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."

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.

Ruth Fremson/The New York Times

By AMELIA GENTLEMAN Published: August 7, 2007

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. T

he 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."

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.

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.)

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

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