Novartis loses landmark patent case on glivec

[anonymus]

Supreme court of India has ruled that Novartis does not deserve patent on gleevac as there has been no significant innovation in making beta version of imantib mesaylate, tha active compound of gleevac

The Bench noted that in the United States, ‘Gleevec’ came to the market in 2001, and what was marketed then, beyond doubt, was Imatinib Mesylate. “On its package, the drug was described as ‘Imatinib Mesylate Tablets 100 mg’ and it was further stated that “each film coated tablet contains: 100 mg Imatinib (as Mesylate).” If that be so, and the [appellant’s] claim for patent for the beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.”

Novartis loses landmark India patent case on Glivec | Reuters

Artful claims can


A lot of organisations are hailing it as a victory of helpless patients against big bad pharma as court has prevented the practice of evergreening that pharmaceutical companies indulge in which the same product is patented again and again by making marginal changes in composition of active element of drug.

Right to affordable drugs upheld: activists - The Hindu

But an important detail that same article states but miss while making it assertion is that novartis never filed for renewal of patent of imantib mesaylate itself but only for its beta isomer which it has manufactured outside its original zimmerman patent.

Novartis was seeking patent for the beta-crystalline form of imatinib mesylate, a drug used to treat chronic myeloid leukaemia (CML), a type of blood cancer.

the moot point that i think that should be thought over and discussed are

1.The very basic idea that forcing pharmaceutical companies to sell drug for cheap is in best interest of patients.

Research costs money,the very reason that original drugs are much more costlier than generics.When people assail big pharma for producing drugs at much higher cost than generic producers,people ignore that while generic manufacturers have to cover only manufacturing cost,original producers have to cover research costs also.

Could it not be the very cause that research in tropical diseases is stagnate?

If a pharmaceutical company does not have guarantee that it would be able to profit from it's invention,why would it put its resources in drug research?

2.The effect this judgement would have on Indigenous R&D

A judgement by supreme court becomes common law or law by precedence://en.wikipedia.org/wiki/Common_law.This law, being result of lobbying by Indian pharmaceutical companies would be good for them but would it be good for R&D research in India as a whole.

India is not a country which have a positive environment of innovation.Would this ruling not be a deterrent for Indians who want to take up careers in R&D as same precedence would be applied for their innovations too.

3. The morality of this ruling

Novartis had asked for patent of beta isomer of imantib .It is pretty evident to anyone who had science even upto high school level that Cis,Trans,Levo forms of a compound are different from each other.In some cases while one form of sugar is absorbed,other is not.

Even ignoring that,Novartis asked for a patent only of beta imantid not for the whole compound.Even if the courts believed that it is evergreening and does not have significant therapeutic benefit ,what was the basis of denying them the patent for the beta imantib.

The patent would not have obliged companies to pay royalty for imantib amylase but only for its beta form.

Is it not a legal banditry on by highest court of land.I was in favor of court granting compulsory licensing in nexvar case as it was our legal right under wto as we have gained it by bartering away our interest in AoA and GATT.


I may be wrong or may have missed some important aspect and would like to know the view of members on this. @Syama Ayas @Armstrong @Bang Galore @Koovie @KRAIT @haviZsultan @Joe Shearer @jbgt90 @fateh71 @Sashan @Chinese-Dragon @Capt.Popeye @neehar @arp2041 and any other member interested.

 

[Joe Shearer]

This is a very useful mention.

There are both positive and negative directions in the consideration of the impact of the patent regime on healthcare in south Asia. There is an informed and educated body of opinion that has more or less been informing the rest of us, less knowledgeable in these areas, that there is an unfortunate body of judicial pronouncement which endangers medical research, or at the lowest level, prevents us from getting the fruits of this research.

Medicine makers must get the fruits of their research. However, looking at their balance sheets, the matter has gone far beyond the right of individual scientists to get protection of their intellectual property. It now seems to some that we are looking at exploitation of the seriously ill and the diversion of money from poor people to very rich shareholders.

What you have is relevant, but I am not personally so knowledgeable about this very complex matter that I can make meaningful comment.

 

[Bang Galore]

The full Supreme Court ruling.
Novartis patent Judgement

The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our Constitutional scheme) at the minimum. Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as “the pharmacy of the world.”

Novartis first applied for patent protection for a form of Gleevec, which is based on the chemical compound Imatinib Mesylate, in India in Chennai in 1998, the court noted:

In the application it claimed that the invented product, the beta crystal form of Imatinib Mesylate, has (i) more beneficial flow properties: (ii) better thermodynamic stability; and (iii) lower hygroscopicity than the alpha crystal form of Imatinib Mesylate. It further claimed that the aforesaid properties makes the invented product “new” (and superior!) as it “stores better and is easier to process”; has “better processability of themethanesulfonic acid addition salt of a compound of formula I”, and has a “further advantage for processing and storing.”

