After more than 12 weeks of evidence in the country’s Supreme Court, the high-profile hearing that involves Novartis’ legal challenge against India’s patent laws has concluded.
Following a series of postponements, the hearings started on September 11. Two judges have been examining the case which 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 against the Government of India stems from an attempt to obtain a patent on Gleevec/Glivec (imatinib mesylate), for chronic myeloid leukaemia and other cancers, which was turned down by the country’s Patent Office in 2006.
Novartis said that it “deeply appreciates the opportunity to present the case before the court and will look forward to the outcome”. The Swiss major says it pursued the litigation “with a view to seek clarity on the unique aspects of India’s patent law and to foster an innovative environment to the benefit of patients”.__ The verdict and the timing of its ruling “are entirely at the discretion of the court”, Novartis said, saying that “we expect to have a decision sometime before the end of the first quarter of 2013”.
The international aid agency Medecins Sans Frontieres (Doctors Without Borders), which has been very critical of Novartis’ stance, said that in recent weeks, the judges heard the counsel for the Indian government, and then representatives for the Cancer Patient Aid Association “on arguments to defend India’s stricter patentability criteria”.
Leena Menghaney, MSF’s access campaign manager in India, said that “With this precedent-setting case nearing its end, we sincerely hope that the integrity and intention of India’s patent law, and Section 3d in particular, is upheld”. She added that India’s ability to continue production of affordable medicines for the developing world “depends a great deal on the country’s patentability standards and how they are interpreted by the courts in India”.
