TWN Info Service on Intellectual Property Issues (Jan07/01)

26 January 2007

PEOPLE BEFORE PATENTS: SIGN ON PETITION TO ASK NOVARTIS TO DROP THE CASE

Novartis is challenging the TRIPS-compliant public health provisions in India’s Patent Act which could affect supply of affordable medicines globally. Médecins sans Frontières (MSF) has a petition calling on Novartis to drop the case. The next hearing in the Novartis’ cases is 29 January 2007.

You can sign MSF’s petition at http://www.msf.org/petition_india/international.html and find more background information on MSF at www.msf.org  

Imatinib mesylate (Gleevec or Glivec) is a crucial medicine for patients suffering from certain types of cancer.

As a developing country member of the World Trade Organization, India did not have to allow patents on medicines until 1 January 2005. Prior to this, it had to provide a ‘mailbox’ where patent applications could be lodged. Novartis dropped its patent application for Glivec into the Indian mailbox in 1998. Novartis sells Glivec at US$2500 per patient per month. Generic versions of Glivec in India cost about US$175 per patient per month.

In 2005, India opened the mailbox and began examining the patent applications.

India’s patent law allows people to oppose patent applications before they are granted. This pre-grant opposition is allowed under the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The Cancer Patients Aid Association in India opposed Novartis’ patent application.

In January 2006, the patent office rejected Novartis’ patent application. The patent office refused to give Novartis a patent for Glivec because it said it was merely a new form of an old medicine and under Indian patent law, this did not deserve a patent.

In May 2006, Novartis appealed the patent office’s decision to reject its patent application. If Novartis succeeds in getting a patent, Indian patients will be faced with paying the US$2500 price.

Novartis also brought a case arguing that the Indian Patents Act provision the patent office relied on is not compliant with TRIPS. In fact, Article 1 of TRIPS allows each WTO member to decide how to interpret the three criteria for granting a patent (novelty, inventive step and industrial applicability). Therefore India can choose to say that it is not inventive enough to get a patent if a company merely makes a salt version of the same medicine etc. India’s provision reduces the ‘evergreening’ that pharmaceutical companies commonly do to extend the patent monopolies on their medicines and so is an important public health safeguard. If Novartis wins this case, it will eliminate one of the key public health safeguards in India’s patent law that allows India to produce cheaper generic medicines for the world.

Novartis was also one of the 39 pharmaceutical companies that sued the South African Government in 2001 in a case that would have reduced the access to affordable medicines. MSF collected nearly 300,000 signatures from more than 130 countries in that case and the global public outcry forced the companies to drop the case.

MSF has been awarded the Nobel Peace Prize and its petition campaign this time has been reported in Nature, http://www.nature.com/news/2007/070115/full/070115-1.html (or http://lists.essential.org/pipermail/ip-health/2007-January/010403.html for those who do not subscribe to Nature).

For more news stories, see below.

Best wishes,
Third World Network

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SUNS #6167 Thursday 21 December 2006

Novartis urged to drop patent case against India

Geneva, 20 Dec (Kanaga Raja) -- A legal challenge by the Swiss pharmaceutical company Novartis against India's patent law could have disastrous consequences on access to affordable essential medicines for millions of people across the developing world, the international medical humanitarian agency Medecins Sans Frontieres (MSF) warned on Wednesday.

In launching an international petition to put pressure on the company, MSF urged Novartis to immediately drop the case.

At a media briefing on Wednesday, Christian Captier, General Director of MSF Switzerland, said that what was at issue is the legal steps being taken by Novartis in challenging the government of India in its ability and capacity to develop, produce and export affordable generic drugs to developing countries.

India is one of the most vital sources of generic drugs, he added, pointing to the fact that generic antiretroviral medicines produced in India are being used to treat over 80% of the 80,000 people that receive treatment today in MSF's AIDS projects in more than 30 countries.

This is a battle for principle, he said, recalling what had happened in South Africa in 2001 when 39 pharmaceutical companies - Novartis among them - took the South African government to court in an effort to prevent the government from importing cheaper AIDS medicines.

The campaign launched at that time by MSF and other organizations ultimately persuaded the pharmaceutical companies to drop their legal proceedings against the South African government.