In fairness to Novartis, the court notes, the application was made under a different patent regime, and lay dormant under something called “the mailbox procedure” until January 2005. But that, too, worked against Novartis’s push to differentiate it:

It is seen above that in the US the drug Gleevec came to the market in 2001. It is beyond doubt that what was marketed then was Imatinib Mesylate and not the subject product, Imatinib Mesylate in beta crystal form. It is also seen above that even while the appellant’s application for grant of patent lay in the “mailbox” awaiting amendments in the law of patent in India, the appellant was granted Exclusive Marketing Rights on November 10,2003, following which Gleevec was marketed in India as well. On its package, the drug was described as “Imatinib Mesylate Tablets 100 mg” and it was further stated that “each film coated tablet contains: 100 mg Imatinib (as Mesylate)”. On the package there is no reference at all to Imatinib Mesylate in beta crystalline form. What appears, therefore, is that what was sold as Gleevec was Imatinib Mesylate and not the subject product, the beta crystalline form of Imatinib Mesylate.

If that be so, then the case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.

The Novartis Patent Case: The Full Supreme Court Ruling - NYTimes.com

I believe Indian patent law deals in a far more serious manner, the process of "evergreening" which is used to effectively increase patent period by making minor alterations to an existing drug scheduled to go off patent as compared to the U.S. & Europe. This was the law that was used to quash the present case which wound up in the Supreme Court only after Novartis had lost the case in the chennai High Court.

The Supreme court did point out that Novartis produced no evidence & studies to show that the beta crystalline form of Imatinib Mesylate in anyways increased the efficacy of the drug significantly. I'm not sure there was any other way the case would have ended.

 

[neehar]

Supreme court of India has ruled that Novartis does not deserve patent on gleevac as there has been no significant innovation in making beta version of imantib mesaylate, tha active compound of gleevac



Novartis loses landmark India patent case on Glivec | Reuters

Artful claims can


A lot of organisations are hailing it as a victory of helpless patients against big bad pharma as court has prevented the practice of evergreening that pharmaceutical companies indulge in which the same product is patented again and again by making marginal changes in composition of active element of drug.

Right to affordable drugs upheld: activists - The Hindu

But an important detail that same article states but miss while making it assertion is that novartis never filed for renewal of patent of imantib mesaylate itself but only for its beta isomer which it has manufactured outside its original zimmerman patent.





the moot point that i think that should be thought over and discussed are

1.The very basic idea that forcing pharmaceutical companies to sell drug for cheap is in best interest of patients.

Research costs money,the very reason that original drugs are much more costlier than generics.When people assail big pharma for producing drugs at much higher cost than generic producers,people ignore that while generic manufacturers have to cover only manufacturing cost,original producers have to cover research costs also.

Could it not be the very cause that research in tropical diseases is stagnate?

If a pharmaceutical company does not have guarantee that it would be able to profit from it's invention,why would it put its resources in drug research?

2.The effect this judgement would have on Indigenous R&D

A judgement by supreme court becomes common law or law by precedence://en.wikipedia.org/wiki/Common_law.This law, being result of lobbying by Indian pharmaceutical companies would be good for them but would it be good for R&D research in India as a whole.

India is not a country which have a positive environment of innovation.Would this ruling not be a deterrent for Indians who want to take up careers in R&D as same precedence would be applied for their innovations too.

3. The morality of this ruling

Novartis had asked for patent of beta isomer of imantib .It is pretty evident to anyone who had science even upto high school level that Cis,Trans,Levo forms of a compound are different from each other.In some cases while one form of sugar is absorbed,other is not.

Even ignoring that,Novartis asked for a patent only of beta imantid not for the whole compound.Even if the courts believed that it is evergreening and does not have significant therapeutic benefit ,what was the basis of denying them the patent for the beta imantib.

The patent would not have obliged companies to pay royalty for imantib amylase but only for its beta form.

Is it not a legal banditry on by highest court of land.I was in favor of court granting compulsory licensing in nexvar case as it was our legal right under wto as we have gained it by bartering away our interest in AoA and GATT.


I may be wrong or may have missed some important aspect and would like to know the view of members on this. @Syama Ayas @Armstrong @Bang Galore @Koovie @KRAIT @haviZsultan @Joe Shearer @jbgt90 @fateh71 @Sashan @Chinese-Dragon @Capt.Popeye @neehar @arp2041 and any other member interested.

our cotton farmers used to suffer because of an insect called boll worm..now there is a company named monsanto which claimed that they found a new species of cotton which is immune to this boll worm and with a good yield theres a drawback too these bt cotton donot have seeds which means unlike previous crops where he got seeds from the last crop farmer has to buy the seeds for every new crop..the cotton remained good for 2 crops and the boll worm grew immune to the nature of cotton so again the problem started.this time worse why??because they dont have the seeds and they're completely dependent on monsanto for seeds.. they have to take loans for new crops and u knew the results
Ministry blames Bt cotton for farmer suicides - Hindustan Times
Three farmers commit suicide in Andhra Pradesh | NDTV.com
Cotton farmer commits suicide - The Hindu


how is it relate to this story??let me explain..in this case..this company novartis claims that this so called "imatinib mesylate" a beta crystalline form of a medicine called zimmermann the original cancer drug is 30% more soluble in human body than its original counter part..if yes..then its a good thing but ..this just remained to be a claim and the supereme court observed that "efficacy of solubility over its predecessor chemical is not established" and it clearly posess all the properties of its original chemical with out any change..so how can a mere optical isomer can be claimed as a new invention if its no different to a original one??this benefits about 30 lakhs of cancer patients..they reaped benifits for their invention till the patent expired.its not that any injustice is done to them.

now lets look at the bigger picture..this is just a medicine for cancer..now talk about other diseases like b.p, diabetes,hiv or even maleria,cholera and others..if this is encouraged all the other pharma companies will take its path and guess the result..

is it going to impact our r & d?? no because our pharma sector is huge and growing..they can not just sustain their growth with out inventions..and they have to invest in r &d no matter what..and the trend is rising..further if the drug was invented even in australia or japan..it can be still used in india..so it has nothing to do with indian r&d..

and the last thing is., supreme court of india has some of the worlds best intellectual resources at its disposal..so it wouldnt do mistakes.trust it..it has dealt with many bigger issues and more experienced..the people who are sitting there are no ordinary people..they know whats good for the country better than us..

