Inter Press Service - August 6, 2007
Gustavo Capdevila

The ruling handed down Monday by the High Court of Chennai, the Indian city known as Madras (the name was formally changed in 1996), is a basic condition for achieving access to drugs, not only in India, but also in other developing countries, Julien Reinhard, director of the health campaign at the Swiss NGO Berne Declaration, told IPS.

Tido von Schoen-Angerer, head of 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 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 recognise 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 leukaemia drug Glivec (also known as Gleevec), India's patent office ruled the drug was simply a new form of an existing treatment that was 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 told IPS at the time, India has become the pharmacy for the world's poor. More than half of all the developing world's HIV/AIDS patients rely on low-cost generic drugs from India.

Reinhard told IPS Monday that the Berne Declaration, one of Switzerland's oldest NGOs, has urged Novartis and Swiss authorities to respect the ruling.

He said he was worried that Switzerland or some other country could bring a complaint against India in the World Trade Organisation's (WTO) 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 in India 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 26,000 dollars a year per patient, similar to the prices it charges in other developing countries, according to the Berne Declaration, which noted that "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 dollars per patient per year.

However, Brandi Robinson, a Novartis spokesperson in New York, told IPS early this year that the company actually gave the drug away, under the Gleevec donation programme, to "99 percent of the people who need it" because they could not afford it.

In a communique issued Monday, the MSF observed that "A ruling in favour 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 (U.N. Children's Fund) and the Clinton Foundation rely heavily on importing affordable drugs from India, and 84 percent 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.'"

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+ INDIA: Patients Before Patents, Groups Urge - January 2007 (http://www.aegis.org/news/ips/2007/ip070111.html)

+ Berne Declaration (http://www.evb.ch)

+ Medecins Sans Frontieres (http://www.msf.org)

+ Novartis (http://www.novartis.com)

+ AUSTRALIA: Focus on Drug Access at HIV/AIDS Meet (http://www.aegis.org/news/ips/2007/ip070712.html)

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