What is at stake, Captier warned, is the undermining of the ability of millions of people to have access to efficient and affordable drugs.

He also said that since the legal case started a few months ago and the first hearing took place in September, MSF has been trying to discuss the issue with Novartis. It has written to the CEO of Novartis asking the company to drop the case and to meet with MSF. The company however replied that it was going to continue with its action.

Captier said that this was the reason why MSF decided to launch the petition to raise public awareness and mobilize various actors around this issue. He added that similar public events will be taking place in India and Brussels.

Dr Christophe Fournier, President of the MSF International Council, said that the court case could have a disastrous consequence on the patients that MSF is treating as well as the millions of patients all over the world that need access to generic drugs.

In citing the reduction in AIDS treatment costs of over $10,000 per patient per year in 2000 to about $130 per patient per year today, Fournier highlighted the impact that generic drugs have on the ability to scale up the offer of good and affordable treatment that MSF can provide to patients.

AIDS is a lifetime disease that requires lifetime treatment, and since patients will one day become resistant to the drug combinations they take, newer drugs will be needed. To illustrate, Fournier cited one of MSF's AIDS treatment programs in South Africa where MSF in five years' of treatment has seen 17% of patients becoming resistant to the AIDS drugs. Thus, there is an urgent need to have access to newer drugs, said Fournier.

He also pointed out that where only about 240,000-280,000 patients were able to receive treatment for AIDS from 2001, there now are 1.3 million patients receiving treatment. While there has been a real improvement in access to treatment for AIDS patients, there are still some 3.7 million who remain in urgent need of treatment.

If there is no longer any access to newer generic AIDS drugs, ''we will be back to square one with all these patients not having access to proper treatment and that will have a disastrous consequence,'' he said.

Dr Tido von Schoen-Angerer, Director of MSF's Campaign for Access to Essential Medicines, said that there is already a situation where people in the developing countries are cornered due to WTO rules.

In 2005, India had to change its patent law due to WTO rules, which Von Schoen-Angerer said MSF foresees as having a severe impact on access to newer generic medicines.

Von Schoen-Angerer added that India however has put a safeguard in the law that means that patenting is relatively strict and patents should only be granted for real new innovations and not for simple improvements of existing medicines. The Indian law has also put in place another safeguard called 'pre-grant opposition' that allows any interested group to oppose a patent before it is granted.

He pointed out that this happened with respect to Novartis' patent on the cancer drug Gleevec where Indian patient groups opposed this patent and it was not granted on the grounds that it was only an improved version of a previous compound.

This was the reason why Novartis was taking the Indian government to court, and to have the particular safeguard (Article 3d) reversed, he said.

According to an MSF briefing note, Section 3(d) of the Indian Patents Act stipulates that patents should only be granted on medicines that are truly new and innovative. This means that companies should not be able to obtain patents in India for medicines that are not actual inventions, such as drug combinations or slightly improved formulations of existing medicines.

Section 3(d) was specifically targeted at preventing a common practice among drug companies of trying to get additional patents on the basis of insignificant improvements of drugs already patented, said MSF, adding that it is this part of the law that Novartis is challenging.

According to the MSF briefing note, if Novartis succeeds in its challenge against Section 3(d) of India's Patents Act, patents could end up being granted in India just as broadly as they are in wealthier countries. This would mean that virtually no generic versions of newer drugs could be produced by Indian manufacturers during patent terms lasting at least 20 years. And that would mean that much of the developing world would no longer be able to rely on Indian manufacturers for their supply of cheap essential medicines, in particular newer medicines.

Von Schoen-Angerer said that if Novartis wins the case, it would have disastrous consequences on access to medicines. He feared that patents would then be granted on a much easier scale similar to what is being seen in rich countries, in a practice called 'ever-greening' - where companies try at the end of a product's patent term to make a small improvement in order to prolong the patent.

He stressed that there are not many alternatives to India as a key supplier. ''There is no place today that can replace India as a key supplier especially of new quality generic medicines for the developing world,'' he said.

Today, he added, other developing countries have also had to change their patent laws and recognize patents. This has been the result of efforts by pharmaceutical companies with the support of rich countries over many years to change the rules of the game. India had fulfilled its obligation last year by changing its patent law but it has also made an effort to balance the need to protect public health and to recognize intellectual property.

