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Affordable drugs versus Rights of Intellectual Property

The future of the medical bill: 
Manu Joseph, [15 Apr, 2007 Times of India, Mumbai]

Laxman Bhaskar's face looks pale, as though an inner glow has been turned off. He is a grim man in his thirties who is right now in the almost silent workshop of the Cancer Patients Aid Association (CPAA). He is printing a design on a cloth bag, a small favour to an organisation that is keeping him alive. 

Bhaskar has a rare cancer - chronic myeloid leukemia (CML). About 30,000 Indians are diagnosed with the disease every year. The drugs that CPAA gives him cost Rs. 10,000 a month. And that's cheap. He takes the generic versions, the copies, made by Indian companies. The original, usually called Glivec, owned by Swiss pharma giant, Novartis, would have cost him over Rs. 1,20,000 a month.  

Novartis is at the moment in a battle with the CPAA and, in a way, the Indian government, to win the exclusive marketing rights for Glivec which will result in local companies being ordered to stop making cheaper copies of the drug.  Novartis says that it invented the base compound (imatinib) and deserves the exclusive rights to market it. The appeal of Novartis, till recently heard by the Madras High Court, has now been transferred to the newly created Intellectual Property Appellate Board (IPAB) which is expected to pass a verdict soon.  

At stake is a very complex issue, almost philosophical. That the poor have a right to live is a truth that has no meaning if there are no life-saving drugs in the first place. And it is not the goodness of activists that cures diseases, but the commercial motives of big pharma companies like Novartis which spawn multi-million dollar research.

If Novartis wins the battle for Glivec, Indian generics, whom the Swiss company's CEO Daniel Vasella had once described as "thieves", will be wiped out and not only a cancer cure but also HIV, TB and other treatments will become many times more expensive. The ramifications of the Glivec battle is so important to the commerce of cure and the very meaning of a poor person's life in a capitalistic world, that journalists from the first world, especially Europe, have been landing in the country in the last few weeks.  

At the heart of the battle, as always, is a technicality. It is called, without affection by Novartis, 3d. It is a section in the Indian Patents Act. The base compound of Glivec was invented in 1993. It was only two years later that India joined the World Trade Organisation.  

India said that over the next 10 years, as it moved towards a patents regime, it would consider fresh patent applications of inventions that did not exist before 1995. So the original base compound of Glivec did not qualify, but Novartis filed for patent for a slight variation, a beta crystal form.   

In 2003, Novartis was granted the exclusive marketing rights for that. But when the Indian Patent Law came into effect in 2005, there was a clause in section 3d that implied that cosmetic variations, like the beta crystal form of imatinib, cannot be considered. So, in 2006, Novartis lost its exclusive rights and the Indian generics who were debarred from making copies rose again.  

Novartis claims that it is only fighting for its rights and not for money. A spokesperson of the company says that its Glivec International Patient Assistance program (GIPAP) has given the drug free to 8,000 patients in India. "Ninety-nine percent of the Indians who have been taking Glivec, have been getting it free."

It is a claim that makes Y K Sapru, the gritty chief of CPAA, a former pharma executive himself, laugh. "What they don't tell you is that they give the drug to patients free for one or two months, that's all. Novartis is not here for social service. It is here to make money. Last year, Glivec made $2.6 billion worldwide.

They want to make more money. And this argument that they deserve to earn because they invested in the research of the drug is not very good. Fifty percent of the funding came from the US government, 30% from a US NGO and 10% from the Oregon Health and Science Institute. Only 10% came from Novartis."(Novartis did not respond when asked for a confirmation.)

A few months ago, Novartis CEO Daniel Vasella is reported to have said that Sapru was being financed by Indian pharma companies. Sapru filed a defamation suit for half a million dollars. Vasella eventually claimed that he never made the statements. It is also said that Sapru is angry because Novartis did not choose CPAA to run its free treatment programme but instead chose an international cancer charity organisation called Max Foundation.

"It's true that we were in talks with Novartis and things didn't work out between us, but that's all there is to it," Sapru says. He accuses Novartis of using Max Foundation, "to promote both Glivec and to collect clinical trial data. This has been confirmed by the founder of Max Foundation, Pedro Rivarola. "Rivarola's son, Max had died of cancer and so he was emotionally involved in the charity.

