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Affordable Drugs:

 Campaign for Affordable Trastuzumab

Open letter to the Prime Minister of India Shri Manmohan Singh

Hon'ble Shri Manmohan Singh
Prime Minister of India
Room No. 148-B
South Block New Delhi – 110 001
Tel: 23012312, Fax: 23016857

Subject: Access to Trastuzumab – a life-saving breast-cancer drug

Respected Prime Minister,

We the undersigned cancer survivors and patients, women's groups, public interest organisations, health rights groups and treatment activists are writing to urge you to take immediate steps to make the cancer drug trastuzumab available free at public cancer treatment facilities, and at an affordable price in the private market.

Trastuzumab is used in treatment of HER2+ type of breast cancer, which affects about one in four patients diagnosed with the disease.

Some facts about breast cancer in India You may be aware that as many as one lakh women in India are diagnosed with breast cancer every year. One out of every 22 Indian women is likely to get breast cancer during her lifetime. One Indian woman succumbs to breast cancer every ten minutes. Breast cancer is now the most common form of cancer in urban areas, and the second most common cancer in rural areas in India. ICMR data suggest some extremely worrying trends – breast cancer is becoming more common in younger women, with almost 50% of patients being women under 50. Younger women are showing an increased incidence of HER2+, a particularly aggressive form of breast cancer.

Trastuzumab: hope for women with HER2+ breast cancer Clinical trials have demonstrated that trastuzumab has a strongly positive impact on HER2+ metastatic breast cancer in terms of reducing the rates of recurrence and improving the chances of disease-free survival. In 2006, the US Food and Drug Administration approved trastuzumab for treatment of all HER2+ breast cancers. It is now the standard practice to prescribe Trastuzumab along with post-surgery chemotherapy for women with metastatic breast cancer. Treatment consists of approximately 12 intravenous doses of the drug, administered every three to four weeks over the course of a year.

High costs block access to treatment Roche, the Swiss drug major (the originator company) has been marketing trastuzumab in India under the trade name ‘Herceptin’.

Indian companies are still to register and market a biosimilar version of trastuzumab. As a result, Roche has a complete monopoly over both the private market and the public sector purchases made by the Central Government Health Service and Indian Railways.

When Herceptin first became available in India, it was priced at around Rs. 1,10,000 per vial, making it unaffordable to all except the very wealthy. In March 2012, soon after the decision of the Indian Patent Controller to grant a compulsory license on Sorafenib (a drug used in the treatment of liver and kidney cancers), Roche announced a cut in the price of Herceptin from Rs.1.08 lakh per dose to Rs.92,000 per dose – a reduction of about 15%. Roche also signed a commercial agreement with Emcure Pharma. As of August 2012, Emcure is offering a repacked and renamed version of trastuzumab (Herclone) to patients at a price of Rs.72,000/- per dose – a reduction of around 33% from the price in 2011.

While Roche is using the deal with Emcure and its “voluntary” price reductions to claim that it is concerned about access issues, it is clear that the company's pricing policy is motivated by greed for profits and the determination to retain control of the Indian market. The price cuts are defensive and pre-emptive measures to preserve its patent monopoly in India against the issuance of compulsory licensing and price control measures by the Indian government.

The agreement between Roche and Emcure does not involve any transfer of technology or create any possibility for the entry of other players into the market - Roche will continue to produce the drug at its plants in the US, Singapore and Germany and ship vials to Emcure for packaging.

The patent on trastuzumab expires in 2014, but Roche is attempting to maintain its market monopoly by filing several new patent applications in the 4 different patent offices in India. If granted, these patents can be used to file IP infringement suits claiming damages of crores of rupees against Indian companies who develop and launch a bio-similar of trastuzumab. This strategy has already been employed by Roche to discourage the entry of a bio-similar of a pegylated interferon (Alpha-2a) used in the treatment of Hepatitis C.

Generic competition can ensure access Experience shows that competition from Indian companies can bring down the price of essential drugs far more effectively than discounts or differential pricing schemes controlled by companies. In 2001, the cost of first line antiretroviral therapy for HIV treatment was brought down from over USD 10,439, (which was a discounted price for MSF) to USD 350 per patient per year (PPY) when Indian companies started manufacturing affordable generic versions. Similarly, in the area of biotechnology, the local development and registration of recombinant Hepatitis B vaccine by Indian companies has brought prices down from over Rs. 1000 per dose to less than Rs. 50 a dose.

