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Indian Patent Law Upheld
Aug 8, 2007
Indian court rejects Novartis' drug patent suit
By Gustavo Capdevila
GENEVA - Non-governmental organizations that advocate poor countries' access to affordable medicines applauded an Indian court's dismissal of a challenge brought by Swiss-based drug-maker Novartis.
The ruling handed down on Monday by the High Court of Chennai is a basic condition for achieving access to drugs, not only in India, but also in other developing countries, said Julien Reinhard, director of the health campaign at the Swiss non-governmental
organization (NGO) Berne Declaration.
Tido von Schoen-Angerer, head of the Doctors Without Borders/Medecins Sans Frontieres (MSF) Campaign for Access to Essential Medicines, said the decision "is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India".
Novartis, meanwhile, which is based in the northern Swiss city of Basel, said in a statement on Monday that the ruling would "have long-term negative consequences for research and development into better medicines for patients in India and abroad".
"Medical progress occurs through incremental innovation. If Indian patent law does not recognize these important advances, patients will be denied new and better medicines," said Paul Herrling, head of research at Novartis.
The court decision, which was anxiously awaited by activists concerned about the issue of drug patents and patients' rights, rejected the challenge by Novartis that questioned the constitutionality of Section 3d of the Indian Patent Act of 2005. Section 3d basically permits the manufacture of low-cost life-saving generic drugs for the world's poor, by only allowing drug patents on completely new compounds invented after 1995.
When Novartis filed for a patent on its leukemia drug Glivec (also known as Gleevec), India's patent office ruled that the drug was simply a new form of an existing treatment that had been developed before 1995. It was India's first ever drug-patent rejection. The company then decided to challenge Section 3d as unconstitutional.
The stakes in the case were high. When the Swiss drug giant brought the case in January, the MSF's von Schoen-Angerer said, "If Novartis wins, it could mean the end of India's generic drug industry." As he said at the time, India has become the pharmacy for the world's poor. More than half of all the developing world's HIV (human immunodeficiency virus) and AIDS patients rely on low-cost generic drugs from India.
Reinhard said Berne Declaration, one of Switzerland's oldest NGOs, has urged Novartis and Swiss authorities to respect the ruling.
He said he is worried that Switzerland or some other country could bring a complaint against India in the World Trade Organization's dispute-settlement mechanism, under pressure from Novartis, based on the argument that Section 3d is not compatible with TRIPS (the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights). Novartis said the Indian court "deferred to the WTO forum to resolve the TRIPS compliance question."
If Monday's ruling is weakened or overturned, access to affordable drugs in India and other developing countries will be put in jeopardy, Reinhard warned.
Von Schoen-Angerer also urged transnational drug corporations and rich countries "to leave the Indian Patents Act alone and stop pushing for ever-stricter patent regimes in developing countries".
Reinhard said that by challenging Section 3d, Novartis was attempting to undermine the Indian government's ability to adopt provisions aimed at protecting public health and to maintain a patent system in keeping with the country's social and economic reality.
Novartis was selling Glivec in India at a cost of US$26,000 a year per patient, similar to the prices it charges in other developing countries, according to Berne Declaration, which noted, "This price is well above the financial capacity of most of the patients." By contrast, generic versions of the drug in India cost about $2,100 per patient per year.
However, Brandi Robinson, a Novartis spokesperson in New York, said early this year that the company actually gave the drug away, under the Gleevec donation program, to "99% of the people who need it" because they could not afford it.
In a communique issued on Monday, the MSF observed, "A ruling in favor of the company would have drastically restricted the production of affordable medicines in India that are crucial for the treatment of diseases throughout the developing world.
"Developing-country governments and international agencies like UNICEF [United Nations Children's Fund] and the Clinton Foundation rely heavily on importing affordable drugs from India, and 84% of the antiretrovirals [anti-AIDS drugs] that MSF prescribes to its patients worldwide come from Indian generic companies. India must be allowed to remain the 'pharmacy of the developing world'."
(Inter Press Service)