5. Exclusions and exceptions for biotechnological inventions
5.2 Patentable biotechnological inventions
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A revised version of this publication entered into force. |
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. Judgments of the Court of Justice of the European Union on the interpretation of EU Directive 98/44/EC are not binding on the EPO. Still, they may be considered as being 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
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).
Rule 29(1) and Rule 29(2)
The examination of a patent application or a patent for gene sequences or partial sequences 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).
(ii)Plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety and if said plants or animals are not exclusively obtained by means of an essentially biological process
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 must not be exclusively obtained by means of an essentially biological process (see G‑II, 5.4).
The exclusion regarding plants and animals exclusively obtained by means of an essentially biological process applies to patent applications with a filing date and/or a priority date after 1 July 2017. It does not apply to patents granted before that date or 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, 5.4.2.1 and G‑II, 5.4). Such a disclaimer will only be necessary for patent applications with a filing date and/or a priority date after 1 July 2017. A disclaimer will not be required for patents granted before that date or for 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, on the other hand, the feature in question can be obtained by technical intervention only, e.g. a transgene, no disclaimer is necessary. For the general principles governing disclaimers, see 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. More detailed instructions on the exclusions on plant varieties can be found in G‑II, 5.4.1.
"Microbiological process" means any process involving or performed upon or resulting in microbiological material.