5.3 List of exceptions (Rule 28)

Under Art. 53(a), in conjunction with Rule 28(1), European patents are not to be granted for biotechnological inventions which concern:

(i)Processes for cloning human beings 

For the purpose of this exception, a process for the cloning of human beings can be defined as any process, including techniques of embryo splitting, designed to create a human being with the same nuclear genetic information as another living or deceased human being (EU Dir. 98/44/EC, rec. 41).

(ii)Processes for modifying the germ line genetic identity of human beings 

(iii)Uses of human embryos for industrial or commercial purposes 

A claim directed to a product which at the date of filing date of the application could be obtained exclusively by a method which necessarily involved the destruction of human embryos from which the product is derived is excluded from patentability under Rule 28(1)(c), even if the method is not part of the claim (see G 2/06). The point in time at which such destruction takes place is irrelevant (T 2221/10).

When examining subject-matter relating to human embryonic stem cells under Art. 53(a) and Rule 28(1)(c), the following has to be taken into account:

(a)the entire teaching of the application, not only the claim category and wording, and

(b)the relevant disclosure in the description in order to establish whether or not products such as stem cell cultures are obtained exclusively by a use of a human embryo that involves its destruction. For this purpose, the disclosure of the description has to be considered in view of the state of the art at the date of filing.

An application concerning human pluripotent stem cells, including human embryonic stem cells, uses of such cells or products derived from them cannot be regarded as excluded from patentability under Art. 53(a) and Rule 28(1)(c) (T 0385/14) if (i) it has an effective date (i.e. a valid priority date or, if no priority is claimed or the priority is not valid, a filing date of filing) on or after 5 June 2003 and (ii) its technical teaching can be put into practice using human embryonic stem cells derived from parthenogenetically activated human oocytes. In such cases, any disclosure, embodiment, example or similar encompassing the use of human embryonic stem cells excluded from patentability under Art. 53(a) must be excised from the description or prominently marked as not being according to the claimed invention (e.g. by using the term "reference human embryonic stem cell") (see F‑IV, 4.3).

Foetal and post-natal human cells are not excluded from patentability in principle.

Culture media, supports and apparatuses "suitable for" use with human embryonic cells, or even "specifically designed" for this purpose, are not per se excluded from patentability. Their production normally does not require the use of human embryos as base material.

The exclusion of the use of human embryos for industrial or commercial purposes does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it (EU Dir. 98/44/EC, rec. 42).

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

A claim directed to genetically modified animals or to processes for genetically modifying animals needs to meet the requirements of Rule 28(1)(d) and Art. 53(a) (see T 315/03 and T 19/90).

To fulfil the requirements of Rule 28(1)(d), the following needs to be established:

(a)that the subject-matter in question concerns a process for modifying the genetic identity of animals or animals resulting from that process  

(b)the likelihood of animal suffering 

(c)the likelihood of substantial medical benefit and 

(d)the necessary correspondence between suffering and substantial medical benefit in terms of the animals claimed. 

The level or standard of proof for establishing animal suffering and substantial medical benefit is likelihood. The correspondence has to be established according to the balance-of-probabilities approach (E‑IV, 4.3).

For the purposes of Art. 53(a), the suffering of animals and possible risks to the environment are carefully weighed up against the invention's usefulness to humankind, to the extent that these two opposing aspects are supported by evidence (see T 19/90 and T 315/03).

The substantial medical benefit referred to above includes any benefit in terms of research, prevention, diagnosis or therapy (EU Dir. 98/44/EC, rec. 45).

The above must be applied to the whole scope of the claim.

For applications relating to non-genetically modified animals, in all cases where animal suffering or possible risks to the environment are involved, the invention's usefulness to humankind must be considered when carrying out the assessment under Art. 53(a) (T 1553/15).

In addition, the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions (see, however, G‑II, 5.2). Such stages in the formation or development of the human body include germ cells (EU Dir. 98/44/EC, rec. 16).

A parthenote is neither a human body at a stage of its formation and development nor one of its elements (i.e. human germ cell) and so, in principle, a parthenote or cells derived from one are not excluded from patentability under Rule 29(1).

Also excluded from patentability under Art. 53(a) are processes to produce chimeras from germ cells or totipotent cells of humans and animals (EU Dir. 98/44/EC, rec. 38).