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35 NGO issue common press release

The Novartis laboratory’s lawsuit is dismissed by the Indian Supreme Court to the immense relief of patients and activists throughout the world.

Monday 1 April 2013

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After a seven-year trial, New Delhi’s Supreme Court finally dismissed today the case brought by the Swiss laboratory Novartis against the State of India. Since 2006, the pharmaceutical company has been trying to patent the reformulation of an existing cancer treatment called Glivec. Pursuant to its patent laws [1], India had refused to patent this new formula (see below). After a first unsuccessful appeal on this decision Novartis took the matter to the Supreme Court attempting at the same time to weaken patent laws. The Indian justice just ruled in favor of patients and all those who fight to improve access to high-quality, low-cost treatment for developing countries. The signatory organizations welcome this decision.

What this decision means

If the judges had ruled in favor of Novartis, the production of generic versions of Glivec, 50 times cheaper than the original, would have been seriously undermined. Additionally, the precedent set would have facilitated future patents on reformulations, jeopardizing access to high-quality, low-cost generic medicines for millions of people. « 80% of the antiretrovirals distributed in low or middle-income are generics made in India. If we stop producing them who will tell the patients that they can no longer get treatment ? » had warned doctor Camille Anoma, director of the organization Espace Confiance in Côte d’Ivoire, one of the signatories. The Supreme Court finally ruled that the new Glivec formula did not fit the innovation criteria required in the Indian law in order to obtain a patent. By upholding a strict interpretation of article 3d of the Indian Patent Act, the Supreme Court recognized its safeguarding role for access to medicines.

Generics in India and treatment in the South

If there are several versions of generics on the market and competition between the various different producers, this means that the price of medicines can be reduced by 90%. India, the world’s pharmacy must be able to produce high-quality generics for its domestic market and also for resource-limited settings. That is why patients and activists the world over welcome the decision of the Indian supreme court: « This decision is a great relief to all those patients whose lives depend on Indian generic medicines » says Jeanne Gapiya Niyonzima of the National Association to support HIV positive people and AIDS patients (ANSS) in Burundi.

This judicial victory is capital. However, the Novartis case is just another trial in a long list of lawsuits brought to court by patent-holder pharmaceutical companies against India’s generic medicines policy. Therefore, our organizations remain committed to facilitating access to low-cost high-quality treatment for the world’s poorest people.

Some background on the Novartis trial

Novartis filed a patent application in India for a cancer treatment called Imatinib Mesylate, marketed in many countries by the laboratory under the name Glivec (Gleevec in the US). India rejected this application in January 2006, on the grounds that it was actually only a reformulation of an existing drug. Novartis appealed this decision in 2009 and the case was dismissed before it got to the highest court in India: the Supreme Court.

In 2007, in the United States, Novartis faced a similar situation in the reconsideration of its patent the imatinib formula, on the grounds that the formulation technique used was long known, was not innovative, and did not deserve per se a 20-year monopoly. In this case however, Novartis did not seek to further defend the so-called innovative character of the substance obtained by applying the well-known formulation technique to imatinib.

Signatories :
− Act Up-Paris (FRANCE)
− Action Santé Plus (IVORY COAST)
− Actions traitements (FRANCE)
− Alternatives Durables pour le Développement (ADD) (CAMEROON)
− Association African Solidarité (AAS) (BURKINA FASO)
− Association Femmes et Développement (BURKINA FASO)
− Association pour la Promotion de l’Éducation Thérapeutique (BURKINA FASO)
− Association Solidarité Action Faire Face (ASAFF) (BURKINA FASO)
− Coalition PLUS (FRANCE)
− District Sanitaire de Cinkassé (TOGO)
− Espace Confiance (IVORY COAST)
− Femme Plus (DRC)
− Global & Local (FRANCE)
− Médecins du Monde (FRANCE)
− Positive-Generation (CAMEROON)
− Renaissance Santé Bouaké (RSB) (IVORY COAST)
− Réseau National des ONG pour le Développement de la Femme (RENADEF) (DRC)
− Réseau pour l’Accès aux Médicaments Essentiels (RAME) (BURKINA FASO)
− Sidaction (FRANCE)
− Solthis (FRANCE)
− Stop Tuberculose (IVORY COAST)
− Walé (MALI)

[1In accordance with international law, Indian legislation (Article 3d of the Patent Act) authorizes the grant of a patent only to truly innovative and effective drugs, thus excluding simple cosmetic changes and preventing evergreening, a practice of the pharmaceutical industry, to extend a monopoly by patenting a slightly modified version (re-formulation, dosage change, etc.) of an existing drug.