Some say the ‘indications’ backed in the patent are next to useless because they are not matched by European Food Safety Authority (EFSA) approved claims, some of which are expected by January, 2010.
Others say the patent validation still provides a powerful marketing tool, especially at a B2B level, even if specific claims are yet to be approved by EFSA.
The health indications patent (EP 0656786) was granted to Australian firm, Novogen Research, in 2004, but was challenged by 10 groups and companies in a Munich appeals court recently.
The judge approved a series of menopausal and pre-menstrual treatment indications related to products containing between 20mg and 200mg of the isoflavones forms, genistein and daidzein. Indications for prostate cancer and hypercholesterolemia were not upheld.
Validation is important
David Hart, SoyLife product manager at Israeli supplier, Frutarom, the exclusive European licensee for Novogen's patent via ADM, said the key point about the verdict is that a major component of the patent has been upheld.
“The is great public knowledge about isoflavones and women’s health and, while no specific claims can yet be made, this decision will assist with marketing materials, at least on a B2B level. But like everyone else, we wait to see what EFSA has to say about these claims.”
Frutarom was involved in the submission of about 400 article 13.1 generic health claims in the area to the EU nutrition and health claims process.
But vice president of marketing and development, Gary Brenner, from Israeli soy ingredients specialist, Solbar, said the menopausal and premenstrual indications approved in the patent will be difficult to translate to market
“The patent and the state of play in Europe means claims on these kinds of soy isoflavones will be narrowed to almost nothing,” he said.
“If any products are going to make treatment claims they are going to find themselves in trouble with EU trading standards if they have not been approved by the European Food Safety Authority (EFSA).”
How reference to the patent approval used in marketing materials is viewed by regulators is not clear, but Hart said he trusted in his customers and noted there were more than 150 isoflavone-bearing products on the market in the Europe that conveyed targeted messages without making explicit claims.
Medicament
Hart acknowledged it was unfortunate the word ‘medicament’ featured in the patent to indicate its ‘treatment indication’, as it was “not an EFSA-friendly” term, and there was some doubt about how it might be interpreted by various EU bodies.
The patent states that isoflavones are a ‘Medicament’ for the “treatment of pre-menstrual syndrome or symptoms associated with menopause."
“There is a fine line between different regulatory bodies,” Hart told NutraIngredients.com.
Both companies asserted the robustness of the clinical data backing their forms of soy isoflavones.
Novogen’s patent was originally applied for in 1993 and took 11 years to be validated after fighting off much commercial opposition. The European application was made in 1999.