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 Origanum vulgare (Common or Wild marjoram) as Brain tonic and Exhilarant and for the treatment of Psychoneurosis, Melancholia, Palpitation, Ecstasy/Catalepsy due to obstruction, Erotomania, Amnesia, Fatigue, Epilepsy, Tremor, Pain, Headache, Headache (Melancholic), Headache (Nervous), Headache (Migraine), Headache (Phlegmatic), Melancholic diseases, Hallucinations, Diseases of nervous system from the books – Khazaain-al-Advia by Mohammad Najmul Ghani Khan (Unani, Exhibit 1), Kitaab-al-Haawi-fil-Tibb by Abu Bakr Mohammad.Bin Zakariyya Al-Razi (Unani, Exhibit 2), Ikseer Azam by Mohammad Azam Khan (Unani, Exhibit 3, 6 & 8), Al-Qaanoon-fil-Tibb by Abu Ali Ibn-e-Sina (Unani, Exhibit 4), Muheet-e-Azam by Mohammad Azam Khan (Unani, Exhibit 5), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani, Exhibit 7 & 10) and Bayaaz-e-Kabir, Vol. II by Mohammad Kabiruddin (Unani, Exhibit 9).

2. Relevant Extract of CGPDTM Examination report

CGPDTM Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at Para 1 are reproduced below.



“Objections:

Subject matter of the claims does not constitute an invention u/s 2(1) (j) as the claims lack novelty and inventive step in view of cited documents-

D1: Database TKDL- Following traditionally known formulations retrieved from TKDL comprising claimed plants used for treatment of disorders connected to impaired or reduced neurotransmission-

(i) Name of formulation- Joshanda-e-Marzanjosh; formulation ID- JA6/744A [see annex. D1 (i)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) used as a single ingredient for the treatment of psychoneurosis, headache (phlegmatic), headache (melancholic), and headache (nervous) through oral administration.

(ii) Name of formulation- Dawa-e-Marzanjosh; formulation ID- AA7/118 [see annex. D1 (ii)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) used as a single ingredient for the treatment of palpitation through oral administration.

(iii) Name of formulation- Dawa-e- Falanja; formulation ID- NA5/395A [see annex. D1 (iii)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) along with one other ingredient used as brain tonic and for the treatment of headache through oral administration.

(iv) Name of formulation- Marzanjosh; formulation ID- AH1/656 [see annex. D1 (iv)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) used as a single ingredient for the treatment of fatigue, headache (migraine), headache and headache (melancholic). Mode of administration is as directed by physician.

(v) Name of formulation- Jaosheer Barai Amraaz Baridah; formulation ID- MH4/115L [see annex. D1 (v)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) along with one other ingredient used for the treatment of epilepsy, tremor, pain and diseases of nervous system through oral administration.

(vi) Name of formulation- Arq-e- Marzanjosh; formulation ID- NA5/358 [see annex. D1 (vi)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) along with few other ingredients used for the treatment of headache, epilepsy and ecstasy/catalepsy due to obstruction through oral administration.

(vii) Name of formulation- Dawa-e-mufarreh; formulation ID- NA4/1342 [see annex. D1 (vii)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) along with few other ingredients used as exhilarant and for the treatment of erotomania through oral administration.

(viii) Name of formulation- Habb-e- Qaranfal Bara-e- Nisyaan; formulation ID- NA5/2468P [see annex. D1 (viii)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) along with few other ingredients used for the treatment of amnesia through oral administration.

(ix) Name of formulation- Jawarish Shahanshahi Ambari; formulation ID- MA3/63 [see annex. D1 (ix)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn. ) along with few other ingredients used for the treatment of palpitation, hallucinations and as brain tonic through oral administration.

(x) Name of formulation- Itreefal Shahtra Deegar; formulation ID- NA4/55 [see annex. D1 (x)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) along with few other ingredients used for the treatment of melancholia, headache, neurological diseases through oral administration.

(xi) Name of formulation- Inkebaab Bara-e- Amraaz Dimaghi Ratab; formulation ID- NA5/173 [see annex. D1 (xi)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) along with few other ingredients used for the treatment of neurological diseases.

(xii) Name of formulation- Nutool Bara-e- Amraaz Dimaghi Ratab; formulation ID- NA5/173 [see annex. D1 (xii)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) along with few other ingredients used for the treatment of neurological diseases.

(xiii) Name of formulation- Hashayish Haarrah Barae Bakhoor; formulation ID- MH5/93 [see annex. D1 (xiii)] refers to a formulation containing common or wild marjoram (Origanum vulgare Linn.) along with few other ingredients used for the treatment of neurological diseases.

As per guiding principle 1 of ?Guidelines for Processing of Patent Applications Relating to Traditional Knowledge and Biological Material?, as issued by CGPDTM, 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. When the subject-matter of claims relates to extracts of plant 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. In the present case Origanum species is traditionally known for its use as treatment of disorders connected to impaired or reduced neurotransmission and also the constituents of the extract is not defined hence the claims lack novelty and inventive step in view of the cited documents. Further as per guiding principle-5 of said guidelines, in case multiple ingredients are known to have the same therapeutic activity as per traditional knowledge, taking out one single component out of them cannot be considered as inventive. The claims of alleged invention relate to an extract of Origanum species. As per the prior art disclosure of TKDL, the multi-component formulation comprising Origanum species have the same therapeutic activity i.e. treatment of disorders connected to impaired or reduced neurotransmission, therefore it is not surprising that one single component namely Origanum species taken out of them again would have the same therapeutic activity. Hence, a person skilled in the art would have been motivated to arrive at the invention without exercise of inventive skills and thus, the claims of alleged invention lacks inventive step. Further as per guiding principle 4 of above said guidelines- discovering the optimum or workable ranges of traditionally known ingredients by routine experimentation is not inventive.

Hence in view of the cited documents D1-D9 it is obvious for a person skilled in the art to use extract of Origanum sp. as pharmaceutically active ingredient for treatment of disorders connected to impaired or reduced neurotransmission, which is traditionally known for said medicinal properties as evident from D1 and also disclosed in prior art D2-D9 for said use.”

Full examination report can be referred at 909-DELNP-2009.pdf

3. 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 and reply is still awaited from the Applicant DSM IP ASSETS B. V./ Netherlands.