T0815/22 – therapeutic effect


Therapeutic effect, Article 54(5) EPC

T0815/22 – therapeutic effect of infant formula promoting growth
The opponents (appellants) filed appeals against the opposition division's decision finding that the European patent as amended according to the main request met the requirements of the EPC.
Claim 1 relates to:
- an infant formula or follow-on formula comprising lipid globules having a certain lipid architecture, defined by a specific minimum globule size and the presence of a phospholipid coating,
- the formula being for use in promoting a postnatal growth trajectory or body development in an infant towards a growth trajectory or body development similar to that observed in human milk-fed infants.
According to the respondent, the invention was limited to a therapeutic use of the nutritional composition. The respondent argued that the benefits of breastfeeding on growth and long-term health were well known and that formula-fed infants, i.e. infants who were non-breastfed, were known to be at risk of developing metabolic diseases such as obesity. It also argued that by inducing a growth trajectory or body development similar to that observed in breastfed infants, the risk of those diseases was diminished. Hence, the claimed composition had a prophylactic therapeutic effect.
Therefore, in its opinion, claim 1 did not merely relate to feeding an infant to promote growth, but to the use of the claimed infant formula in an "at-risk" group of formula-fed infants to promote a growth pattern or body development which prevented the occurrence of metabolic diseases such as diabetes.
Thus, the claim related to a therapeutic effect and had to be construed as a purpose-limited product claim under Article 54(5) EPC limited to this effect.
The Board does not agree with the respondent's view.
Article 54(5) EPC acknowledges the novelty of substances or compositions even when they are already comprised in the state of the art, provided they are claimed for a new use in a therapeutic method practiced on the human or animal body which Article 53(c) EPC excludes from patent protection. In such cases, the novelty is derived not from the substance or composition as such but from its intended therapeutic use.
Malnutrition occurs when a human or animal gets either too few or too many of certain nutrients (by ingesting too little, too much or the wrong kind of food). A malnourished subject may develop a variety of diet-related diseases.
However, it would go against the rationale underlying Article 53(c) EPC if the ordinary provision of food (i.e. of a substance containing nutrients) in order to provide nourishment - and without any further qualification - were considered a prophylactic therapeutic method within the meaning of this provision. Furthermore, not every deviation from what is considered an optimum diet results in a pathological condition.
If a certain method does not qualify as a therapeutic method under Article 53(c) EPC, a claim directed to the substance or composition for a further use in such a method cannot qualify as a medical use claim under Article 54(5) EPC either. The Board considers that this is the situation in this case.
The idea underlying the claimed invention is to administer a nutritional composition for infants which is similar to human milk, in order to promote a postnatal growth trajectory or body development which is similar to that observed in infants fed with human milk.
It is uncontested that breastfeeding is the natural way and the "gold standard" to provide nourishment and promote normal healthy growth in an infant.
The purpose of feeding an infant with an infant formula or follow-on formula instead of breastfeeding is the same as that of breastfeeding, namely to provide nourishment and to promote the normal growth of the infant. Hence, feeding an infant with a formula promoting normal growth and body development is, as such, not therapeutic.
The Board further notes that claim 1 does not refer to infants who are affected by or at risk of any disorder. Furthermore, paragraph [0009] of the patent explicitly states that all the infants concerned (i.e. the infants in both of the groups compared in the study) are healthy.
It must also be considered that infant formulas can be put on the market and purchased in a non-medical, commercial environment.
Considering all of the above, excluding from patentability, under Article 53(c) EPC, the use of infant formulas for providing nourishment and promoting the normal growth trajectory and body development observed in breastfed infants would not serve the purpose of excluding therapeutic treatments from patentability in the interest of public health.
Claim 1 does not qualify as a purpose-limited product claim falling under Article 54(5) EPC. The claimed subject-matter merely defines an infant or follow-on formula suitable for the claimed uses.
The appellants argued that the subject-matter of claim 1 was not novel over, inter alia, the teaching of D2, D3 and D8.
The respondent did not dispute that these documents disclosed infant formulas containing all the ingredients specified in claim 1. It argued, however, that claim 1 was purpose-limited under Article 54(5) EPC and that the specified uses distinguished the claimed subject-matter from the teaching of the prior art documents.
This argument fails to persuade. As already mentioned above, the uses specified in claim 1 are not therapeutic and do not limit the claimed subject-matter to a therapeutic treatment under Article 54(5) EPC.
Since the infant formulas disclosed in D2, D3 and D8 comprise all the ingredients specified in claim 1, they are suitable to promote a postnatal growth trajectory and body development similar to those observed in human milk-fed infants. Accordingly, the subject-matter of claim 1 lacks novelty over the teaching of these documents.
The patent is revoked.