Austrian supplements infringe isoflavones patent

An Austrian court has ruled against a red clover food supplement for making misleading menopausal claims in breach of a European health indications patent held by the Australian firm, Novogen.

The Vienna Commercial Court found Vitalady supplements were inappropriately using menopause claims protected under the patent in relation to the isoflavone properties of red clover.

The dispute centred around the use of the term ‘medicament’, which is used to describe products that fall under the patent – the court found food supplements were indeed medicaments.

Novogen recently had the menopausal and pre-menstrual aspects of its patent (EP 0656786) validated in a Munich court after it was challenged by about 10 companies and groups. Indications for prostate cancer and hypercholesterolemia were not upheld.

The upheld claims were granted to Novogen in Europe in 2004 and refer to genistein, daidzein, biochanin A and formononetin in products containing between 20mg and 200mg of the isoflavones forms.

The claims are sub-licensed to ADM outside of Australia and New Zealand.

Claim indications versus claims

In Europe the manner in which the claims can be used on-market is not straightforward as the claims backed in the patent have not been approved at European Union level, although they may soon if the European Food Safety Authority (EFSA) views positively pending applications.

David Hart, SoyLife product manager at Israeli supplier, Frutarom, the exclusive European licensee for Novogen's patent via ADM, told this publication recently:

“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 has about 400 article 13.1 generic health claims waiting for processing under the EU nutrition and health claims process.

But vice president of marketing and development, Gary Brenner, from Israeli soy ingredients specialist, Solbar, one of the challengers to the patent, highlighted potential problems.

“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),” he said.

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.