In the second part of this two-part article, we take a deeper dive into the European Patent Office (EPO) Board of Appeal case law relating to inventions in the field of food technology.
Specifically, this article reviews several decisions on patents directed to the use of foodstuffs to treat a medical condition.
Patent maintained after Appeal Board confirms plausibility of therapeutic effect
The first of those cases, EPO Board of Appeal decision T 1057/22, was regarding a patent relating to a composition comprising fish oil and juice for use in the treatment of a list of specific types of cancer (i.e. second medical use claims). The patent was opposed, and the opposition hearing concluded with the patent being revoked. The opposition decision stated that the patent was insufficient because the scope of the claims was broader than was justified by the data in the patent.
Subsequently, the patentee appealed this decision and submitted an amended claim 1 in which the types of cancer to be treated were significantly reduced to just pancreatic cancer and neurological cancer. The opponent argued that this claim remained insufficient because there was no guidance in the application, as filed, as to which juices, when combined with fish oil, provided an anti-cancer effect.
However, the Appeal Board took the view that the examples, which contained data on the anti-tumour activity of a composition according to claim 1 against pancreatic (Example 2) and neurological (Example 4) cancer cells, meant that the invention was plausible. In relation to the term "juice", the Appeal Board's opinion was that the application as filed, provided sufficient guidance of the types of juices that could be used in the claimed composition. The amended version of claim 1 was therefore considered to be sufficient, and now met the EPO's other requirements for patentability. The initial opposition decision was thus reversed, and the patent was maintained.
This decision highlights the importance of including data in patent applications to support any claimed therapeutic effect. However, it also suggests that a large and extensive data set is not required to substantiate a second medical use invention at the EPO.
EPO upholds second medical use claim with narrowed scope
A further case about treating medical conditions with a foodstuff is EPO Board of Appeal decision T 1863/21. Here, the granted patent was directed to a non-digestible oligosaccharide for use in enhancing partial protein hydrosylate-induced oral tolerance against dietary proteins. Thus, this patent also contained a second medical use claim. The use here was for reducing the risk of a person developing a food allergy due to dietary proteins. The patent was opposed. However, the patentee was successful in defending the patent in the opposition hearing, and the patent was maintained as granted.
The opponent appealed this decision and argued that the claims as granted were effectively directed to a mixture of the oligosaccharide and the partial protein hydrosylate. On this basis, the opponent said that the claim was directed to the mechanism of action of this mixture (i.e. the use), meaning that the mechanism could be ignored when assessing novelty. The Appeal Board disagreed, saying that the claim is to be interpreted as a second medical use claim, and that it would not lack novelty over the disclosure of a mixture of the oligosaccharide and the partial protein hydrosylate where the role of the oligosaccharide for inducing oral tolerance was not mentioned.
The opponent also argued, via a statistical analysis of the patentee's data, that there was no experimental evidence to show that the effect of oral tolerance was achieved over the entire scope of the claims. Specifically, the patent only contained results for a partially hydrolysed whey protein ("pWH"), a blend of three non-digestible oligosaccharides ("NDO"), and a partially hydrolysed whey protein and a blend of three non-digestible oligosaccharides ("pWH + NDO"). The strongest effects were observed for pWH + NDO.
The Appeal Board's view was that this demonstrated that non-digestible oligosaccharides enhance the partial protein hydrolysate's ability to induce oral tolerance. They also concluded that there was no indication that this would not work if different non-digestible oligosaccharides were used.
The opponent additionally argued that the claims were insufficiently disclosed across their entire scope because the protein fragments defined in the claims could only generate oral tolerance against milk proteins. The Appeal Board agreed with this objection. However, it was overcome by the patentee restricting claim 1 to oral tolerance against milk proteins. The patent was therefore maintained with this amendment.
This decision again shows that extensive data might not be required for a second medical use claim relating to a foodstuff to meet the EPO's sufficiency requirements. However, if the patent application as filed contains only minimal data, this might restrict the scope of the claim that is ultimately granted.
EPO rejects second medical use for infant formula based on growth promotion
Finally, T 0815/22 relates to a patent for an infant formula having a specific composition for use in promoting postnatal growth or body development. This claim was therefore again in a second medical use format. Two parties opposed the patent, but it was maintained in the opposition hearing based on the claims as granted. Both opponents filed an appeal against this decision. In the appeal, the Board noted that the purpose of feeding an infant with an infant formula or follow-on is to provide nourishment and promote an infant's normal growth.
This is a prerequisite for healthy development and for preventing disorders and is therefore not therapeutic. This meant that, in contrast to decision T 1863/21 mentioned above, the purpose limitation in the claims did not qualify as a second medical use.
The subject-matter of the claim is interpreted to be any infant formula that has the specified composition, and which was suitable for the claimed use. This meant that the claims were considered to lack novelty over the cited documents, and the patent was revoked. Thus, when seeking patent protection for food compositions that are used for normal, non-therapeutic, nourishment, it is unlikely to be possible to obtain grant of second medical use claims at the EPO.
In conclusion
Together, these decisions reflect the EPO's nuanced approach to second medical use claims in the food technology space, particularly regarding the assessment of data and where the line between therapeutic and nutritional benefits must be clearly drawn.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
