Chapter IV – State of the art
2. Enabling disclosure
Subject-matter described by documentary evidence, i.e. in written, oral or pictorial form, can be regarded as having been made available to the public, and therefore as forming part of the state of the art within the meaning of Art. 54(1), only if the information given is sufficient to enable the skilled person, at the relevant date (see G‑VI, 3) and taking into account the common general knowledge in the field at that time, to put the disclosed technical teaching into practice (see T 26/85, T 206/83 and T 491/99).
A product put on the market before the date of filing of a European patent application cannot be excluded from the state of the art within the meaning of Art. 54(2) for the sole reason that its composition or internal structure could not be analysed and reproduced by the skilled person before that date (G 1/23, order 1). The requirement of reproducibility (enablement, see G 1/23, summary V) is inherently fulfilled, as it is satisfied by the skilled person’s ability to obtain and possess the marketed product (G 1/23, reason 73). A product put on the market is thus part of the state of the art and all analysable properties of that product are also part of the state of the art (G 1/23, Reasons 74 and 91). In this context, the term “product put on the market” includes man-made products as well as naturally occurring materials (G 1/23, Reasons 30). Such products are usually relied upon as prior use, see G‑IV, 7.2. Technical information about such a product (e.g. a technical brochure, non-patent or patent literature) which was made available to the public before the filing date forms part of the state of the art within the meaning of Art. 54(2), irrespective of whether the skilled person could analyse and reproduce the product and its composition or internal structure before that date (G 1/23, order 2).Where a prior-art document discloses subject-matter which is relevant to the novelty and/or inventive step of the claimed invention, the disclosure of that document must be such that the skilled person can reproduce that subject-matter using common general knowledge (see G‑VII, 3.1). Subject-matter is not necessarily common general knowledge simply because it has been disclosed in the state of the art: in particular, if the information can only be obtained after a comprehensive search, it cannot be considered common general knowledge and cannot be used to complete the disclosure (see T 206/83).
For example, a document discloses a chemical compound (identified by name or by structural formula), indicating that the compound may be produced by a process defined in the document itself. It does not, however, indicate how to obtain the starting materials and/or reagents used in the process. If, moreover, the skilled person cannot obtain these starting materials or reagents on the basis of common general knowledge (e.g. from text books, by purchasing them or taking from nature, see G 1/23), the document is insufficiently disclosed with respect to that compound. As a result, it is not considered to form part of the state of the art under Art. 54(2) (at least in so far as it relates to that compound) and so does not prejudice the patentability of the claimed invention.
If, on the other hand, the skilled person knows how to obtain the starting materials and reagents (e.g. they are commercially available, or are well-known and appear in reference text books, or can be taken from nature, see G 1/23), the document is sufficiently disclosed with respect to the compound and is therefore state of the art under Art. 54(2). The examiner can then validly rely on it to raise objections to the claimed invention.
For the enabling disclosure of preclinical data and clinical trials, see G‑VI, 6.1.2.1.