 

[JanjaWeed]

U.S. trade office reviewing India's Supreme Court drug ruling

(Reuters) - The United States said on Tuesday it was considering its response to an Indian Supreme Court ruling that U.S. drug manufacturers warn is the latest sign of a "deteriorating" environment for intellectual property rights in the country.

"We are ... reviewing the Court's order. We look forward to continued engagement and successful collaboration with India on these issues," said Andrea Mead, a spokeswoman for the U.S. Trade Representative's office.




India's top court on Monday dismissed Swiss drugmaker Novartis AG's attempt to win patent protection for its cancer drug Glivec in a victory for Indian manufacturers of cheap generics.

The U.S.-India Business Council on Tuesday joined other U.S. business groups in criticizing the ruling, which bodes badly for other drug companies including Pfizer and Roche Holding AG, which have ongoing disputes in India.

"Over 40 countries including China, Russia and Taiwan have already granted a patent for Novartis' Glivec and India now stands out as unique for not granting a patent to this incremental innovation," the council said in a statement.

"The denial of the Glivec patent may now exclude from patentability many other significant inventions in the pharmaceuticals area," the council said in a statement.

Pharmaceutical Research and Manufacturers of America (PhRMA) said on Monday it was "very disappointed" with the ruling that Glivec was not different enough from previous versions of the drug to warrant patent protection.

"This decision marks yet another example of the deteriorating innovation environment in India," said PhRMA President John Castellani.

Pfizer's chief intellectual property counsel, Roy Waldron, in March told a U.S. congressional hearing India had created a "protectionist regime that harms U.S. job creators" in favor of the country's generic drug manufacturers.

India last year revoked Pfizer's patent for Sutent, a cancer medicine, and is currently considering allowing generic production of additional patented drugs.

"If left alone, this trend will destroy the market for innovative pharmaceuticals in India," Waldron said at the March congressional hearing.

He urged U.S. government officials to pursue both direct talks with India and to "review all available policy tools," including possible action at the World Trade Organization, to defend U.S. intellectual property rights.

The U.S. Trade Representative's office has a chance to further comment on the Indian Supreme Court ruling at the end of this month, when it releases its annual report on intellectual property rights protection around the world.

India is already on that's report "priority watch list" for countries with weak property rights protections.

U.S. trade office reviewing India's Supreme Court drug ruling | Reuters

There could be some sort of ramification due this ruling by the court. India could be deprived of modern medicine. Very tricky situation...

 

[Bang Galore]

There could be some sort of ramification due this ruling by the court. India could be deprived of modern medicine. Very tricky situation...

No it can't, that is just hot air. If companies deliberately or otherwise, chose to keep their drug out of India or price it exorbitantly in India, they will face the threat of compulsory licensing (permissible under WTO rules).

 

[anonymus]

our cotton farmers used to suffer because of an insect called boll worm..now there is a company named monsanto which claimed that they found a new species of cotton which is immune to this boll worm and with a good yield theres a drawback too these bt cotton donot have seeds which means unlike previous crops where he got seeds from the last crop farmer has to buy the seeds for every new crop..the cotton remained good for 2 crops and the boll worm grew immune to the nature of cotton so again the problem started.this time worse why??because they dont have the seeds and they're completely dependent on monsanto for seeds.. they have to take loans for new crops and u knew the results
Ministry blames Bt cotton for farmer suicides - Hindustan Times
Three farmers commit suicide in Andhra Pradesh | NDTV.com
Cotton farmer commits suicide - The Hindu


how is it relate to this story??let me explain..in this case..this company novartis claims that this so called "imatinib mesylate" a beta crystalline form of a medicine called zimmermann the original cancer drug is 30% more soluble in human body than its original counter part..if yes..then its a good thing but ..this just remained to be a claim and the supereme court observed that "efficacy of solubility over its predecessor chemical is not established" and it clearly posess all the properties of its original chemical with out any change..so how can a mere optical isomer can be claimed as a new invention if its no different to a original one??this benefits about 30 lakhs of cancer patients..they reaped benifits for their invention till the patent expired.its not that any injustice is done to them.

now lets look at the bigger picture..this is just a medicine for cancer..now talk about other diseases like b.p, diabetes,hiv or even maleria,cholera and others..if this is encouraged all the other pharma companies will take its path and guess the result..

is it going to impact our r & d?? no because our pharma sector is huge and growing..they can not just sustain their growth with out inventions..and they have to invest in r &d no matter what..and the trend is rising..further if the drug was invented even in australia or japan..it can be still used in india..so it has nothing to do with indian r&d..

and the last thing is., supreme court of india has some of the worlds best intellectual resources at its disposal..so it wouldnt do mistakes.trust it..it has dealt with many bigger issues and more experienced..the people who are sitting there are no ordinary people..they know whats good for the country better than us..