More recently, the landmark decision in March by the Patent Controller to allow generic competition on the cancer drug sorafenib tosylate (Sorafenib) via a 'compulsory licence' issued to an Indian company brought the price of this patented cancer drug down by 97% (from over Rs 280,000 to Rs. 8,800 per month).

We therefore urge the government to immediately institute measures for the local development of biosimilars of trastuzumab so that competition can bring down prices effectively for patients in India and other developing countries.

Specifically, we request your government (particularly various Ministries dealing with pharmaceuticals) to:

  • Make trastuzumab available free of cost to patients in government hospitals, and at a reasonable and affordable cost in the open market.

  • Constitute a High-Level inter-Ministerial Task Force in the Health Ministry involving biotechnology experts from public funded research organisations and civil society organisations to address the technological issues that may be involved in production of trastuzumab.

  • Take effective measures to ensure that no secondary patents on trastuzumab are granted or enforced in India.

  • Issue compulsory licenses on existing process or product patents that block the development of bio-similars of trastuzumab, as allowed by the Indian Patents Act, 2005.

  • Provide adequate resources for research and development, manufacture and clinical trials of a bio-similar of trastuzumab, and ensure a fast track process for regulatory approval.

Respected Prime Minister, we look forward to your urgent actions in response to this letter.

(signed)

Kalyani Menon-Sen, Women's rights activist
Third World Network
Leena Menghaney, Lawyer

Copy to:

  1. Mr. Pulok Chatterjee, Principal Secretary, Prime Minister’s Secretariat
  2. Mr. Ghulam Nabi Azad, Hon’ble Minster of Health and Family Welfare, Ministry of Health and Family Welfare (MoHFW)
  3. Mr. P. K. Pradhan, Secretary, Dept of Health & Family Welfare, MoHFW
  4. Dr.V. M. Katoch, Secretary, Dept of Health Research, MoHFW
  5. Mr. Keshav Desiraju, Additional Secretary, Dept of Health & Family Welfare, MoHFW
  6. Mr. Anand Sharma, Hon’ble Minster of Commerce & Industry
  7. Mr. S R Rao, Secretary, Department of Commerce, Ministry of Commerce & Industry
  8. Mr. Saurabh Chandra, Secretary, Department of Industrial Policy and Promotion (DIPP), MoC
  9. Mr. D.V. Prasad, Joint Secretary, Department of Industrial Policy and Promotion (DIPP), MoC
  10. Dr. G.N. Singh, Drug Controller General of India
  11. Mr. Chaitanya Prasad, Controller General of Patents
  12. Dr. Ashwani Kumar, Hon’ble Minister of State for Science and Technology
  13. Prof. Samir K. Brahmachari, Director General, Council of Scientific and Industrial Research
  14. Dr. M.K.Bhan, Secretary, Department of Biotechnology, Ministry of Science & Technology
  15. Dr. T. Ramasami, Secretary, Department of Science & Technology
  16. Mr. Srikanta Kumar Jena, Hon’ble Minister of State for Chemicals and Fertilizers
  17. Mr. Dilsher Singh Kalha, Secretary, Department of Pharmaceuticals
  18. Mr. Shanta Kumar, Chairman, Parliamentary Standing Committee on Commerce
  19. Mr. Brajesh Pathak, Parliamentary Standing Committee on Health and Family Welfare
  20. Mrs. Sonia Gandhi, Chairperson, National Advisory Council
  21. Ms. Rita Sharma, Secretary, National Advisory Council
  22. Ms. Mamata Banerjee, Chairperson, All India Trinamool Congress
  23. Mrs. Brinda Karat, Former Member of Parliament, Rajya Sabha
  24. Dr. (Smt.) Jyoti Mirdha, Member of Parliament, Lok Sabha
  25. Prof. K. Srinath Reddy, President, Public Health Foundation of India
  26. Mr. Y.K. Sapru, Founder Chairman and CEO, Cancer Patients Aid Association
  27. Mr. D G Shah, Secretary General, Indian Pharmaceutical Alliance

About Glivec

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.

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.


Articles:


Roche to offer 'significantly' cheaper, locally branded versions of its two cancer drugs Herceptin and MabThera

Roche to offer discounted cancer drugs in India: Roche, the world's biggest maker of cancer drugs, said it would offer 'significantly' cheaper, locally branded versions of its two cancer drugs Herceptin and MabThera by early next year
Julia Kollewe guardian.co.uk, Friday 23 March 2012 10.57 EDT

Swiss drugmaker Roche plans to offer cut-price versions of two blockbuster cancer drugs for the Indian market soon.

