INDIA UNDER PRESSURE TO GIVE UP ON GENERIC PRODUCTION – FTA NEGOTIATIONS AND NOVARTIS CASE

Health and HIV groups should be concerned about the future of low cost generic production as both – FTA negotiations on intellectual property (IP) with the European Commission (EC) and the Novartis legal challenge to a key public health safeguard in the Indian patent law before the Supreme Court – hit the last lap.

Next three months critical: The next few months of FTA negotiations and the ‘Novartis case’ hearings in Supreme Court case starting next week will determine whether India continues to be the pharmacy of the developing world and indeed for its own people.  In this battle to fight pharmaceutical companies, EC and now the Swiss negotiators, Indian groups and government will need all the help that they can get from UN bodies, health and HIV organizations across the world.

FTA NEGOTIATIONS

EU-India FTA at a critical point: Next round of negotiations on IP chapter are scheduled for 5-9 December 2011 in New Delhi. The negotiations will start with the meeting of chief negotiators on 5th and 6th of December.

EC Trade Commissioner Karel De Gucht and the EU negotiators have been pressuring India to accept harmful intellectual property provisions in the agreement that go beyond international trade rules and undermine health safeguards included by India’s Parliament in its patent law – something that India’s Health and Commerce Ministers have officially pledged to resist in several public meetings and statements.

International organizations Oxfam, MSF and PLHIV networks in India and across the developing world took a strong position against the inclusion of intellectual property in the FTA negotiations, particularly the TRIPS Plus and IP enforcement provisions as they would hamper the production and supply of affordable generic drugs from India.

See the letter here signed by 240 organizations across the world with a request to Prime Minister of India not to sign IP provisions in EU-India FTA.

EC pressure in FTA IP negotiations goes up: Now, as negotiators hit the last lap before the EU-India bilateral summit scheduled for February 2012, the EC has adopted a number of tactics to pressurize Indian negotiators to concede. First EU officials publicly warned the Indian government and negotiators that negotiations will be broken off if an agreement is not reached by February 2012 (AFP, Tuesday 27 Sep 2011).

Ahead of World AIDS Day, the EC has gone back on its promise of withdrawing its demand on data exclusivity. The EC in fact is now aggressively demanding that India provide a justification as to how it has made the legal argument that Article 39.3 of TRIPS does not require India to provide exclusivity on test data i.e. data exclusivity.

Earlier in the year, the EC’s had publicly confirmed that patent term extension and data exclusivity will no longer be a part of the prospective European Union-India free trade agreement. The hard-fought exclusion of data exclusivity represented the greatest achievement of Indian negotiators so far. See old posting here.

The key TRIPS Plus provisions in the IP chapter originally tabled by the EC included patent term extension (now excluded), data exclusivity (still in) and several IP enforcement measures (still in). IP is now also included in the investment negotiations by the EC.

EFTA negotiations with India also reach critical point: India is also under pressure on IP in the EFTA negotiations with India in which the Swiss lead the negotiations on intellectual property as it has several pharmaceutical companies -Novartis and Roche – who are keen to have India adopt TRIPS Plus measures.

The EFTA negotiators are pressing to wrap up negotiations and seal the EFTA deal by early next year. Swiss demands on IP in EFTA negotiations are reflected in the leaked text which is available on

Leaked text: Draft IP Chapter of India-EFTA Free Trade Agreement

NOVARTIS CASE

It’s the biggest patent dispute that patient groups have with a pharmaceutical company in the developing world. The Supreme Court case is the final act in a legal battle between Novartis and Cancer Patient Aid association that stretches back more than seven years over India’s future capacity to act as the pharmacy of the developing world.  The final arguments have started before a new bench – with the next hearing date set for 29 November 2011 – in a case that will determine the future of generic competition.

A public health safeguard enshrined in India’s Patent Act, Section 3(d), has long irked pharmaceutical companies. In 2006, when the Indian patent office ruled that Novartis did not deserve a patent for imatinib mesylate (Gleevec) on the grounds that the application claimed a new form of an old drug, the company embarked on a series of lawsuits. Having lost both the case to have Section 3(d) declared unconstitutional in 2007 and the appeal for a patent on imatinib mesylate in 2009, Novartis is now attempting to ensure that Section 3(d) is interpreted in a way that allows even improvements to an old medicine – such as imatinib mesylate – to be patentable.

If Novartis succeeds, India may end up granting far more patents than required under international trade rules or envisioned by India’s lawmakers, with huge ramifications on generic production and the availability of affordable medicines for people across the developing world.

Indian groups have been long requesting the Law Ministry to take this case seriously and immediately appoint its senior most and best legal team to argue the matter before the Supreme Court.  A strong defense is definitely required from the Indian government (who is also party to the case) to prevent Novartis from making the section 3(d) safeguard in the patent law meaningless.

Groups in India are closely following the FTA negotiations and the Novartis case in the Supreme Court.