India: India Moving Towards a TRIPS Compliant Patent Regime - Implications for the Pharmaceutical Industry

Last Updated: 11 August 2004
Article by Manisha Singh


After independence in 1947, it took twenty-one years for India to enact a patent law. After joining WTO in 1995, India struggled through seven years of deliberations before it could amend its patent law to make it even partially TRIPS compliant. The last in the series of TRIPS compliance amendments in the national patent law was introduced in the Lok Sabha (the lower house of the Indian Parliament) on December 22, 2003. This Bill had been referred to the Department Related Parliamentary Standing Committee on Commerce. However, the dissolution of the Lok Sabha has necessitated the re-introduction of the Bill when the Parliament is convened after the general elections.

Introduction of product patents & other major changes

The proposed Patents (Amendment) Bill, 2003 aims to achieve the following:

  1. make the national law compliant with Art. 27 of the TRIPS agreement;
  2. provide for product patent protection for all categories of inventions;
  3. repeal the provisions concerning Exclusive Marketing Rights (EMRs);
  4. provide for a transitional provision to protect EMRs already granted;
  5. introduce provisions to give effect to the Doha Declaration on TRIPS and Public Health; and
  6. empower the IP Appellate Tribunal to adjudicate upon revocation of patents.

The proposed Bill will introduce product patents covering ‘all fields of technology’ ‘without discrimination as to the place of invention’, ‘the field of technology’ and irrespective of ‘whether products are imported or locally produced’. In all likelihood the product patent regime will change the way the pharmaceutical companies do business in India.

Exclusive Marketing Rights

At the time of joining the WTO, India did not have product patents for certain categories of inventions viz., food, drug and medicine. As a WTO member, India was under obligation to provide transitional protection for inventions in these fields.

In December 1994, India promulgated an Ordinance to amend the Patents Act to provide for a ‘Mail Box’ mechanism to receive product patent applications. However the, Government of India failed to substitute this Ordinance with a legislation passed by the Parliament. Consequently, a case was filed at the WTO by the US and the EU against India for not complying with the TRIPS obligation. India lost the case at the Dispute Settlement Panel of the WTO. India preferred an appeal against the decision of the Panel to the Appellate Body. The Appellate Body also decided the case against India by December 1997 and gave fifteen months time till April 1999 to comply with the TRIPS obligation respecting the transitional protection. The controversy ended when India amended its Patent law in March 1999 and introduced a new chapter IVA dealing with Exclusive Marketing Rights. The Patent Rules 1972 was also amended in June 1999 to introduce Chapter IIIA to provide for filing and prosecution mechanism for Exclusive Marketing Rights.

EMR has been a key topic for deliberations in the Indian pharmaceutical business circles in the recent past. Very few companies have been able to meet with the requirements set under the amended patents law. The details of the EMRs granted so far as well as EMRs applied for are as follows:




Title of the EMR/Patent Application and related Drug Product

Brand Name


Glaxosmithkline Beecham

Rosiglitazone (Novel compounds)


EMR rejected

Glaxosmithkline Beecham

Novel compounds (name of drug product not available)

Not known

EMR Rejected


Imatinib mesylate


EMR granted (the first EMR in India)




EMR granted

United Phosphorus

Combination of Carbedazim & Macozeb


EMR granted (first EMR of an Indian company)

Nicolas Piramal



EMR Application Pending


Saquinavir mesylate


EMR rejected




EMR Application Pending

Astra Zeneca



EMR Application Pending

Astra Zenca



EMR Application Pending


Pharmaceutical compositions containing Benzoquinolizines

Not known

EMR Application Pending

Schering Plough

Biotech – interferon alpha

Not known

EMR Application Pending

Bristol-Myers Squibb



EMR Application Pending




EMR Application Pending


Zoledronic acid


EMR Application Pending


Once-a-day oral controlled release form


EMR Application Rejected

Eli Lilly

Tetracyclic derivatives, process for preparation and use thereof

Not known

EMR Application Pending

Clause 21 of the proposed amendment bill omits Chapter IV A of the Patents Act, 1970 that deals with Exclusive Marketing Rights. A new set of provisions has been proposed in the Bill to protect the EMRs already granted. The pending applications for EMRs will be treated as request for examination under Section 11B. All EMR related infringement suits pending before the courts will be treated as patent infringement suits once the new law takes effect.

Compulsory licensing – the balancing act

The availability of medicines at affordable prices is a key health concern. It was this key concern that compelled the Government of India to augment the reach and scope of compulsory licensing in the Patents Act. The Patents Act, 1970 contained detailed provisions respecting compulsory licenses. But these provisions were never put to use. However, in view of the introduction of product patents, the Government of India has made compulsory licensing provisions further stringent. Any interested person can apply to the Controller of Patents seeking a compulsory license if the ‘reasonable requirements’ of the public with respect to the patented invention is not satisfied, or the patented invention is not available to the public at reasonably affordable price, or when the patented invention is not worked in the territory of India. An attempt has been made to explain the meaning of an otherwise vague expression ‘reasonable requirements’ in Section 84(7). However these explanations do not clarify clearly the situations in which an interested person can invoke compulsory licensing provisions, leaving the expression ‘reasonable requirements’ more or less ambiguous.

The Patents (Amendment) Bill, 2003 introduces a new section namely 92A in the principal Act relating to the grant of compulsory licenses for manufacture and export of patented pharmaceutical products in certain exceptional circumstances. This amendment is intended to implement Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. According to this provision compulsory license will be granted to manufacture and export patented pharmaceutical products to a country, having insufficient or no manufacturing capacity in respect of that product, provided the applicant has obtained a compulsory license in that country for that product.

The provisions on compulsory licensing will have a bearing on the way the multinational pharmaceutical companies propose to do business in India after January 1, 2005. Making drugs available at affordable prices will be a key issue for multinational pharmaceutical companies. Those who do not have their own manufacturing units will need to enter into licensing arrangements with local counterparts. Indian pharmaceutical companies are likely to make use of the ambiguity in the provisions relating compulsory licenses. The sub-clauses (a) through to (e) of Clause (7) of Section 84 are adequately ambiguous, giving the Indian companies the scope to use it to their advantage.

Parties aggrieved by the grant as well as the refusal of EMRs have filed cases at the High Court setting the scene for a large number of potential product patent litigations.


The scene has been set in India for an interesting era in the national patent system. The decade ahead will witness a vibrant phase of dialectics that will hopefully contribute to the emergence of a patent system capable of absorbing the often conflicting interests of the stakeholders – the Indian and the multinational pharmaceutical companies, the patent administration system and judiciary and the people of India.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

In association with
Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions