The final judgment from the eagerly-anticipated court case that involves Novartis; legal challenge against India's patent laws has been put back to July 10.
The Swiss major's long-running case against the Government of India centres around the country's patent law, notably Section 3(d), which states that a modification of a known chemical composition is non-patentable. Specifically, Novartis' legal action stems from an attempt to obtain an Indian patent on Gleevec/Glivec (imatinib mesylate), its drug for chronic myeloid leukaemia and other cancers, which was denied by India's Patent Office in 2006.
India’s Supreme Court was scheduled to start the final hearing of the case on March 28, a month later than originally expected. However, the international aid agency Medecins Sans Frontieres (Doctors Without Borders) has told PharmaTimes World News that final arguments have now been re-scheduled for July.
MSF notes that the reason for "the much lengthier delay than anticipated" is that the Mumbai terror attack case, which one of the Novartis judges is also hearing, is expected to run over schedule "by a few weeks". Then, the court will break for its summer holidays in May.
MSF has repeatedly urged Novartis to stop what it refers to as "a direct attack on the pharmacy of the developing world". It argues that more stringent intellectual property regulation would have a negative impact on access to medicines - for example, generic medicines produced in India make up 80% of the HIV drugs MSF uses to treat 170,000 people in 19 countries.
Novartis vehemently denies such claims and last month told PharmaTimes World News that "the basis of this argument is false and very misleading". The company said that "we believe that working through the judicial system is the legitimate and appropriate approach to gaining clarity on the unique aspects of India’s patent law", adding that it has "confidence the Supreme Court will make the right decision based on the law of India".
As well as the attention on the Supreme Court case, India's IP laws were put firmly under the spotlight earlier this month when a first-ever compulsory licence - for Bayer's cancer drug Nexavar (sorafenib) - was granted to generics company Natco Pharma. The decision will bring the drug's price down from $5,500 per person per month to just $175.
Last week, Roche said it would offer significantly cheaper, locally-branded versions of its two cancer blockbusters, Herceptin (trastuzumab) and MabThera (rituximab) in India by early next year, as part of a deal with generics firm Emcure Pharmaceuticals. The drugs will be renamed for the Indian market,