4.12 Product-by-process claim
A claim defining a product in terms of a process is to be construed as a claim to the product as such. The technical content of the invention lies not in the process per se, but rather in the technical properties imparted to the product by the process. Claims defining plants or animals produced by a method including a technical step which imparts a technical feature to a product constitute an exception in so far as the requirements of Art. 53(b) as interpreted by Rule 28(2) are concerned. The exclusion under Rule 28(2) regarding plants and animals exclusively obtained by means of an essentially biological process does not apply to patents granted before 1 July 2017 nor to pending patent applications with a filing date and/or a priority date before 1 July 2017 (see G 3/19, OJ EPO 2020, A119).
If a technical feature of a claimed plant or animal, e.g. a single nucleotide exchange in the genome, can be the result of both a technical intervention (e.g. directed mutagenesis) and an essentially biological process (a natural allele), a disclaimer is necessary to delimit the claimed subject-matter to the technically produced product (see examples in G‑II, 126.96.36.199 and G‑II, 5.4). If, on the other hand, the feature in question can unambiguously be obtained by technical intervention only, e.g. a transgene, no disclaimer is necessary. For the general principles governing disclaimers see H‑V, 4.1 and H‑V, 4.2.
If the process through which the claimed plant or animal is defined does not impart identifiable and unambiguous technical features to the plant or animal, e.g. the genetic information present in the genome, the claim directed to a plant or animal lacks clarity.
Claims for products defined in terms of a process of manufacture are allowable only if the products as such fulfil the requirements for patentability, i.e. inter alia that they are new and inventive, and it is impossible to define the claimed product other than in terms of a process of manufacture. A product is not rendered novel merely by the fact that it is produced by means of a new process. The claim may for instance take the form "Product X obtainable by process Y". Irrespective of whether the term "obtainable", "obtained", "directly obtained" or an equivalent wording is used in the product-by-process claim, it is still directed to the product per se and confers absolute protection upon the product.
As regards novelty, when a product is defined by its method of manufacture, the question to be answered is whether the product under consideration is identical to known products. The burden of proof for an allegedly distinguishing "product-by-process" feature lies with the applicant, who has to provide evidence that the modification of the process parameters results in another product, for example by showing that distinct differences exist in the properties of the products. Nevertheless, the division needs to furnish reasoned argumentation to support the alleged lack of novelty of a product-by-process claim, especially if this objection is contested by the applicant (see G 1/98, T 828/08).