The face of an Indian woman in traditional dress and the link to a 'Glivec Information Center' which explains why the anti-cancer of discord is "true innovation" and not the result of a so-called "evergreening" operation. In the aftermath of the sentence, the Glivec case opens the home page of the Swiss multinational.
In particular, the Basel-based giant seeks to clarify the concept of pharmaceutical innovation and why it is right to consider Glivec a truly innovative medicine, therefore a patentable entity.
The drug, based on imatinib mesylate, is "a revolutionary treatment that has changed the diagnoses of Philadelphia-positive chronic myeloid leukemia and Kit-positive gastrointestinal stromal tumors (Gist) – recalls Novartis – from diseases with few effective treatments to manageable chronic diseases" .
"There is a misconception in India that Glivec is not a new drug, but an improvement on a drug." A "confusion", explains Novartis, which arises from "a patent granted in 1993 (not in India) for the synthesis of the molecule imatinib". However, imatinib as such, without the further developments that led to the formulation of the definitive version imatinib mesylate, "would not have been safely administered to patients".
In other words, for Novartis the '93 patent "was only a first step in the process that led to the development of Glivec as a viable cancer treatment".
The step forward that made the initial molecule a real drug was having "selected the mesylate salt of imatinib, and then developed the beta crystalline form of imatinib mesylate". It was this step, the manufacturer points out, which allowed patients to take the anticancer therapy "in the form of a pill capable of releasing consistent, effective and safe levels of active ingredient".
April 3, 2013 – PharmaKronos
India: non-innovative drug, Novartis loses Glivec appeal
