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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
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
Posted by chemist on April 26, 2005, at 9:32:52
In reply to Olanzapine story, generics suck???, posted by ixus on April 26, 2005, at 8:06:23
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
>
Posted by Phillipa on April 26, 2005, at 21:59:19
In reply to Re: Olanzapine story, generics suck??? » ixus, posted by chemist on April 26, 2005, at 9:32:52
Believe me, Chemist knows his stuff. Fondly, Phillipa
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
Posted by chemist on April 27, 2005, at 12:29:55
In reply to Re: Olanzapine story, generics suck???, posted by ixus on April 27, 2005, at 1:50:01
> 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".
> /ixushello there, chemist here...the naming schemes are quite well established, in the international realm. olanzapine is the generic USAN (united states adopted names) word for a chemical compound that is further described using nomenclature from the Chemical Abstracts Service (CAS, and olanzapine has the registry number [132539-06-1]). olanzapine is also the International Nonproprietary Name (INN) which is under the World Health Organization (WHO) that would be perhaps more relevant here. then, the International Union of Pure and Applied Chemistry (IUPAC) naming conventions are given, which indicate structure and, for instance, whether the substance is a particular stereomer - usually. we are supposed to refrain from the form-, acet-, prop-, etc. naming conventions and use meth-, eth-, prop-, instead. but i digress...
in this regard, my earlier assertion in re: polymorphs not being subject to patent is incorrect, and for reasons that are at least semantic and at most related to the conformational arrangement of the atoms in the molecule. more on that in a bit.
next up is the CAS name, and olanzapine is known as 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine.
additional names are not in the monograph i am grabbing this information from (the Merck Index, Twelfth Edition): however, one can usually tell which pharma came up with the stuff, as there are codes for drugs for which an NDA has been filed and a patent has been granted. in the case of olanzapine, the drug was known as LY-170053 (LY = Eli Lilly and Co., also A, Ro = Hoffmann-La Roche Ltd.).adamed - i have been through their website, and note that my maternal grandmother emigrated to the u.s. from Lodz in the early 1920's - states that they are marketing drugs for compassionate need and of high quality. this is not unlike the indian drug companies who have raised the ire of patent-holders in the u.s. the goal is admirable, but remember that all parties are businesses and the ultimate goal is to make a profit. this goes for lilly and adamed and the city of Lodz, which lured adamed from Pienkow, offering a production facility (and employment opportunities) and access to the medical academy. this is the way it works.
back to the patents. the trademark for eli lilly's patented formulation of olanzapine is Zyprexa. this means only lilly can market it under that name. there are variations - SM, TM, etc. - but the registered trademark is what matters. adamed chose Zolafren, the english/american hints at ``Zoloft'' and ``-phren'' from schizophrenia coming to my mind. likewise, adamed chose the name Luteina for their progesterone drug, and i immediately think of luteinizing hormone, which is exactly what i am supposed to think: female sexual development (and male, but more pronounced in women, at least to me), hormones, and the association is made. that, and it being a carcinogin. but no trademark infringement.
anyhow, the sterochemistry of the compound is something that falls under the patent class, as opposed to intellectual property or intellectual capital. mixtures of stereomers are afforded patents (adderall, ritalin, e.g.), as are new formulations, such as the olanzapine + fluoxetine combo trademark Symbyax (lilly, and this is another extension of prozac, after Serafem). the name Symbyax is a trademark and one can see Prozac and Zyprexa if one looks hard enough - that's the idea. brand loyalty. diphenhydramine is used by the masses, and we all call it Benadryl, although parke/davis' 1947 patent long expired and the company actually was absorbed by wyeth. or american home products. it's very convoluted...anyhow, enough, all the best, chemist
This is the end of the thread.
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