[Ip-health] HEALTH-INDIA: Anger Grows at Novartis' Bid to Hog Cancer Drug

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HEALTH-INDIA:
Anger Grows at Novartis' Bid to Hog Cancer Drug

Keya Acharya
  BANGALORE, Jan 30 (IPS) - A public outcry has followed the challenge offe=
red by Novartis AG in the Madras High Court to the Indian Patents Act as vi=
olating international trade laws and restricting the Swiss pharmaceutical g=
iant's trade.
In April 2005, the Indian government as a member of the World Trade Organis=
ation (WTO) and signatory to its trade-related intellectual property (TRIPS=
) provisions amended domestic law to recognise 20-year patents on products,=
 annulling the country's 7-year patents on processes.

A slew of important generic-drugs or those being produced after patent expi=
ry have since been forced off the market, unless, as per clauses in the ame=
nded Indian Patents Act, the patent applications can be proved to be not 'n=
ew' or involving innovative molecular research.

In the first test of the amended Indian law, Novartis applied for a patent =
on its leukaemia-treatment drug 'Gleevec', but was rejected by the Patents =
Office in southern Chennai city as not being innovative enough. The company=
 thereafter filed a writ in the Madras High Court, located in Chennai, chal=
lenging the rejection.

The court hearing was adjourned to Feb. 15 due to Novartis wishing to inclu=
de a recent report commissioned by Indian Parliament and headed by R.A. Mas=
helkar, former head of the Council of Scientific and Industrial Research, t=
o look into the question of patentability.

The Mashelkar report asks for inclusion of patents on medical entities with=
 'one or more' inventive steps, in the 'national interest', thereby allowin=
g patents on products that do not involve new molecules.

Several legal and civic groups are outraged at the report as having 'sold o=
ut' to corporate interests, and have been slamming Novartis ever since it e=
xerted exclusive marketing rights in 2004 for Gleevec, pushing prices up fr=
om 175 US dollars to 2,000 dollars per month of treatment, affecting immedi=
ately India's 25 million leukaemia patients.

"I think what happened in court yesterday (Monday) is an example of 'double=
-speak' in India," says Dr. Thelma Narayan, joint convenor of 'Jan Swasthya=
 Abhiyan', the national face of the global People's Health Movement (PHF).

" Novartis was recently given a global award with United Nations recognitio=
n for 'corporate social responsibility', yet millions in India and poor cou=
ntries are either dying or not being able to afford treatment due to the co=
mpany's bid at market monopoly of a generic drug. I think such giant MNCs n=
eed to be exposed," Bangalore-based Narayan told IPS.

"If the Mashelkar report had defined inventions properly, we could have sav=
ed the situation," B.K Keyala, a former patent commissioner of India and pa=
rt of the 'People's Commission' headed by former prime minister Inder Kumar=
 Gujral, told IPS. Keyala says he has organised four commissions on patents=
 awareness with influential individuals participating but, ''no one has car=
ed enough.''

At least seven civic, legal and health groups together with the PHF and the=
 Medicins san Frontieres (MSF) have been campaigning actively in the last y=
ear against Novartis filing for patent claim on Gleevec.

Lawyers' Collective, the legal advisers to the Cancer Patients Aid Associat=
ion opposing Novartis in court, have broadened the issue in public to inclu=
de essential drugs since the Novartis judgement will indirectly impact the =
manufacture and affordability of generic drugs for not only leukaemia but a=
lso for treatment of other significant cancers, HIV/AIDS and several other =
diseases in developing countries.

Anand Grover of the Lawyers' Collective blames the Indian government's seem=
ingly pro-corporate stance and says it is being influenced by western trade=
 agendas, especially that of the United States. "Government policies are on=
ly thinking about the hype of India being poised as an economic powerhouse,=
 without addressing the needs of its poor. "

Keyala too agrees that corporate agendas, especially of multinational drug =
giants, have influenced government, but believes that civic groups could ha=
ve strategised differently for better effect.

"They need to campaign for including HIV as a national emergency and then g=
et generic drugs out of the patents' circle," Keyala said. According to Gro=
ver there are several equally essential drugs that cannot be termed as trea=
tments for national emergencies.

Under Indian law, and allowed by WTO under the Doha Declaration, generic dr=
ugs used for public health emergencies can be manufactured under licence.

"Winning from the patent office itself, due to our pre-grant opposition, wa=
s a big thing, " says Naveen Thomas of the All India Drug Action Network, b=
ased in Bangalore.

"We can still fight with 'them', everything is not lost," said Dr. Prakash =
Rao of the state-level Drug Action Forum in Bangalore.

Yet the Indian medical fraternity has been visibly silent in this civic dis=
content against what Novartis' patent claim stands for. Dr. Ananth Phadke o=
f the Centre for Enquiry into Health and Allied Themes at Pune in south-wes=
tern India, feels that Indian doctors are not sensitised enough to drug his=
tories and patents in their medical curricula, besides being 'wooed' by dru=
g manufacturers.

But Dr. Ajay Kumar, president of the Indian Medical Association (IMA) with =
over 178,000 doctor-members countrywide, says he feels 'very strongly' abou=
t the whole issue of generic drugs and price rise through patenting.

"Corporatisation of medicine serves only one percent of India's population.=
 I will be taking up the issue of pricing and allowing Indian pharmaceutica=
ls to manufacture generics with the government,'' Kumar told IPS, over tele=
phone from the eastern Indian city of Patna.

The next legal challenge taking shape in India is the multinational drug lo=
bbies' pressure on the government to insert 'data exclusivity' or the preve=
ntion of use of data from clinical trials by the Drug Controller's Office, =
through amendments in the Drugs and Cosmetics Act that controls drug market=
ing.

"By implication, as long as the exclusivity lasts, generic producers would =
have to submit their own data to prove safety and efficacy, which would obl=
ige them to repeat the clinical trials. This is something that would cause =
significant delay that many generic manufacturers cannot afford,'' says a W=
HO bulletin released in March 2006.

The Affordable Medicines and Treatment Campaign, spearheaded by the Delhi-b=
ased Lawyers' Collective has conveyed its concern to Indian Prime Minister,=
 Manmohan Singh, highlighting how data exclusivity impedes the use of compu=
lsory licences in public health emergencies and prevents drug regulatory au=
thorities themselves from relying on test data already in their possession =
for subsequent approval of generic versions of the medicine. (FIN/2007)


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