The news comes after the Indian government stripped the German drugmaker Bayer of exclusive rights to produce the kidney cancer drug Nexavar earlier this month, and licensed a local company to make a cheap, generic version, arguing that many Indians could not otherwise afford the life-saving drug.

Roche, the world's biggest maker of cancer drugs, said it would offer "significantly" cheaper, locally branded versions of its two cancer drugs Herceptin and MabThera towards the end of the year or in 2013. They will be renamed and packaged by Roche's Indian partner Emcure Pharmaceuticals.

"The scope is to enable access for a large majority of patients who currently pay out of pocket as well as to partner with the government to enable increased access to our products for people in need," said a Roche spokesman.

Monthly doses of Herceptin, for breast cancer, and MabThera, for cancers of the blood and lymphatic system, cost between $3,000 (1,889 pounds) and $ 4,500 per patient at wholesale prices.

The spokesman added: "With this strategy, we expect to significantly increase the number of patients treated with our therapies and help patients currently under treatment to continue to use our products properly."

He denied that the move was prompted by the Bayer case. "Rather it is part of our overall strategy in emerging markets, where we work closely with governments and payers in order to enable access to our medicines," he said. For example, working with the Egyptian health authorities Roche introduced a second brand of its HCV medicine Pegasys in Egypt that was packaged locally. "This allowed for differential pricing, with the local brand available at a significantly reduced price enabling greater access to those in need. We are considering this approach as part of our strategy for various emerging markets."

Roche's decision will reignite the debate over whether prices for life-saving medicines should be cut in poorer countries. Several drugmakers, including GlaxoSmithKline, have already slashed their prices for HIV/Aids drugs in Africa, as well as some middle-income countries elsewhere. However, there are fears that a proposed free trade agreement between the EU and India, which could be signed by the autumn, could spell the end of cheap drugs for the developing world.

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First Compulsory License granted in India to generic company for anti-cancer drug
Monday, March 12, 2012

The Compulsory License (CL) on sorafenib tosylate - the anti-cancer drug has been granted to Natco Pharma till 2020 (balance of the patent term). Natco will be required to pay 6% of net sales as royalty to Bayer. Natco's right to manufacture and sell the drug is limited to the territory of India.

Background: "In July 2011, NATCO, an Indian pharmaceutical company, applied for a CL in the Mumbai patent office to manufacture an affordable generic version of sorafenib tosylate - the anti-cancer drug for which Bayer has obtained a patent IN215758 in India in 2008, which will expire in 2020. In its CL application NATCO is proposing to market the same drug at Rs. 8,800 per patient per month if the patent office grants it a compulsory license. This is 31 times cheaper than Bayer's sorafenib tosylate or 3% of the price at which Bayer sells the drug in India. Bayer currently markets the drug at a high price of approximately Rs. 2,80,000 per patient per month. This case is also important as it will test Section 84 of the India patent act, under which the CL mechanism kicks in when generic companies apply for a CL."

If this CL is granted for the cancer drug, then it will open up avenue for many other generics to apply for Compulsory License and will make the costly cancer and HIV drugs accessible to common man. Hence, this decision is very crucial for all of us working in the area of access to medicines. Bayer in partnership with Novartis and Pfizer has already launched a campaign against misuse of CL by generics in India to influence the decision. The main points Bayer/ Novartis/ OPPI/ Pfizer raised are:

Patent laws have been misused in several countries, a stark example is that of Thailand where compulsory licenses were allowed for AIDS drugs. The impact of this has been felt by the Thai economy that has forgone a large amount of investment into the pharmaceutical sector, especially research based companies who are apprehensive of bringing blockbuster drugs for fear of their drugs being misappropriated by compulsory licenses. Several access to medicines programs exist to provide access to drugs to the lower socio economic classes. An example of this is Novartis that has helped patients by providing one billion dollars worth of their anti cancer drug (Glivec)".

CPAA has experienced how difficult it has been for cancer patients to access appropriate treatment given the high cost of drugs, making it unaffordable even for upper middle class and welcomes the decision.

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Delhi High Court Rejects Bayer's Plea for Patent Linkage

18 August 2009, New Delhi. The Delhi High Court today rejected an attempt by Bayer Corporation, a multinational pharmaceutical company, to sanction the patent linkage system in India through a court direction. While holding that unpatented (generic) drugs are not spurious drugs, Justice Ravindra Bhat held that this petition was an attempt to tweak public policy. While dismissing the petition, the Court also held that this is a vexatious and luxury litigation which should discouraged and imposed cost of approximately Rupees 6 lakhs to be paid by Bayer Corporation to Respondents - Union of India and the Cipla Ltd. Patent linkage is a system in which the Drug Controller refuses to grant or delay a marketing approval to a generic drug manufacturer to manufacture and sell a drug if the drug is already patented. Patent linkage is known to be against public health interests as it will delay the entry of cheap, generic medicines into the market and keep medicines out of reach of those who need them.


