APAA 54 th Council Meeting 2007 Alelaide, Australia Emerging Intellectual Property Rights Committee Emerging Intellectual Property Rights Committee Decision of Opposition made by Indian Patent Office Yulan Kuo, Partner Formosa Transnational, Attorneys at Law

APAA 54th Council Meeting The nanocurcumin compound claimed by the father and son team is a new substance different from the prior art curcumin composition, and having novelty and inventive step over the prior art curcumin composition.

APAA 54th Council Meeting Summary of Decision of Opposition 1.The nanocurcumin compound claimed by the father and son team comprises nanocurcumin particles with hydrophilic polymer outershells. The nanocurcumin compound has nano-scale structure and improved solubility in aqueous solutions. The bioavailability of the nanocurcumin compound is increased due to its improved solubility in aqueous solutions.

APAA 54th Council Meeting The prior art curcumin composition is an admixture of curcumin crystals and the essential oil of tumeric. The curcumin crystals have large-scale structures and insolubility nature. The curcumin crystals have poor bioavailability due to its insolubility nature. The bioavailability of the curcumin crystals in the prior art curcumin composition is enhanced by the synergistic effect of the essential oil.

APAA 54th Council Meeting The nanocurcumin compound is a new pharmaceutical product different from the prior art curcumin composition, and having novelty and inventive step over the prior art curcumin composition.

APAA 54th Council Meeting Description of the Claimed Invention The father and son team researched on the preparation of nanoparticles of curcumin to overcome the problem posed by the insolubility of curcumin and make it readily usable in therapy. The team used special polymer to synthesize tiny nanoparticles of curcumin about nanometers in diameter. The nanoparticles have hydrophobic interiors and hydrophilic exteriors. The hydrophobic core traps the nanocurcumin, while the hydrophilic exteriors make the nanoparticles soluble in water or any other aqueous media. By this way, the nanoparticles can pass easily from the gut to the bloodstream. Once in the blood, the curcumin leaks out as the polymers slowly degrade. The increasing bioavailability of nanocurcumin due to improved aqueous solubility overcomes the need to consume doses as high as 12 gms and the problems associated with its unbearable after-taste.

APAA 54th Council Meeting Description of the Prior Art Curcumin Composition The prior art application WO2006/12932 discloses a composition having curcuminoid with an essential oil of tumeric to enhance the bioavailability of curcumin and to increase the biological activity of curcumin, wherein the curcumin is the main constitute of curcuminoid. The curcumin has insolubility nature in the aqueous solutions and hence poor bioavailability. The essential oil of tumeric is itself bioactive, and thus is expected to synergistically enhance bioactivity of curcumin. Curcuminoid is extracted from turmeric, and curcumin is the major component of curcuminoid, occupying 95% weight ratio of curcuminoid. The essential oil of tumeric is obtained as a by- product during extraction of curcuminoid from turmeric. In the composition, the essential oil of tumeric is present in an amount sufficient to cause an enhancement of bioavailability of curcumin when the composition is administered to a human. The enhancement of bioavailability of the curcumin ranges from about 5-fold to about 16-fold compared to a composition of curcuminoid alone. The composition is marketed as Biocurcumax capsule.

APAA 54th Council Meeting Patentability of the claimed Nanocurcumin compound over the prior art curcumin composition disclosed in WO2006/ The prior art curcumin composition is a blend (admixture) of curcumin crystals and the essential oil of tumeric. Curcumin crystals have large-scale structure and insoluble nature for aqueous media. Curcumin crystals have poor bioavailability to a human due to their insolubility in the aqueous solutions. In the prior art curcumin composition, the essential oil is bioactive itself, and the bioavailability of curcumin crystals is enhanced by the synergistic effect of the essential oil of tumeric. A composition of curcumin crystals alone has poor bioavailability due to its insoluble nature.

APAA 54th Council Meeting As to the nanocurcumin compound claimed by the father and son team, the claimed nanocurcumin compound has interior nanocurcumin particles with hydrophilic polymer outershells. The hydrophilic polymer outershells make the nanocurcumin particles soluble in water or any other aqueous media. By this way, the nanocurcumin particles can pass easily from the gut to the bloodstream. Once in the blood, the curcumin leaks out as the polymer outershells slowly degrade. The hydrophilic polymer outershells of the nanocurcumin particles improve the aqueous solubility of the nanocurcumin particles compound, and thus increasing the bioavailability of it to a human.

APAA 54th Council Meeting The bioavailability of curcumin crystals of the prior art composition is enhanced by the synergistic effect of the essential oil of tumeric, which is another component in the prior art composition. The claimed nanocurcumin particles itself has higher bioavailability due to its improved solubility.

APAA 54th Council Meeting The claimed nanocurcumin compound has nano-scale structures constituted by the interior nanocurcumin particles with hydrophilic polymer outershells. The curcumin crystals in the prior art compound are pure curcumin and have larger-scale structures. The claimed nanocurcumin compound is nanocurcumin particles with hydrophilic polymer outershells, while the prior art curcumin composition is a blend (admixture) of curcumin crystals and the essential oil of tumeric. The components of the claimed nanocurcumin compound are different from those of the prior art curcumin composition. As such, the claimed nanocurcumin compound is a new pharmaceutical product over the prior art curcumin composition.