Worldwide: Novartis´ Glivec Battle With India - Patentability Of Pharmaceutical Extension Patents

Last Updated: 8 August 2007
Article by Duncan Bucknell
Update and brief strategy analysis

On Monday 6 August Novartis suffered a blow in its battle to obtain Indian patent protection for its beta crystalline form of Glivec (Imatinib mesylate). The case has attracted a lot of attention (a) because of India's unusual section 3(d) which limits patentability and (b) because this is the first patent to be challenged from the famous mail-box procedure. Although Novartis' TRIPS challenge looks like a difficult one to win before the WTO, there may be some room to move.

This article provides the background, an update and some strategic options in the dispute and finishes with a list of online resources for further reading. You can comment on this article at the equivalent post on my blog IP ThinkTank.


The patent in issue claims a new crystalline form of imatinib mesylate. The original composition of matter patent is not patentable in India as it a drug product patent which was originally filed prior to 1995 when the mail box procedure began.

The Indian Patent Office refused to grant the patent on the ground that it lacked patentability under section 3(d) which states:

'The following are not inventions within the meaning of this Act,
‘the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.'

A brief consideration of the section quickly reveals a few ambiguities (which I won't discuss here). Section 3(d) was added to the Indian Patent Act as part of the 2005 amendments. The explanation to the amendment states:

'For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.'

Novartis files two High Court challenges

Novartis' response to the refusal was to file two High Court Challenges:

  1. - an appeal from the original decision to the Chennai High Court, arguing that the new crystalline form does in fact have an enhanced efficacy as it has a 30% increased bioavailability;
  2. - a challenge to the enactment of section 3(c) on the ground that it was "unconstitutional as it is vague, arbitrary and violative of Article 14 of the constitution (right to equality)."

(1) The Appeal

Unfortunately, this has not progressed very far. On 2 April 2007, the Indian Government issued a notification declaring that section 117G of the Indian Patent (Amendment) Act 2005 (which provided that all pending appeals in the High Court shall be transferred to the Appellate Board set up under the Act), was to be made effective as of 2 April 2007.

Consequently, the Glivec appeal was transferred to the Intellectual Property Appeals Board (IPAB). The IPAB had been running since 2003, but had never heard a patent case as it did not have a 'technical member'. Former Patent Controller S Chandrasekharan was appointed as the technical member of the newly constituted IPAB for patents.

Novartis appealed Chandrasekharan's appointment as he had been the presiding Controller at the office which originally refused the patent. To make the perceived conflict worse, before the proceedings were transferred from the High Court, Chandrasekharan had filed an affidavit defending the rejection of the patent application by the patent office.

Curiously, the IPAB itself heard the appeal about its own membership, and unsurprisingly, dismissed the appeal. On 3 August 2007, Novartis appealed this decision at the Chennai High Court.

So, we're back before the Chennai High Court on a narrow question of the composition of the IPAB. This could take a while, folks.

It seems reasonably clear that the IPAB will be forced to remove Chandrasekharan by the High Court. The same mess has recently occurred, also concerning Chandrasekharan in the Magotteaux International appeal. (Magotteaux had to go through the same 5-step process - High Court writ, removal to IPAB, challenge to membership, refusal, appeal to High Court.)

Once the membership of the IPAB is sorted out, the real question will be whether the beta crystalline form is patentable within the confines of s3(d) (and the more usual ground of obviousness). In other words, does the beta crystalline form result in the enhancement of the known efficacy of imatinib free base form (the subject of the 1992 patent), and is it non-obvious in light of that patent?

Novartis will argue that the 30% increase in bioavailability makes it so. However, there's a semantic argument that bioavailability is not efficacy to start with. Then there's the question of whether the 30% threshhold is sufficient to be an 'enhancement'. After that, there's always the argument that notwithstanding these section 3(d) arguments, it would have been obvious to produce the mesylate and beta crystalliine form with a reasonable expectation that it would improve therapeutic use and most likely bioavailability. (Note here that to succeed, this obviousness argument needs two steps - the first to the mesylate salt and the second to the beta crystalline form.)

The danger posed by the obviousness argument is clear - it makes irrelevant the s3(d) challenge (which will go to the WTO as explained below). Having said that, (and subject to the prior art), one would expect that Novartis will have some pretty good counter arguments - they do this all the time all over the world.

