The Chemical, Industrial &

Pharmaceutical
Laboratories
CIPLA
India's oldest pharmaceutical company
Journey began in 1935 when founder,
Dr. K. A. Hamied, set up an enterprise
with the vision to make India self-
sufficient in healthcare
Gilead Hits Cipla With Patent Suit Over
HIV Drug Emtriva (August 21, 2012)

Mumbai-based Cipla
According to Gilead, Cipla filed ANDA number 91-168 with the FDA to
make and sell a version of Emtriva prior to the expiration dates of the
245 and 396 patents.
Pirate or messiah?
Name: YK Hamied, cipla
Age: 76
Why the Company Won: For making AIDS treatment affordable. Cipla
made a conscious decision not to profit from anti-AIDS drugs. In 2001,
the company took on MNCs by announcing that it would sell its triple
cocktail of antiretroviral drugs in developing countries for $350 per
patient per year, a fraction of what the MNCs were charging at that
time (about $12,000).


Two months earlier, Indias patent office had issued the first
compulsory licence to Natco Pharma to make kidney cancer drug
Sorafenib by paying royalty to German drug maker Bayer, which holds
the patent.
Cipla went one step further: It had already challenged Bayers patent;
now it further reduced the price of Sorafenib and two other cancer
drugs of the same family. Bayer has challenged the government
decision as well as Ciplas move.
But for Hamied, 76, it is a matter of principle, a battle against
monopoly.

Back in the 1960s, when he was heading the Indian Drug Manufacturers
Association, the industry had fought for a change in the patent law, from
product patents to process patents. The policy was finally changed in 1972,
spurring the Indian pharmaceutical industry to grow from Rs 360 crore to
Rs 65,000 crore in 2011.

The next turning point, Hamied recalls, was the Gujral parliamentary
committee recommendation of 1993. It advised, that patents are granted
to encourage innovation and not so that the holder enjoys a monopoly.
This, in fact, is at the heart of most pharmaceutical court cases today. Then
came the Doha declaration of 2001 that gives each member country the
right to determine what constitutes a national emergency;
This is retroactive patenting, against WTO principles, says Hamied.
When I argue how you can backdate *legislation+, they say it was
agreed at the WTO but nobody shows me the proof. Id like to see the
proof as today we are fighting cases that were filed in 1996, he says
defiantly.


Rather, he does his homework and uses loopholes in existing
patents. Take for instance, Tenofovir, the anti-HIV drug for which he
fought with Gilead for several years. He won it in 2009 because the
drugs patent was filed in erstwhile Czechoslovakia in 1992 and Cipla
proved that it couldnt be patented in India as prior knowledge
existed before 1995. The same logic applied to Roches flu drug
Tamiflu where Cipla found another patent dating pre-1995.

In 1970, we spearheaded the New Patent Law by which an Indian pharmaceutical company was allowed to manufacture a
patented product as long as the process to manufacture it was changed. This enabled Indian companies for the first time
to manufacture any medicines and make them available and affordable for all Indians.
In 1978, we pioneered inhalation therapy in India with the manufacture of Metered-Dose Inhaler (MDI), at a time when
the country stopped receiving imported supplies. Today, we have the worlds largest range of inhaled medication and
devices.
In 1994, we launched Deferiprone, the worlds first oral iron chelator which revolutionized the treatment for thalassemia.
For the first time patients with thalassemia had an option that was affordable, painless and convenient.
In 1996, we gave the world the first transparent dry powder inhaler which was so simple and easy to use, it changed the
face of inhalation therapy in India.
In 2001, we pioneered the access to HIV treatment by making antiretrovirals (ARVs) available at less than a Dollar a Day'.
The cost of treatment dramatically fell from $12,000 per patient per year to $300 per patient per year. This caused a
revolution where HIV treatment became a reality for the world and millions of lives could be saved.
During the 2005 Bird Flu epidemic, we produced an anti-flu drug within a period of 2-3 months, which would have
normally taken at least 3 years to develop.
In 2012, we made a breakthrough in reducing the prices of cancer drugs, thus making world-class medicines affordable
and accessible to cancer patients.
Cipla also pioneered a three-in-one tablet called Triomune containing a
fixed-dose combination (FDC) of three ARVs (Lamivudine, stavudine and
Nevirapine), something difficult elsewhere because the three patents were
held by different companies.
Another popular fixed-dose combination is produced under the name
Duovir-N. This contains Lamivudine, Zidovudine and Nevirapine.
In December 2008, Cipla won a court case in India allowing it to
manufacture a cheaper generic version of oseltamivir, marketed
by Hoffmann-La Roche (Roche) under the trade name Tamiflu, under the
Cipla tradename Antiflu. In May 2009, Cipla won approval from the World
Health Organization certifying that its drug Antiflu was as effective as
Tamiflu, and Antiflu is included in the World Health Organization list of
prequalified medicinal products.
Oseltamivir is indicated for use in the treatment of influenza A (H1N1)
infection commonly known as swine flu.
The revised prices averaged roughly 75% less than the previous ones, and
Hamied announced plans to similarly reduce prices on the full range of
cancer drugs made by Cipla. The move was expected to prompt significant
price drops from other producers, providing access to medicine and saving
many millions of cancer patients unnecessary suffering and/or death.
Pharmaceutical companies Cipla and Hoffmann-La Roche have agreed to a
mediation process to resolve their dispute over the patent of cancer drug
Tarceva (Erlotinib) as per the suggestion of a division bench of the Delhi
High Court.
U.S. drugmaker Gilead Sciences Inc (GILD.O) has licensed its hepatitis
C drug Sovaldi to seven India-based drugmakers that will sell far
cheaper versions of the $1,000-a-pill medicine in 91 developing
nations.
Sovaldi, chemically known as sofosbuvir, is a far more effective and
better-tolerated treatment than older injection regimens, but Gilead
has come under fire over its U.S. price tag, with cost presenting a
huge barrier in poor countries.
The seven Indian companies which has signed the deal include Cadila
Healthcare, Cipla, Mylan Lab, Ranbaxy Lab and Strides Arcolab to
manufacture Sofosbuvir (hepatitis C drug) and the investigational
single tablet regimen of ledipasvir/ sofosbuvir for distribution in 91
developing countries.