Y K Sapru, Chairperson of Cancer Patients Aid Association (CPAA), who had intervened in the case filed by Bayer Corporation against the Drug Controller of General of India, said, "We are very glad that the Court has recognised the aspect of access to drugs and has rejected Bayer's attempt to introduce a policy change with adverse public health consequences through the court."


Bayer Corporation had filed a Writ Petition before the Delhi High Court against Union of India, the Drug Controller General of India and Cipla Ltd. seeking an order that the DCGI should consider the patent status of its drug, Sorefenib Tosylate, before granting a marketing approval to any generic pharmaceutical company and refuse marketing approval to any generic company. Sorefenib Tosylate is used to treat kidney cancer and is sold by Bayer at Rs. 2, 85,000 (Rupees two lakh eighty five thousand) for 120 tablets for a month dosage.


On 7.11.2008, the Delhi High Court had granted an interim injunction to Bayer stopping the DCGI from granting marketing approval to the generic company (Cipla) until a final order is passed in this matter.
CPAA had filed an intervention application to be added as a party, which was allowed by the Delhi High Court. It was pointed out by CPAA that due to the stay in this case, the DCGI is not accepting the applications for marketing approval from any generic companies on any drug. The Court had then clarified that the stay would operate only with respect to the drug in question in the matter, i.e. Sorefenib Tosylate.


Anand Grover, counsel for CPAA and Project Director of Lawyers Collective HIV/AIDS Unit, said, "We welcome the High Court's judgment. In India, we do not have a patent linkage system. The patent system and the drug regulatory system are two separate and independent mechanisms and this is Parliament's intent. If introduced, the patent linkage system would have seriously impacted the early entry of generic drugs into the market. Such early entry is possible either through mechanisms such as compulsory licensing within the Patents Act itself, or where there is a bona fide belief that a patent has been wrongly granted This is especially important as we are now seeing an increase in the number of patents being granted to drugs, which we believe are being wrongly granted. Moreover, a patentee cannot use the DCGI, a government agency, to enforce its private rights. This was an attempt to introduce a TRIPS-plus requirement in India, which has been rejected."


CPAA had urged that the introduction of patent linkages in India would have adverse public health consequences. It had argued that despite the fact that the Legislature has kept the patent and regulatory systems separate, Bayer is attempting to link the two independent and separate systems and introduce a policy change through the Court.
Ms Kiran Hukku, Director, Cancer Patients Aid Association, New Delhi, said, "With this rejection, we can hope to have early access to cheaper, generic medicines. This will benefit our patients."

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Setback for Novartis in India Over Drug Patent
By AMELIA GENTLEMAN Published: August 7, 2007
Ruth Fremson/The New York Times

NEW DELHI, Aug. 6 - Indian companies will be free to continue making less expensive generic drugs, much of which flow to the developing world, after a court rejected a challenge to the patent law on Monday. Aid organizations declared the ruling a victory for the "rights of patients over patents," but the Swiss drug company Novartis, which filed the case, warned that the ruling would discourage investments in innovation and would undermine drug companies' efforts to improve their products. 

In the case, brought last year, Novartis asked the High Court in Madras to clarify a key element of India's 2005 patent legislation, arguing that it violated trade rules and breached the Indian Constitution. Indian law says a drug qualifies for a patent when it is a new invention or a significant improvement to an existing one. The law denies patent protection to new versions of drugs invented before 1995. Novartis sought to determine whether an Indian court had been right to deny a patent on a modified form of the Novartis leukemia drug Gleevec, known in Europe and India as Glivec. The application was rejected on the grounds that the new drug was insufficiently different from the previous version. Novartis argued that the section of the law prohibiting patents for any drug that is an "incremental innovation" violated the World Trade Organization's agreement on trade-related aspects of intellectual property rights. 

If the Madras court had ruled the other way, the decision could have set an important precedent that might have allowed other international companies to receive patents on modified versions of existing medicines, thereby extending the period of their exclusive right to produce the drug. Such drugs account for most of the estimated 9,000 patent applications waiting for approval in India, according to Doctors Without Borders, which warned that such a ruling would have resulted in a "shutdown of the pharmacy for the developing world." Indian companies provide 84 percent of the drugs to fight H.I.V. and AIDS that Doctors Without Borders supplies to patients worldwide. They also provide more than 25 percent of other essential drugs used by the organization. 