There is a hint of immorality and petty jealousy on part on activist in this line of reasoning,the reason that i started this thread.

1. Regarding Monsanto,Monsanto invented genetically modified cotton which is resistant to bollworm and it was clear from the start that it could not be used for replanting (BTW hybrids also could not be replanted) but it was the decision of farmers to use it in their fields.They did that because yields of GM cotton was much higher than ordinary cotton and offset the increased input cost by large margin,the reason that GM cotton is universally planted on commercial plantations.

SO is it even moral to blame monsanto for the fact that it's seed could not reproduce.They did not committed a fraud by hiding this fact.It was known to all and the decision to use GM crops was taken by farmers willingly on their own.

Regarding immunity,pest get immune as time passes to all innovations.For anyone who has studied farm ecology,pest keep on developing immunity to the pesticides that farmer uses and farmers know that they have to change pesticides after prolonged use or risk losing crops.And Bollworm getting immunity after 2 cycles is a pure lie told by activists.I have to study agriculture as part of geography and know that this is neither biologically possible nor has happened. BT cotton is used in India since 2002.

Also activists has a penchant for misinformation.

Higher yields & farmer preferences show, Bt cotton detractors spreading patent falsehoods - Economic Times


2. I had similar objection with supreme court ruling.

If according to court an optical isomer is not a significant innovation,why not grant patent to a company for that particular isomer.The base compound would still be open to Generic drug makers on which they can base their product.

Who should and why should this discretionary power be granted to Patent boards to decide what is significant and what is not.

And the logic for welfare of poor patients has a flaw.If Pharmaceutical companies had not innovated,these medicines would not have came into the being and research cost money and would be done only if it is attractive.

Some of the diseases you mentioned ( tropical diseases like malaria) does not have significant R&D just because intellectual property is not guaranteed and Americans do not suffer from them to make them attractive for Pharma companies to spend money on.

3.Pharma sector is growing by pirating the research of others.No significant research in field of Drugs and medicines has been undertaken by Indian companies.This growth does not have good externalities.

4. Supreme court, as any other court is not free from bias.You remember jessica lal case.Even though it was pretty much clear that jessica lal has been shot by manu sharma,the fact was unproveable in any court of law based on evidences in front of court. SC by punishing sharma did the right but not exactly legal thing.

Similar is the case with Italian ambassador.SC had no right to prevent ambassador from moving out of country.

And no one can overlook the megalomania of Katju.

SO SC judges like anyone are not free from bias and personality shortcomings and o take decision which even they may found hard to justify.

 

[neehar]

There is a hint of immorality and petty jealousy on part on activist in this line of reasoning,the reason that i started this thread.

1. Regarding Monsanto,Monsanto invented genetically modified cotton which is resistant to bollworm and it was clear from the start that it could not be used for replanting (BTW hybrids also could not be replanted) but it was the decision of farmers to use it in their fields.They did that because yields of GM cotton was much higher than ordinary cotton and offset the increased input cost by large margin,the reason that GM cotton is universally planted on commercial plantations.

SO is it even moral to blame monsanto for the fact that it's seed could not reproduce.They did not committed a fraud by hiding this fact.It was known to all and the decision to use GM crops was taken by farmers willingly on their own.

Regarding immunity,pest get immune as time passes to all innovations.For anyone who has studied farm ecology,pest keep on developing immunity to the pesticides that farmer uses and farmers know that they have to change pesticides after prolonged use or risk losing crops.And Bollworm getting immunity after 2 cycles is a pure lie told by activists.I have to study agriculture as part of geography and know that this is neither biologically possible nor has happened. BT cotton is used in India since 2002.

Also activists has a penchant for misinformation.

Higher yields & farmer preferences show, Bt cotton detractors spreading patent falsehoods - Economic Times


2. I had similar objection with supreme court ruling.

If according to court an optical isomer is not a significant innovation,why not grant patent to a company for that particular isomer.The base compound would still be open to Generic drug makers on which they can base their product.

Who should and why should this discretionary power be granted to Patent boards to decide what is significant and what is not.

And the logic for welfare of poor patients has a flaw.If Pharmaceutical companies had not innovated,these medicines would not have came into the being and research cost money and would be done only if it is attractive.

Some of the diseases you mentioned ( tropical diseases like malaria) does not have significant R&D just because intellectual property is not guaranteed and Americans do not suffer from them to make them attractive for Pharma companies to spend money on.

3.Pharma sector is growing by pirating the research of others.No significant research in field of Drugs and medicines has been undertaken by Indian companies.This growth does not have good externalities.

4. Supreme court, as any other court is not free from bias.You remember jessica lal case.Even though it was pretty much clear that jessica lal has been shot by manu sharma,the fact was unproveable in any court of law based on evidences in front of court. SC by punishing sharma did the right but not exactly legal thing.

Similar is the case with Italian ambassador.SC had no right to prevent ambassador from moving out of country.

And no one can overlook the megalomania of Katju.

