India: ‘Patent’ly In Force?

Last Updated: 13 January 2005

By Mustafa Safiyuddin and Ajay Shaw, DSK Legal


Pharmaceutical product patents and patents for computer programs have at last found their way into the Indian patent regime through the Patents Amendment (Ordinance), 2004 promulgated by the President. The expediency of an Ordinance has been resorted to in an endeavour to comply with India’s obligations under Agreement on Trade Related Aspects of Intellectual Property Rights popularly known as "TRIPS" by the January 1, 2005 deadline. However, the Ordinance, seeking to amend the Patents Act, 1970 could lapse if it is not approved by Parliament during the monsoon session. It is questionable as to whether the Government should resort to a Presidential Ordinance bringing about far reaching changes in the patent law without a Parliamentary debate in the first place, in respect of issues on which views have been divided across the country.

The key amendments to the patent regime brought about by the Ordinance and their practical implications may be summarized under the following heads.

Pharmaceutical product patents:

From January 1, 2005, for the first time, the grant of full-fledged pharmaceutical product patents for a term of 20 years will be permissible. Pharmaceutical product patents are advantageous to multinational companies like Pfizer, Glaxco, Novartis and research based Indian drug companies such as Ranbaxy, Dr. Reddy’s and Wockhardt. However, the grant of such product patents may be detrimental to small indigenous generic drug manufacturers.

Further, patents for chemical products and food items are also being introduced. Until now only process patents for pharmaceutical products, chemicals and food items were permissible.

A hybrid system of exclusive marketing rights popularly know as "EMR" for pharmaceutical products had been in place for some time, but is now abolished by the Ordinance in view of the pharmaceutical products patent regime coming into force.

New use patents:

Earlier "new use for a known substance" could not be patented, however, the Ordinance now provides that "mere new use for known substance" cannot be patented. The insertion of a single word "mere" would open the floodgates for pharmaceutical product patents. This is because the word "mere" restricts the scope of non-patentable subject matter and widens the scope of patentability. The effect is that "new pharmaceutical use of a known substance", even though "the substance itself is known and comprises part of the state of the art" would be patentable. Not only first new medical use of known products but also second and subsequent new uses would be patentable. This can be achieved through cleverly drafted "Swiss form" of patent claims. For example, the new discovery that the consumption of the known substance aspirin can also be useful in thinning the blood can be patentable by making a claim for "use of aspirin in making a medicament for use in the prevention of blood clots".

Computer programs:

In an endeavour to encourage the software industry, the scope of patentablity of computer programs has been broadened. This is sought to be achieved by restricting non patentability to "computer programs per se" whilst computer programs’ technical application to industry or a combination with hardware would constitute patentable subject matter. Perhaps the effect is that patents shall not be granted for computer programs in the form of abstract creations lacking in technical character. But patent claims for computer programs having a technical effect may be granted. Thus a computer program product could be patentable if it resulted in additional technical effects that went beyond the ‘normal’ physical interaction between the program (software) and the computer (hardware) on which it was run. With this provision, the standards of patentability of computer programs would perhaps be close to that of the European Union but may not be as liberal as that prevailing in US.

Parallel imports and international exhaustion:

Patent holders often take recourse to the territorial nature of patent rights to prevent parallel imports. Thus if a US patented product is once sold in US, parallel imports thereof into developing countries are sought to be restricted by resorting to legally separate patent rights conferred upon the same product in the developing countries. This anti competitive practice of dividing markets is detrimental to the interests of the developing countries and enables the patentee to earn windfall profits. Through the Ordinance parallel imports into India cannot be prevented by resorting to the above method. This is because India has recognized the "first sale doctrine" also known as the doctrine of "international exhaustion" whereby the patent holder exhausts his rights upon first sale of the patent product in any part of the world and cannot prevent parallel importation thereof by resorting to the patent regime of each country.

Compulsory licensing of pharmaceutical products for exports:

Whilst resorting to the Doha declaration, the Ordinance permits the grant of a compulsory license by the patent authorities (and which may be against the wishes of the patentee) to manufacture and export patented pharmaceutical products from India to countries having insufficient supplies and facing public health problems. This is a departure from the normal rules of compulsory licensing which is permissible primarily to meet the local demands after the expiry of 3 years from the grant of the patent.

Opposition to grant of patent

Prior to grant:

Fundamental changes have been brought about in the opposition procedure with an endeavor to expedite the grant of patents. Earlier any person could oppose the grant of a patent by initiating opposition proceedings and the opponent had a right of audience in such proceeding. Now, under the new procedure, prior to grant of a patent, any person may merely make written representations to the patent authorities against the grant, but has no right of personal hearing.

Post grant:

The earlier law does not provide for any opposition procedure once the patent is granted but only for a right to apply for revocation. The Ordinance now introduces a system of opposition, which can be initiated within a period of one-year post grant of the patent. This is in addition to the revocation procedure which is already in place but only that the same needs to be filed before the newly constituted Appellant Board unless such revocation proceedings are by way of a counter attack in a High Court infringement suit. Since there is already a revocation procedure in place post grant, the need for introducing a new concurrent opposition procedure post grant is perhaps unnecessary.


If the patent regime is implemented in an efficient manner, it can assist India in attracting foreign investments and technology transfers so as to acquire a leadership position in the emerging markets. It can also encourage indigenous research and development.

© DSK Legal, 2005.

The views expressed in this article are those of the authors and do not represent the views of the firm. This article does not purport to be professional advice, nor a complete or comprehensive study on the subject. It is recommended that professional advice be sought before taking any action pursuant to any matter contained in this article.

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