The latest changes to the EPO Guidelines for Examination provide several updates in relation to the patent protection of (i) plants and animals, (ii) human-derived cells, and (iii) methods of treatment by therapy. These updates entered into force on 1 March 2021.
i) Patent protection of plants and animals
Most notably, following the Enlarged Board of Appeal’s recent decision in G 3/19, claims to plants or animals (i.e. products) exclusively obtained by means of an essentially biological process (EBP) are not permitted for applications having a filing date and/or a priority date after 1 July 2017 (Guidelines, F-IV, 4.12; 4.5.2 and G-II, 5.2; 5.3; 5.4; 5.5).
Examples of plants and animals that are not exclusively obtained by means of an essentially biological process
Transgenic and technically induced mutants of plants and animals are patentable, while the products of conventional breeding are not. Offspring of transgenic organisms or mutants, which also have the transgene or mutation are not considered to be produced exclusively by an EBP and are thus also patentable. In other words, a plant or animal originating from a technical process or characterised by a technical intervention in the genome is not excluded from patentability even if a non-technical method (e.g. crossing and selection) is also applied in its production (Guidelines, G-II, 5.4).
Products of a microbiological process (including plant cells and tissues) may be patentable per se. However, plant cells or tissues are usually totipotent and able to regenerate the full plant. Therefore, even if plant cells or cell cultures may be regarded as the product of a microbiological process, plant material which is able to propagate the full plant and originates from a plant exclusively produced by an EBP is excluded from patentability (subject to the filing date provisions noted above; Guidelines, G-II, 5.5.1).
Disclaimers for claims to plants or animals
If a technical feature of a claimed plant or animal, e.g. a single nucleotide substitution in the genome, might be the result of either a technical intervention (e.g. site-directed mutagenesis) or an EBP (e.g. a natural allele), a disclaimer is necessary to limit the claimed subject-matter to the technically produced product. A disclaimer is required even if the description does not mention an EBP. However, if the feature in question can unambiguously be obtained solely by technical intervention, e.g. a transgene, a disclaimer is not required.
Such disclaimers will only be necessary for patent applications with a filing date and/or a priority date after 1 July 2017 (Guidelines, G-II, 5.4).
Product-by-process claims concerning plants or animals
In the latest update, Part F-IV, 4.12; 4.5.2 has been amended to specify particular requirements for product-by-process claims concerning plants or animals not exclusively produced by an EBP.
For such product-by-process claims which comprise a functionally defined phenotypic trait of the plant or animal, the process must clearly impart identifiable and unambiguous technical features to the plant or animal, such as the genetic information present in the genome. Otherwise, the claim will be deemed to lack clarity.
(ii) Patent protection of human-derived cells
At the EPO, human embryonic stem cells and their use for industrial or commercial purposes are excluded from patentability. However, a process making use of human embryonic stem cells or a product derived therefrom may be patentable provided that, at the filing date, the product could have been obtained by a method that does not necessarily involve the destruction of a human embryo.
In Part G-II, 5.3, the Guidelines have been updated to clarify the following:
- Applications relating to human pluripotent stem cells, including human embryonic stem cells, uses thereof and products derived therefrom, are not excluded from patentability provided the invention can be put into practice using human embryonic stem cells derived from parthenogenetically activated human oocytes (and provided that the application has a filing date or valid priority date on or after 5 June 2003).
- Foetal and post-natal human cells are in principle not excluded from patentability.
- Culture media, supports and apparatuses suitable for use with human embryonic cells are also not per se excluded from patentability.
- A parthenote is not a human body at a stage of its formation nor one of its elements, and therefore a parthenote or cells derived therefrom are not per se excluded from patentability under Rule 29(1) EPC.
(iii) What constitutes a “therapy” in relation to the exclusion of methods of treatment by therapy performed on the human or animal body (Article 53(c) EPC)?
In the latest update to the Guidelines, Part G-II, 188.8.131.52 has been updated to specify that “therapy” pertains specifically to the prevention or remedying of a pathological state. On the other hand, the provision of relief from discomfort, where that discomfort is not associated with the existence or potential development of a pathological state, does not constitute “therapy”. For example, the cooling of an animal which does nothing to prevent or remedy a pathological state in that animal would not constitute “therapy”, e.g. if the animal would not develop a disorder were it not cooled (T 385/09).
If you wish to know more about these updates or would like further advice, please contact Ed Ronan or your usual Boult Wade Tennant LLP advisor.
For an overview of the latest updates to the EPO Guidelines in relation to antibodies, amino acid sequences and nucleic acid sequences, please follow this link.