A final decision from the court case involving Novartis' legal challenge against India's patent laws has been postponed once again.
The Indian Supreme Court case of Novartis versus the Government of India has been re-scheduled for September 11, although final arguments were supposed to start yesterday (August 22). The postponement is due to other pending cases which need to be heard.
The eagerly-anticipated final hearing, which is expected to last a couple of months, has been put back several times. The Supreme Court was scheduled to start the final hearing of the case on March 28, a month later than originally expected, but final arguments were then re-scheduled for July 10.
The dispute centres around India's patent law, notably Section 3(d), which states that a modification of a known chemical composition is non-patentable. Novartis' legal challenge stems from an attempt to obtain a patent on Gleevec/Glivec (imatinib mesylate), its drug for chronic myeloid leukaemia and other cancers, which was turned down by India's Patent Office in 2006.
The case is extremely high-profile and Novartis has come under pressure to drop it, notably from international aid agency Medecins Sans Frontieres (Doctors Without Borders). The latter claims that should Novartis win, "patents would be granted in India as broadly as they are in wealthy countries and on new formulations of known medicines already in use. India would no longer be able to supply much of the developing world with quality affordable medicines".
Novartis has repeatedly denied this claim, noting that 90% of patients diagnosed with CML in India get Gleevec free through the firm's donation programme, though it is sold by generic companies. Rather the issue at stake is the state of patent protection in the country and what type of innovation can be protected.
Bayer/Natco hearing postponed
Meantime, earlier this week, India's Intellectual Property Appellate Board postponed Bayer's appeal against the granting of a compulsory licence of the cancer drug Nexavar (sorafenib) to Natco Pharma to September 3.
In March, India issued its first-ever compulsory licence allowing Natco to legally make and sell its low-cost version of the drug. The landmark move brought the price of the drug down 97%, from over $5,500 per month to $175 and Natco pays Bayer a 6% royalty on sales.
Bayer argues the compulsory licence should be withdrawn given that generic Nexavar is already sold in India by Cipla (in breach of the patent), therefore there is already a low-cost alternative available.