EP 3 361 885 B1 relates to nutrition for infants, in particular infant formula, intended to be used as a sole source of nutrition. In other words, it replaces mother milk.
Brief outline of the case
The opposition was rejected and both opponents appealed.
The OD considered that the claims at stake where related to a medical use and were purpose limited claims under Art 54(5) used in a method of according to Art 53(c).
The board did not agree with the position of the OD and found that claim 1 as granted lacked N over D2=WO 2010/027258 or D3=WO 2010/027259 or D8=WO 2012/173486.
The other AR were also lacking N so that the patent was revoked.
The opponents’ point of view
The claims did not relate to a therapeutic method of treatment. Promoting a postnatal growth trajectory or body development similar to that observed in human milk-fed infants was not a therapeutic use. The tests in the patent did not provide evidence of any therapeutic effects.
The risk of obesity in infants fed with compositions according to the invention was the same as that observed with compositions of the prior art. Thus, the claims were not purpose-limited product claims under Art 54(5); they merely defined infant formulas suitable for promoting the claimed growth and body development.
Several documents, including D2, D3 and D8, disclosed infant formulas comprising all the ingredients specified in the claims, including lipid globules having the claimed lipid architecture. These infant formulas were suitable for the uses mentioned in the claims. Therefore, the claimed subject-matter lacked novelty.
These arguments applied to the MR as well as to the AR.
The proprietor’s point of view
The claims related to a therapeutic method of treatment and were purpose-limited under Art 54(5).
The skilled person understood that the claims related to formula-fed infants and that these infants were at risk of developing metabolic diseases such as diabetes.
By providing a growth trajectory similar to that observed in breastfed infants, these diseases could be prevented in formula-fed infants.
Thus, the claimed uses were therapeutic and the claims were limited to therapeutic uses. Since none of the cited prior art documents disclosed these uses, the claimed subject-matter was novel.
These arguments applied to the MR as well as to the AR.
The board’s decision
The board first established the rationale behind Art 54(5) and Art 53(c) and referred to various G decisions. .
The board reminded that it is established case law that both curative and prophylactic methods of treating disease are covered by the word therapy, since both are directed to the maintenance or restoration of health and referred to the Case Law of the Boards of Appeal, 10th edition, 2022, I.B.4.5.1(b).
For the board, it is, however, important not to dilute the concept of treatment by therapy within the meaning of Art 53(c). Taking into account the rationale underlying this article, this concept must be understood as the curative or prophylactic treatment of a pathological condition which is part of the core of the medical profession’s activities.
Malnutrition occurs when a human or animal gets either too few or too many of certain nutrients. However, it would go against the rationale underlying Art 53(c) if the ordinary provision of food 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 the treatment of which is part of the core of the medical profession’s activities.
The board also relied on earlier case law on nutritional compositions and quoted the following decisions:
In T 586/16, the board, acknowledging that ordinary nutrition is needed for maintaining the body’s principal functions, held that it would take the definition of therapeutic treatment too far if every parent feeding their newborn baby with an infant formula were considered to be carrying out a therapeutic step.
In T 182/16 the claims were directed to an infant composition for use in “improving body composition”, the improvement being selected from an “increase in lean body mass and increased muscle mass”. The board did not agree and considered that the claimed improvements of body composition “were typically non-therapeutic and in any case covered non-therapeutic improvements”.
In T 1186/16 the claims related to a food material comprising palatinose for reducing the postprandial increase of blood glucose levels induced by the ingestion of foods comprising, e.g. carbohydrates. The proprietor argued that the skilled person would have recognised that the claims concerned exclusively individuals vulnerable to hyperglycaemia requiring a therapeutic control of blood glucose levels. Thus, the claims were purpose-limited under Art 54(5). In T 1186/16 the board confirmed that a claim directed at obtaining an effect – reducing postprandial glycaemia – which may result in a therapeutic benefit in subjects requiring control of glucose levels was not “intrinsically” purpose-limited to those therapeutic benefits under Art 54(5).
In T 135/98, the relevant claim related to a fish-feed containing certain ingredients “for use in obtaining a prophylactic effect on diseases or improved health and growth for fish fed with said feed”. According to the proprietor, this use was limited to a medical treatment of the animal body. The board noted that the claim did not specify either the pathological conditions to be prevented or any detail of the alleged improvement, in terms of the health and growth achieved by feeding fish with the claimed diet. Any prophylactic effect on an unspecified disease and any unspecified improvement in health and growth had to be regarded as the natural function or direct consequence of properly feeding the fish with the claimed feed.
Like the boards in the aforementioned cases, the board in this case considered that the use indicated in claim 1 is not therapeutic.
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 and does not fall under the prohibition of Art 53(c) which could justify a claim according to Art 54(5).
Comments
In the present case it is difficult not to agree with the board that a formula intended to replace breast-feeding cannot be considered as having a therapeutic purpose.
On the other hand, there is an established line of case law stating that when therapeutic aspects and non-therapeutic aspects are indistinguishable or difficult to tell apart, the method should be considered as essentially therapeutic. A corresponding substance or composition should thus be protected by a purpose limited claim under Art 54(5).
Although it did not relate to feeding babies, but domestic animals, in T 438/91, a prophylactic treatment, the remedying of scours, which cannot be distinguished from the non-prophylactic feeding of the animal was to be considered in essence prophylactic. A corresponding feed was patentable.
T 780/89, it was held that, even if the claimed method of immune stimulation would have for consequence an increase in meat production, this was merely a secondary effect of the prophylactic and hence non patentable therapeutic treatment. A corresponding substance was patentable.
To say in T 1186/16 that by reducing postprandial glycaemia it could be distinguished between diabetic patients and non-diabetic patients is somehow difficult to follow.
Contrary to T 135/98, in which no pathological condition was disclosed, T 438/91 and T 780/89 had a clear therapeutic aspect which could not be distinguished from the non-therapeutic aspects.
In the present case, there was also no ailment which had to be fought with the infant formula.
On the procedure
The ISR established by the EPO mentioned no less than 6 documents of category A.
D2=WO 2010/027258 and D3=WO 2010/027259 were both not found in the ISR.
D8=WO 2012/173486 was the second document of category A in the ISR.
The conclusion to be drawn is manifest.
https://www.epo.org/en/boards-of-appeal/decisions/t220815eu1
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