8 October 2016

EPO Guidelines 2016: Parts G and H

The salient changes in Part G (Patentability) and Part F (Amendments) of the EPO Guidelines 2016



G-II 5.4.2 Essentially biological processes for the production of plants or animals 
On the other hand, a process involving inserting a gene or trait into a plant by genetic engineering does not rely on recombination of whole genomes and the natural mixing of plant genes, and hence is patentable. However, claims directed to such processes may not contain crossing and selection steps.
However, if a process of sexual crossing and selection includes within it 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 such a process is not excluded from patentability under Art. 53(b) but qualifies as a potentially patentable technical teaching (see G 1/08, G 2/07).
Genetic engineering techniques applied to plants which techniques differ profoundly from conventional breeding techniques as they work primarily through the purposeful insertion and/or modification of one or more genes in a plant, are patentable (see T 356/93). However, in such cases the claims should not, explicitly or implicitly, include the sexual crossing and selection process.
Processes for selecting plants or animals using genetic molecular markers without crossing the plants or animals are not excluded from patentability. Technical means, such as genetic molecular markers, used in such processes are not excluded, either.
A process for producing triploid seedless melon fruit which involves the pollination of sterile female flowers of a triploid plant, unable to carry out successful meiosis, with pollen of the diploid polliniser plant and which therefore does not concern sexually crossing two whole genomes of plants (implying meiosis and fertilisation) and the subsequent selection of plants is not an essentially biological process and is hence not excluded from patentability (1729/06).
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If a process of sexual crossing and selection contains within the steps of crossing and selection an additional step of a technical nature, which by itself introduces a trait into the genome or modifies a trait in the genome of the plant or animal produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants or animals chosen for sexual crossing, then the process is not regarded as an essentially biological process under Art. 53(b).


G-VI 7.1.4 Surgical uses pursuant to Art. 54(5)
A claim defining a second surgical use may read "Substance X/ Composition comprising X for use in a method of intracardiac catheterisation as a protector of blood vessel walls".

If the independent claim is directed to a composition, the definition of the composition may be inserted before or after the term “for use”. 



G-VII 5.4.2 Examples of applying the steps listed in G‑VII, 5.4
The following examples aim at illustrating the application of the steps listed in G‑VII, 5.4, in various scenarios. The scenarios are adapted from case law. The claims are greatly simplified for illustrative purposes.


H-III 4.2 Different text in respect of the state of the art according to Art. 54(3) and Art. 54(4) under EPC 1973
See here.


H-III 4.3 Different text where a partial transfer of right has taken place pursuant to Art. 61 or Rule 78 in respect of certain designated states


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