Other relief programs are equally dependent on Indian-manufactured products. Indian companies would have been prevented from manufacturing generic versions of Gleevec, which they sell domestically and internationally for about a tenth of what Novartis charges. The Swiss company charges $2,600 for a month's worth of the drug. This could have left large numbers of patients without access to the cancer treatment, and the precedent created would have prevented the manufacture of many other drugs that Indian companies produce at a fraction of the cost of the brand-name originals. The full text of the judgment was not immediately released, but according to Reuters, which attended the ruling, the judge said the court had no jurisdiction to decide whether Indian patent laws complied with the W.T.O. guidelines on intellectual property law. The international pharmaceutical industry and global relief organizations have been scrutinizing this long-running case, aware that the ruling would have profound implications for their work. 

"This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India," Tido von Schoen-Angerer, director of the essential medicines campaign at Doctors Without Borders, said in a statement released by the organization. Novartis said in a statement that the case would "have long-term negative consequences for research and development into better medicines" that could benefit people in India and other nations. "It is clear there are inadequacies in Indian patent law that will have negative consequences for patients and public health in India," said Paul Herrling, head of research at Novartis. "Medical progress occurs through incremental innovation. If Indian patent law does not recognize these important advances, patients will be denied new and better medicines." Officials from Novartis said they were awaiting the release of the full text of the ruling "to better understand the court's decision." Dr. Ranjit Shahani, a vice chairman of Novartis, said in a statement: "We disagree with this ruling, however we likely will not appeal to the Supreme Court." A spokeswoman for the company said Novartis thought it had "advanced the debate" with this court case and now wanted to combine forces with other interested parties to continue its campaign. Novartis is awaiting a ruling in a separate case before the intellectual property rights appellate board in Delhi, appealing the earlier decision not to grant a patent for the modified form of Gleevec.

The position of the Indian government became clear in April when the health minister, Dr. Anbumani Ramadoss, said that the government was "very concerned" that the challenge by Novartis would restrict India's ability to produce cheap AIDS drugs. The head of the Mumbai cancer patients' support group, Y. K. Sapru, welcomed the decision. "This is a very major victory domestically and internationally," he said. "India has a $5 billion pharma industry, and 65 percent of those drugs are sold to the developing world and poorer people in the developed world. All that would have been suspended if the judgment had gone the other way, and there would have been a dearth of affordable drugs. That calamity has been prevented." Yusuf Hamied, chairman of the Indian pharmaceutical company Cipla, also described it as a positive ruling. "If Novartis had won, this would have been a tremendous setback for us," he said. "I am willing to pay a royalty on a new invention, but I am against monopolies. This would have increased monopolies, which would have meant higher prices."

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Novartis Plea rejected by Madras HC- 8 August 2007 - The Times of India, Mumbai

Seeking Fresh Patent Protection : Mumbai: It was a sweet moment of victory for a patients' support group on Monday when the Madras high court rejected a plea by pharma giant Novartis on Monday. In 2005, the Mumbai-based Cancer Patients Aid Association (CPAA) had kick-started the movement against the company's move to seek fresh patent protection for its life-saving drug called Glivec. On Tuesday at a press meet held to discuss the impact of the judgment, CPAA founder Y K Sapru said, "We fought for the patients' rights and we are relieved that the court bas ruled in our favour and recognised that patients need protection more than patents." 

The Glivec case bas ensured that the 25,000 patients of Chronic Myeloid Leukemia that are detected in India every year will be able to get treatment at one-tenth the cost. Domestic Pharma firms sell generic versions of the anti-cancer drug Glivec at Rs.8,000 to Rs 9,000 per patient, per month. Glivec costs Rs 1.24 lakh per patient per month. The Glivec story began in 2005 when India had to amend its patent law to comply with WTO rules. "But India innovated in designing safeguards so that patents can only be granted for real innovations and not for mere modifications to a molecule already invented," said Anand Grover who argued the case for the CPAA. This amendment - named Section 3 (d) - became the focus of the drawn-out court battle between Novartis and the patient-groups. While the company moved Madras high court to overturn the section for "not complying with the TRIPS Agreement", the patient group felt that, as per the section, the company's modification of the Glivec molecule didn't merit a new patent cover.

 The court ruled in favour of the patients, said Grover adding that the decision meant that effective and affordable generic medicines would continue to be produced in India.

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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 naive) 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.  

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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.

Y K Sapru, Chairman, Cancer Patients Aid Association

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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

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