SO SC judges like anyone are not free from bias and personality shortcomings and o take decision which even they may found hard to justify.

high yields of monsanto are not proved.they claimed that bollworm takes 40 years to develop resistance but relality is otherwise.it failed not just in india but also in china and america..especially in india's case where farmers are poor and unaware of science govts have to be extra careful to protect them..
http://www.isb.vt.edu/news/2012/Oct/Tabashnik.pdf
Explanation- Maureen and Mike Mansfield Centers Program on Ethics and Public Affairs - The University Of Montana
Press Information Bureau English Releases
Bt cotton has failed admits Monsanto : North, News - India Today
Bt cotton losing steam, productivity at 5-yr low | Business Standard
http://sap.einaudi.cornell.edu/system/files/Bt cotton article1.pdf

so not every claim made by these so called r&d gaints is true.in this case they failed to pove that this isomer got better solubility and court observed that it has no special properties compared to its original counterpart so it rejected the patient.its not that the court got a personal vendetta against the company.regarding marines case .host govts have the power to resrict the movements of ambassadors to certain places if they feel that it may jeopardise national security or soverignity..in this case the ambassador was restricted access to airports which is why they returned the marines to us.so what they did was not aything against law.i dnt wnt to comment abt other cases and further derail this topic

 

[anonymus]

high yields of monsanto are not proved.they claimed that bollworm takes 40 years to develop resistance but relality is otherwise.it failed not just in india but also in china and america..especially in india's case where farmers are poor and unaware of science govts have to be extra careful to protect them..
http://www.isb.vt.edu/news/2012/Oct/Tabashnik.pdf
Explanation- Maureen and Mike Mansfield Centers Program on Ethics and Public Affairs - The University Of Montana
Press Information Bureau English Releases
Bt cotton has failed admits Monsanto : North, News - India Today
Bt cotton losing steam, productivity at 5-yr low | Business Standard
http://sap.einaudi.cornell.edu/system/files/Bt cotton article1.pdf

so not every claim made by these so called r&d gaints is true.in this case they failed to pove that this isomer got better solubility and court observed that it has no special properties compared to its original counterpart so it rejected the patient.its not that the court got a personal vendetta against the company.regarding marines case .host govts have the power to resrict the movements of ambassadors to certain places if they feel that it may jeopardise national security or soverignity..in this case the ambassador was restricted access to airports which is why they returned the marines to us.so what they did was not aything against law.i dnt wnt to comment abt other cases and further derail this topic

You should read the links that you have put up yourself rather than believing in how activists interpret that data.

1.The PIB link that you posted that normally Bollworm develops resistance to Bt toxin in 11-20 years but by using some strategies suggested by CICR,it could be delayed by 40 years.

This is in no way a criticism of Genetically modified crops.The Press release suggest on methods that are developed by ICAR which may delay the inevitable from happening.

The link was certainly a good one.

2.The link you have posted from Business standard has explained the lowering of yields

the reason stated for lowering of yield are

a. Expansion of BT crops in non viable areas

b. Attacks by pests other than bollworm

c. Development of resistance at a faster rate than expected due to improper farming practices of not planting a non-cotton refuge.

Even then the Cry 1-ac resistance has been found in field inspections not after the epidemic of Bt resistant bollworm had broken out.

3.The India today link that you posted points out that Cry 1-ac resistant bollworm has been reported in 2009

But it also states that since 2006, Bollgard II crop is present which has two,Cry 1-Ac and Cry 2-Ab genes which are lethal to even resistant bollworms.

Since farmer has to buy new seeds every year,the fact that Bollworm has developed resistance to Cry 1-Ac which is natural should not even be an issue.

+ MAHAYACO is a government owned company.

4. The economic and political weekly link is the classical example of dishonest activism that i was talking about.

They use the data which is in the favor of their argument as the failure of GM crops (Soyabean example) while discount the data when it shows correlation between yield and GM crops saying that there are many factors.

Also there is a reason that they took data from 1984 ownwards. Before 1980's, Agriculture was dependent on conventional crops which had a low yield historically.The hybrid revolution of 1980's was based on concept of using hybrid crops which were tailor made to increase yield.Add this fact to the low base yield before the coming of hybrid crop,you get the reason as to why the gain in yields under GM crops (which were not designed for it explicitly) are lower than the ones under Hybrids (whose mention EPW conveniently ignored)

PS: EPW and Hindu are Marxist Opium.They could turn you into a left wing Zombie.

5. The efficacy of GM Crops is evident from their widespread use.

90% area under India and 75% area under US is under BT cultivation.Had it not been bringing benefits to farmers,why would they had adopted it with so much enthusiasm.

The attitude of activist toward farmers is paternalistic and reek of superiority complex.It assumes that only activists knows what is good for farmers and they cannot decide for themselves.

This is the very reason for the widespread resistance to GM crops rather than any scientific reason.

6. The fact whether isomer increases the efficacy appreciably or not is tangential to my argument.

The fact that Novartis had claimed a new isomer which has better physical and thermodynamic properties (which it had proven) makes it in my opinion a candidate to get the patent on the specific beta isomer.

Generics would still be free to manufacture and market imantib mesylate and if there is no appreciable difference between the two form of drugs,it would not make any difference in the market.

Why give discretionary power to patent board to decide what is significant or what is not?

If a new isomer is not a significant improvement,it would not matter whether a company has exclusive right over that isomer or not as generic drug manufacturers have right to manufacture base compound anyway.

7. India is a signatory of Vienna convention and could not legally hold a Diplomat hostage.SC was asking government to commit an international crime to assuage their Ego.

