EP 3 220 752 B1 relates to relates to a composition comprising polysaccharides and whey protein micelles (WPM) for use in improving postprandial insulin levels in a subject.
The polysaccharide used has a negative zeta potential at a pH value in the range of 2.5 to 4.5 and is selected from the group consisting of alginate, xanthan, pectin, gum karaya, gum Arabic and carrageenan, and the weight ratio of WPM to polysaccharide is 30:1 to 0.8:1.
Brief outline of the case
The opposition was rejected and the opponent appealed.
The board confirmed the rejection of the opposition.
The opponent’s point of view
Sufficiency of disclosure
Claim 1 was formulated in the second medical use format under Art 54(5). However, it did not specify the patients for which treatment was intended, the form of the composition or the nature and minimum amount of the WPM-polysaccharide complex in the composition.
The claimed complex was a nutritional ingredient, not a therapeutically active agent. Since it could not reach the bloodstream, it could not lower the postprandial insulin response induced by a meal. No test was provided in which a pathologic insulin response was induced after ingestion of a meal, nor one containing a slow protein such as casein that caused a moderate insulin release.
The effective doses were not specified. For these reasons, the claimed therapeutic effect could not be achieved and the claimed invention could not be carried out.
Lack of IS
The claimed invention did not involve an IS starting from the CPA. The claimed subject-matter differed from the teaching of the CPA in that the WPM were in complexed form.
The test with meal C showed that complexation was not associated with the purported effect. The problem could be regarded, at most, as the “reduction of postprandial insulin response of a specific composition comprising WPM”.
Prior art showed that polysaccharides slowed gastric emptying by increasing viscosity, and that they formed complexes with proteins, including whey proteins, slowing down their digestion. As a consequence, they also decreased postprandial insulinaemia.
It would thus have been obvious to add polysaccharides to the compositions of the CPA to obtain this effect. The WMP of the CPA could be expected to behave like known non-micellar whey proteins.
The proprietor’s point of view
Sufficiency of disclosure
The claimed invention was sufficiently disclosed. Claim 1 was in the second medical use format. It defined the patients to be treated, complexes of WPM and how to prepare them. The tests in the patent confirmed that complexes were formed. More than one protein could bind to a single polysaccharide chain.
Claim 1 excluded an excess of polysaccharide which could induce thickening and gelation. The patent showed that the claimed complexes induced a lower insulin response than isocaloric compositions comprising whey protein isolates and uncomplexed WPM. Thus, less insulin was required to clear the same amount of glucose.
The claimed therapeutic effect was credible. The patent showed how to carry out the invention. There was no need to explicitly mention the effective amount of complex in the claim or to exclude additional ingredients.
No lack of IS
The claimed invention involved an IS over the CPA. It differed from the teaching of the CPA in that the WPM were complexed with polysaccharides, in a specified ratio. The complexation reduced the postprandial insulin release required to clear the same amount of glucose. Since glycaemia remained unaffected, the observed effect could not be attributed to gelation or delayed gastric emptying. Moreover, there was no evidence that polysaccharides induced gelation in the tested compositions.
The OTP was providing an improved whey-based composition for treating diabetes by reducing postprandial plasma insulin levels. None of the cited documents suggested replacing WPM with their complexes to achieve this effect. Only the CPA and another document disclosed WPM, but not in complex form. The known effects of polysaccharides on gastric emptying, insulinaemia and protein digestion could not be expected to apply to compositions comprising complexes of WPM.
The board’s decision
Sufficiency of disclosure
Claim 1 defines the relevant ingredients, namely complexes between WPM and specific polysaccharides. The skilled person would understand that a complex is a molecular entity formed by an association between two or more entities, in this case the WPM and polysaccharides. The ratio of these components and how they can be prepared is specified in claim 1.
The tests made it credible that complexes are formed within the claimed ratios. The claimed ratios exclude the presence of an excess of polysaccharide which could induce thickening or gelation or form aggregates without binding to the micelles.
When consulting the description of the opposed patent, the skilled person understands that the claimed WPM complexes are intended to replace the whey proteins conventionally used as a protein source in nutritional compositions.
For the board, the patent teaches that using the claimed WPM complexes rather than conventional whey proteins is beneficial for subjects who are at risk of or suffer from the diseases indicated in claim 1.
It is immaterial what the underlying mechanism of action is, and also whether the complexes act on a specific target and whether a comparator such as whey protein isolate or uncomplexed WPM is explicitly mentioned in claim 1.
In the context of the invention, the claimed compositions comprising WPM complexes can thus be regarded as “a substance or composition” within the meaning of Art 54(5) that is used to carry out the claimed therapeutic method.
Inventive step
The patent provides evidence that WPM form electrostatic complexes with the claimed polysaccharides..
For the board it was credible that although meal C did not contain complexes, such complexes were formed in vivo, after ingestion, at the pH of the stomach. Thus, even if meal C is considered to be outside the claimed scope, the effects observed after ingestion of meal C are induced by WPM complexes. Meal C demonstrates that the effect can be achieved irrespective of whether the complex is formed before or after ingestion.
The fact that WPM were used in excess in most tests, combined with the observation that no increase in viscosity was detected, makes it credible that the observed effect originated from the WPM complexes themselves rather than from any viscosity increase induced by the polysaccharide.
The formation of a complex between WPM and polysaccharides had been documented for the first time in the application for the opposed patent as filed. None of the prior-art documents disclosed complexes of polysaccharides with WPM, let alone any information on their biological properties.
In view of the different spatial geometry and charge distribution of WPM, the skilled person would not have expected the interactions between polysaccharides and these micelles to be the same as those with uncomplexed whey protein or with micellar casein.
Comments
The present decision reminds us that in order to demonstrate sufficiency it is immaterial what the underlying mechanism of action could be. It has merely to be credible (“plausible” seems definitely banned) and reproducible.
As far as IS is concerned, when it comes to a composition having a therapeutic effect, the notion of expectation of success plays an important role.
Last but not least, the board held that a substance or composition that induces a therapeutic effect when used to replace a known essential nutrient in a nutritional composition may be considered a “substance or composition” within the meaning of Art 54(5).
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