(2) The challenge to section 3(d)

On 6 August, the High Court in Chennai dismissed the writ petition challenging the constitutionality of Section 3(d), and deferred to the World Trade Organization (WTO) to resolve the TRIPS compliance question.

It makes sense that the Chennai High Court refused to hear the application. Compliance with TRIPS isn't a constitutional matter under Indian law.

Having said that, the case has certainly created a lot of publicity about this unusual section of Indian patent law. The ongoing debate is not a bad place to launch a WTO challenge. Strategically then, by running the challenge, Novartis has helped set the stage for the real battle - before the WTO.

But will they win?

Shamnad Basheer over at Spicy IP thinks not:

"...section 3(d) is compatible with TRIPS, as it is an "obviousness" standard that member states are free to define in a manner consistent with their national policy. Section 3(d) does not "discriminate" against the pharmaceutical sector but only makes a "justified" differentiation, given the specificity of salt forms in the pharmaceutical sector i.e. other technology sectors such as mechanicals, electronics etc do not face "different salt form" kind of issues.

It bears noting that US patent law encompasses a heightened utility requirement in the context of gene patents—i.e. in order to be patentable, a gene sequence has to demonstrate "substantial", "specific" and "credible" utility. This came out of a desire to put a stop on the multitude of frivolous gene patent applications that cited the obvious utility of being a "mere probe". These steps that cater to the specificities of technology sectors are perfectly legitimate exercises of national discretion by member states. And India is no different. For similar reasons, section 3(d) is not likely to be struck down as an "arbitrary" standard under Art 14 of the Constitution of India."

I tend to agree with Shamnad - at least in relation to patentability of new forms of known substances.

However, section 3(d) also provides a blanket ban from patentability of all new uses of known substances. The difference is that new forms of known substances are subject to the proviso that they are not patentable if they '[do] not result in the enhancement of the known efficacy of that substance'. This proviso brings Shamnad's argument into play - that this is merely an obviousness requirement and so is in compliance with TRIPS. (The obviousness analogy is a very good one, and it is quite arguable that the law of many jurisdictions would bar from patentability a very similar set of patents as are barred under India's s3(d). See for example the anonymous comment on the situation in Europe at the IPKat's post "Novartis fight for patentability in India").

However, the ban on new uses of known substances does not have any such proviso. It simply states:

'The following are not inventions within the meaning of this Act':


(d) ... a new use for a known substance...'

I haven't looked, but I wonder whether there is any disclosure in the patent in issue to enable claims to a new use. If this were the case, perhaps Novartis could win at least on the new use of a known substance limb of the argument. If successful on both, then back India, they could argue that the beta crystalline form is used in a new way (subject to the disclosure in the patent, and an amendment, of course).

(The other ban from section 3(d) is on discoveries of new properties of a known substance. It is well known across the world that mere discoveries themselves are not patentable. Consequently, patent protection would be sought for the new use which becomes possible as a result of the new property.)

Summing Up

In the Appeal, the IPAB will likely be reconstituted without Mr Chandrasekharan. The IPAB will then have to consider patentability and, to win, Novartis must convince the IPAB that (a) in relation to s3(d) the 30% increase in bioavailability is an enhanced efficacy and so the beta crystalline form is patentable, and (b) the beta crystalline form of the mesylate salt is not obvious in light of the free base form.

Whoever wins, there will be an appeal back to the Chennai High Court, and then possibly on to the Supreme Court.

The s 3(d) challenge will take a long time to wind its way through the WTO process. Novartis appear to have a difficult task to win on the argument that the restriction on patentability of new forms is not compliant with TRIPS. However, a challenge to the ban on new uses of known substances may be more successful (though fruitless unless they can obtain claims to a new use).

As I mentioned in my earlier blog post, after all of that, India could still grant a Compulsory License to a generic company. To the best of my knowledge, India has not granted a Compulsory License before - presumably because of the lack of product patents has meant that they did not need to.



Spicy IP

Economic Times of India:

Novartis hits a blind spot with Glivec appeal;

Times of India - Novartis loses fight for cancer drug patent

Lawyer's Collective (public interest service provider in India that represents patient groups in the Novartis Group)


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.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Mondaq Advice Centre (MACs)
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.