reason needed to analyse the compound and the difficulty of such an analysis is rarely relevant. The tricky issue is reproducibility.
Where it is possible for the skilled person to discover the composition or the internal structure of the product and to reproduce it without undue burden, then both the product and its composition or internal structure become state of the art.
The question is how exact does any reproduction need to be?
There are essentially two conflicting lines of case law. In T1833/14, the board considered whether a polyethylene that was on the market could be considered state of the art. Polyethylenes are complex molecules and are challenging to reproduce exactly but there are many features of a polyethylene that could readily be measured and reproduced. The board in this case concluded however that the polyethylene had to be exactly reproducible:
“Rather, in order for the product to be state of the art, the question is whether or not the skilled person would have been in a position to prepare the product as such, i.e. a sample identical to the polyethylene in all its properties (not only those specified in claim 1).
The board considered that the test for reproducibility mirrored the requirements for sufficiency and as there was no disclosed method for the preparation of the polyethylene, it was not enabled and hence was not part of the state of the art. It wasn’t even available therefore as prior art for inventive step.
In contrast in T0952/02, the board found that what mattered was whether a commercial product existed that had all the key features of claim 1 of the patent at issue. It didn’t matter whether the exact product could be reproduced.
It seems that the Appeal board may be taking steps to resolve this contradiction as in recent case T0438/19 (handled by the author of this piece), the preliminary opinion suggests that a referral to the enlarged board is required and the case has been stayed. The board make the obvious point that it would be anomalous if features of a commercial product that could easily be analysed and reproduced might not be considered state of the art because the exact product cannot be reproduced. It would be obscure if Coca Cola® wasn’t prior art against a claim to a caffeinated fizzy drink on the basis that Coca Cola® cannot be exactly reproduced.
It seems almost certain therefore that a new enlarged board referral will seek to clarify the law in this area.