Posted by ixus on April 27, 2005, at 1:50:01
In reply to Re: Olanzapine story, generics suck??? » ixus, posted by chemist on April 26, 2005, at 9:32:52
> hello there, chemist here...my comments delineated with asterisks....all the best, chemist
>
>
>
> > Olanzapine turned out to be Eli Lilly's greatest success in history.
>
> **** i disagree. making the vaccine for fighting polio available to the masses is the first thing that comes to my mind. ****
>
> 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.
>
> **** and it only cost $800,000,000.00 US to develop and test. 16 million people have taken zyprexa since 1996, according to lilly. i assume many have found the drug to be useful ****
>
> > 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.
>
>
> **** that would be because the patents have not expired yet: the NDF/NP patents on zyprexa and symbyax have a way to go. check out the patent and exclusivity info on file at the FDA - online ****
>
> > However, the case looks different in Poland.
>
> **** olanzapine was granted patents in europe and the u.s. in 1991 and 1993, respectively. whether poland chooses to honor international law or not is up to 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.
>
> **** either poland honors european/u.s. patents or they do not. lilly can easily flood the market with free zyprexa and bankrupt adamed in a heartbeat. it appears that there is a very real case involving a patent dispute. period. ****
>
>
> 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.
>
> **** pardon me, but a full staff of less than 300 employees for an entire nation seems a bit on the conservative side. perhaps lilly did not invest resources in poland because of real or perceived threats to maintaining a foothold there. ****
>
> 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.
>
>
> **** 6th to 18th in poland, i presume, not worldwide.****
>
> > 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.
>
> **** if 45% of their profit is on the line, it makes sense that they would be certain that they are ``right.'' ****
>
> > Yet Adamed is sure that they are right. They insist that they did not violate any
> > patent rights of Eli Lilly.
>
> **** hence the courtroom. ****
>
> > "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.
>
> **** not so. crystal habits are not patented: formulae are. further, the six to eight references involving olanzapine intermediates emanate from laboratories in canada and japan. besides, polymorphs must be stabilized, introducing perhaps untoward effects along with the compound of interest. *****
>
>
> 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.
>
> **** that puts adamed as starting their ``research'' in 1999, almost a decade after lilly patented the drug in europe, and 3 years after it was marketed worldwide. the timing seems a bit off to me....*****
>
>
> > Eli Lilly insists that their research proved the so called first version of
> > olanzapine is 'unstable', so it cannot be used for medicines production.
>
>
> **** there will be differences depending on the synthetic route. one will try to optimize the yield of the most stable and effective polymorph. however, look at the structure and note the high degree of symmetry. not much room for chiral centers....****
>
> 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.
>
>
> **** and everyone who produces CPUs and markets them as Intel Pentium 4 chips is in the same position with the notable exception of Intel and partners....*****
>
>
> > Date of the next trial has not been disclosed yet.
> >
> > Gazeta Wyborcza, Wednesday April 20 2005
> >
>
>Hi Chemist,
is the international name (olanzapine) also patented? It is the biggest question for me how it could be, that Adamed used name "olanzapine".
/ixus
poster:ixus
thread:489699
URL: http://www.dr-bob.org/babble/20050423/msgs/490220.html