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[e-drug] Boehringer Ingelheim looses case in India

  • From: "Gopal Dabade" <dabadedr@yahoo.com>
  • Date: Sun, 10 Aug 2008 11:04:00 -0700 (PDT)

E-DRUG: Boehringer Ingelheim looses case in India

DECCAN HERALD, Date 4th July 2008


It's a relief for the HIV-infected

By Gopal Dabade

If patents are granted to a company, the price of the drug would be
beyond the reach of the masses.

Just a few days back several groups of individuals, known popularly by
their acronyms as INP+ and PWN, which stand for Indian Network of
People Living with HIV/AIDS and the Positive Women's Network, working
and campaigning for the rights of those having HIV/AIDS (most of them
need medicines just for their just survival) celebrated it. Not many know
and appreciate this victory. It was because Boehringer Ingelheim, the
Germany based giant - a profit making drug manufacturing company - had
its patent application rejected by the Indian Patent Office at Delhi, for a
drug by name Nevirapine.

Boehringer Ingelheim is one of the world's 20 leading pharmaceutical
companies operating globally in 47 countries. In 2007, the company
posted net sales of 10.9 billion euro, thus proving to be among the most
profitable and also a powerful drug company in the world.

The drug nevirapine sold by the company under the trade name Viramune 
is used by AIDS patients. It is specially useful when the pregnant mother is
HIV positive, as it needs to be either administered to her just before the
baby is born or given to the baby soon after birth as it prevents the new
born getting HIV.

It is estimated that a mother infected with HIV has 25 to 45 per cent risk
of passing on the infection to her baby and when this drug is administered,
the risk of transmission can be brought down to less than 1 per cent. Thus
this drug prevents MTCT - an abbreviation used for Mother To Child

India has the second highest number of HIV infected individuals. Of these,
approximately more than two lakh are children. These children face some
of the most tragic consequences of HIV infection: Being orphaned, nursing
sick and dying parents or struggling for survival on streets.

Mother to child transmission is the largest source of HIV infection in
children below 15 years.

It is obvious that this particular drug has an important public health role
in the Indian context. And it was for the syrup form of this particular
drug that the company Boehringer Ingelheim had sought the patent.

If patents were granted for this drug to the company that would have
meant that the price of the drug would be at the dictates of the company,
which in no time would have put it beyond the reach of the vast majority of

The reasons for the decision of not granting patents on the syrup form of
the drug is enshrined in the Indian Patent Act, under section 3(d).

This particular section prevents drug companies from making frivolous
claim on patents i.e., claim on patents that are not really discoveries or
they are claims which are not worth granting patents, as they happen to be
just minor changes. It is also known as "evergreening of patents."

This particular section of Indian Patent Act has received much needed
attention. Not just in India but globally as well. A similar incident
occurred when the Swiss multinational  drug company Novartis' application
for grant of patents was rejected by the Chennai patent office during
January 2006. Novartis claimed that its drug i.e., Glivec was an
innovation, while it was not so.

If at all the patent was granted to Novartis for this drug meant to treat a
form of blood cancer, then other Indian companies would have had to stop
manufacturing it as Novartis would have the absolute monopoly rights. The
Indian companies manufacture the drug for Rs 8,000 per month per
person, where as Novartis would sell the same drug for Rs 1.2 lakh per
person per month!

When Novartis application was rejected, it went to the Chennai high court
and challenged rejection of it, forcing several doctors and consumers to
resort to a campaign to boycott Novartis products.

Will Boehringer Ingelheim, follow the same path? We need to watch and
wait. It is not just these two drugs that are at stake, but a whole lot of
them are in the pipeline.

And if these two drugs get clearance, they will set a precedence and then
plenty of life saving drugs will be beyond the reach of a vast majority of

Dr Gopal Dabade,
57, Tejaswinagar,
Dharwad 580 002
Tel 0836-2461722
Cell (0)9448862270