A letter written by Rivarola to Sapru is part of the legal documents in the Glivec case. Rivarola says in the letter, "I believed (being truly naïve) in the good will of Novartis... The relationship changed into a daily struggle to keep my beloved foundation independent from Novartis' insatiable paws...The last drop in the goblet made me leave. It was the situation in Thailand where Novartis demanded that patients had to buy three months of supply before qualifying for the program; It's time to stop this as the name of my son is being trashed and abused just for marketing reasons."

The battle beween CPAA and Novartis also has racial overtones. It is being unofficially viewed as MNC vs India. Anand Grover, a lawyer representing CPAA against Novartis says, "It's time the whites know that they cannot walk into this country and expect us to be intimidated as before. We know how to fight."He is optimistic that the future of Indian generics is not in jeopardy. "But don't forget, they too are in it for the money."

Sapru says that the production cost of a Glivec generic is about Rs 1,000. "Indian companies are selling it at 10 times the price. So, they are making huge profits. But, at least, they are cheaper than Glivec." DG Shah, secretary general of the Indian Pharmaceutical Alliance, says matter-of-factly, "It's true, we are not here for charity." Indian pharma is valued at over $ 5 billion, 65% of this coming from the export of generic drugs to developing.

"These revenues will help us invest in research," DG Shah says, "and in the coming years, India will be known as not just the maker of cheap copies but as a research hub which makes its own blockbuster drugs. "But the future of generics and how the poor will buy their right to stay alive is still not clear.

 Discussion on the article:

SUNDAY MAILBOX (April 22nd, 2007)

 Glivec controversy

The article captioned 'The Future of the 'Medical Bill' by Manu Joseph, which appeared in 'The Sunday Times of India' dated 15 April 2007 begins on a dramatic note, no doubt to attract eyeballs, but is grossly misleading because as you will note from the email response sent to him, all patients who are prescribed Glivec for chronic myeloid leukemia (CML) or gastrointestinal stromal tumours and cannot afford to buy the drug and are not reimbursed or insured receive it free and this continues.

Glivec currently is given free to more than 7,000 patients and not 8,000 patients, as quoted in the article under reference. The author chose to quote Mr. Sapru as say­ing that the drug is given free for one or two months. 

The article is a great disservice to the work we have been doing through The Max Foundation in making sure that anyone, and I repeat anyone, who is prescribed Glivec and .cannot afford the drug and is not reimbursed or insured receives it absolutely free of any charge. The generic version of the drug that is available in the market costs 4.5 times the average income in India and could well be out of the reach for many.

 -Ranjit Shahani, Vice Chairman & Managing Director Novartis India Limited

 The writer responds: 

The claim of Novartis that it supplies Glivec (priced at Rs. 1,20,000 per month) free to those who cannot afford it has been contested not only by the Cancer Patients Aid Association but also by Pedro Rivarola, the founder of Max Foundation, the NGO through which the Novartis charity programme is being run. Also, in a questionnaire to Mr. Shahani this correspondent specifically raised the issue of how Glivec is being provided to India's poor but I was then told that he was not available for comment.

- Manu Joseph       

 II

 The Novartis claim that all poor CML pa­tients who needed Glivec since 2002 till today have had an access to free Glivec through Glivec International Patient As­sistance programme (GIPAP) is not true. This is obvious from Novartis' own claim of having given Glivec free to around 7,000 CML patients from 2002 to 2007. Does it mean that in this five-year span, out of 30,000 CML patients detected every year i.e. 150,000 CML patients in five years in India, only 7,000 poor CML patients needed Glivec?

The reality is that Glivec is available free to only a few selected patients recommended by doctors chosen by Novartis while thou­sands of others are treated by generic versions of Glivec manufactured by nine Indian generic manufacturing companies.

Novartis is seeking patent and monopoly for Glivec which would mean non-availability of generic versions of Glivec at one twelfth the price of Glivec (Rs 10,000 as against Novartis' price of Rs 1,20,000 for a month's treatment). This means sure death for thousands of poor CML patients as NGOs will not be able to provide the drug at affordable prices to poor CML patients.

