European Patent Office Ruling on Novogen Opens Way for Other Isoflavones

It is expected that the opponents to the Novogen patent will appeal to the EPO for a complete rejection of all claims, just as in 2008 the Dutch District Court of Appeal upheld the District Court of The Hague rejection of Novogen's patent violation claim.

Jul 22 2009 The European Patent Office (EPO) has rejected large parts of the Novogen patent claims, as originally granted in 2004, for the use of isoflavone phyto-oestrogen extracts. The patent EP 0656786 was originally submitted to the EPO for approval in 1993.

Following objections submitted by 10 European groups from Germany, France, Spain, Italy and the UK, and by Solbar (Israel), the EPO finally restricted claims, wherein the isoflavone phytoestrogen extract comprises genistein and daidzein (aglycones) from soybeans, and biochanin A or formononetin in red clover, "in a ratio of about 1:2 to 2:1."

Solgen natural soy isoflavone extracts, marketed and produced by Solbar Industries Ltd., are processed from the whole soybean, in their natural form as with traditional soy foods. Solgen glycoside phytoestrogens contain 55% genistin (minimum), approximately 40% daidzin with the remainder as glycitin.

The approved part of the Novogen patent clearly states, "Medicament" for the "treatment of pre-menstrual syndrome or symptoms associated with menopause." In accordance with Council of Responsible Nutrition symposium (May 2009, Milan) on the Efficacy and Safety of Isoflavones for Postmenopausal Women, Solbar's Solgen soy isoflavones are designed to alleviate symptoms experienced by postmenopausal women as used in non-medical nutraceutical products. Until an official statement of approval from European Food Safety Authority (EFSA), a "treatment" claim is not possible.

It is expected that the opponents to the Novogen patent will appeal to the EPO for a complete rejection of all claims, just as in 2008 the Dutch District Court of Appeal upheld the District Court of The Hague rejection of Novogen's patent violation claim against Care for Woman, a Dutch dietary supplement brand.