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TWN Info Service on Intellectual Property Issues (Feb07/03) 5 February 2007
Nearly
a quarter of a million people from 150 countries have voiced concerns
over the negative impact of a legal challenge brought by Novartis that
could have on access to medicines in developing countries and have asked
Novartis to drop the case. The challenge (if won by Novartis) could
deal a major blow to production, domestic use and exports of generics
to the world. The drug at issue here is a cancer drug (Glivec) which
Novartis sells at US$2500 per patient per month while generic versions
of Glivec in The hearing before the Madras High Court in Chennai on 29th January has now been adjourned until 15 February for final hearing on all issues as Novartis wanted to place on record the recently released report commissioned by the Indian Parliament and headed by R.A.Mashelkar, former head of the Council of Scientific and Industrial Research, to look into the question of patentability. As soon as the report was released, it faced a barrage of criticisms from health activists, legal experts and academics globally, with some indicating that the Commission had sold out to corporate interests, while sidelining public health interests. With permission, we reproduce the SUNS reports on the Novartis case, published by Third World Network. If you are interested to join the on-going petition by MSF calling on Novartis to drop the case, please go to http://www.msf.org/petition_india/international.html In a separate but related event, the Cancer Patients Aid Association (CPAA) issued a legal notice of defamation to the CEO of Novartis with the demand that the CEO retract a statement it made and issue an unconditional apology over its company website and on Intellectual Property Watch, or pay an amount of USD 500,000 to CPAA, failing which CPAA would be forced to initiate legal proceedings. CPAA is the only patient group presently opposing the proceedings at the Madras High Court. The legal notice (also found below) refers to “certain defamatory statements and insinuations” about CPAA published on 19 October 2006 in an article titled "Novartis Persists With Challenge to Indian Patent Law Despite Adversity", which is available on the Internet at http://ip-watch.org/weblog/wp-trackback.php?p=430. The
article states: "Vasella said that generic companies are often
behind patient groups in Best
Wishes GROUPS
URGE NOVARTIS TO DROP PATENT CASE AGAINST SUNS #6180 Wednesday 31 January 2007 Geneva,
30 Jan (Kanaga Raja) -- Nearly a quarter of a million persons from more
than 150 countries have voiced concerns over the negative impact that
a legal challenge brought by the multinational pharmaceutical company
Novartis against The legal challenge brought by the Swiss-based Novartis against the government of India began to be heard in the Chennai High Court on Monday - despite an international petition launched by the international medical humanitarian organization Medicins Sans Frontieres (MSF) last December to put pressure on the company to drop its patent case against India. According to MSF, nearly a quarter of a million people from 150 countries had signed its petition. Novartis
is seeking to overturn On
Monday, the Indian Network for People with HIV/AIDS (INP+), the People's
Health Movement, the Centre for Trade and Development (Centad), and
MSF, again called on Novartis to immediately cease its legal action
in According
to the groups, many developing countries rely on affordable medicines
produced in "Novartis
is trying to shut down the pharmacy of the developing world," said
Dr. Unni Karunakara, Medical Director of MSF's Campaign for Access to
Essential Medicines, in "Indian
drugs account for at least a quarter of all medicines we buy, and form
the backbone of our AIDS programmes, in which 80,000 people in over
30 countries receive treatment. Over 80% of the medicines we use to
treat AIDS come from Novartis
is challenging a specific provision in "Here
in The
World Trade Organization's Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) obliged "The
TRIPS Agreement already makes it difficult for According to the groups, one provision of the Indian law states that any interested party can oppose a patent before it is granted in a "pre-grant opposition" process. Such oppositions have been filed against numerous patent applications on essential medicines that do not warrant patents under Indian law. "We
have opposed patent applications for crucial AIDS drugs that we need
to be able to access at affordable prices," said Elango Ramchandar,
President of INP+. "Our survival depends greatly on winning these
patent oppositions. We need everyone, everywhere to join us in our effort
to get Novartis to back off here in A
joint NGO statement on Novartis' challenge to the Indian Patents Act
said that the stakes of the case reach far beyond Over
6,000 drug patents including for AIDS drugs are awaiting examination
by the Indian patent offices. Whether patents on these medicines are
granted may depend on the outcome of this case. If Novartis prevails,
The
statement, released on Monday, urged Novartis to immediately cease its
legal action in The NGOs that signed the statement included MSF, Oxfam, Knowledge Ecology International, Health Action International, Third World Network, Delhi Network of Positive People, India, Centre for Trade and Development, India, Instituto Brasileiro de Defesa do Consumidor, Brazil, Associacao Brasileira Interdisciplinar de Aids, Brazil, Grupo de Trabalho da REPRIB sobre Propriedade Intelectual (GTPI), Brazil, and Berne Declaration, Switzerland. IPS
adds from However, the WTO's 2001 Doha Declaration allows developing countries to manufacture generic drugs and override patents in times of public health crises and to export these to others that don't have the ability to make them. "Big