What is more Glivec will be only the be­ginning which will be followed by several life-saving drugs for diseases like AIDS/HIV, cancer, tuberculosis, diabetes, etc. getting patent on similar logic as used by Novartis and then becoming unaffordable to not only the Indian population but even globally as India is the main supplier of generic drugs the world over. How serious this issue can become is realised more by the public in foreign countries, a reason why there is so much more agitations against the Glivec patent dispute in the foreign media than in India.

YKSapru, Chairman, Cancer Patients Aid Association

 

In a Nutshell…CPAA's Chairman and CEO - Mr. Y. K. Sapru, Executive Director - Shubha Maudgal and Joint Secretary - Mrs. Rekha Sapru

We at CPAA are fighting tooth and nail against Novartis, which has priced its life saving drug, Glivec for Leukemia patients at an astronomical price of Rs. 1,25,000 per month to be continued life long in majority of cases against Rs. 10,000 per month for the generic version. CPAA's Chairman and CEO - Mr. Y. K. Sapru, Executive Director - Dr. Shubha Maudgal and Joint Secretary - Mrs. Rekha Sapru were recently invited to Davos to make a presentation on "Affordable drugs versus Rights of Intellectual Property" held parallel to  the World Economic Forum. They also participated in a public forum panel discussion held in Basel on 26th January along with the President of the Swiss Cancer League and NGOs Berne Declaration and ProNatura as well as Novartis representatives , Dr. Petra Laux, Head Global Public Affairs and John Gilardi, Head of Corporate Public Relations.

CPAA recently also filed a defamation case against Novartis for their slanderous statements. CPAA is continuing its ongoing case which Novartis has filed against the denial of patent for the drug and against section 3d of the Patent Act.

This case has global ramifications as Novartis winning this case will make numerous other lifesaving drugs beyond the reach of millions of patients of Cancer, TB and AIDS in African and Asian countries.

Public Eye Swiss Award 2007The "Public Eye Swiss Award 2007" for Irresponsible Corporate Behaviour goes to Novartis

On the opening day of the World Economic Forum in Davos, Switzerland, the Public Eye Swiss Award 2007 for irresponsible corporate behaviour was given to Novartis International on the basis of a nomination made by Cancer Patients Aid Association (CPAA). The Berne Declaration and Pro Natura, Switzerland, have given out this negative award for the last three years.

 

Novartis, a Basel based pharmaceutical company is currently using patent lawsuits in an attempt to limit access to affordable generic drugs in India and developing countries. As CPAA Chairman and CEO, Y.K. Sapru said, "It's aggressive patent policy makes Novartis responsible for the misery of thousands of cancer patients in India today and if not restrained will have similar effect at the global level." 

 

Speech by Mr. Y. K. Sapru, Chairman and CEO, CPAA India 24 January 2007 - Davos, Switzerland:

Dear friends,To Davos

Novartis, through its actions of pricing Glivec a life saving drug for CML (Chronic Myeloid Leukemia) patients at an astronomical rate has inflicted misery, ill health, poverty and even death on thousands of sick cancer patients in India. If they are not restrained even greater misery, greater agony and widespread deaths will inflict millions of human beings at a global level.

The Glivec Story

India has around 30,000 cases of Chronic Myeloid Leukemia (CML) reported every year.

In 2001, Novartis introduced Glivec (Imatinib Mesylate) in India - A wonder drug producing remission in over 90% of CML patients. Novartis priced Glivec at US$ 2500 for 1 month's treatment to be taken life long to keep the patient alive. In a developing country like India where there is no health insurance for a vast majority of the population, the pricing of Glivec was just out of reach for nearly everyone. Fortunately, almost simultaneously, 9 Indian companies started manufacturing its generic versions priced at an affordable US$ 180 for 1 month's treatment.

In 1998, Novartis applied in India for a patent for Glivec and was granted Exclusive Marketing Rights (EMR) in January 2003. As a result Indian courts forbade 6 out of 9 generic producers to market Imatanib Mesylate.

