T 1972/14 - Novelty of second medical use and doubts

Key points

• Claim 1 is directed to a Swiss-type claim of using a infant food formulation with low protein  content " reduce the risk of development of obesity later in life". 
The Board finds that D30 already discloses this. D30 uses the same formulation, the debate is whether the effect is disclosed in D30 (as required for lack of novelty of a Swiss-type claim).
• " The appellant argued that, if not in D30 itself, there was doubt in the prior art as to whether there really was a link between feeding high protein contents early in life and obesity later in life. The appellant in this respect referred to D2, D8 and D42. This argument is not convincing. What matters is what D30 discloses, rather than other prior-art documents. And as set out above, the skilled reader deduces from D30 that such a link is present. " 
• This decision illustrates the interesting questions that arise by incorporating the 'technical effect'  question under for second medical use claims. 

EPO T 1972/14 -  link


Claim 1 of the main request:
"The use of whey, casein and mixtures thereof from cow's milk as a source of proteins for the preparation of an infant formula for administration to a human infant so as to continuously reduce the circulating level of IGF-1 in the first few months of the life of the infant and thereby reduce the risk of development of obesity later in life wherein the infant formula contains less than 2.25 g of protein per 100 kcal."

Reasons for the Decision

Main request

1. Novelty

1.1 Claim 1 is a Swiss-type claim directed to the preparation of a certain infant formula so as to continuously reduce the circulating level of IGF-1 in the first few months of the life of an infant and thereby reduce the risk of development of obesity later in life. As was common ground between the parties, reducing the risk of developing obesity later in life represents the therapeutic effect to be achieved by claim 1, while the continuous reduction of the circulating level of IGF-1 represents the mechanism underlying this effect. A Swiss-type claim can derive novelty from the claimed therapeutic effect, but not from the mechanism underlying it.

1.2 Respondents 1 and 3 attacked novelty on the basis inter alia of D30.

1.3.2 It was acknowledged by the appellant that the formula as used in the study of D30 was as required by claim 1.

1.3.3 As set out above, D30 teaches to avoid excessive protein intake in early life in order to exclude the possibility of predisposition to obesity later in life. D30 thus discloses the claimed therapeutic effect of reducing the risk of development of obesity later in life.

1.3.4 The appellant argued that the link between a reduced protein content and the avoidance of a predisposition to obesity later in life as referred to in D30 was mere speculation, and thus not directly and unambiguously disclosed.

1.3.5 The board does not agree. As set out above, just after addressing predisposition to obesity caused by excessive amounts of protein, D30 presents a study that investigates a formula with reduced protein content. D30 thus does not merely speculate about whether there may be a link between reduced protein content and obesity later in life. On the contrary, it starts from the very premise that this link is present. In fact, otherwise the study disclosed in D30 on formulae with reduced protein contents would not make sense.

This conclusion is not changed by the fact that D30 only discloses that a high protein intake in early life may - and hence not necessarily must - predispose to obesity later in life. Nothing else is required by claim 1, which merely stipulates that the risk of developing obesity later in life is reduced. Referring to a risk does not rule out the possibility of some of the infants fed the formula as defined in claim 1 becoming obese later in life; hence an infant fed this formula may, but not necessarily must, be free of obesity later in life.

1.4 The appellant argued that, if not in D30 itself, there was doubt in the prior art as to whether there really was a link between feeding high protein contents early in life and obesity later in life. The appellant in this respect referred to D2, D8 and D42.

This argument is not convincing. What matters is what D30 discloses, rather than other prior-art documents. And as set out above, the skilled reader deduces from D30 that such a link is present. Incidentally, it is noted that the review article D42 referenced in the introductory section of D30 and referred to by the appellant acknowledges epidemiological evidence, albeit weak, for a link between high protein intake during early childhood and the development of obesity in adults (second sentence of the last full paragraph in the right-hand column of page 2064). There is thus no general doubt in the prior art as regards the presence of this link.

1.5 The appellant also argued that in the prior art, e.g. D2 and D8, the effect on obesity later in life had been investigated only for infants that had been fed formulae with high protein contents after six months of age. This was different from claim 1, which required feeding to take place in the first few months of life.

This argument is not convincing either. The study in D30 was carried out during the first 112 days of life ("Study design" section on page S66), i.e. until roughly four months of age, rather than beyond the age of six months. Thus, the study in D30 was conducted in the same time range as required by claim 1. In fact, the time range in D30 has been acknowledged by the appellant to be identical to that applied in the example of the opposed patent. That other documents such as D2 and D8 relate to different time intervals is of no relevance. What matters is whether D30 itself anticipates the claimed subject-matter, not D2 or D8.

1.6 In view of the above, the subject-matter of claim 1 of the main request lacks novelty over D30.