This revised version of the Guidelines for Examination will apply as from 1 November 2015. Until then, the September 2014 edition of the Guidelines remains valid.

5.2 Patentable biotechnological inventions

In principle, biotechnological inventions are patentable under the EPC. For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the EPC are to be applied and interpreted in accordance with the provisions of Rules 26 to 29. European Union Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (OJ EPO 1999, 101) is to be used as a supplementary means of interpretation. In particular the recitals (abbreviated as rec.) preceding the provisions of the Directive are also to be taken into account.

Biotechnological inventions are also patentable if they concern an item on the following non-exhaustive list:

Biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature

Hence, biological material may be considered patentable even if it already occurs in nature (see also G‑II, 3.1).

Although the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions (see G‑II, 5.3), an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. Such an element is not a priori excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to produce it outside the human body, techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing itself (EU Dir. 98/44/EC, rec. 21).

The examination of a patent application or a patent for gene sequences or partial sequences should be subject to the same criteria of patentability as in all other areas of technology (EU Dir. 98/44/EC, rec. 22). The industrial application of a sequence or partial sequence must be disclosed in the patent application as filed (see G‑III, 4);

Plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety 

Inventions which concern plants or animals are patentable provided that the application of the invention is not technically confined to a single plant or animal variety (EU Dir. 98/44/EC, rec. 29).

This applies even if the only method available at the filing date for generating the claimed plant or plant material is an essentially biological process excluded as such from patentability under Art. 53(b) (see G 2/12 and G 2/13, G‑II, 5.4.2).

A claim wherein specific plant varieties are not individually claimed is not excluded from patentability under Art. 53(b) even though it may embrace plant varieties (see G 1/98, and G‑II, 5.4).

The subject-matter of a claim covering but not identifying plant varieties is not a claim to a variety or varieties (see G 1/98, Reasons 3.8). In the absence of the identification of a specific plant variety in a product claim, the subject-matter of the claimed invention is neither limited nor directed to a variety or varieties within the meaning of Art. 53(b) (G 1/98, Reasons 3.1 and 3.10); or

A microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety 

"Microbiological process" means any process involving or performed upon or resulting in microbiological material.

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