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 Rule 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:
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 is 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);
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). However, said plants or animals should must not be exclusively obtained by means of an essentially biological process (see G‑II, 5.4).
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, 126.96.36.199 and G-II, 5.4). For the general principles governing disclaimers see H-V, 3.5 and H-V, 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) and therefore is not excluded from patentability; or
"Microbiological process" means any process involving or performed upon or resulting in microbiological material.