[Ip-health] Pharma giant loses legal battle

[Gopal Dabade]

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DECCAN HERALD, 9th July 2009

*Pharma giant loses legal battle*

By Dr Gopal Dabade

*The drug that Novartis had sought patent for was Glivac, a medicine to
treat a variety of blood cancer.*

While the media has been busy and preoccupied with reporting about the
global problem of Swine flu, many of them really missed an important news
item. This is with regard to multinational drug major Novartis losing its
legal battle in India and a real victory for the people.

Novartis is a Switzerland-based drug manufacturing company. It=92s a pharma
giant operating in 140 countries with a net sale of $ 41.5 billion for the
year 2008. But in spite of being rich and powerful it lost a battle which
lasted for over three years.

Novartis had applied for a drug patent at India Patent Office and the same
was rejected by the office. Here are the details of the battle: A patent is
a set of exclusive rights granted by a state to an inventor or his assignee
for a limited period of time in exchange for a disclosure of an invention o=
r
innovation. In April 2005, India=92s parliament amended the Indian Patents =
Act
1970; medicines could now be product-patented and also for a period of 20
years in India (whereas it was earlier only for seven years).

However, Section 3(d) of the amended Act specifies that new forms of known
substances do not deserve patents. Section 3(d) is a unique provision, whic=
h
states that =93mere discovery of a new form of a known substance which does
not result in the enhancement of the known efficacy of that
substance....unless such known process results in a new product or employs
at least one new reactant.=94

 In simple words it means that Section 3(d) does not allow frivolous or
incremental patents or ever greening of patents and restricts it to patents
that are genuine discoveries. This particular legal frame work has attracte=
d
global attention and many countries are eagerly looking forward to
incorporate it in their own patent laws.

The drug that Novartis had sought patent for was Glivac (imatinib mesylate)
-- a useful medicine to treat a variety of blood cancer. This drug needs to
be taken life long and it not only increases longevity but also improves th=
e
quality of life.

Treatment with Glivec, the one manufactured and marketed by Novartis, costs
Rs 1.2 lakh a month, whereas Indian companies, nine of them, are making and
marketing it at a price of about Rs 8,000 to Rs 9,000 per month. It actuall=
y
costs about Rs 1,000 or less, so it is obvious that Indian companies too ar=
e
deriving high profit margins, though much less than Novartis.

If patents had been granted to Glivec then it would have been out of reach
for nearly everyone in India as Indian companies cannot produce the drug.
Glivec is a classic illustration of how a patentenable drug monopoly can be
and is harmful to the majority but good for the company's huge profits.
Novartis sold globally in 2006 $ 2.6 billion worth of Glivec.

*Good precedent set **

*The real issue at stake is not about a single drug (in this case Glivec)
that gets patented or not but if patents had been granted then it would hav=
e
let lose a flood of such frivolous patents applications. Thus the Glivec
issue would have set a bad precedent. This would have had an extremely
deleterious effect on access to medicines to several people not only in
India but all over the world, as India exports drugs to around 200
countries.

But all is not well. There was news recently highlighting the release of a
US business funded study on India=92s patent law at the US - India Business
Council (USIBC) summit. The study reportedly mentions that Section 3(d) of
India=92s Patents Act, =93prevents=94 incremental pharmaceutical innovation=
s from
receiving patent protection, =93inhibits development of safer, more
efficacious and more useful drugs for Indian patients.=94

This is not a new allegation made by US based pharmaceutical industry and
its backers and neither is it true. The Union minister of commerce and
industry Anand Sharma will shortly be participating in a meeting being
organised by USIBC and it will be interesting to see his reaction.

While introducing Section 3(d) the parliament recognised public health
concerns regarding =91ever greening=92 - a common practice of pharmaceutica=
l
companies to extend their patent monopolies on known medicines by making
insignificant or minor changes.
 This provision acts as a check on pharmaceutical companies obtaining paten=
t
monopolies for medicines that are not actual inventions, such as
combinations or slightly modified formulation of existing medicines. So we
need to get proactively involved to keep our laws safe. Eternal vigilance i=
s
the only remedy and answer to the onslaught from the big companies.

*(The writer is co-convener, All India Drug Action Network)*