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 Article 53(b) are concerned.

If a technical feature of a claimed plant or animal, e.g. a single nucleotide exchange in the genome, might be the result of either a technical intervention (e.g. directed mutagenesis) or 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, 5.4.2.1, and G‑II, 5.4). For the general principles governing disclaimers by which plants and animals excluded from patentability are removed from protection, see H‑V, 3.5 and H‑V, 4.

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 (see T 150/82). 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 (see T 20/94).

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 (see T 205/83). Nevertheless, the division examiner 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).

Similarly, examination of product or product-by-process claims in respect of their patentability under the EPC is unaffected by the extent of the protection conferred by the patent or the patent application (see G 2/12 and G 2/13, Reasons VIII(2)(6)(b)).

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