EPO clarifies the exceptions to patentability for products obtained by biological processes

On June 29th, 2017 the Administrative Council amended Rules 27 and 28 of the European Patent Convention (EPC) in order to clarify the exceptions to patentability related to products obtained by essentially biological processes.

1. In recent decisions (G2/12; G2/13), the Enlarged Board of Appeals took the view that plants and animals obtained by essentially biological processes are not excluded from patentability, even if the underlying process is excluded from patentability.


This approach was criticized as not being in line with the intention of the EU directive on biotechnological inventions (98/44/EC), which had been transposed in the EPC in 1999.


2. In order to clarify the EPC in this respect, Rules 27 EPC and 28 EPC were amended.


Rule 28 EPC is amended to contain an added paragraph 2:


"1. Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:

(a) processes for cloning human beings; 

(b) processes for modifying the germ line genetic identity of human beings;

(c) uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.


2. Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.


Rule 27 EPC (b) is accordingly amended to "(b) without prejudice to Rule 28, paragraph 2, plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety.


The new rules became effective July 1st, 2017. The previously stayed proceedings before the EPO related to cases pertaining to plants or animals obtained by biological processes will be resumed and the new rules will be applied to the pending cases.


This IP Alert is for information purposes only and does not constitute legal advice

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