phamaceutical corporations have been pushing to ignore Novartis acknowledges that Glivec is an improved version of an older drug. And despite the fact that the company gives the drug away free to anyone in India who can't afford to buy it, it wants the courts to overturn the patent decision and is challenging Section 3d of the Indian Patent Act of 2005. "The
Indian Patent office is creating hurdles to pharmaceutical innovation,"
says Brandi Robinson, a Novartis spokesperson in Since the company gives away the drug to "99% of the people who need it", the court case is about patent rights and not access to life-saving drugs, Robinson said in an interview. Hundreds
of thousands of AIDS patients are living today because of Leading medical journals such as The Lancet, global health organisations and officials in many countries have all asked Novartis to drop the case. MSF launched a petition that now has nearly a quarter of a million people from over 150 countries who expressed their concern about the impact of the Novartis case on access to medicines in developing countries. "It
feels like we're back in Novartis was one of the 39 companies that took the South African government to court five years ago in an effort to overturn the country's medicines act that was designed to bring drug prices down. "The current economic model of drug R&D doesn't work for the developing world," said Hoen. Under this model, high levels of patent protection for at least 20 years and often longer means that companies with proprietary products have monopolies and can charge whatever price they want, guaranteeing money for research and plenty of profits. "In some cases, this works, boosting R&D investment but in many cases, the money doesn't go into research," Hoen noted. Pharmaceuticals are a $600 billion a year industry and there are "lots of opportunities to make money", she said. Free handouts from drug companies aren't the answer either. These benefit a few thousand people, but by no means do all drug companies have such donation programmes and they are often short term or one time only offers, said Hoen. "We need a new and affordable system for drug research and manufacturing," she concluded. ANGER GROWS AT NOVARTIS' BID TO HOG CANCER DRUG SUNS #6181 Thursday 1 February 2007 Bangalore, 30 Jan (IPS/Keya Acharya) -- A public outcry has followed the challenge offered by Novartis AG in the Madras High Court to the Indian Patents Act as violating international trade laws and restricting the Swiss pharmaceutical giant's trade. In April 2005, the Indian government as a member of the World Trade Organisation (WTO) and signatory to its trade-related intellectual property (TRIPS) provisions, amended domestic law to recognize 20-year patents on products, annulling the country's 7-year patents on processes. A slew of important generic drugs or those being produced after patent expiry have since been forced off the market, unless, as per clauses in the amended Indian Patents Act, the patent applications can be proved to be not 'new' or involving innovative molecular research. In the first test of the amended Indian law, Novartis applied for a patent on its leukaemia-treatment drug 'Gleevec', but was rejected by the Patents Office in southern Chennai city as not being innovative enough. The company thereafter filed a writ in the Madras High Court, located in Chennai, challenging the rejection. The court hearing was adjourned to February 15 due to Novartis wishing to include a recent report commissioned by the Indian Parliament and headed by R.A. Mashelkar, former head of the Council of Scientific and Industrial Research, to look into the question of patentability. The Mashelkar report asks for inclusion of patents on medical entities with 'one or more' inventive steps, in the 'national interest', thereby allowing patents on products that do not involve new molecules. Several legal and civic groups are outraged at the report as having 'sold out' to corporate interests, and have been slamming Novartis ever since it exerted exclusive marketing rights in 2004 for Gleevec, pushing prices up from $175 to $2,000 per month of treatment, affecting immediately India's 25 million leukaemia patients. "I
think what happened in court yesterday (Monday) is an example of 'double-speak'
in "Novartis was recently given a global award with United Nations recognition for 'corporate social responsibility', yet millions in India and poor countries are either dying or not being able to afford treatment due to the company's bid at market monopoly of a generic drug. I think such giant MNCs need to be exposed," Bangalore-based Narayan told IPS. "If
the Mashelkar report had defined inventions properly, we could have
saved the situation," B.K Keyala, a former patent commissioner
of At least seven civic, legal and health groups together with the PHF and Medicins Sans Frontieres (MSF) have been campaigning actively in the last year against Novartis filing for patent claim on Gleevec. Lawyers' Collective, the legal advisers to the Cancer Patients Aid Association opposing Novartis in court, have broadened the issue in public to include essential drugs, since the Novartis judgement will indirectly impact the manufacture and affordability of generic drugs for not only leukaemia but also for treatment of other significant cancers, HIV/AIDS and several other diseases in developing countries. Anand
Grover of the Lawyers' Collective blames the Indian government's seemingly
pro-corporate stance and says it is being influenced by western trade
agendas, especially that of the Keyala too agrees that corporate agendas, especially of multinational drug giants, have influenced government, but believes that civic groups could have strategised differently for better effect. "They need to campaign for including HIV as a national emergency and then get generic drugs out of the patents' circle," Keyala said. Under
Indian law, and allowed by WTO under the Doha Declaration, generic drugs
used for public health emergencies can be manufactured under licence.
