Lok Sabha Question No. 513 (UNSTARRED), answered on 2018-07-20
Subject: Patenting Indian Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: B.V. NAYAK

## GOVERNMENT OF INDIA MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)

LOK  SABHA UNSTARRED  QUESTION NO. 513 TO BE ANSWERED ON 20 TH JULY, 2018

## PATENTING INDIAN MED ICINES

## 513. SHRI B.V. NAIK:

Will  the  Minister of AYURVEDA,  YOGA  AND  NATUROPATHY,  UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

- (a) the number of medicines made of herbs/plants as per the traditional knowledge books of along with the number of medicines which have been patented;
- (b) whether it is a fact that some countries are patenting the Indian medicines and i number of such incidents that have come to light and the action being taken by the Governm
- (c) whether the Government proposes to amend the Drugs and Cosme tics Act, 1940 and Rules, 1945 with a view to registering all Ayurvedic medicines; and
- (d) if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, U NANI, SIDDHA AND HOMOEOPATHY (SHRI SHRIPAD YESSO NAIK)

(a) & (b):   Medicines made of herbs/plants as per the traditional knowledge books of In not patentable in view of the provisions of Section 3(p) of the Patents Act, 1970. This providesthat an invention which, in effect, is based on traditional knowledge or which aggregation or duplication of known properties of traditionally known component or compon is  not  an  invention  within  the  meaning  of  the  Act.  However,  patents  can  be  gr anted  to formulations  based  on  products  related  to  Ayurvedic/Herbal - based  inventions,  or  processes related  thereto,  which  fulfill  the  criteria  of  patentability  as  per  the  Act.  As  per received  from  the  Department  of  Industrial  Policy  &  Promotio n  (IPR - patent  section)  under Ministry of Commerce and Industry, 194 patents have been granted to Indian entities fo inventions based on traditional medicines/herbal related products and 28 patents to var various foreign entities for formulation s/processes based on herbal/plant products.

Contd……..

The criteria of patentability i.e. novelty, inventive step and industrial applic followed uniformly across all the patent offices in the world. Patents cannot be grante country  for  products/processes,  if  they  are  already  in  public  do main  and  do  not  fulfill  the patentability criteria. All countries have mechanism for challenging any wrongly granted and invalidation of the same.  Government of India has established a defensive mechanis Traditional  Knowledge  Digital  Library  (T KDL)  for  preventing  grant  of  patents  to  inventions based on traditional medicinal knowledge. TKDL is a digital database of traditional formu & interventions taken from the literature of Ayurveda, Unani, Siddha and Yoga and present international patent classification format in five international languages. This database bre language  and  format  barriers  and  makes  traditional  medicinal  knowledge  accessible searchable to patent examiners for establishing prior art. TKDL has been made acce ssible under non- disclosure agreement to various International Patent Offices across the world for pre of wrong patenting and revocation of patents based on traditional Indian medicine.

(c) & (d): As of now, amendment of Drugs & Cosmetics Act, 19 40 and rules thereunder for registration of Ayurvedic medicines is not envisaged.