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PATENT EXAMINATION GUIDELINES FOR INVENTIONS COVERING CHINESE HERBAL MEDICINES



From early November 2007 the Intellectual Property Office (IPO) has held several public hearings to solicit comments on its draft Examination Guidelines for Inventions Covering Chinese Herbal Medicines.

"Chinese herbal medicines" as referred to in the draft Guidelines include natural materials such as plants, animals, minerals, algae, and fungi, or their derivatives or combinations. Unlike inventions covering western medicines, which have chemical substances as their active ingredients, the active ingredients of Chinese herbal medicine inventions are in most cases unclear, and single active ingredients with a specific structure cannot readily be isolated or purified from them. Furthermore, the basic theories involved in Chinese Herbal Medicines differ from those of western medicines, and the characteristic modes of use of Chinese herbal medicines both singly and in combination are rarely seen in western medicines. Thus it is difficult to apply the current patent examination guidelines for western medicine inventions when examining claim(s) of a Chinese her medicine invention.

For patent applications covering Chinese herbal medicine inventions, regardless of whether they relate to medical drugs, foods, beverages, cosmetics, materials for the preparation of medicines, medical devices or equipments, methods for their manufacture or processing, or their uses, they will be subject to the provisions of the proposed Guidelines. But, aspects of applications that fall within the scope of the common and general provisions of other parts of the Patent Examination Guidelines, inventions related to single compounds or their combinations, or pharmaceutical or biological inventions involving special fields, will be handled according to the relevant provisions of other sections of the Patent Examination Guidelines.

We will continue to monitor developments concerning the new Guidelines and keep readers informed.
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