Current practice of the European Patent Office regarding the examination of plant patentability
As these major legal developments are relatively recent and their application remains subject to interpretation by the Boards of Appeal, questions surrounding the exclusion from patentability of plants obtained by essentially biological processes, as well as these processes themselves, remain relevant.
How are these exclusions handled in practice by EPO examiners and what solutions are available to applicants faced with these exclusions?
We have selected and analyzed various cases representative of EPO practice, paying particular attention to objections raising an exclusion from patentability and applicants' responses to these objections.
Our analysis confirms that the substantive examination of patent applications begins with a check to ensure that the protection sought does not include such objects excluded from patentability. Thus, no patent can be granted if a claim includes a plant variety, an essentially biological process for obtaining plants, or a plant obtained by such a process, even if these objects meet all other conditions for patentability (novelty, inventive step, sufficient description, clarity, etc.).
In the case of claims relating to a plant, an objection will be raised if the examiner considers that the plants included, in whole or in part, in the scope, are likely to be obtained by essentially biological processes (i.e., processes based on the sexual crossing of complete genomes and the subsequent selection of plants).
When faced with this type of objection, most applicants are forced to amend their claims in order to exclude these rejected non-patentable objects. Several types of amendments are possible. However, the explicit exclusion of these plants (by adding a “disclaimer”) seems to be the most commonly used response (used in approximately 45% of the cases analyzed).
Alternatively, when the text of the application as filed allows it, it may be possible to specify the artificial genome modification technique(s) used.
Although this seems to be quite rare, objections may be raised against claims allegedly relating to a plant variety as such. According to our analysis, these objections appear to be mainly related to the interpretation of the claim. While challenging this type of objection seems to have been sufficient in examination proceedings of the cases we analyzed, it cannot be ruled out that these issues may be more difficult to resolve before an EPO Board of Appeal (these aspects are not dealt with here and may be the subject of a future article).
In the case of claims relating to a process, objections of exclusion from patentability apply when the process is considered to include a crossing step, even when this step is not explicitly mentioned in the claims (but is inherent or implicit in them). This also applies to the use of plants in such processes.
In response to these objections, applicants adopt various solutions, mainly based on the removal or exclusion of the crossing and/or selection steps, limitation to non-essentially biological genome modification techniques, and/or reorientation of the objective of the method.
Regardless of the strategies pursued by applicants to overcome objections to patentability relating to inventions in the plant field, our analysis shows that they are not always sufficient to obtain a patent. In fact, they may in turn give rise to objections under other patentability criteria applied by the EPO, in particular for insufficient disclosure under Article 83 EPC or for extension of the subject matter under Article 123(2) EPC.
These “consequential” objections are particularly frequent in the case of disclaimers. We found them in 50% of the cases analyzed in which a disclaimer had been introduced to exclude plants obtained by means of an essentially biological process. Applicants thus find themselves caught in a trap between exclusions from patentability and support requirements.
To escape this trap, applicants are generally compelled to further limit the scope of their claims.
It is therefore essential to anticipate these various constraints when filing the priority application.
Have you developed a new genetically modified plant or a new process for obtaining plants? Do you have questions about this?
The REGIMBEAU teams are at your disposal to assist you in your efforts to protect by patent your inventions in the plant field.
