Lok Sabha Question No. 2456 (UNSTARRED), answered on 2016-05-09
Subject: Issue of Compulsory Licences
Ministry: COMMERCE AND INDUSTRY
Asked by: M. UDHAYAKUMAR

## GOVERNMENT OF INDIA MINISTRY OF COMMERCE & INDUSTRY DEPARTMENT OF INDUSTRIAL POLICY & PROMOTION

## LOK SABHA

UNSTARRED QUESTION NO. 2456. TO BE ANSWERED ON MONDAY, THE 9 TH  MAY, 2016.

## ISSUE OF COMPULSORY LICENCES

## 2456.  ADV. M. UDHAYAKUMAR:

Will the Minister of COMMERCE AND INDUSTRY be pleased to state:

## वाणिज ् य एवं उद्योग मंत्री

- (a) whether as per recent media reports, India has privately assured that it will not issue anymore compulsory licences allowing local firms to override patents and make cheaper copies of drugs developed by global drug majors;
- (b) if so, the reaction of the Government thereto;
- (c) whether India is likely to grant licences under certain conditions such as public health emergencies to ensure such access to affordable medicine; and
- (d) if so, the details thereof?

## ANSWER

वाणिज्् य्एवं्उद्योग्ााज्् यमंत्री्स्् वतंंत्र््रभााा(स्ीमतंी्िरममलाा्ीीतंाामि(् THE MINISTER OF STATE (INDEPENDENT CHARGE) OF THE MINISTRY OF COMMERCE & INDUSTRY (SHRIMATI NIRMALA SITHARAMAN)

- (a)&(b): No, Madam. No such assurance has been given by the Government of India. Any such media reports are factually incorrect. A clarification in this regard has already  been  issued  by  the  Department  of  Industrial  Policy  and  Promotion through the Press Information Bureau on 22.3.2016 (copy enclosed).  Even as Government of India is conscious of the need to spur innovation and protect individual rights, it retains the sovereign right to utilize the flexibilities provided in the international IPR regime.
- (c)&(d): The  Patents  Act,  1970  ('the  Act')  provides  for  issue  of  compulsory  licenses under  certain  conditions  contained  in  chapters  XVI  and  XVII  of  the  Act.  A Compulsory License (CL) can be issued only if the conditions prescribed under the Act are satisfied.

Under section 84, a CL can be issued by the Controller General of Patents, Designs and Trademarks (CGPDTM)  on  the grounds that reasonable requirements  of  the  public  with  respect  to  the  patented  invention  have  not been satisfied, or that the patented invention is not available to the public at a reasonably affordable price, or that the patented invention is not worked in the territory  of  India.  Under  Section  91,  CL  can  be  issued  for  a  related  patent. Under  Section  92,  the  CGPDTM  can  issue  CL  based  upon  a  notification issued by the Central Government under circumstances of national emergency or  of  extreme  urgency  or  in  a  case  of  public  non-commercial  use.  Under Section 92 A, the CGPDTM can issue CL on application for manufacture and export of patented pharmaceutical product to any country having insufficient or no  manufacturing  capacity  in  the  pharmaceutical  sector  for  the  concerned product to address public health problems. In addition, Chapter XVII of the Act provides for use of inventions for the purposes of government and acquisition of inventions by Central Government.

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## ANNEXURE

## ANNEXURE  REFFERED  TO  IN  REPLY  TO  PARTS  (a)  &  (b)  OF  THE  LOK  SABHA UNSTARRED QUESTION NO. 2456 FOR ANSWER ON 09.05.2016.

## Press Information Bureau Government of India Ministry of Commerce and Industry

22-March, 2016  20:21 IST

## Clarification on Media Reports regarding Compulsory licence

There  have  been  recent  media  reports  that  the  Government  of  India  has  privately assured that it will  not  issue  any  more  compulsory  license.    It  is  hereby  clarified  that such reports are factually incorrect.  In this regard, it may be noted that India has a wellestablished  TRIPS  compliant  legislative,  administrative  and  judicial  framework  to safeguard IPRs.  Under the Doha Declaration on the TRIPS Agreement Public Health, each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.

Even as Government of India is conscious of the need to spur innovation and protect individual  rights,  it  retains  the  sovereign  right  to  utilize  the  flexibilities  provided  in  the international IPR regime.  It may be noted that to date there has been only one case of compulsory license in India and that too after a well-thought out and laid down process, which was subsequently upheld right up to the highest Court of the land.

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