Earlier this month, the Supreme Court of India dismissed an appeal brought by Novartis against the Indian Intellectual Property Board’s 2009 decision which rejected a patent application for a form of Imatinib Mesylate, a drug used to treat myeloid leukaemia and other tumours, marketed as ‘Glivec’ (EU) or ‘Gleevec’ (US) (see previous post here). The decision was based on the patent’s inability to satisfy the tests of invention and patentability under Indian patents legislation. However, clear policy imperatives – involving the balancing of access to affordable medicines through generic pharmaceuticals (especially in nations with areas of widespread poverty) against encouraging investment and innovation by ‘big pharma’ – were at play.
Novartis first applied for a patent for the beta crystalline form of Imatinib Mesylate in India in 1998. In rejecting this application in 2006, the Indian Patent Office referred to a prior US patent granted in 1996 which disclosed the manner of preparation of Imatinib Mesylate. As a known substance, whose pharmacological properties were described in the prior US patent, the Office said that the beta crystalline form of this compound did not qualify as an ‘invention’. Novartis commenced its appeal from this decision in the Supreme Court in 2009.
In its decision earlier this month, the Supreme Court provisionally accepted the novelty of Novartis’ formulation, but found that it failed the test of patentability. This was because no breakthrough step in therapeutic efficacy could be established, despite any improvements in processability or storability. This provision, as explained by the two judge panel, guards against pharmaceutical companies making incremental changes to a drug, without any real medical benefit, in order to extend the effective patent life of a drug and delay the introduction of low-cost generic competition.
The decision highlights the fact that in developing nations like India many patients – and the Government – cannot afford to pay for medicines like Gleevec, which costs each patient $2,600 per month as opposed to $175 for its generic equivalent.
Predictably, the decision has sparked polarised reactions. Novartis and other originators have criticized the ruling for stifling innovation and investment by global pharmaceutical companies in India, whose domestic pharmaceutical market has been tipped to grow from a $11 billion domestic market to $50 billion by 2020. Public health advocates and legal activists, however, have hailed the decision for promoting access to affordable medicines and breaking “big pharma’s” stranglehold and abuse of the patent system by ever-greening.
The decision will no doubt cause all pharmaceutical companies operating in India to review the strength of their patent portfolio.