Von Shoen-Angerer said: The question is how far do pharmaceutical companies want to go with this. Have they not already won the battle? Where does public health and the rights of patients come into the equation?

The impact of this case is enormous for access to medicines across the developing world and this is the reason why MSF takes this case very seriously, he said.

He expressed hope that India will stand firm in its position as well as stand by the important steps that it has taken. This is very much about Novartis challenging a law that tries to balance the rights of patent holders and patients, he said. +

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SUNS #6134 Monday 6 November 2006

Patents case challenges the world

Brussels, 2 Nov (IPS/Ann De Ron) -- Medecins Sans Frontieres and other groups campaigning for access to affordable medicines in developing countries are closely following a case filed by the Swiss pharmaceuticals giant Novartis against Indian patent law.

A decision in this case can create an important precedent, with consequences that go far beyond India.

"If the Novartis challenge against the Indian patent law is successful, patients worldwide who depend on India for affordable medicines risk becoming victims," Ellen't Hoen, policy director with the Medecins Sans Frontieres (MSF) Campaign for Access to Essential Medicines, told IPS.

"Eighty-four percent of AIDS medicines we currently use for patients in more than 40 countries come from India," Ellen't Hoen said. "Because of the lower prices, we can treat 60,000 people. If we would use only patented medicines, this would be a lot less. And this is only one example."

As of 2005, India is bound by WTO rules in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). But India remains one of the largest producers of generic medicines. Until 2005, it only recognised patents for a production process, not for a product, and this was good for Indian producers of generic medicines that develop their own process to produce a known medicine.

"India simply does not obey TRIPS, and our company has the right to make profit from its investment in research there too," Novartis spokesman in Belgium Xavier Thiriar told IPS. "India will be one of the largest markets in the world in terms of population, and they export a lot too."

Thiriar acknowledges that access to basic medicines can be a problem, but says that Novartis cooperates with MSF and gives free medicines worth large amounts of money.

But discounts and free medicines from companies are not a structural solution for the pressing lack of available medicines, Sigrid Sterckx, professor of ethics and expert on patents at the University of Ghent in Belgium, told IPS.

And India does obey TRIPS, argues Ellen't Hoen of MSF. "India refuses patent applications for medicines for trivial improvements of known molecules. That is allowed under TRIPS."

Such "trivial improvements" can for instance involve removing a limy taste, says Sterckx. "I find it morally evident that this should not be patentable. But in Europe and the US, this sort of change is sufficient to get a new patent. The medicine is then sold more expensively, and people are made to think it is a real improvement."

The challenge to India's patent law arose when an Indian patent bureau rejected a patent application for the Novartis cancer drug Gleevec on the argument that the company wanted to patent a 'trivial improvement'.

Thiriar denies that Novartis has ever patented trivial improvements, whether in India or elsewhere.

But more is at stake here than the question of whether the Gleevec version that Novartis wanted to patent in India is innovative or not. Novartis not only went to court to fight the Gleevec case, but challenged the entire Indian patent law.

The company has sued the Indian government, Indian producers of generic medicines and an Indian group of cancer patients before the Chennai High Court in southern India.

The case came up first on September 26. A new hearing is expected later in November.

"This is a very dangerous precedent for India and other countries," Leena Menghaney of MSF India told IPS on phone. "Now, it's about Gleevec, but later on it will be about all other medicines."

The patent law cannot be allowed to weaken, Menghaney insists. "We cannot follow the western system - people here have no health insurance, and when they get ill, they may have to sell their house, their jewellery."

MSF and 16 other organisations are asking Novartis to withdraw the case. One of the signatories to an open letter that the groups have written to Novartis is former Swiss president Ruth Dreifuss, who also chairs the World Health Organisation Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH).

Sterckx compares the current court case with the case that major pharmaceutical companies filed in 1998 against the government of Nelson Mandela in South Africa. They demanded that South Africa abolish a law that made it possible to produce or import affordable versions of patented AIDS medicines. They finally withdrew the case in 2001.

"It was a total PR (public relations) disaster for the pharmaceutical industry," Sterckx said. "Have they learned nothing from the debacle of those days?"