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