New Novartis Supreme Court Date and Response to Novartis ...

UPDATE:?

India?s Supreme Court today decided to re-schedule the final hearing of the Novartis vs. the Government of India case for 28 March 2012. The hearings were initially scheduled to start today (28 February), but the Mumbai terror attack trial in the Supreme Court has been running later than anticipated, and Justice Aftab Alam, who has been hearing the Mumbai attack case, is also part of the two judge bench that will hear the Novartis case.

The Novartis Supreme Court case is the final act in a legal battle that stretches back six years over India?s future capacity to produce low-cost generic medicines for its people, and for patients in other developing countries. Given the potentially huge ramifications on generic production and the availability of affordable medicines from India, M?decins Sans Frontie?res, along with many other treatment providers, patient groups and affected communities has appealed to Novartis to stop its legal attacks on the ?pharmacy of the developing world.?

Please find below a response to Novatis?s recent argumentation, regarding the impact of their legal proceedings, which relate to the patent that was refused for imatinib mesylate (which Novartis markets as Gleevec).

WHAT NOVARTIS SAYS:
NOVARTIS: Gleevec will continue to be (generically) available under the transition clause in the Indian patent law regardless of the legal outcome of our case.

NOTE: Novartis is referring to the transition clause which is also known as the ?automatic licensing? clause in India?s patent law. This means that Indian companies already producing a generic version of a drug?if this production began before 1 January 2005?do not have to negotiate for a voluntary license or request a compulsory license from the government but can continue to produce the product, provided a ?reasonable royalty? is paid to the patent holder.

BUT if imatinib can still be produced generically ? providing a ?reasonable royalty? is paid ? what?s the concern?
Response from public interest groups:
1. If Novartis does finally manage to obtain a patent in India, by having managed to change the law, production of generic versions of imatinib by companies that do not already produce it may no longer be possible.
2. Even for companies who already produce generic versions of imatinib, there are still many concerns. What a ?reasonable royalty? entails remains very undefined and could potentially increase the price of the generic drug and thus affect its availability. Patient groups also fear that once a patent is granted and thus a stronger right for the patent holder exists, generic producers may become subject to legal actions (infringement suits) by the patent holder.
3. The imatinib mesylate patent application was the first application in India that was rejected on the grounds that ?it is a new form of a known medicine.? The decision of the Supreme Court to reverse this decision could determine how the patent office decides other applications covering new forms of essential medicines. Unlike imatinib, many other drugs may not have been in generic production before 1 January 2005, and therefore Indian producers will not be able to apply the automatic licensing clause.

This limits the generic competition needed to keep prices down. TIMELINE: Novartis?s attack on the pharmacy of the developing world ? KEY DATES
1994 ? India signs the World Trade Organization (WTO)?s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) which means that it must now start granting patents on medicines no later than 2005.
2003 ? Novartis launches its imatinib mesylate as a blood cancer medicine (brand name: Gleevec) in the US at $2,600 per patient per month. Generic versions of Gleevec soon become available in India for under $200 per patient per month.
2005 ? India changes its patent law to comply with the TRIPS Agreement, and medicines can now be patented. But the law stipulates that only true medical innovations will be granted patents. Section 3(d) of the law specifies that new forms and new uses of known substances cannot be patented, unless they demonstrate a significant increase in efficacy.
2005 ? India?s patent office starts examining patent applications on medicines including Novartis?s patent application for imatinib mesylate.
January 2006 ? Novartis?s patent application on imatinib mesylate (Gleevec) is rejected by an Indian patent office on several grounds, including on Section 3(d) that it is simply a new form of a known substance.
May 2006 ? Novartis files two legal challenges in the Madras High Court. One is to appeal the rejection of the patent. The second is to have Section 3(d) of the Indian Patents Act declared contrary to the TRIPS Agreement and to the Indian Constitution.
December 2006 ? M?decins Sans Fronti?res launches an international petition calling on Novartis to ?Drop the case?. 450,000 people sign on but the company does not back down.
August 2007 ? The Madras High Court rules against Novartis in its case to overturn Section 3(d) in India?s patent law. The Madras High Court also rules that ?efficacy? under Section 3(d) would require Novartis show an increase in therapeutic efficacy. MSF hands over its petition of close to half a million signatures to Novartis in Basel.
August 2007 ? The scientist behind the discovery of imatinib, Brian Druker, writes an opinion piece publicly stating that ?the price at which imatinib has been offered for sale by Novartis around the world has caused me considerable discomfort. Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible.?
June 2009 ? The Intellectual Property Appellate Board which is responsible for hearing appeals on patent applications rejects Novartis?s appeal and confirms that imatinib mesylate does not deserve a patent, on the grounds that the company was unable to show significant increase in (therapeutic) efficacy as required under Section 3(d) of India?s patent law.
August 2009 ? Novartis approaches the Supreme Court of India in a new case ? this time seeking to challenge the interpretation and application of Section 3(d) by Indian courts and patent offices.

Final arguments are due to start before the Supreme Court on 28th March 2012.

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