1. Pre-Grant Opposition under Section 25.(1) of Indian Patent Act 1970

TKDL Pre-Grant Opposition under Section 25.(1) brought to the notice of examination division the prior art references on the use of Syzygium cuminii (Jamun) for the treatment of Diabetes mellitus from the books – Khazaain-al-Advia, Vol II by Mohammad Najmul Ghani Khan (Unani, Exhibit 1 & 2), TherayarKappiyam by Therayar (Siddha, Exhibit 3), aryabhisaka by smkaradajisastripade (Ayurveda, Exhibit 4) and Muheet-e-Azam Vol. II ( Part I) by Mohammad Azam Khan (Unani, Exhibit 5).

2. Relevant Extract of Applicant Reply Statement

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 5 & 6 are reproduced below.

“Claims 1-16 are not patentable u/S 3( p) of the Act as they relate to Traditional Knowledge. Use of Eugenia jambolana for treatment of diabetes and related disorders is traditionally known. Refer enclosed TKDL documents D1:AN2/226G, D2: AN2/22612, D3:SR06/54, D4: RS17/828, D5:MH4/110A1.

Not withstanding above mentioned objections, claims 2-8 lack novelty/inventive step in view of prior art documents D1-D5.
The use of organic solvent and aqueous extracts of Eugenia jambolana for treating diabetes and related disorders would have been obvious to a person skilled in the art from the teachings of the cited prior art documents. If the subject-matter as claimed relates to extracts/alkaloids and/or isolation of active ingredients of plants, which are naturally/inherently present in plants, such claims cannot be considered as novel and/or inventive when use of such plants is pre-known as part of teachings of Traditional Knowledge (TK). When the subject-matter of claims relate to extracts ofplant materials containing undefined active ingredients, such claims cannot be said to be novel if the use of such plants or plant materials is pre-known as a part of teaching of TK. However, if the claims relate to alkaloids and/or active principles obtained from the plant materials and structures of the said alkaloids and/or active principles are characterized, which do not form the part of the prior art, such claims cannot be said to involve an inventive step, since the use of said plant materials and their therapeutic effects are known from the teaching of TK. Thus, the prior art motivates the person skilled in the art to isolate the individual ingredients such as alkaloids, flavonoids, phyto-steroids, etc.”

Full examination report can be referred at 1565-CHE-2006.pdf

3. Outcomes of Pre-Grant Opposition & Examination Report

As the outcome of TKDL references and other documents cited in examination report, the Application is Abandoned U/S 21(1).