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Eating for health
An ageing and affluent population is creating a new market for functional foods
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Next time you refresh yourself with a probiotic yoghurt or an energy drink you are adding to the growing market of ‘functional foods' - which include nutraceuticals and nutritional additives like vitamins, minerals and amino acids.
Three categories of functional foods are recognised for patent purposes: nutritional supplements like vitamins and plant extracts; complete specialised foods such as those for babies, diabetic patients or people on slimming diets; and foods such as dairy products, yoghurt or margarine supplemented with active ingredients claiming certain health benefits. This last category is now the fastest growing.
At the EPO, patenting activity in functional foods rose sharply around 1999-2000, and by 2004 had tripled. It seems to be a phenomenon confined, so far, to the developed, industrialised world. "It's a response, I think, to the emergence of chronic conditions such as obesity, diabetes and cardiovascular diseases, for which nutrition has become quite important," says Mr Leprêtre. "When you look at the claims for functional foods, most of them are oriented to these diseases." There are also claims for the treatment of certain kinds of cancer, in which diet can play a part.
Healthy margarine
Perhaps the best-known example is Benecol margarine which is aimed at lowering blood cholesterol. It was patented by a group of Finnish companies in 1998
(1)
. Another example is an ‘enzyme modified cheese' that can control high blood pressure
(2)
, patented by Meiji Dairies of Japan where the market for functional foods is very strong. The busiest area at the moment is polyunsaturated fatty acids, especially ‘omega-3', which are active against cardiovascular disease and for lowering blood cholesterol. They are derived from fish oils but some also come from plant materials such as flaxes.
Another very active area is plant extracts, many of which have been known in Chinese or Ayurvedic medicine for centuries, says Mr Leprêtre. But there are new applications involving combinations of plant extracts, incorporating them in foods, and new methods of extracting components from plants, and so on. Foods containing plant extracts tend to be those that are eaten without cooking, such as drinks, confectionary, sauces, dressings and dairy products.
Cranberry and tomatoes
Cranberry juice has a known effect on the treatment of urinary tract disease and has been found to be effective against gastric disease caused by Helicobacter pylori bacteria found in the stomach. Ramot University in Israel has patented a functional food based upon it
(3)
. Another example is lycopene which gives tomatoes their red colour and has an effect on cardiovascular disease prevention. It has also been found to inhibit the progression of prostate cancer.
The problem with many of these extracts is that one has to eat large quantities of the foodstuff to see any benefit. "That's why it is important to know the exact effect of these ingredients and the amount necessary to reach the beneficial effects. They can then be extracted from their natural sources and incorporated into normal foods, such as yoghurt or a drink, so that you get the benefit without dramatically changing your nutritional habits."
When does a functional food become a pharmaceutical product? It is not easy to answer. Mr Leprêtre reports that the Japanese Patent Office draws a clear line between foods and medicines, yet he says: "At European Patent Office we don't have such a plain distinction because we think that the grey area is quite large. If one takes chewing gum, for instance, it is classified as a food product but it can also be a vehicle for a pharmaceutical."
Protecting investment
About 25-30% of patents in the food sector are now linked to functional foods, mostly coming from the big food companies but also from small companies and universities. Pharmaceutical and biotech companies are also interested in this area - as confirmed in a WIND trend report
(4)
which predicted a boom in Europe in the coming years.
But the type of science that is underpinning the health claims is costly, says Professor Wim Jongen of the Wageningen Business Generator. "To get a return on investment companies will need proprietary positions and this makes patents more and more important in the food industry," he confirms.
So what can we expect to see in the future? Foods are chemically more complex than medicines and there is much research under way on how ingredients act on the body and how they interact with other compounds in the food, so we can expect a steady stream of discoveries. "It's difficult to say which area will be particularly active," says François Leprêtre. "The companies will apply for patents in areas for which there is a market and for which they will be allowed to claim a beneficial effect. Because functional foods are composed of traditional ingredients, the discovery of a new effect is the only new thing in these foods."
Wim Jongen warns that consumers will have to be better protected against products that "give the impression they have a health claim but they have not substantiated it". If the market is to develop, he suggests there needs to be a clear-cut distinction between credible, science-based products and those with uncertain health benefits.
Saving lives
The perspectives for world health, and low-income countries in particular, are also relevant. Fortified food could be used in cases such as Vitamin A deficiency, which is a serious health problem in Southern and Southeast Asia, Sub-Saharan Africa, and parts of Central and South America.
Most importantly, one-fifth of infants in the world still do not have access to the six key vaccines: against diphtheria, pertussis, polio, measles, tetanus and tuberculosis. They account for some two million unnecessary deaths a year, in the most impoverished part of the world. One day children may get immunised by edible vaccines. Plants could be genetically engineered to produce vaccines in their edible parts, which could then be eaten when inoculation is needed. Food under study as alternatives to traditional vaccines include bananas, potatoes, tomatoes, lettuce, rice, soybeans and corn.
The world awaits this day with great hope.
From the perspective of patenting
"By novelty, we mean that it was not made available to the public before the filing date of the patent application. This could have occurred in written form, in oral form or by use, production or sale." On that criterion you would not be able to patent a family recipe, such as the soup your grandmother cooked up to treat winter colds, nor would you be able to patent a traditional remedy such as a herbal drink. As a matter of fact, prior art search at the EPO encompasses also databases related to traditional knowledge.
Nonetheless, informal know-how can be a rich source of new discoveries in functional foods. "Traditional remedies are carried out without knowledge of the specific active agent or agents contained in the plants used which are responsible for the therapeutic effect," says Mr Heirbaut. "In such cases, it may still be possible to obtain a patent through identification and isolation of such active agents." And one can also patent a new industrial process that allows a foodstuff to be manufactured commercially.
Many patents for functional foods can claim health benefits, but applicants have to prove it. "They have to distinguish clearly between therapeutic and non-therapeutic claims," says Mr Heirbaut. Therapeutic claims are related to the prevention and cure of disease. Claims related to the slowing of ageing or weight loss, for example, are not therapeutic, as ageing is not a disease but a natural process, while deliberately losing weight may be motivated by lifestyle concerns. "However, treatment of obesity is considered therapeutic because it is a health-endangering condition."
If therapeutic effects are claimed in a European patent application, they have to be supported by evidence, usually based on animal or cell culture experiments which can be extrapolated to humans. "It also must be clear from the claim which specific diseases are being targeted," says Mr Heirbaut. In Japan, patenting of therapeutic effects of foodstuffs and food ingredients is not possible, but a FOSHU (food for specified health use) certificate can be obtained instead. European legislation is comparatively more restrictive about health claims than other markets, such as the United States, and claims made in a patent application will not necessarily be permitted on the packaging of a foodstuff.
With functional foods being a relatively new area there is not yet any body of European case law to guide patent examiners in their decisions and patent practitioners in their patent prosecution.
Patenting activity in functional foods rose sharply around 1999-2000 (click to enlarge)
Bruxelles, March 2007
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Journalists: Tony Jones and Christian Nielsen, European Science Network
- Expert Opinion: François Leprêtre, Marc Heirbaut, François Couzy, Niels Stevnsborg, and Roberto Cecchini at the EPO; Wim Jongen at the Wageningen Business Generator.
- Chart: Henry Lehtiniemi, EPO
- Photo Portrait: Virginia Ramalho, EPO
- Research and Co-ordination: Leo Giannotti, EPO
(1) WO9806405
(2) EP1570744
(3) EP1115387
(4) Wind Report, Innovative Trends on the Functional Food Market