Novartis case in India's Madras High Court

[Guest guest]

Dear fellow CMLers,

As some of you know, I have worked for a number of years with Doctors

Without Borders (Medecins Sans Frontieres/MSF) in their campaign to increase

access to essential medicines around the world. Though I've been on

MSF/USA's advisory board since 1989, it was fortuitous that I began focusing

on the access issue in 1999, only a year before my own diagnosis of CML. My

good fortune in obtaining so extraordinary but expensive a drug as Gleevec

increased my determination to do what I could on behalf of the many millions

around the world whose lives may be lost because they cannot afford

similarly lifesaving therapies.

The Access campaign by MSF and others has gone surprisingly well in many

respects. The most dramatic result was a decrease in the average annual

cost of anti-retroviral drugs to AIDS patients in the developing world, from

over $10,000 to below $200.

Now, however, a legal challenge brought by Novartis against the Indian

government has the potential to severely affect access to affordable

essential medicines for millions of people across the developing world.

Novartis is challenging a public health safeguard enshrined within India¹s

Patents Act, which currently allows generic medicine producers in that

country to produce an inexpensive form of Gleevec/Glivec/imatinib. This is

not just about " our " drug, however; if Novartis is successful, the era of

India being a producer of affordable generic medicines for much of the world

could be coming to an end with regard to newer and future medicines. This

would have a devastating impact on people the world over who rely on

affordable medicines manufactured in India.

I won't write more about this complicated issue here because, for one thing,

it would make for way too long a post, and for another, I'm no sort of

expert on international intellectual property law. If you'd like to learn

more, please email me and I'll send you a few documents I've accumulated

that detail the importance of the case and its fine points.

Meanwhile, in hopes of encouraging Novartis to drop their suit, I am mailing

the following letter to Novartis CEO, Dan Vasella. I hope that many of you

may choose to send along something similar. You could use the address below

for snail mail, or send your note via email to daniel.vasella@....

If you email, MSF would appreciate a cc, addressed to

AccessCampaign.NYC@.... Their efforts will be aided by knowing

how many patients on Gleevec are supportive of the campaign. For this reason

they'd appreciate copies of snail mail letters too (in the text of an email

message would be fine).

Alternatively (or in addition!) you can go to

http://www.msf.org/petition_india/cml.html, and sign MSF's " drop the case "

petition.

Thanks for your time in reading this, and warm regards to you all.

Rockefeller, MD

Dx 10/00. On IM/Gleevec since 5/01. PCRU since '02

_____________

Letter to:

Dr. Vasella

Chief Executive Officer

Novartis International AG

Schwarzwaldallee 215

4002 Basel

Geneva.

March __, 2007

Dear Dr. Vasella,

As you know, I participate in several international online listservs

comprising several thousand patients living with Chronic Myelogenous

Leukemia (CML). As we deal with this previously fatal condition every day,

we understand firsthand the importance of innovative medicines such as

imatinib mesylate (Gleevec/Glivec). We are also vitally concerned with

financial barriers that may limit access to these and many other essential

health innovations used by ourselves and others throughout the world.

I am writing to express my concern with recent legal action initiated by

Novartis against the Indian government in May 2006, and am urging my

colleagues with this disease to do likewise. The action by Novartis is

intended to limit generic competition with Gleevec/Glivec. Even more

significantly for the health and wellbeing of many around the world, it will

remove important public health safeguards enshrined in Indian law. These

safeguards were introduced by Indian legislators to prevent the

³evergreening² of patents or the abuse of the patent system by requiring

that a threshold level of invention and product improvement is met before a

20 year patent term can be secured.

Maintaining these and other public health safeguards in Indian law to

promote generic competition is of global importance to ourselves and the

majority of people in the developing world who depend on essential

medicines, as India is the main international supplier of such medicines to

low income populations.

For example, half of the all the medicines used by the United Nations

Children's Fund (UNICEF) to address childhood health conditions in

developing countries are sourced from Indian generic producers. Seventy per

cent of antiretroviral therapies used by the main international funding

agencies including the Global Fund, to treat HIV/AIDS patients in developing

countries, are supplied by Indian generic producers. Equally importantly,

national health departments across the developing world rely on low cost

Indian generic medicines. In the last 30 years, the population with access

to medicines deemed essential for their health and wellbeing increased from

2.1 billion to nearly 4 billion worldwide. Widespread availability of

quality low cost generic drugs has been critical to this improvement. Yet

these are just some of the important international programs and successes

that will be threatened if the case brought by Novartis in India succeeds

and thereby weakens the pro-public health provisions in India¹s patent laws.

As the above concerns have been raised by numerous patient groups and public

health advocates in recent weeks, Novartis has pointed to the Gleevec

International Patient Assistance Program (GIPAP) as a defense of its

actions. As CML patients we acknowledge the contribution that GIPAP is

making to provide Gleevec to some of those who cannot afford the therapy.

However, as patients who will be living with this condition for the rest of

our lives, we also recognize that the sustainability of programs through

which access is obtained, is of vital importance. Additionally, patient care

involves many other therapies to treat symptoms and co-morbidities. Clearly

our lifelong access to medicines that prolong our life cannot and should not

rely on charitable programs funded by for-profit corporations that are

primarily responsible to shareholders and maximizing shareholder returns.

While many of the assistance programs run by industry are commendable,

others have been little more than public relations exercises lacking

funding, transparency, commitment and durability.

I further maintain that the question of access to Gleevec is a separate

issue from that of overturning pro-public health provisions in India¹s

patent laws, and that the GIPAP program should not be used as a means to

confuse these. Patients should not be used as a smokescreen for strategic

efforts to weaken national laws and public health safeguards. Unfortunately

these activities are undermining the positive efforts of the Novartis GIPAP

program.

As a CML patient with a personal understanding of the issues in this case, I

therefore strongly urge you to drop the case in India involving the Indian

Patent Act and patents over Gleevec.

Yours truly,