T 1396/23 - 2nd medical use claim for foodstuff

Key points

• Claim 1: “Composition comprising polysaccharides and whey protein micelles [provided as a complex, a so-called WPM complex] for use in the treatment or prevention of ... diabetes ...  in a subject;  .."
• “The appellant [opponent] did not contest that claim 1 defined a therapeutic method of treatment pursuant to Article 54(5) EPC. It argued, however, that the effect induced by WPM complexes described in the opposed patent was not therapeutic. The claimed complexes provided nutrition but were unsuitable to prevent the claimed conditions, even less so to treat them."
• The Board: “The patent explains that, prior to the filing date, whey protein isolates were considered not only to be essential nutrients [*] but also to be beneficial in reducing the risk of, and treating, metabolic diseases associated with high-fat diets and/or elevated postprandial insulin levels, such as diabetes (see paragraphs [0005] and [0006] and the references cited in those paragraphs). On this basis alone, it is reasonable to assume that the claimed WPM complexes, which contain whey proteins, could likewise induce these effects.”
• • Here, the Board finds that it was known that whey protein isolates were ‘beneficial’ in “treating ... diabetes”, and that on this basis, it is credible that the claimed composition that comprises whey proteins meets the requirement of Art. 83 for the recited second medical use of treating (or preventing) diabetes.
  • It is unclear to me what the Board means by the statement that whey protein isolatesare ‘essential nutrients’. I assume humans can live without a regular intake of whey protein isolates, or even without a regular intake of whey proteins, for that matter. Whey proteins may contain amino acids, including essential amino acids, but that is not the same.
• The Board notes that additionally, “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. ... The tests in example 3 of the patent show that meal D - [with the WPM complex] - induces a substantially lower insulin response compared with isocaloric and isonitrogenous control meals A and B, which comprise uncomplexed WPM or whey protein isolates ... This indicates that less insulin is required to clear glucose from blood after ingestion of meals comprising the WPM complexes” - than with whey protein isolate, I understand.
• The Board: “It is immaterial what the underlying mechanism of action is ... - the skilled person would appreciate that the claimed WPM complexes are intended to be incorporated into a nutritional composition in place of whey proteins in order to achieve the stated therapeutic effect. 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 Article 54(5) EPC that is used to carry out the claimed therapeutic method.”
• This leads the Board to the following headnote: “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 Article 54(5) EPC”
• “It is undisputed that optimising the insulin response by improving the body's sensitivity to insulin is a cornerstone of diabetes therapy. A reduction in insulin demand following a meal is beneficial in patients affected by or at risk of developing insulin resistance, type 2 diabetes and other associated metabolic diseases. Accordingly, the results of the tests described in the patent make it credible that the claimed composition is suitable for treating and preventing the diseases indicated in claim 1.
• • The headnote seems to pertain only to the second argument of the Board, not to the argument based on the known therapeutic effect of the (prior art) whey protein isolates.
  • Possibly, the view of the Board is that WPM complex is a substitute for the known whey protein (isolate), that the known whey protein is a nutrient with a lower insulin response, i.e. with a beneficial effect for diabetes patients (quite comparable to replacing sucrose/glucose with artificial sweeteners, it seems to me) and that beneficial effect on the health of diabetes patients of the known whey protein is sufficient to support a second medical use claim of the substitute WPM complex.
  • See also e.g. T 2036/21 about "omega-3 fatty acids selected from DHA, DPA and EPA, uridine, choline, and vitamin B12 and folate for preventing dementia".

The link to the decision is provided after the jump.

https://www.epo.org/en/boards-of-appeal/decisions/t231396eu1