Use of an infant formula for promoting growth is not a method of treatment by therapy
To ensure that medical and veterinary practitioners are free to use their skills and knowledge of the best available treatments without concerns of patent infringement, the European Patent Office (EPO) does not grant patents for methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body (cf. Art. 53(c) EPC).
However, the exception from patentability does not apply to products, in particular substances or compositions, for use in any of these methods. A known substance or composition may be claimed for use in a surgical, therapeutic and/or in vivo diagnostic method on the human or animal body provided that the use is novel and inventive. In the purpose-limited product claims under Article 54(5) EPC (so-called “second medical use” claims) the notional novelty of the claim is derived not from the substance or composition as such but from its intended therapeutic use.
A recent Technical Board of Appeal decision T 815/22 relates to a decision of the Opposition Division to maintain a European patent application (EP3361885) in amended form. Claim 1 recites a nutritional composition being an infant formula or follow-on formula comprising lipid globules having a certain lipid architecture, defined by a specific minimum globule size and the presence of a phospholipid coating, the formula being for use in promoting growth infants. Particularly, the claim defines 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 opposition division found that the claims related to therapeutic uses of the claimed infant formula and that they had to be construed as purpose-limited product claims under Article 54(5) EPC. The opposition division then considered that none of the cited documents disclosed those uses and that, consequently, the claimed subject-matter was novel.
The appellant argued that the claims did not relate to a therapeutic method of treatment. Promoting a postnatal growth trajectory or body development similar to that observed in human milk-fed infants was not a therapeutic use. Thus, the claims were not purpose-limited product claims but merely defined infant formulas suitable for promoting the claimed growth and body development. Further, according to the appellant, since several prior art documents disclosed infant formulas comprising all the features specified in the claims, these infant formulas were suitable for the uses mentioned in the claims. Therefore, the claimed subject-matter lacked novelty.
The patent proprietor argued that the invention related and was limited to a therapeutic use of the nutritional composition. According to the patent proprietor, the skilled person understood that the claims related to formula-fed infants and that these infants were at risk of developing metabolic diseases such as diabetes. By providing a growth trajectory similar to that observed in breastfed infants, these diseases could be prevented in formula-fed infants. Thus, the claimed uses were therapeutic, and the claims were limited to therapeutic uses. Since none of the cited prior art documents disclosed these uses, the claimed subject-matter was novel.
The board did not agree with the proprietor’s view. The board confirmed established case law that both curative and prophylactic methods of treating disease are covered by the word therapy, since both are directed to the maintenance or restoration of health. However, the board stated that it is important not to dilute the concept of treatment by therapy, which 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. The board reasoned that “it would go against the rationale underlying the exclusion from patentability of methods of treatment 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”.
The board notes that claim 1 does not refer to infants who are affected by or at risk of any disorder. Furthermore, the patent explicitly states that all the infants concerned, i.e. the infants in both of the groups compared in the study, are healthy.
Taking this into account, the board concluded that excluding from patentability the use of infant formulas for providing nourishment and promoting the normal growth trajectory and body development observed in breastfed infants would not serve the purpose of excluding therapeutic treatments from patentability in the interest of public health. For the same reason, the use of such infant formulas does not qualify as a medical use under Article 54(5) EPC.
It follows from the above that the claim was found to lack novelty over the infant formulas disclosed in the prior art since these formulas comprising all the features specified in claim 1 are suitable to promote a postnatal growth trajectory and body development similar to those observed in human milk-fed infants.
In conclusion, when trying to protect a purported medical use of a known product, in particular a substance or composition, it is important to ascertain that the use qualifies as a method of treatment excluded from patentability for it to be taken into account as a claim limitation.
At De Clercq & Partners, we are happy to assist you in selecting the most suitable ways to protect your inventions in the medical field. Please reach out to us at info@dcp-ip.com.