 

[Rocky25]

7. India is a signatory of Vienna convention and could not legally hold a Diplomat hostage.SC was asking government to commit an international crime to assuage their Ego.

That's NOT fair... If you make a promise then you have to keep the promise... The supreme court trusted the diplomat words and based on his words only the naval guards were sent home.

Since the diplomat had failed in his assurance, I hope the supreme court never take any assurance from any diplomats from any country from the world.... Anyways the lives of 2 Indian individuals are also important

 

[anonymus]

That's NOT fair... If you make a promise then you have to keep the promise... The supreme court trusted the diplomat words and based on his words only the naval guards were sent home.

Since the diplomat had failed in his assurance, I hope the supreme court never take any assurance from any diplomats from any country from the world.... Anyways the lives of 2 Indian individuals are also important

Fairness is not synonymous with legality.If India has signed the treaty,it would have to abide by it or else it would lose the advantage offered by that treaty.

 

[Rocky25]

Fairness is not synonymous with legality.If India has signed the treaty,it would have to abide by it or else it would lose the advantage offered by that treaty.

Is it legal to make false promises? Some one made a promise to the highest court in the land, We did NOT kill him... We forced the Marines to return... Which we did, then we removed the ban over the diplomat.

Next time, There is NO respect for the diplomats words.... It will NOT be taken into account by any courts in India and all countries which facing the same issue will NOT believe in the words of the diplomats!

 

[IND151]

This is a very useful mention.

There are both positive and negative directions in the consideration of the impact of the patent regime on healthcare in south Asia. There is an informed and educated body of opinion that has more or less been informing the rest of us, less knowledgeable in these areas, that there is an unfortunate body of judicial pronouncement which endangers medical research, or at the lowest level, prevents us from getting the fruits of this research.

Medicine makers must get the fruits of their research. However, looking at their balance sheets, the matter has gone far beyond the right of individual scientists to get protection of their intellectual property. It now seems to some that we are looking at exploitation of the seriously ill and the diversion of money from poor people to very rich shareholders.

What you have is relevant, but I am not personally so knowledgeable about this very complex matter that I can make meaningful comment.

that is what happening

a medicine mentioned in OP made by Novartis costs Rs. 1.5 lakh; the same type of medicine made by Indian companies costs Rs.8,000

 

[Vinod2070]

Father of Glivec hails SC ruling

WASHINGTON: Big Pharma found little support from the small guy on the street as the Indian Supreme Court's decision to reject patent claims of the drug maker Novartis for its celebrated cancer medicine Gleevec reverberated across the world.

The pharma lobby railed against the decision but the overwhelming sentiment, from physicians to politicians, from academia to media, particularly in a country groaning from the high cost of health care, was that the Indian judiciary did good by workaday people -- not just by the poor in the developing world but also those struggling in the developed world.

The pharma chums argument that denying patents to drug companies and eating into their profits will inhibit research investment into future wonder drugs was knocked down easily in the U.S, particular in the case of Gleevec. The acclaimed drug, considered a magic bullet for leukemia, was actually developed jointly by Dr Brian Druker, director of the Oregon Health and Science University Knight Cancer Institute, in collaboration with Nicholas Lydon of Novartis. In that sense, it had some public funding.

Druker himself welcomed the Indian Supreme Court ruling in an interview with the Times of India, but with a caveat: the price of medications should not be restricted to the extent that it inhibits future investment in new drugs. At the same time, he also criticized the pharma majors' predatory pricing and the enormous profits they made on many blockbuster drugs.

The U.S spends more than $ 2.5 trillion, more than 15 per cent of its GDP, on health care -- more than any other country in the world -- with much less to show than other nations. Much of this is attributed to a broken health care system aggravated by predatory practices of the all-powerful pharmaceutical industry that spends enormous amounts on lobbying and reaps huge profits, to the dismay of even health care professionals

The health care community also rejected Novartis contention that it was supplying Gleevec free to most patients in India who were prescribed the drug, saying patients should not have to depend on the whims of the drug industry or voluntary programs. Among those welcoming the Indian decision was Doctors Without Borders (Medicines Sans Frontier), which depends largely on generics from India for worldwide operations.

"This is a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers like MSF," said Dr. Unni Karunakara, MSF's international president. "The Supreme Court's decision now makes patents on the medicines that we desperately need less likely."

"This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law," Dr Karunakara added.

Even in the United States, where the pharma lobby is considered all-powerful because of its deep pockets and ability to influence legislation in Washington, the general sentiment went with the Indian decision with editorials and commentaries broadly sympathetic to the immediate needs of the poor against the arguments of the rich and powerful claiming to work in long term interests of the needy.

According to think-tank studies, the drug industry has spent more than a billion dollars since 2000 on lobbying, more than any other sector. The industry has more than 1200 registered lobbyists who strive to promote legislation friendly to the industry at the expense of patients.

Many of them sprang to Novartis' defense on Monday, pointing to what they saw as the folly of shooting down pharma majors' profit for short term gains for patients. Some of them tried to isolate India, which is seen as taking the lead role in the fight against branded drugs by the so-called generics.

"India is the odd man out," fumed Mark Eliot, a spokesman for the US Chamber of Commerce's Global Intellectual Property Center, in a radio interview, pointing out that Gleevec's patent was recognized by 38 other major countries including China and Russia.

