Are functional foods worth the fuss?

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From kombucha bars to hangover ‘cures’, there’s no escaping so-called functional foods. These are sold with the promise of a range of health benefits, from promoting gut flora to reducing cholesterol. But are they worth the hype?

For those with an eye on IP, there are certainly questions to be answered around patent protection. For example, in Europe, the patent office (EPO) makes no distinction between foods and pharmaceuticals. So, if a patent claim encompasses any activity that constitutes a method of treatment for the human (or animal) body by therapy (interpreted broadly), it is unpatentable under Article 53(c) of the European Patent Convention.

On the other hand, an IP claim to a product for use in such a method is patentable (a ‘medical use’ claim), and use can establish novelty and inventive step. This means that evidence that a particular foodstuff reduces blood pressure might support a claim of ‘[Foodstuff] for use in the treatment or prevention of hypertension’, even if the foodstuff is already known.

However, claims of this kind may have very limited practical value, because of restrictions on the marketing of foodstuffs in the European Union. Regulation 1169/2011 prohibits the labelling of foods with assertions that they prevent, treat or cure human diseases. Yet this is exactly the kind of language that the EPO likes to see in this kind of patent claim.

So what can be done about this apparent impasse? One possibility is to refer to a physiological effect that implies treatment or prevention of a disease but does not explicitly state it. For example, you could try: ‘[Foodstuff] for use in a method reducing blood pressure’. This mirrors the language that might eventually appear on the food labelling. However, it may be open to the challenge that it also covers non-therapeutic use, which is not allowed in this claim format.

Another possibility is writing a pair of claims directed to complementary therapeutic and non-therapeutic applications (for example, ‘[Foodstuff] for use in a method of medical treatment to reduce blood pressure’ and ‘Non-therapeutic use of [foodstuff] to reduce blood pressure’). However, the EPO could potentially object that the dividing line between such claims is not clear.

In some cases, it is possible to argue that the therapeutic and non-therapeutic uses are inextricably linked. That is, even when the intended purpose stated in the claim is non-therapeutic, it is also inevitably associated with a therapeutic effect. In such cases, the EPO will still allow the ‘product for use’ claim format.

Finally, food labelling legislation also permits assertions that the foodstuff reduces the risk of disease. Claims in the following format may be both allowable and practically useful: ‘[Foodstuff] for use to prevent or reduce the risk of [disease]’.

Ultimately, getting patent protection for these popular products will mean giving early consideration to the kind of language permitted under food-labelling legislation – and mirroring this language as closely as possible in a claim.

This article was originally published in the third edition of Forward Magazine. You can view it here.