# \[e-drug\] Novartis response to case statement by India

**URL:** <https://talk.edrugplus.org/t/e-drug-novartis-response-to-case-statement-by-india/27731>\
**Category:** e-drug\
**Created:** [April 18, 2007, 8:53pm UTC](https://talk.edrugplus.org/t/e-drug-novartis-response-to-case-statement-by-india/27731 "2007-04-18T20:53:08Z")\
**Posts on this page:** 1\
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**Author:** ![Dominic\_Atkins](https://avatars.discourse-cdn.com/v4/letter/d/edb3f5/32.png) [@Dominic\_Atkins](https://talk.edrugplus.org/u/Dominic_Atkins)\
**Post date:** [April 18, 2007, 8:53pm UTC](https://talk.edrugplus.org/t/e-drug-novartis-response-to-case-statement-by-india/27731/1 "2007-04-18T20:53:08Z")

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E-DRUG: Novartis response to case statement by India  
----------------------------------------------------

In response to the statement of the Indian Ambassador (to Belgium,  
Luxembourg and the European Union) at the European Parliament which was  
posted on e-drug on 15th April 2007, Novartis would like to add some  
comment. What follows is a briefing which was sent to members of the  
International Trade Committee before that hearing to set out the facts and  
issues in this case.

We would further like to add that the European Parliament has not urged,  
nor even asked Novartis to drop its litigation. We are pursuing an action  
through the Indian courts to clarify the law, as is our right as a  
corporate citizen of India. Our actions will not endanger the supply of  
Glivec to patients in India, or the supply of generic drugs to the  
developing world given the international safeguards in place.

Dominic Atkins  
Novartis  
dominic.atkins@novartis.com

---  
11th April 2007

This afternoon, the International Trade Committee will discuss the legal  
action brought by Novartis in India concerning our medicine Glivec.

As a result, I thought it would be useful for you to have a short written  
briefing prior to this discussion.

These are the main points I would like to address:

The legal case does not concern access to medicines. On the contrary, 99%  
of the Indian patients who take Glivec (circa 6,600 patients in total)  
receive it from Novartis for free. Worldwide, Novartis is donating Glivec  
at no cost to approximately 19,000 patients in 80 countries.  
Our legal action in India does not undermine the provisions that allow  
access to medicines. Novartis only challenges those provisions of Indian  
Patent Law which are not currently in compliance with international law.  
Novartis fully supports the TRIPS conditions that promote access to  
medicines for developing countries and the Doha declaration.  
Our legal case has no impact on pending patent applications for new HIV  
treatments. Most new HIV treatments are new compounds, thus falling  
completely outside the scope of the current dispute.

Our case concerns incremental improvements of earlier compounds.  
Novartis?s position is that such innovations should also be patented. Our  
opponents argue that such stepwise innovations do not deserve to be  
protected as they often bring no additional value. This is however, a  
strange argument. Patents for incremental innovation do not prolong the  
life of the original patent. Thus, generic companies can always produce  
medicines based on the initial compound when the patent expires if they  
believe that the incremental innovation does not add value to the original  
product.

The case also concerns the conflicting interests of Indian generic  
manufacturers and the innovative pharmaceutical industry. Indian generic  
manufacturers target the middle income populations but not the ?real  
poor?. In India, the generic version of Glivec costs 4.5 times the average  
annual income.

A strong patent law is in the interest of India. One third of pending  
patent applications for pharmaceuticals comes from Indian pharmaceutical  
firms. Indian companies have a strong interest in having patents for  
incremental innovations and they have publicly supported our case.  
Novartis contests strongly that our case undermines the supply of  
affordable medicines to the developing world. Indian generic companies  
focus on the developed world and India; only 8% of their sales goes to the  
developing world outside India. By contrast, the innovative  
pharmaceutical industry treats 716,000 HIV patients in the developing  
world.

Novartis is deeply committed to ensure that patients have access to  
medicines. In 2006, our access to medicines program reached 33.6 million  
patients. Novartis spent USD 755 million last year alone. Public private  
partnerships can play an important part. Novartis is committed to  
exploring the issue of access to medicines. But, any solution must be  
sustainable. Generics and the demise of the patent system is not a viable  
solution in the long-term.

As the world's second largest manufacturer of generic medicines, Novartis  
understands and recognizes the contribution of generics once drug patents  
expire. Our concern is with the non-recognition of intellectual property  
rights that ultimately advance pharmaceutical research and development for  
better medicines so that patients needs will be met in the future.
