Case law - patentable subject matter Flashcards
G1/98 Article 53(b) EPC does not exclude claims encompassing but not identifying plant
varieties
Only a claim to a specific plant variety is excluded from patentability under Article 53(b) EPC. A claim that is not directed to a specific plant variety but which embraces multiple plant varieties is not excluded from patentability under Article 53(b) EPC.
When a claim to a process for the production of a plant variety is examined, Article 64(2) EPC is not to be taken into consideration.
The exception to patentability in Article 53(b), first half-sentence, EPC applies to plant varieties
irrespective of the way in which they were produced. Therefore, plant varieties containing genes
introduced into an ancestral plant by recombinant gene technology are excluded from patentability.
G1/04 Diagnostic methods
In order for the subject matter of a claim relating to a diagnostic method practised on the human or
animal body to fall within the prohibition of Article 53(c) EPC, the claim must include features relating
to:
(i) the diagnosis for curative purposes stricto sensu representing the deductive medical or
veterinary decision phase as a purely intellectual exercise,
(ii) the preceding steps which are constitutive for making that diagnosis, and
(iii) the specific interactions with the human or animal body which occur when carrying those
out among these preceding steps which are of a technical nature.
Whether or not a method is a diagnostic method within the meaning of Article 53(c) does not depend on the participation of a medical or veterinary practitioner, nor on whether all method steps can also, or can only, be practised by medical or technical support staff, the patient himself or herself or an automated system. Moreover, no distinction is to be made in this context between essential method steps having diagnostic character and non-essential method steps lacking it.
In a diagnostic method under Article 53(c) EPC, the method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis for curative purposes stricto sensu must satisfy the criterion “practised on the human or animal body”.
Article 53(c) EPC does not require a specific type and intensity of interaction with the human or
animal body; a preceding step of a technical nature thus satisfies the criterion “practised on the
human or animal body” if its performance implies any interaction with the human or animal body, necessitating the presence of the latter.
G2/06 Stem cells
Rule 28(c) EPC forbids the patenting of claims directed to products which – as described in the
application – could, at the filing date, have been prepared exclusively by a method that necessarily involves the destruction of the human embryo from which the said products are derived, even if the said method is not part of the claims. It is not of relevance that after the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos.
G1/07 Treatment by surgery
A claimed imaging method, in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise, is excluded from patentability as a method for treatment of the human or animal body by surgery pursuant to Article 53(c) EPC.
A claim which comprises a step encompassing an embodiment which is a “method for treatment of the human or animal body by surgery” within the meaning of Article 53(c) EPC cannot be left to encompass that embodiment.
The exclusion from patentability under Article 53(c) EPC can be avoided by disclaiming the
embodiment, it being understood that in order to be patentable the claim including the disclaimer must fulfil all the requirements of the EPC and, where applicable, the requirements for a disclaimer to be allowable as defined in decisions G 1/03 and G 2/03 of the Enlarged Board of Appeal.
Whether or not the wording of the claim can be amended so as to omit the surgical step without offending against the EPC must be assessed on the basis of the overall circumstances of the individual case under consideration.
A claimed imaging method is not to be considered as being a “treatment of the human or animal body by surgery” within the meaning of Article 53(c) EPC merely because during a surgical intervention the data obtained by the use of the method immediately allow a surgeon to decide on the course of action to be taken during a surgical intervention.
G2/08 Dosage regime
Where it is already known to use a medicament to treat an illness, Article 54(5) EPC does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness.
Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.
Where the subject matter of a claim is rendered novel only by a new therapeutic use of a
medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G 5/83.
Note that not all of the national courts agree with this decision…
G2/07 and G1/08 Essentially biological processes (Broccoli and Tomatoes)
A non-microbiological process for the production of plants which contains or consists of the steps of sexually crossing the whole genomes of plants and of subsequently selecting plants is in principle excluded from patentability as being “essentially biological” within the meaning of Article 53(b) EPC.
Such a process does not escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants.
If, however, such a process contains within the steps of sexually crossing and selecting an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then the process is not excluded from patentability under Article 53(b) EPC.
In the context of examining whether such a process is excluded from patentability as being
“essentially biological” within the meaning of Article 53(b) EPC, it is not relevant whether a step of a technical nature is a new or known measure, whether it is trivial or a fundamental alteration of a known process, whether it does or could occur in nature or whether the essence of the invention lies in it.
G2/12 Tomatoes II
The exclusion of essentially biological processes for the production of plants in Article 53(b) EPC
does not have a negative effect on the allowability of a product claim directed to plants or plant
material such as a fruit.
In particular, the fact that the only method available at the filing date for generating the claimed
subject-matter is an essentially biological process for the production of plants disclosed in the patent application does not render a claim directed to plants or plant material other than a plant variety unallowable.
In the circumstances, it is of no relevance that the protection conferred by the product claim
encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Article 53(b) EPC.
G2/13 Broccoli II
The exclusion of essentially biological processes for the production of plants in Article 53(b) EPC
does not have a negative effect on the allowability of a product claim directed to plants or plant
material such as plant parts.
The fact that the process features of a product-by-process claim directed to plants or plant material other than a plant variety define an essentially biological process for the production of plants does not render the claim unallowable.
The fact that the only method available at the filing date for generating the claimed subject-matter is an essentially biological process for the production of plants disclosed in the patent application does not render a claim directed to plants or plant material other than a plant variety unallowable.
In the circumstances, it is of no relevance that the protection conferred by the product claim
encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Article 53(b) EPC.