He called the decision a "symptom of India's cavalier attitude" towards patent rights, saying it was not the first incident of its kind and "there is pattern of behavior over many years that concerns the business community."

The US-India Business Council was slightly more guarded in its criticism, expressing "unease" at the Supreme Court decision. "We recognize the importance of generics to the contribution of health once patents expire, but believe that in order for India to become the 'innovation nation of the 21st century,' it should reward and encourage innovation, including incremental innovation, by respecting the significant resources and costs associated with finding new and better cures to treat diseases," USIBC President Ron Somers said.

 

[Bang Galore]

EU, Australia, Canada may follow India's Patent Law

MUMBAI: India's strong stance on minor drug innovations could reverberate in national parliaments and courthouses of the developed world as Australia, the EU and Canada get ready to discuss and ban patent protection for frivolous improvements. A top Australian government body on Wednesday asked for changes in its patent laws relating to drugs saying that the indiscriminate grant of patents to incremental innovations should be checked and that an independent review should be set up to vet these proposals.

A draft report on the possible changes was released by IP Australia, the government body. Canadian lawyers and health industry officials are discussing tighter standards and taking comfort from the Indian law and the Supreme Court ruling on Monday denying patent protection to Glivec of Novartis. India was one of the first few countries to introduce a specific clause such as Section 3(d) way back in 1995 when it passed the product patent legislation. This section forces the patent applicant to prove the medical or therapeutic efficacy of any incremental innovation for which it is seeking a patent. The law came into effect from 2005 and Novartis filed the case against the Indian government in 2006.

Though the final decision on Novartis came only on Monday, the provisions of the Indian law was well known in international IP and pharma circles and countries and courts have been modifying their stance since then.

Last year, the Canadian Supreme Court refused to grant patent to Pfizer's Viagra saying that the company has not proved the efficacy of the compound that it was seeking to patent. Last month, the European Union sounded an alarm last month over loose patent standards saying that there is widespread concern that patent quality is deteriorating and that the low patent quality threatens the functioning of the entire system.
India's strong stance on minor drug innovations could reverberate in national parliaments and courthouses of the developed world.

"The Indian ruling is not an isolated one; we are seeing in Canada, courts are under pressure to strengthen their patent standards. What we are seeing is that the developed world is taking a cue from developing countries in drafting patent norms" said Ikechi Mgbeoji, lawyer, and associate professor with Osgoode Hall Law School based out of Toronto, Canada.


Last year, Argentina amended its patent act to incorporate a law that said "the discovery of a different or improved characteristic or property for a particular element or a group of elements already known in the prior art does not mean that the product or process is novel". Other countries like Indonesia are also following suit taking a cue from Indian law. "What the Novartis decision does is give other countries an imprimatur from a highly respected court that restricting ever greening is an important public policy," says Brooke Baker, professor of Law, Northeastern School of Law, who advised the Uganda government in drafting its patent law.

"I think that the decision could well embolden other countries to adopt India-style protections against ever greening," he added. India's Supreme Court on Monday declined to grant patent protection to Novartis' blood-cancer busting drug Glivec. The denial created a world-wide stir and was widely welcomed by pharma NGOs, activists and aid organisations and by Indian government and domestic pharma companies. Novartis and other multinationals criticised the ruling saying that it is a setback to innovation and research. But the release of the Australian government report shows that Australia and health experts are also concerned about what they see as a widespread misuse of "evergreening" or trivial innovations in an effort to get patent protection.

"The decision by India's SC is an important addition in our case as an example to the fact, that national courts and national laws can have more control over patents and limit patents," said Dr Patricia Ranald, convenor of Australian Fair Trade and Investment Network, a lobby group that advises government on trade and investment decisions. The organisation was one of the many which submitted recommendations to the report.

She added that IP Australia's draft report is recommending that Australia not extend patents any further and that existing patent law be reviewed to make it more difficult to obtain patents on drugs that really do not add to the medical efficiency or effectiveness of the medicines.

EU, Australia, Canada may follow India's Patent Law - The Times of India

South Africa: Why the Indian Supreme Court Ruling On Novartis Matters to South Africa

The landmark decision on Monday by the Indian Supreme Court in Delhi to uphold India's Patents Act in the face of the seven-year challenge by Swiss pharmaceutical company Novartis, is a major victory for access to affordable medicines in developing countries, and sets a strong example for South Africa to follow as it amends its patent laws, the medical humanitarian organization Médecins Sans Frontières/Doctors Without Borders (MSF)

Section 3(d) of India's patent law prevents companies from gaining patents on modifications to existing drugs, in order to extend monopolies. Novartis filed suit against the law in 2006, in order to gain greater patent protection for a mesylate salt form of its cancer drug, imatinib (branded as Gleevec), but lost the initial case in an Indian High Court.

By upholding this decision and the legality of Section 3(d), the Indian Supreme Court has verified that India can reject frivolous patent applications and, as a result, keep providing affordable Indian generic medicines to patients in developing countries.

The Novartis ruling is critically important for South Africa, as the Department of Trade and Industry (DTI) is currently drafting amendments to the country's outdated patent laws. While India has weathered an intense legal battle to maintain its critical approach for granting patents, South Africa's patent system does not include protections like India's Section 3(d) at all. Instead, South Africa allows companies to easily register patents and extend monopolies through minor drug modifications.

