5. Exclusions and exceptions for biotechnological inventions
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 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 to "rec." below) in the preamble to the Directive are also to be taken into account. Judgments of the Court of Justice of the European Union on the interpretation of the Directive are not binding on the EPO but they may still be considered persuasive (T 2221/10 and T 1441/13).
Biotechnological inventions are also patentable if they concern an item on the following non-exhaustive list:
(i)Biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature
Biological material may therefore 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 be patentable inventions (see G‑II, 5.3), an element that is isolated from the human body or otherwise produced by means of a technical process and is susceptible of industrial application, including the sequence or partial sequence of a gene, may be a patentable invention, even if its structure is identical to that of a natural element. Such an element is not excluded from patentability on principle, 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).
Rule 29(1) and Rule 29(2)
A patent application or a patent for gene sequences or partial sequences must be examined on the basis of the same patentability criteria as apply 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).
(ii)Plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety and if the plants or animals are not exclusively obtained by means of an essentially biological process
Inventions which concern plants or animals are patentable if their application is not technically confined to a single plant or animal variety (EU Dir. 98/44/EC, rec. 29). However, the plants or animals in question must not be exclusively obtained by means of an essentially biological process (see G‑II, 5.4).
The exclusion of plants and animals exclusively obtained by means of an essentially biological process applies to patent applications with a filing date of filing and/or a priority date after 1 July 2017. It does not apply to patents granted before 1 July 2017 or to pending patent applications with a date of filing date and/or a priority date before that date (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 needed to limit the claimed subject-matter to the technically produced product (see examples in G‑II, 5.4.2.1 and G‑II, 5.4). This applies only to patent applications with a filing date of filing and/or a priority date after 1 July 2017. It is not required for patents granted before 1 July 2017 or for pending patent applications with a date of filing date and/or a priority date before that date (see G 3/19, OJ EPO 2020, A119). If, on the other hand, the feature in question can be obtained by technical intervention only, e.g. a transgene, no disclaimer is needed. For the general principles governing disclaimers, see H‑V, 4.
Where the claimed subject-matter covers but does not identify plant varieties, the claim is not considered to be directed to a variety or varieties (see G 1/98, Reasons 3.8). If no specific plant variety is identified 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 is therefore not excluded from patentability. More detailed instructions on the exclusions of plant varieties can be found in G‑II, 5.4.1.
"Microbiological process" means any process involving, performed on or resulting in microbiological material.