A recent decision by an EPO Board of Appeal provides guidance on drafting claims to the therapeutic use of foods.
It follows a case of a patent related to infant formula milk with a claimed “nutritional composition” said to treat infants at risk of developing metabolic diseases.
The patent
European Patent No. 3361885 (“the patent”) was granted in 2019. The patent was opposed by two parties. During opposition, the patentee amended the patent and the Opposition Division (“the OD”) found the patent as amended to meet with the requirements of the EPC.
The opponents (appellants) appealed the finding of the OD.
Claim 1 of the patent under appeal read (underlined section for emphasis):
- A nutritional composition selected from an infant formula and a follow on formula comprising 3 to 7 g lipid/100 kcal, 1.25 to 5 g protein/100 kcal and 6 to 18 g digestible carbohydrate/100 kcal and comprising lipid globules having
a) mode diameter, based on volume of at least 1.0 μm and/or having a diameter of 2 to 12 μm in an amount of at least 45 volume % based on total lipid, and
b) on the surface at least partly a coating of phospholipids
for use in promoting a postnatal growth trajectory or body development in an infant towards a growth trajectory or body development which is similar to the growth trajectory or body development observed in human milk fed infants.
The patentee (respondent) argued from the outset that the purpose of the claimed “nutritional composition” was to treat infants who were at risk of developing metabolic diseases such as diabetes. The theory was that by providing a growth trajectory similar to that observed in breastfed infants, these diseases could be prevented in formula-fed infants by way of the claimed nutritional composition.
How to construe claim 1
At first glance, the claim reads as an EPO style second medical use claim, with everything after “for use” placing a therapeutic purpose limitation on the claim. Indeed, the OD construed the claim as a therapeutic purpose limited product claim under Article 54(5) EPC. The significance of applying a therapeutic purpose limited construction to the claim is that in order to be novelty destroying, a piece of prior art must explicitly disclose that a nutritional composition having the compositional attributes of claim 1 is to be used in therapy to achieve the technical effect of “promoting a postnatal growth trajectory or body development in an infant towards a growth trajectory or body development which is similar to the growth trajectory or body development observed in human milk fed infants”.
The opponents (appellants) argued that the claim does not relate to a therapeutic method of treatment. They argued that the claimed language of “promoting a postnatal growth trajectory or body development in an infant” is not a therapeutic use. Therefore, the “for use” language used at the end of claim 1 should be construed as “suitable for use” and not as a therapeutic purpose limitation. Given the prior art disclosures, the opponents (appellants) argued that the claim lacked novelty.
The patentee argued that, compared to infants fed with human milk, formula fed infants were at higher risk of certain conditions (such as obesity). There was a prophylactic therapeutic effect because providing the claimed nutritional composition to infants diminished the risk of certain disease conditions developing, compared to other formula fed infants. In other words, the claim related to providing formula to an “at-risk” group of infants.
The EPO Board of Appeal (“the Board”) did not agree with the patentee. In their reasoning, the Board provided an interesting discussion of when “for use” claims are therapeutically purpose limited, in the field of food innovations.
The Board’s decision
At the EPO, claims in the format, “Product X for use in treating disease Y,” are novel, even if the product per se, i.e. Product X, is known. Novelty arises from the new therapeutic use of Product X to treat disease Y.
The Board discussed when methods of treatment are excluded from patentability (under Article 53(c) EPC) and when second medical use claims are permitted (under Article 54(5) EPC). The exception to patentability under Article 53(c) EPC and the special approach to novelty under Article 54(5) EPC are complementary.
The Board stated in their decision that, “It would go against the rationale underlying Article 53(c) EPC… if the ordinary provision of food (i.e. of a substance containing nutrients) in order to provide nourishment – and without any further qualification – were considered a prophylactic therapeutic method within the meaning of this provision.” Therefore, the Board construed claim 1 as not therapeutic purpose limited and the “for use” was read as “suitable for use”.
Based on this construction, claim 1 (and other claims in the patent) were found to lack novelty because the prior art disclosed a nutritional composition having all the compositional attributes of claim 1. With a “suitable for” construction that is all that matters and any therapeutic utility can be ignored.
Drafting claims to medical uses
The Board provided guidance on drafting therapeutic purpose limited claims. When second medical use claims are directed to the use of pharmaceutically active components, it is usually straightforward to identify a therapeutic effect. When claiming foods with a biological effect, there can be a grey area between therapy/prophylactic treatment and the provision of nourishment.
The Board indicated that claims to the therapeutic use of foods should refer to specific diseases rather than to the attainment of a biological effect.
We recommend that when claims are drafted to relatively broad biological effects, it is beneficial to include dependent claims to specific diseases (to provide fall back positions).
Additionally, when an invention potentially falls in a grey area between therapy and the provision of nourishment, a claim set should be drafted to include both second medical use claims and traditional “use” claims, at different levels of generality. The aim here is to secure protection for both therapeutic and non-therapeutic facets of an invention.