"South Africans are missing out on affordable versions of life-saving medicines because generic competition is blocked by frivolous patents that prevent or delay generic competition," said Julia Hill of MSF's Access Campaign in Johannesburg.

While India avoided patenting imatinib, South Africa granted Novartis an initial patent on imatinib in 1993, which expires this month. However, secondary patents granted by South Africa, including one on imatinib mesylate salts, extend Novartis' monopoly until 2022. As a result, treating a patient with imatinib for a year in South Africa costs $33,896 (R312,234) — 259 times more expensive than the least expensive Indian generic alternative.

Maintaining high prices on certain medicines through secondary patent monopolies blocks access for South Africans and for the Department of Health. Unnecessary high drug prices drive up medical aid rates and impoverish people with life-threatening illnesses. In the public sector some drugs are being rationed because of unnecessary high prices.

The Indian Supreme Court decision confirms that Indian patent law meets international standards. South Africa could implement similar rules without violating international trade rules – just like India did in 2005 when it amended patent law in 2005 to comply with World Trade Organization (WTO) requirements, but kept provisions such as Section 3(d) to keep companies from abusing the patent system.

"As South Africa's new patent law is drafted, including provisions similar to India's Section 3(d), and implementing a patent examination system will better ensure small changes to existing medicines do not warrant new patents that keep them out of reach of those in need. MSF urges South Africa to follow India's lead. By developing a strong legal framework, South Africa could better guarantee affordable access to life-saving medicines," Hill said.

http://allafrica.com/stories/201304021161.html?utm_source=twitterfeed&utm_medium=twitter

Independent states are good for democracy


A Swiss conglomerate, Novartis AG, has been seeking to lock out the manufacturing in India, of a generic drug called “Gleevec”, used for the treatment of a certain type of cancer. Novartis AG, a Swiss company, asserted that it owned the patent rights to the drug; therefore, third parties could not reproduce it.

But this assertion was thrown out by India’s Supreme court on Monday, leaving the Indian masses and, indeed, the peoples of the world, truly elated. Registration of patents bestows exclusive rights to holders to commercialize products by denying anyone else a right to copy or imitate them unless it is specifically authorized by the patentee. This enforced practice reflects the law on intellectual property rights that purports to protect inventors and their financiers to recoup the rewards of their research.

But in a world divided between rich and poor countries, the practice has elicited mixed feelings. The poor feel that developed countries act unfairly when they monopolise and overprice products even if they [the products] emanate from development of human knowledge and of science by the developed countries. The poor also complain that the rule helps to strengthen the wealth of the rich world while sucking out the little remaining sap in the poor third-world countries.

This reality is reflected in vital elements like drugs. Millions of poor people perish from curable diseases due to their incapacity to afford the huge rates imposed by the owners of drug-researching corporations of the rich countries [For instance in the US, Gleevec costs a patient around $70,000 per year. In India, that price is only $2,500 (for a generic version) over the same period].

Even though patent rights are permissible at most for twenty years, the rich corporations always extend the rights endlessly through what is known as “ever-greening”. Here every new form of packaging the same thing can still be registered as if it’s a new development requiring patent exclusivity.

The patent regime is riddled with unconscionable inequality. The prolific products of the third world that are visualized in the arts, rare exhibits, crafts, music, minerals, wildlife, natural phenomena, etc, are often not patentable. The genes of plants, including the latest find of coffee from Ethiopia and other parts of Africa are kept for further research and seeding in London and other Western capitals, rather than anywhere in Africa.

African creation of music is easily pirated or paid for at a minimal fee by the developed world. Constant changes of technology offer new distribution channels that augment the wealth of the super-rich while rendering just tit-bits to creators of know-how within Africa. In any case, piracy invalidates the patent law.

India is one of the exemplary countries in the third world that has been persistent in pursuing the search for fairness and a new world order for the poverty-stricken lot. This earnest quest for independence of the country has changed its foreign relations with the Western world from being blind loyalists of the colonial powers, to pursuing objectives that suit their situation.

This independent posture has finally spilled into the economic and social arena, making India such a magnificent country to be reckoned with. Thanks to India’s independent initiative, it now produces generic drugs that are a cheaper option, in the third world, to the unaffordable drugs produced in the West.

The resourcefulness and independence of mind of the Indian state, its refusal to succumb to the unwarranted clamour of the already wealth-soaked countries, is a stirring example of what independence ought to mean. You ought to ask what the official verdict would have been if Uganda had been the one that had faced the onslaught of Novartis’ application for exclusive vending of its drugs in the country.

Uganda’s affairs are notorious for their unpredictability. There is absence of the institutionalization of state principles vis-a-vis the interests of foreign countries/ firms. Astute foreign speculators now presume that the only rational and national institution in Uganda is the intrepid President Museveni.

Consequently, firms are having good time riding rough-shod over their customers. Many fake investors who do not add any value to our country strut off with bags of billions of shillings amidst the helplessness of our people. When the entire state life is anchored on dependence on the omnipotence of the president, the vagary constitutes subversion of democracy and negation of the exercise of independence.This is why there is need to build a state that is independent of individuals and foreign interests so as to guarantee the possibility of democracy and respect for human rights.

http://www.observer.ug/index.php?option=com_content&view=article&id=24543:-independent-states-are-good-for-democracy&catid=37:guest-writers&Itemid=66