Wednesday, 21 April 2010

T 286/09 – Composition vs. Ingredients

The present decision deals with the patentability of a second medical indication. It provides an interesting complement to T 254/93 where the Board had come to the conclusion that the mere explanation of an effect obtained when using a compound in a known composition - even if the effect was not known to be due to this compound in the known composition - could not confer novelty on a known process if the skilled person was already aware of the occurrence of the desired effect.

Claim 1 of the main request read:

1. Use of at least one prebiotic in the manufacture of a medicament for decreasing inflammatory process in an elderly human.

[2.3.1] Document D7 discloses a composition which comprises a source of protein, a source of carbohydrate, a source of fat, a probiotic lactic acid bacterium and additionally FOS (fructo-oligosaccharides) and/or inulin. This composition is used in the manufacture of a functional food or a medicament for the prevention or treatment of an immune condition, particularly in elderly patients. Such condition is further defined as including inter alia “conditions associated with aging and leading to an increase of inflammatory responses” […].

Thus, document D7 disclosed the administration of a composition including among others a prebiotic (FOS and/or inulin) to persons (by implication elderly persons) with an immune condition associated with aging and leading to an increase of inflammatory responses. It does not however disclose that the prebiotic as such, or any other ingredient of the composition, has any effect per se in alleviating the condition.

This is to be contrasted with the subject-matter of claim 1, which concerns the effect of a prebiotic for decreasing the inflammatory process. This effect of the prebiotic is moreover shown in the description of the patent is suit which includes a report of a study where the diet of elderly persons was supplemented by a prebiotic (FOS) and a clear effect was observed in terms of decreasing the inflammatory process that could only be attributed to the FOS. Accordingly, the subject-matter of claim 1 of the main request is novel vis-à-vis document D7.

[2.3.2] The Board does not agree with the respondents’ submissions that the skilled person reading document D7 would deduce that FOS and/or inulin were the active ingredients merely because they were specifically mentioned in the composition, whereas the other ingredients were mentioned in more generic terms, or because they would arrive at that conclusion by default since they know that fat and protein are there as bulk food and the prebiotic for preventing diarrhea […], so that the remaining ingredients, namely the probiotic FOS and/or inulin, must be the ones having the effect of decreasing inflammatory process.

In fact, document D7 discloses […] that FOS and inuline “may” be added to the composition and that they provide up to 5% of the energy of the composition.

Thus, contrary to the respondents’ view, in the light of the above passage in document D7, the skilled person can only conclude that the overall composition disclosed in the description is effective in the prevention or treatment of an immune condition, including conditions associated with aging and leading to an increase of inflammatory responses, since each ingredient taken alone plays a different role in the compositions which has no link with inflammatory process.

As to the argument relating to selecting from a single list of ingredients, the Board cannot agree with the respondents either. In fact, as discussed above, document D7 does not disclose a list of several ingredients having each an effect on the inflammatory process, but a composition of several ingredients wherein the effect can only be understood as being the result of the combined effect of all of the ingredients.

Finally, the present situation is to be distinguished from the one in T 254/93.

Indeed, in T 254/93, contrary to the present case, the prior art formulation comprises two ingredients, namely a corticosteroid, well-known for inducing skin atrophy, and a retinoid. Moreover, it was accepted that skin atrophy induced by corticosteroids was accompanied by such strong symptoms that the fact that skin atrophy did not occur when using this prior art composition containing the second ingredient, namely the retinoid, could not be overlooked by the medical practitioner.

Under these circumstances, the Board decided that, although not mentioned expressis verbis in the prior art , the effect of the retinoid on the prevention of skin atrophy caused by corticosteroids could not be regarded as novel because the skilled person was already aware of the occurrence of the desired effect, i.e. he knew from the prior art that the retinoid must have had the effect of preventing skin atrophy (point 4.8).

The present situation is different since, as discussed above, the skilled person could not be already aware of the occurrence of the desired effect, i.e. the skilled person could not know from the prior art that the prebiotic had an effect on inflammatory process because the prior art advocated the use of the prebiotic for a specific purpose, namely to “provide up to 5% of the energy of the composition” […].

The request to refer a question of law to the Enlarged Board of Appeal […] does not need to be considered since in the present case no contradiction to decision T 254/93 occurs since the situation underlying the present case can be distinguished from the situation forming the basis for the decision T 254/93.

To read the whole decision, click here.