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Chemical and Biochemical Practice at the EPO

Novelty Issues

The most important decision on this topic is an Enlarged Board of Appeals decision in case G 01/92, a case brought before the Board by the President of the EPO acting under the powers granted to him under Article 112(1)(b). The Board was asked to resolve a difference between two ordinary appeal boards on the same point of law.[1] In this case, the Board held that making a product available to the public made its composition or construction available to the public, so long as one skilled in the art could directly and unambiguously determine that composition by analysis and reproduce it whether or not particular reasons can be identified for carrying out the analysis.[2]

In the case of Prior use/Packard[3] the question to be decided was formulated in two parts: (1) whether the means of disclosure was available to the public and, if so, (2) whether the information in question was accessible and derivable from such means. The Board went on to state that

it is the fact that direct and unambiguous access to information concerning the composition or internal structure of a prior used product is possible, for example by means of analysis which makes such composition or structure "available" to the public.

However, to meet this test a full analysis of the prior used composition may not be necessary. All that is required is an analysis that is sufficiently detailed to show that the prior used material must have fallen within the claims in question. The fact that detailed analysis of the components of the prior used composition was not possible or was very difficult was not relevant to determining a question of novelty if this could be determined with less detailed analysis.

In principle, in order to reject an application for lack of novelty, it is necessary that a single document discloses that which is claimed. Such a disclosure must be unambiguous.[4] In general, it seems that the EPO will accept that a prior disclosure of a racemate does not destroy the novelty of enantiomers contained in the racemic mixture. However, in view of the known fact that one enantiomer is likely to be much more biologically active than the other if the intended use of the enantiomer is biological in nature, there may be problems in establishing an inventive step. It has been held that it would be obvious to separate them and determine which is the more active, and that making such a determination does not impart patentability: "an enhanced effect cannot be adduced as evidence of inventive step if it emerges from obvious tests."[5]

Furthermore, any such disclosure should be enabling.[6] This enablement requirement in assessing prior art has been particularly important in the area of biotechnology, where questions as to the patentability of DNA fragments or proteins often arise. Such materials may have existed previously, for example, as part of a longer piece of DNA (such as a chromosome) or have existed unrecognized in a cell (for example, some enzymes that are produced for intracellular use only). Hence, in the alpha interferon opposition,[7] claims to a recombinant DNA molecule were upheld even though it appeared that a fragment meeting the definition in the claim might in fact have been isolated previously, and included in a "gene bank," but had never been identified or described. It was reasoned that the prior existence of the DNA, if it had in fact been isolated, had not in fact made any information "available to the public."

This decision was followed in Interleukin-2/Ajinomoto[8] in which it was also found that supply of samples of a polypeptide to a third party to carry out sequencing of that polypeptide did not make the polypeptide "available to the public" despite the fact that the supply was done without any obligation of confidentiality. The board reasoned:

Whether something has been made available to the public is a question of fact to be decided in each individual case. For a complex biochemical to be made available to the public, the minimum that would seem to be required for publication is a notice to those in the field that samples of the biochemical can be obtained on request. and clear evidence of exactly what the biochemical was. These requirements are not fulfilled here.

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© Copyright 1997 John Richards - Posted 11/29/97 v3
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