Tag Archives: Dwijen Rangnekar

Drugs in 3(d) and What Matters in the Novartis Case at Supreme Court: Dwijen Rangnekar

Guest post by DWIJEN RANGNEKAR

Background

Glivec (called Gliveec in the US) is a drug for chronic myelogenous leukaemia (CML) – a rare and debilitating form of cancer. A Novartis drug, it has been heralded as a sign of pioneering pharmaceutical research. And, no doubt, it is a ‘life-saving’ drug; though, it also has to be taken life-long. Most narratives of the research pathways of Glivec gloss over the 40+ years of publicly funded and conducted research that isolated the cause, a BCR-ABL oncogene, and performed the initial clinical research that identified a promising candidate (STI 571 – imatinib mesylate). Novartis, the Swiss-headquartered pharma transnational, proceeded to synthesise and test STI 571, which in 1993 was patented. Further research found that a beta crystalline form of imatinib mesylate was more stable – and this was also patented (in 1997) and approved in the US in 2001. In 1998, a patent application for this beta crystalline form was filed in India – and this is in dispute here.

Section 3(d) is a provision in India’s patent law – and is unique to India; though, as explained in the article, it reflects a wider authorship of global public concern. The section was introduced in the third amendment to Patent Act, 1970 (i.e. The Patents (Amendment) Act, 2005) when India was fulfilling its final commitments to patent-related obligations at TRIPS. Written in technologically neutral language, 3(d) seeks to deny the availability of patents where a ‘new form of a known substance … does not result in the enhancement of the known efficacy of that substance’. This, along with other provisions, would hopefully make it more difficult to patent trivial and incremental modifications to a drug; thus, extending patent terms and delaying entry of generic alternatives. Continue reading Drugs in 3(d) and What Matters in the Novartis Case at Supreme Court: Dwijen Rangnekar