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 Centella asiatica (Brahmi) as an Intellect promoting, Strength promoting for liver, Brain, Nerves and Memory enhancer and for the treatment of Psychosis/Insanity/Mania, Psychoneurosis, Hysteria, Idiopathic psychotic syndrome, Insomnia, Obesity and Neurological diseases from the books – Khazaain-al-Advia by Mohammad Najmul Ghani Khan (Unani, Exhibit 1), Therayar Kappiyam by Therayar (Siddha, Exhibit 2), Therayar Sekarappa by Therayar (Siddha, Exhibit 3), Rasatantrasarah Evam Siddhaprayogasamgrahah (Ayurveda, Exhibit 4), Bhaisajya Ratnavali by Govinda Dasa (Ayurveda, Exhibit 5), Rasakamadhenu Samhita by Cudamani (Ayurveda, Exhibit 6) and Bhaisajya Ratnavali by Govinda Dasa (Ayurveda, Exhibit 7).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 2 & 3 are reproduced below.

“Subejct-matter claimed in claim 1-7, 8-16 is not patentable u/s 3 (p) of Patents Act. Your attention has been drawn to the pregrant opposition filed under section 25(1) of the Act in this application. Exhibit 1:(pg. no. 05-06) refers to a formulation containing Centella asiatica (Linn.) as a single ingredient used as an Intellect promoting and for the treatment of Neurological diseases and Psychosis/Insanity/Mania through Licking. Exhibit 2:(pg. no. 07-09) refers to a formulation containing Centella asiatica (Linn.) as a single ingredient used as an Intellect promoting and for the treatment of Psychosis/Insanity/Mania through oral administration. Exhibit 3:(pg. no. 10-12) refers to a formulation containing Centella asiatica (Linn.) as a single ingredient used as Memory enhancer through oral administration. Exhibit 4:(pg. no. 13-15) refers to a formulation containing Centella asiatica (Linn.) along with few other ingredients used as Strength promoting for Liver, Brain, Nerves and for the treatment of Insomnia through oral administration. Exhibit 5:(pg. no. 16-18) refers to a formulation containing Centella asiatica (Linn.) along with few other ingredients" used for the treatment of Idiopathic, psychotic syndrome, Hysteria, Psychoneurosis through oral administration. Exhibit 6:(pg. no. 19-21) refers to a formulation containing Centella asiatica (Linn.) along with few other ingredients used for the treatment of Idiopathic psychotic syndrome through oral administration. Exhibit 7:(pg. no. 22-26) refers to a formulation containing Centella asiatica (Linn.) along with few other ingredients used for the treatment of Obesity through oral administration. The alleged patent application 255/MUM/2007 claims the usefulness of a synergistic pharmaceutical composition comprising pentacyclic terpenoid glycosides, preferably asiaticoside and madecassoside optionally along with excipients, wherein pentacyclic terpenoid glycosides are obtained from plant or animal sources, preferably from the plant Centella asiatica for serotonin reuptake inhibition, wherein serotonin reuptake inhibition is useful in the management of depression, obesity, mood elevation and other disorders involving serotonin as novel. However, Centella asiatica (Linn.) has been used alone and in combination with few other ingredients as an Intellect promoting, Strength promoting for liver, Brain, Nerves and Memory enhancer and for the treatment of Psychosis/Insanity/Mania, Psychoneurosis, Hysteria, Idiopathic psychotic syndrome, Insomnia, Obesity and Neurological diseases through oral as well as local application in the Indian systems of Medicine, since long, as is evident from exhibits cited from the books namely, Khazaain- al-Advia by Mohammad Najmul Ghani Khan (Unani, Exhibit 1: pg. no. 05-06), Therayar Kappiyam by Therayar (Siddha, Exhibit 2: pg. no. 07-09), Therayar Sekarappa by Therayar (Siddha, Exhibit 3: pg. no. 10-12), Rasatantrasarah Evam Siddhaprayogasamgrahah (Ayurveda, Exhibit 4: pg. no. 13-15), Bhaisajya _ Ratnavali by Govinda Dasa (Ayurveda, Exhibit 5: pg, no. 16-18), Rasakamadhenu Samhita by Cudamani(Ayurveda, Exhibit 6: pg. no. 19-21) and Bhaisajya Ratnavali by Govinda Dasa (Ayurveda, Exhibit 7: pg. no. 22-26). In addition to the aforesaid references, some other references also exist in TKDL wherein Centella asiatica has been used alone and in combination with few other ingredients for the treatment of above mentioned indications and actions. Hence the said application 255/MUM/2007 is not novel as per the cited prior art and does not involve any inventive step, therefore cannot qualify for the grant of patent rights. (For details refer exhibits filed with pregrant opposition).”

Full examination report can be referred at 255-MUM-2007.pdf

3. Current Status & Outcomes of Pre-Grant Opposition & Examination Report

As the outcome of TKDL Pre-Grant Opposition and other documents cited in examination report, the examination is under process.