Lok Sabha Question No. 2699 (UNSTARRED), answered on 2015-08-05
Subject: CSIR Bid to Contest Patents
Ministry: SCIENCE AND TECHNOLOGY
Asked by: ARJUN RAM  MEGHWAL, VINOD KUMAR BOIANAPALLI, K. MARAGATHAM

# GOVERNMENT OF INDIA

**MINISTRY OF SCIENCE AND TECHNOLOGY**

**DEPARTMENT OF SCIENTIFIC AND INDUSTRIAL RESEARCH**

**LOK SABHA**

**UNSTARRED QUESTION NO. 2699**

**(TO BE ANSWERED ON 05.08.2015)**

**CSIR BID TO CONTEST PATENTS**

**2699.  SHRI ARJUN MEGHWAL:**

**SHRI B. VINOD KUMAR:**

**SHRIMATI K. MARAGATHAM:**

Will the Minister of SCIENCE AND TECHNOLOGY be pleased to state:

1. whether the Council of Scientific and Industrial Research's Traditional Knowledge Digital Library (CSIR-TKDL) has contested a consumer goods giants attempt to patent an ancient Indian formula;
2. if so, the details and the present status thereof;
3. whether the CSIR-TKDL has mentioned various formulas from the ancient Indian books that authenticate the consumer items and if so, the details thereof, item-wise;
4. whether the Government has taken any steps to get those formulas patented; and
5. if so, the details thereof and the steps taken by the Government to get Indian system of medicines patented to avoid such incidences in future?

**ANSWER**

**MINISTER OF STATE FOR SCIENCE AND TECHNOLOGY AND EARTH SCIENCES**

**(SHRI Y.S. CHOWDARY)**

1. Yes, Madam.
2. The Council of Scientific and Industrial Research (CSIR) through the Traditional Knowledge Digital Library (CSIR-TKDL) has successfully contested an attempt made by consumer goods giant M/S Colgate-Palmolive Company (United States of America) to patent a Mouth-wash formula containing herbal extract. Prior art evidences from TKDL provided that the claims made in the patent application filed by M/S Colgate-Palmolive Company were not novel and the use of claimed constituents of the mouth wash under reference was already mentioned in India’s traditional medical literature such as Ayurveda and Unani. The details of the patent applications and the TKDL evidences are given in Annexure 1.
3. The patent application filed by M/S Colgate-Palmolive Company claimed an oral composition comprising: a combination of extracts comprising an extract from *Myristica fragrans* and a natural extract other than the extract from *Myristica fragrans* . The TKDL provided the *prior art* evidences from the following ancient Indian books of Ayurveda and Unani systems of medicine on the use of claimed constituents of the mouth wash under reference:
    - 3.1. Carak Samhita (Ayurveda);
    - 3.2. Ayurveda Sara samgrah (Ayurveda);
    - 3.3. Rasa Yoga Sagar (Ayurveda); and
    - 3.4. Qaraabaadeen Najm-al-Ghani (Unani).

(d)&(e) CSIR has played a major role in protecting India’s rich traditional knowledge concerning healthcare by creating the Traditional Knowledge Digital Library (TKDL), in collaboration with Department of AYUSH. TKDL currently contains information concerning 2.93 lakh medicinal formulations contained in India’s traditional literature on Ayurveda, Unani and Siddha, available in public domain, in five international languages, i.e., English, Japanese, Spanish, French and German. Wrong patents on India’s traditional knowledge, such as that on *‘Haldi’, ‘Neem’, ‘Basmati Rice* ’, were being granted at International Patent Offices since India’s traditional knowledge was not available to patent examiners at International Patent Offices and even in case of availability it being in local languages like Sanskrit, Urdu, Tamil etc., was incomprehensible for the patent examiners. TKDL breaks the language and format barrier. To facilitate the protection of country’s traditional knowledge, access to TKDL has been provided to International Patent Offices but only under TKDL Access (Non-disclosure) Agreement. Since 2009, TKDL Access Agreement has been concluded with European Patent Office (EPO, 34 Member States), US Patent & Trade Mark Office (USPTO), Canadian Intellectual Property Office (CIPO), IP Australia, Japan Patent Office (JPO), United Kingdom Patent and Trademark Office (UKPTO), German Patent Office (GPO) and Chile Patent Office. Examiners of these International Patent offices can utilize TKDL only for search and examination of India’s *prior art* with respect to the Patent applications filed in the area of traditional knowledge, but cannot make any third party disclosure.

As per the Patent law, for a patent to be granted three conditions are essential namely Novelty, Inventive Step and Utility with respect to the claims made for getting the patent.

In addition to the TKDL Access Agreements, CSIR-TKDL Unit is submitting pre-grant oppositions along with *prior art* evidences from TKDL, on a regular basis. The evidences through TKDL safeguard the sovereignty of the country’s traditional knowledge and thus protect the traditional knowledge from being misappropriated in the form of patents on non-original innovations.