As a result: The 3 generic companies could not cover the entire country, CPAA and other charitable agencies could not take up the burden of supplying the drug at subsidized rates or free. Thousands of CML patients suffered and many became bankrupt as they tried to buy Glivec and many even died.

CPAA went to the Supreme Court of India against granting of EMR to Novartis.

In March 2005, the Indian Parliament passed the Indian Patent Act.

In January 2006, The Patent Controller of India rejected the patent application of Novartis for Glivec after evaluating all the points raised by CPAA. As a result once again generic versions of Glivec were available in the Indian market at affordable prices.

In May 2006, Novartis appealed against this judgment and also filed a case against the Indian Patent Act. CPAA, MSF, Oxfam & other NGOs launched a global agitation against Novartis.

In case Novartis wins both these cases in India, not only will thousands of CML patients die but 100s of life saving drugs currently available at affordable prices will get patent protection and will become unaffordable to patients suffering from life threatening diseases such as TB, Aids etc. There will be more misery - more poverty, more agony and more deaths at global level, which will be a major catastrophe.


PRESS UPDATE : CPAA SENDS DEFAMATION NOTICE TO NOVARTIS

PTI [TUESDAY, JANUARY 30, 2007 06:10:14 PM]

NEW DELHI: Mumbai-based social group Cancer Patient Aids Association (CPAA) has sent a defamation notice to Swiss pharmaceutical giant Novartis AG chairman and CEO Daniel Vasella and demanded half a million dollars in damages.

CPAA's chairman Y K Sapru has alleged Vasella made "certain defamatory statements and insinuations" in an article titled 'Novartis persists with challenge to Indian patent law despite adversity' that was picked up by different websites.

In the article, Vasella had said generic companies were often behind (the activism of) patients' groups in India and he would not be surprised if they gave money to the groups.

"It (the article) represents that generic companies paid to us to oppose MNC pharma companies in India," CPAA said. The group, which is involved in a case against Novartis in Madras High Court over the pharma giant's challenge of India's patent law, contended that Vasella's statement was defamatory and CPAA never took money from any generic firm. "This is false and per se defamatory," CPAA said in the notice and added the article had put the group "in an extremely embarrassing position".

CPAA further asked the MNC to retract from its statement and "to issue an unconditional apology over company's website and on the Intellectual Property Watch". It has also warned the company to face civil or criminal proceedings in case of non-completion. Novartis has challenged the government's patent law in the Madras High Court over its cancer drug Glivec. The company was earlier denied a patent by the Chennai-based patent office in January 2006. 

Courtesy: http://economictimes.indiatimes.com/Healthcare 


29 January 2007 - Update 4 pm IST Novartis case

The Novartis matter before the Madras High Court in Chennai adjourned today until15 February for final hearing on all issues, i.e., the challenge to 3(d) of the Patent Act, as well as the challenge to the Patent Controller's order on the merits. The reason being, Novartis wanted to place the Mashelkar committee report on record, which they did only today, and upon which the counsel for the government t of India wanted to seek instructions from government as to its response.

As the order of the patent controller is appealable under the Indian Patent Act, Novartis AG sought to convert the writ petition into an appeal, which was opposed by some of the respondents, as also the Government of India. The issue of whether it can be converted into an appeal, and whether it is within the statutory time limits will be agitated as a preliminary issue on the 15th.

Orders were also passed on the application of the Indian Pharmaceutical Alliance and Indian generic manufacturer, Sun Pharma, to implead them as respondents in the petition challenging 3(d) filed by Novartis AG.

Novartis AG also made it clear that their challenge was two fold: namely, that 3(d) of the Indian Patent Act was not compliant with TRIPS and on the ground that it violates Article 14 of the Indian Constitution, promoting equality and prohibiting discrimination and arbitrary state statute.

On the issue whether the pleadings were sufficient to make out a claim for Article 14, counsel for Novartis contended that it was sufficiently made out in their rejoinder, and that they would stick by that.

Counsel for Novartis also made it clear that they would be dropping the Article 19(1)(g) challenge, which was based on an alleged violation to practice one's business.

Courtesy: http://economictimes.indiatimes.com/Healthcare