The nutritional benefits of baby formula is not a therapeutic use (T 0815/22)

Second-medical use patents can be exceedingly valuable, given that they can provide significant additional exclusivity for an existing commercial product. Accordingly, there are strict requirements for what innovations qualify for the additional protection provided by second medical use claims. In T 0815/22, the Board of Appeal considered whether the nutritional benefits of an infant formula to prophylactically reduce the risk of metabolic disease could be considered "a therapeutic use" in a second medical use claim. 

Purpose-limited medical use claims at the EPO

In Europe, methods of treatment are excluded from patentability (Article 53(c) EPC). This exclusion was included in the EPC to ensure medical professionals are free to treat their patients without worrying about patent infringement (G 1/07).  Importantly, however, it is possible to patent substances or compositions for use in a method of treatment (Articles 54(4) and (5) EPC). In contrast to non-medical use claims, a second medical use claim is construed as including the functional effect of the claimed use in the form of a purpose-limited product claim. The new medical use of a known substance or composition is therefore considered novel (G 2/88, Articles 54(4) and (5) EPC). This provision does not apply to any product, but only to products falling under the definition of "substance or composition" (IPKat). Furthermore, a known product for a new non-medical use cannot be patented at the EPO (IPKat). Such a claim is construed to cover the product as "suitable for" the claimed use. If the product is already known, then the claim is thus anticipated by the product itself. 

When determining the patentability of a product and/or its use, key questions are therefore: 

1) Is the claimed product known? If the product is known neither the product nor its non-medical use is novel. However, the medical use of a known product may be considered novel (see Question 2). 

2) Is the claimed product a "substance or composition"? If the known product is not a substance or composition, e.g. it is a medical device, neither its medical or non-medical use will not be considered novel. If the product is a substance or composition, the medical use of the product may be considered novel (see Question 3). 

3) Is the claimed use "a method of treatment, surgery or diagnosis practised on the human or animal body"? If the use is not a therapeutic use of this type, the use of the known product will not be considered novel. The question before the Board of Appeal in T 0815/22 was whether the claimed effects of a known baby formula should be considered a therapeutic use. 

Baby formula - Case background

In T 0815/22, the granted patent (EP3361885) claimed an infant formula of lipid granules. The baby formula was claimed for use to promote growth in infants. Specifically, the claim defined the infant formula as being "for use in promoting a postnatal growth trajectory or body development in an infant towards a growth trajectory or body development similar to that observed in human milk-fed infants".

The question on appeal was whether the claimed use could be considered a medical use under Articles 54(4) and (5) EPC. The patentee argued that the claimed use of the formula should be considered a therapeutic use. Specifically, the patentee argued that the benefits of breastfeeding on the long-term health of babies was well-known, e.g. non-breastfed babies are known to be at greater risk of developing metabolic diseases such as obesity and diabetes. The claimed formula aimed to reproduce the nutritional benefits of breastfeeding. As such, the patentee argued, the claimed composition had a prophylactic therapeutic effect. 

Healthy baby!

In determining whether the claimed use could be considered "therapy" under Articles 54(4) and (5) EPC, the Board of Appeal agreed that the case law considered prophylactic methods as "therapy". Nonetheless, the Board of Appeal considered it important that the concept of therapy should not be diluted: "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" (r. 1.13). Should then the treatment of malnutrition be considered therapy?

Is prophylactic nutrition therapy?

The Board of Appeal reviewed a number of earlier decisions on the therapeutic effects of nutritional compositions. T 182/16, for example, considered a claim directed to the use of an infant formula to increase lean body mass, which the patentee argued would prophylactically reduce the risk of obesity. The Board of Appeal found that the claims were not restricted in scope to the prophylactic therapeutic use and that the claims could therefore not be considered second medical use claims under Articles 54(4) EPC. Similarly, in T 0135/98 the Board of Appeal was not convinced that fish-feed for use in improving the health and prophylactically preventing disease in fish was a use limited to a medical treatment of the animal body. The Board of Appeal was of the view 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."

Against the backdrop of this less-than-promising case law, it is not surprising that the Board of Appeal in T 0815/22 was similarly not convinced by the patentee's arguments that their baby formula had prophylactic therapeutic effects. The Board of Appeal was particularly not convinced that providing a breast feeding substitute could be considered therapeutic:

"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. For all infants, receiving nourishment is a prerequisite for healthy development and for preventing disorders which could arise if an infant is malnourished or fed with a food which does not promote normal growth. Hence, feeding an infant with a formula promoting normal growth and body development is, as such, not therapeutic" (r. 1.31)

The Board of Appeal thus found that the use was not therapeutic and that the claim did not therefore qualify for the Articles 54(4) EPC provision. The claims were thus found to lack novelty. Auxiliary requests directed to various further functional effects or subpopulation of babies were also found to lack novelty, given that the prior formulations could also be considered "suitable" for these uses. 

Final thoughts

Second medical use claims serve the purpose of rewarding innovation into the second medical use of existing pharmaceuticals. Achieving regulatory approval for a new indication of a known drug will often require a multi-million dollar investment in a phase three clinical trial for that indication in order to demonstrate the required safety and efficacy of the drug. However, regulatory data protection in the EU, which protects against generic and biosimilar entry, is not usually available following approval in a second indication. Second medical use patents may therefore be critical for driving further investment into new indications of an on-market drug. It therefore makes sense that second medical use patents should be available within the pharmaceutical field. A pharmaceutical is also sold with an associated label describing its approved uses. A second medical use claim can therefore be mapped relatively easily to the commercial product. 

By contrast, as observed by the Board of Appeal in the present case, baby formulas do not require anywhere near the same level of investment and are not subject to the level of regulation as pharmaceuticals (r. 1.33). It therefore also makes sense that second medical use patents should not be readily available for baby formulas. For one thing, it would be difficult to determine infringement of such a claim, given that baby formulas are not sold with an associated regulatory label describing their approved therapeutic use. The decision in T 0815/22 confirms the existing case law that something more than a nutritional benefit is required to justify additional IP protection in the form of a second medical use patent. 

Further reading

• Substance or device - a distinction without a difference? (2018) 
• How do you determine the novelty of a second (non-medical) use claim? (T 1395/15) (2020)
• Defining a medical device as a product-by-process (T 1869/19) (2022)
• The challenge of patenting combination claims at the EPO (2022)
• Make no bones about it: The "credibility test" has no place in the novelty assessment of second medical use claims (T 0558/20) (2023)
• Board of Appeal proposes a substantially broader definition of "substance or composition" in second medical use claiming (T 1252/20) (2024)