TKDL is thus the only tool available in preventing misappropriation of India's traditional knowledge at International Patent Offices. Several countries are approaching CSIR in getting TKDL replicated, for protecting their country’s traditional knowledge. Some key achievements of the TKDL are:

(i).	Due to prior art evidences available in TKDL, till date since 2009, India has been successful in preventing grant of wrong patents at International Patent Offices in more than 200 cases without any cost and in few weeks/months of time. The patent applications cancelled/ withdrawn by the applicants, due to TKDL prior art evidences, have been found to be filed mainly by the MNCs of developed nations on India's Traditional Medicinal Knowledge. Reference is made herein to the earlier revocation wherein APEDA had to spend about **`** 7 crores towards legal fees only, for revocation of few claims of wrong patent granted on Basmati rice; and

(ii)	Similar outcome is expected in another 1500 cases wherein Pre-grant opposition along with *prior art* evidences from TKDL have been filed by CSIR-TKDL at International Patent Offices.

TKDL is recognized globally as a model for protection of traditional knowledge.

*******

Annexure 1

The Patent application details of M/S Colgate-Palmolive Company (United States of America) in reference to a Mouth-wash formula containing herbs extract are as follows:

- Patent application (EP2689806) Filed on:  1 December 2010
- Patent application (EP2689806) Published on:  29 January 2014
- International Publication Number: WO 2011/068813 A1
- Title: ORAL COMPOSITIONS CONTAINING EXTRACTS OF MYRISTICA FRAGRANS AND RELATED METHODS
- Claims (WO 2011/068813 A1):
    - 1.1. An oral composition comprising: a combination of extracts comprising an extract from *Myristica fragrans* and a natural extract other than the extract from *Myristica fragrans* ; and an orally acceptable carrier.
    - 1.2. A composition according to claim 1, comprising 0.01 % to 5% by weight of the combination of extracts.
    - 1.3. A composition according to claim 2, comprising 0.1% to 2% by weight of the combination of extracts.
    - 1.4. A composition according to any preceding claim, wherein the natural extract other than the extract from *Myristica fragrans* is one or more natural extracts selected from the group consisting of extracts of oregano, magnolia, cranberry, rosemary, *Camellia* , morin, *zingiber officinale* , *Zizyphus joazeiro, Punica granatum, Garcinia mangos tana L., Jabara, Azadirachta indica, Acacia, Oolong tea, Juglans regia, Zanthoxylum alantum, Mimusops elengi, Hibiscus abelmoschus, Ayurvedic, Carapa procera, Khaya senegalensis, Salvadora persica. Cucurbitaceae (Citrulhis colocynthis), Acacia catechu, Acacia nilotica, Achyrathes aspera, Azadirachta indica, Aristolochia bracteolate, Cinnamomum camphora, Cinnamomum verum, Curcuma longa, Eucalyptus globulus, Ficus bengalensis, Juglans regia, Madhuca longifolia, Mimusops elengi, Ocimum sanctum, Oolonga tea, Piper betel leaves, Piper longum, Piper nigrum, Potentilla fulgens, Syzygium aromaticum, Spilanthes calva, Vaccinium macrocarpon, Zanthoxylum armatum* , and mixtures thereof.
    - 1.5. A composition according to any preceding claim, further comprising an additional antibacterial agent selected from: phenolic compounds, stannous ions, zinc ions, and mixtures thereof.
    - 1.6. A composition according to claim 5, wherein the zinc ions are provided by one or more zinc-containing compounds selected from the group consisting of zinc acetate, zinc citrate, zinc gluconate, zinc glycinate, zinc oxide, zinc sulfate, sodium zinc citrate, and mixtures thereof.
    - 1.7. A composition according to any preceding claim, wherein the composition further comprises at least one additional component selected from the group consisting of humectants, abrasives, anticaries agents, anticalculus or tartar control agents, anionic carboxylate polymers, viscosity modifiers, surfactants, flavorants, pigments, and mixtures thereof.
    - 1.8. A composition according to any preceding claim, wherein the composition is a dentifrice in a form selected from the group consisting of: powder; toothpaste or dental gel; a periodontal gel; a liquid suitable for painting a dental surface; a chewing gum; a dissolvable, partially dissolvable or non-dissolvable film or strip; a bead, a wafer; a wipe or towelette; an implant; a mouthrinse, a foam, and dental floss.
    - 1.9. A method of treating a disease or condition of oral cavity soft tissue comprising administering to the oral cavity of a patient in need thereof, a composition according to any of claims 1 to 8.
    - 1.10. The method according to claim 9, wherein the disease or condition is xerostomia.

The Prior art evidences from India’s Traditional Knowledge Digital Library were submitted on 3 July 2014.

- TKDL evidences submitted to patent office on:  3 July 2014
- Examination report (including TKDL evidences) communicated to applicant on:  6 October 2014
- Application deemed to be withdrawn on: 17 March 2015
- Closing of Application on:  22 June 2015