India: Cipla Seems To Be On The Skids

Last Updated: 22 December 2014
Article by Zoya Nafis

Earlier in the month of November, Indian generic drug maker Cipla Ltd. had requested the Central government to revoke five patents held by Swiss firm Novartis AG on respiratory drug Indacetorol, used for the treatment of Chronic Obstructive Pulmonary Disease (COPD) under the brand name 'ONBREZ'. Cipla had filed a representation before the Department of Industrial Policy & Promotion (DIPP) to cancel the patents on the ground that the Swiss company had held them for six years without making the medicine locally or importing it in the quantity which is required.

The representation was filed under section 66 and section 92 of the Indian Patents Act, 1970.

Section 66 empowers Central Government to revoke a patent on the grounds of it being mischievous to the State or prejudicial to the public. The power given to the Government of India under section 66 of the Indian Patents Act has been exercised only twice so far. The first was when a process patent had been granted to Agracetus, a U.S. based company for genetically engineered cotton cell lines. This patent was revoked on the ground that it was against the public interest, cotton being an important source of India's national economy. The second case was when the Avesthagen patent for "synergistic ayurvedic/functional food bioactive composition" was revoked. On an application by the Traditional Knowledge Digital Library, this patent was revoked by the DIPP for "generally being prejudicial to the public". In the present case Cipla had applied for revocation on the ground of non-working of patent and sheer obviousness.

Section 66 of the Indian Patents Law acts as a correctional provision and the Government is considered as the adjudicating authority, which ensures that interest of public is given more priority than personal or commercial interests.

Under Section 92, the Central Government has the power to grant Compulsory License if it is satisfied that there is a circumstance of national emergency or of extreme urgency or in case of public non-commercial use. Cipla believed that COPD is one of the major causes of fatalities in India and therefore, proper treatment is essential. COPD has, in recent years, assumed epidemic proportions as it is prevalent in people residing in urban, semi-urban and rural areas. The causes of COPD are several and the sheer magnitude of the disease as per the publicly available data is sufficient for the Central Government to invoke the provisions of Section 92 and to treat it as an "epidemic" or a "public health crisis". Such exercise of power in the present case would be in consonance with the avowed purpose for which Section 92 has been enacted.

Cipla had already launched the generic version of Novartis' Indacetorol, under the brand name UNIBREZ.

However, Central Government after examining Cipla's petition considered it of minimal merit. The Health Ministry also suggested that Cipla's proposal for a compulsory license for the medicines under section 92 of the Patents Act a rarest of rare provision to be used in case of national emergency or in extreme urgency or for public non-commercial use may not be "fit" to pass legal scrutiny and if at all there is a chance for the grant of Compulsory License Cipla should opt for the route provided under section 84 of the Patents Act.

In a blow to Cipla, Novartis approached the Delhi High Court in a patent as well as trademark dispute in this regard.

Novartis filed a trademark suit on November 7, 2014 against Cipla for using the impugned mark UNIBREZ for pharmaceutical products which is deceptively similar to its mark ONBREZ used for pharma products. The Delhi High Court vide its order dated November 17, 2014 passed the order in favor of Novartis permanently restraining Cipla from using the impugned mark.

Novartis also petitioned before the Delhi High Court to permanently restrain Cipla from manufacturing Indacaterol in any form and selling it in India, claiming its patent rights and also sought damages and payment for infringing the patented pharmaceutical product.

Cipla stated in its reply the court that the drug sold by Novartis is way too expensive for the general public in India and is only available to government hospitals and this led Cipla to file a representation before the DIPP, to revoke exclusive patent rights granted to Novartis, claiming non-working of Novartis' patents in India.

After hearing the detailed arguments of both the parties, the Delhi High Court reserved its judgment.

Keeping in view the stand of the Health Ministry and the Delhi High Court in this issue, it is undoubtedly evident that a stringent approach is followed in matters relating to IP protection now, as the USTR had already blamed India for its lenient stand over approval to generic drug makers in regard to patented pharmaceutical products, posing serious challenges to the innovators.

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.

Zoya Nafis
Similar Articles
Relevancy Powered by MondaqAI
Singh & Associates
Vaish Associates Advocates
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Singh & Associates
Vaish Associates Advocates
Related Articles
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