"Winning from the patent office itself, due to our pre-grant opposition,
was a big thing," says Naveen Thomas of the All India Drug Action
Network, based in "We
can still fight with 'them', everything is not lost," said Dr.
Prakash Rao of the state-level Drug Action Forum in Yet the Indian medical fraternity has been visibly silent in this civic discontent against what Novartis' patent claim stands for. Dr. Ananth Phadke of the Centre for Enquiry into Health and Allied Themes at Pune in south-western India, feels that Indian doctors are not sensitised enough to drug histories and patents in their medical curricula, besides being 'wooed' by drug manufacturers. But Dr. Ajay Kumar, president of the Indian Medical Association (IMA) with over 178,000 doctor-members countrywide, says that he feels 'very strongly' about the whole issue of generic drugs and price rise through patenting. "Corporatisation
of medicine serves only one percent of The
next legal challenge taking shape in "By implication, as long as the exclusivity lasts, generic producers would have to submit their own data to prove safety and efficacy, which would oblige them to repeat the clinical trials. This is something that would cause significant delay that many generic manufacturers cannot afford,'' says a WHO bulletin released in March 2006. The Affordable Medicines and Treatment Campaign, spearheaded by the Delhi-based Lawyers' Collective, has conveyed its concern to Indian Prime Minister Manmohan Singh, highlighting how data exclusivity impedes the use of compulsory licences in public health emergencies and prevents drug regulatory authorities themselves from relying on test data already in their possession for subsequent approval of generic versions of the medicine. 22 January 2007 Dr.
Daniel Vasella Chairman and Chief Executive Officer Dr.
Daniel Vasella Sub: Defamatory statements made by you Dear Dr. Vasella, Under instructions from my client, Cancer Patients Aid Association, through its founder-Chairman, Mr. Y. K. Sapru, I have to state as under: My
client, Cancer Patients Aid Association, is a charitable organisation
and was registered in My client states that it was founded with the objective of providing holistic and total management of cancer patients, including awareness, prevention, treatment and rehabilitation of cancer patients. Over the past three decades, through sheer dint of hard work, my client has built up tremendous goodwill for itself as an organisation that offers help for the holistic and total management of cancer. My
client states that on 10 November 2003, Novartis AG was granted exclusive
marketing rights for Gleevec by the Patent Controller of India. Subsequently,
Novartis AG instituted infringement actions against Indian companies,
who were manufacturing and selling Gleevec at Rs. 8,000-12,000 per month
in My client states that therefore on 22 July 2004, it filed a petition against Novartis AG, the company of which you are the Chairman and Chief Executive Officer, before the Hon’ble Supreme Court of India challenging the Exclusive Marketing Rights that was granted to Novartis AG by the Patent Controller of India. My client states that after the amendment to the Indian Patents Act in 2005, it filed a pre-grant opposition to the grant of a patent to the application filed by Novartis AG for the drug Gleevec. On 25 January 2006, the Patent Controller rejected Novartis AG’s application. My client states that pursuant to the order of the Patent Controller, Novartis AG has challenged the decision of the Patent Controller and also Section 3(d) of the Indian Patents Act, 1970 before the Hon’ble Madras High Court at Chennai. My
client states that it has recently come to its notice that you have
made certain defamatory statements and insinuations about my client,
which were published on 19 October 2006 in an article titled "Novartis
Persists With Challenge to Indian Patent Law Despite Adversity",
which is available on the Internet at http://ip-watch.org/weblog/wp-trackback.php?p=430.
It is indisputable that this article is with reference to the aforementioned
cases before the Hon’ble Madras High Court. It is also well-known that
my client is the only patient group that is presently a party opposing
you in the proceedings before the Hon’ble Madras High Court. The article
states: "Vasella said that generic companies are often behind patient
groups in My
client has, through sheer dint of hard work, obtained for itself a lot
of credibility and goodwill in society. As stated above, my client has
a reputation in My client wishes to state that it has not accepted any money from generic companies for the case relating to Gleevec at any time whatsoever. Moreover, the lawyers acting for my client in the Gleevec case have acted and agreed to act for my client pro bono. My
client states that due to the statement made by you, my client has been
portrayed as a sham patient group. This article is accessible over the
Internet and can be accessed by thousands interested in the issue of
access to medicines. My client has received telephone calls from journalists
from You are hereby called upon to forthwith retract your statement and issue an unconditional apology over your company website and on Intellectual Property Watch, and pay an amount of USD 500,000 to my client as damages, failing which my client will be forced to initiate legal proceedings, civil or criminal, against you, entirely at your risk as to the costs and consequences, which please note.
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