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Novartis lawsuit (re India patent law & access to medicine)

Glivec Novartis By: D. Meyer, creative commons
Worldwide, Novartis is the main producer of Glivec, a drug used for treating blood cancer.  The company has sought a patent that would give it the exclusive right to produce Glivec, stopping production by the generic drugs industry in India.  

In 1997, when India did not allow protection for pharmaceutical products, Novartis filed a patent application in the Chennai Patent Controller’s office for what Novartis claimed was a new form of Glivec.  The application was kept on hold until 2005 when India amended its patent system.  In January 2006, the Patent Controller rejected the application, stating that the Patents Act does not allow protection for products that are a modified version of an existing drug, and that in this case the new version lacked novelty.  In May 2006, Novartis challenged this decision in the Chennai High Court. 

In August 2007, the Chennai High Court transferred the case to the newly-created Patent Office in the Intellectual Property Appellate Board.  In June 2009, the Appellate Board disagreed with the Patent Controller and found that Glivec was new and involved an inventive step.  However, it still denied patent protection because it said Novartis did not demonstrate that the new product was more effective than the previous one, as laid required by the Patents Act.

Novartis petitioned the Supreme Court to review the Intellectual Property Appellate Board’s decision.  The company argued that Glivec had satisfied key criteria including novelty, and hence it should be considered an “invention” under the Patents Act.  In April 2013 the Supreme Court upheld the Appellate Board’s decision and its finding that Novartis failed to prove improved therapeutic efficacy of the new version.

- “To patent or not to patent? the case of Novartis’ cancer drug Glivec in India”, Ravinder Gabble, Dalla Lana School of Public Health, Univ. Toronto, & Jillian Clare Kohler, Associate Professor & Director Global Health, Leslie Dan Faculty of Pharmacy, & Munk School of Global Affairs, Univ. Toronto, in Global Health, 6 Jan 2014
- “5 Take-Home Points From India’s Historic Novartis Patent Case”, Arvind Subramanian, Senior Fellow at Peterson Institute for International Economics & Senior Fellow at Center for Global Development, in Asian Scientist, 29 Apr 2013
- “Why Novartis case will help innovation”, Achal Prabhala, Sudhir Krishnaswamy, Azim Premji Univ., & Dr. B.R. Ambedkar, Visiting Professor of Indian Constitutional Law at Columbia Law School, in The Hindu, 15 Apr 2013
- “India’s Patently Wise Decision” Joseph E. Stiglitz, Nobel laureate in economics, Columbia Univ., & Arjun Jayadev, Univ. of Massachusetts, in Project Syndicate, 8 Apr 2013
- “Indian Supreme Court Delivers Verdict in Novartis Case”, NGO Pulse (So. Africa), 2 Apr 2013
- “Landmark verdict gives big boost to cancer patients”, J. Venkatesan, Hindu, 1 Apr 2013

Novartis: “Supreme Court denial of Glivec patent clarifies limited intellectual property protection and discourages future innovation in India”, 1 Apr 2013

Supreme Court of India: “Novartis AG v. Union of India & Others”, Judgment, 1 Apr 2013

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1 April 2013

Novartis AG v. Union of India & Others - Judgment

Author: Supreme Court of India

[full text of Supreme Court decision rejecting Novartis’ patent claim.]

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1 April 2013

Supreme Court denial of Glivec patent clarifies limited intellectual property protection and discourages future innovation in India

Author: Novartis

A decision issued today by the Indian Supreme Court regarding the Novartis breakthrough medicine Glivec® (imatinib mesylate) provides clarification on Indian patent law and discourages innovative drug discovery essential to advancing medical science for patients...

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12 September 2011

Analysis: Legal case in India threatens HIV drug access for poorest

Author: Melanie Newman, Bureau of Investigative Journalism [UK]

A technical case going through the Supreme Court in India is being carefully watched by aid agencies and other human rights organisations, who claim it could have severe consequences for the supply of lifesaving drugs to the developing world...Novartis is seeking patent protection for its leukaemia drug Glivec...It is challenging India’s interpretation of a section of the nation’s patent law — Section 3(d) — which prevents ‘evergreening’. India is literally the lifeline of patients in the developing world, especially in the poorest parts of Africa…If Sec. 3(d) is overturned, it means any meaningful effort to make these vital medicines available will be put in jeopardy...as other pharmaceutical companies [seek] to extend the patents for drugs used to treat diseases such as HIV/AIDS and TB .It is an argument that Novartis wholeheartedly rejects. ‘Currently available generic drugs launched in India before 2005...will continue to be available under the transition clause in the Indian patent law regardless of the legal outcome of our case,’ it says...

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Author: Julien Bouissou, Le Monde

...Novartis est de retour devant les tribunaux indiens pour tenter de faire breveter le Glivec, un médicament utilisé dans le traitement contre la leucémie, malgré trois refus déjà prononcés par la justice du pays...Elles devraient durer plusieurs mois...Au-delà du Glivec, c'est toute la question de l'accès aux soins des plus pauvres grâce aux génériques qui est en jeu. Des organisations non gouvernementales (ONG) comme Sidaction ou Médecins sans frontières craignent qu'une éventuelle victoire de Novartis fasse jurisprudence et menace l'accès aux médicaments bon marché produits en Inde. Novartis estime, au contraire, que "les brevets sauvent des vies en stimulant la recherche"...Sans générique, chaque patient devra [actuellement] débourser 30 000 euros par an pour se soigner. Ce tarif est prohibitif pour l'immense majorité de la population indienne... [fait également référence à Bayer]

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29 October 2008

Indian drugs boss hails Aids deal

Author: Soutik Biswas, BBC

Three years ago, Yusuf K Hamied, head of Indian drugs company Cipla, stunned a European Commission medical meeting in Brussels by offering to sell anti-Aids drugs at a fraction of the going rate...Last week, Dr Hamied won a major victory when former US president Bill Clinton brokered a deal whereby four companies making cheap, generic Aids drugs could begin supplying to millions of people in developing countries...one of them is Cipla, India's third largest drug company.

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Author: InfoSud

Le procès de Novartis contre l’Inde a repris lundi à Madras. Portant initialement sur le brevetage de l’anti-cancéreux Glivec, l’affaire prend vite une dimension plus large. Selon MSF, une victoire du géant pharmaceutique suisse priverait les malades des pays pauvres de médicaments essentiels...Novartis attaque une loi indienne qui limite la délivrance des brevets aux seules innovations. En cas de victoire pour Novartis, les brevets seraient appliqués de manière bien plus large en Inde. Du coup, on réduirait la production de médicaments génériques, vitale pour le traitement de maladies dans les pays pauvres.

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14 November 2006

World's poor still deprived of drugs - activists

Author: Reuters

Poor people in developing countries are still not getting access to many life-saving medicines five years after a trade declaration that rich countries should put patients before profits, campaigners said on Tuesday...Oxfam and AIDS groups said...rich countries, particularly the United States, were bullying developing countries to impose stricter patent rules in order to preserve pharmaceutical monopolies...[An example is]...a dispute over the cancer drug Glivec, made by...Novartis...An Indian court in January rejected its patent application for Glivec, but Novartis is fighting back, arguing that the principle of intellectual property protection must be protected if innovation is to flourish.

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