In 2006, Swiss pharmaceutical giant Novartis launched a legal battle challenging India’s adoption of strict standards used to regulate patents on medicines. They argued that Section 3(d) of the recently amended Patents Act was ‘unconstitutional and violated international standards’ and wanted a 20-year patent monopoly on their anti-cancer medicine, Glivec (Gleevec in the USA). Global campaigning organisations, backed by half a million people, voiced their opposition and Novartis lost the case. However Novartis is trying again to undermine India’s right to produce affordable medicines and next week, on February 28, there will be a hearing in the Indian Supreme Court. The company is now challenging the established interpretation of Section (d) which requires a minor variation to previously invented medicines not be granted unless it significantly enhances the efficiency of the medicine in treating human illness or disease.
Today, a few days before the hearing, Novartis’ shareholders are meeting in Basel at their Annual General Meeting (AGM). As the Indian Government gears up to fight this legal battle, campaigning groups around the world, including Oxfam, the Berne Declaration, Health GAP, and Act Up, will be holding demonstrations to coincide with the day of the AGM, with a clear message for Novartis to stop the attack on the Indian law and generic medicines. The groups point out that the price of Novartis’s Glivec is ten times the cost of generic equivalents. They also argue that Section 3(d) of the Indian Patent Act is a legitimate and invaluable flexibility that represents an important public health safeguard in Indian law meant to support access to essential medicines.
Rohit Malpani, Oxfam’s Policy Advisor, said: “Novartis seems determined to pursue its case against the Indian Government. If they win the case the consequences will be devastating, not only for patients in India but also the millions of people in poor countries across the globe whose lives depend on the affordable generic medicines India currently produces.”
Patrick Durisch, Health Programme Coordinator of the Berne Declaration, a Swiss advocacy NGO, said: “What is at stake goes far beyond the granting of a patent for this anticancer drug. Glivec’s successor drug Tasigna (nilotinib) has already been granted a patent in India. In fact, Novartis is acting as a corporate bully for all of Big Pharma to weaken the Indian Patents Act, so as to allow patenting on trivial changes to all sorts of existing medicines in the future.”
Brook Baker, a spokesperson from Act Up Basel and Health GAP said: “How long should poor people be forced to wait for new medicines – 20 years, 30 years, 40 years? To gain monopoly rights to sell to rich middle class consumers in India, Novartis is willing to sacrifice the health rights of a billion poorer Indians and a similar number of other poor patients worldwide. We defend India’s rights to try to limit monopolization of trivial changes to existing medicines.”
Notes to editors: Full list of organisations protesting: ACT UP-BASEL, ACT UP-PARIS, ASIA PACIFIC NETWORK OF POSITIVE PEOPLE (APN+), BERNE DECLARATION, HEALTH GAP, INTERNATIONAL TREATMENT PREPAREDNESS COALITION (ITPC) & OXFAM INTERNATIONAL
What is the current Novartis case in India about?
Novartis patented the molecule imatinib in 1993. After the signing of the WTO TRIPS agreement by India in 1995, Novartis filed another patent application on the mesylate salt form of imatinib in 1998 at the Indian patent office. In 2005 India amended its patent law to comply with the WTO TRIPS agreement but also included Section 3(d) an important health safeguard that does not allow companies to get patents on new forms of old medicines. Novartis’ application was rejected by the Indian patent office on several grounds including that the application claimed a new form of an already existing medicine. The company then sued the Indian Government, cancer patients and several generic companies in order to get its patent monopoly on imatinib mesylate by getting Section 3(d) knocked out of the patent law. Simultaneously, Novartis pursued a separate appeal of the denial of its patent application on Glivec arguing that it met the standards of India law. When its administrative appeal failed, Novartis appealed again, this time to the Indian Supreme Court to try and change the interpretation of Section 3(d). In essence, Novartis wants section 3(d), which requires stringent evidence of proof of significantly enhanced therapeutic efficacy if a modification of an existing pharmaceutical entity is to receive new patent protection, to be reinterpreted to allow routine “ever-greening” of minor modifications to existing medicines resulting in additional 20-year patent monopolies.