| Bedroom
pill ache in boardroom - Weekend clones strike
when original is caught in patent red tape
March 26, 2004
The weekend sex drug has hit the Indian markets;
and it’s better than Viagra!
The trouble is that two Indian pharmaceutical
companies — Ranbaxy and Ajanta Pharmaceuticals
— have come up with clones of the wonder
drug even before Eli
Lilly of the US could press its claim to
introduce its blockbuster drug called Cialis
in India.
Cialis is a long-lasting, lifestyle drug —
directed at people with erectile dysfunctional
problems — that one can pop on a Friday
and stay super active over the weekend. It is
the first sexual tablet that allows up to 36
hours to choose the moment that’s right
to be intimate.
Pfizer’s Viagra has to be popped an hour
in advance and its effect wears off in about
four hours — which exacerbates stress
and anxiety levels in a pill popper.
The Indian clones of Cialis — which were
introduced early this month — have brought
into sharp focus India’s quixotic patent
regulations. Eli Lilly had applied for exclusive
marketing rights (EMRs) for its drug in an attempt
to stall knockoffs by reengineered clones.
The EMR is a provision incorporated in the
Patents Act of 1970 through an amendment in
1999. Under this amendment, it is possible to
make an application for patent protection for
a drug developed in India or abroad. However,
the application will not be processed until
the end of 2004.
The proviso provides for exclusive marketing
rights for the drug for a period of five years
or till the date of grant of the patent or the
date of rejection of the patent application,
whichever is earlier.
“It is a classic case of the clone coming
before the original. We have applied for an
exclusive marketing right and are very sure
that we will not market it in India unless we
get an EMR,” an official spokesperson
for Eli Lilly and Company (India) said.
It took Eli Lilly almost 10 years and hundreds
of millions of dollars in development costs
to create the drug — and they are upset
over the local clones.
The Cialis clones will in all probability be
one of the last patent knockoffs in India which
will switch over to a product patent regime
from January 1, 2005.
Ranbaxy sells its product — which it
calls ForZest — at a rock-bottom price
of Rs 19.50 for a 10-mg dose and Rs 29.50 per
tablet for a 20-mg dose. The tablets, to be
sold on prescription only, are available in
a strip of four. Ajanta — which was the
first out with the weekend sex drug —
markets it under the brand name Tadalis.
Cialis, which is manufactured at Eli Lilly’s
plant in Puerto Rico, sells for about $10 (Rs
450) per pill, which explains why the clones
do so well in India.
Viagra — which Pfizer launched with great
fanfare in 1998 — is made from a bulk
drug called sildenafil citrate. It created a
storm in bedrooms across the world but also
carried health warnings against indiscriminate
use by people who had heart problems. Viagra
has racked up annual sales of $1.7 billion with
about 23 million men having popped it around
the world — making it a formidable competitor
in this drug segment.
Cialis
was launched in Europe about nine months ago
and has been well received. In December 2003,
Cialis had a 33 per cent share in France, 30
per cent in Germany, 27 per cent in Italy and
18 per cent in both Spain and Britain, the firm
said.
The yellow pill is the third anti-impotence
drug to win approval from the US Food and Drug
Administration in the past five years. Competitors
are Viagra and Levitra, a medication from Bayer
AG and GlaxoSmithKline.
Cialis works by relaxing blood vessels in the
penis, allowing increased blood flow that causes
an erection. Like Viagra and Levitra, it does
have several side
effects and restrictions. The drug should
not be used in combination with nitroglycerin
tablets or medicines used to treat high blood
pressure.
It is also not recommended for men who have
suffered a stroke or heart attack in the past
six months. Side effects include headache, indigestion,
back pain, muscle aches and stuffy nose. A few
patients have also experienced
blurred vision, according to the FDA.
There is another downside: one pill usually
equals one sexual attempt. Icos Corp, the biotechnology
company that helped develop the drug for Eli
Lilly, said of the 40,000 records of sexual
attempts chronicled during its research, only
a handful of men had sex more than once during
the 36-hour period on one dose.
Drug patent knockoffs have given India a bad
name in the world of pharmaceuticals. Drug makers
spend billions of dollars in research to come
up with products whose commercial potential
they cannot fully exploit in countries like
India that do not have a product patent regime.
Besides Ranbaxy and Ajanta, two others are
waiting to jump on to the Cialis bandwagon:
Cadila Pharmaceuticals and Ritchie Pharmaceuticals.
Currently, the available oral medication for
management of erectile dysfunction is sildenafil,
whose market size is valued at Rs 70 crore in
India. Ranbaxy’s Caverta is a leading
player while there are many others in the fray.
source:-http://www.telegraphindia.com
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