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Olanzapine story, generics suck???

Posted by ixus on April 26, 2005, at 8:06:23

Olanzapine turned out to be Eli Lilly's greatest success in history. Zyprexa, a drug
containing the substance accounts for over 30% of the American company's overall
revenue. No wonder the concern figths like a lion for keeping their patent rights to
this medicine.
At the end of the last week, the concern achieved a crucial success - the American
Federal Court adjudicated that the generic drugs' producers (generic drugs are cheap
counterparts of the drugs whose patent protection has expired) cannot yet produce a
generic counterpart of Zyprexa in the US.
However, the case looks different in Poland. Zolafren, a rival drug produced by
Adamed, is present on our market. Due to much lower price (as much as by half)
Zolafren is far more often used in Poland.
Through legal action, Eli Lilly tried to stop the expansion of Zolafren on the
Polish market. The lawsuit concerning patent violation started in June 2002.
However, in November 2003 the District Court of Warsaw adjudicated to the giant's
disadvantage. Zolafren appeared on reimbursement drugs list (i.e. It could be widely
used by public healthcare) two months later.
Presence of the cheaper rival drug turned out to be disastrous for the Polish
subsidiary of Eli Lilly. - The company was forced to make 86 empoyees redundant,
which meant decreasing employment by one-third, at the beginning of 2004. Hubert
Zawadzki, Eli Lilly Poland's spokesperson stated that the company went down to the
18th, from the 6th, position in the rating of pharmaceutical companies.
The drug using olanzapine accounts for Polish Adamed's approx. 45% income. Adamed
(existing since 1986) employs 450 people in Poland.
Decpite their first defeat, Eli Lilly kept fighting. It turned to the appeal court.
The court of second instance ordered further consideration of the case by the
district court.
Yet Adamed is sure that they are right. They insist that they did not violate any
patent rights of Eli Lilly.
"The patent which is binding in Poland differs fro the one binding in the USA. In
Poland Eli Lilly patented only one form of olanzapine, the so called second
polymorphic form. We use a different one to produce our drug, the so called first
polymorphic form, so we do not violate their patent. We have scientific evidence to
prove so", claims Maciej Adamkiewicz, the President. He stresses that Adamed began
research on Zolafren as early as six years ago.
Eli Lilly insists that their research proved the so called first version of
olanzapine is 'unstable', so it cannot be used for medicines production. The second
form of olanzapine is the only one to be suitable. So everyone who produces a drug
with this substance violates Eli Lilly's patent rights, also Polish ones.
Date of the next trial has not been disclosed yet.

Gazeta Wyborcza, Wednesday April 20 2005


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poster:ixus thread:489699
URL: http://www.dr-bob.org/babble/20050423/msgs/489699.html