Glivec is an important and expensive drug in the treatment of myeloid leukaemia that blocks cancer growth in patients and is already on the market. Novartis decided to seek a patent on a slightly altered version, potentially giving it a longer period of market exclusivity.
Novartis application for a patent for its new version of the drug, arguing that it was easier to absorb and therefore qualified as an innovation was rejected by the Controller of Patents in 2006.
The Appeal in said matter was finally decided by the supreme court of India on April 01, 2013 wherein the Hon’ble Court noted that the new drug is not significantly different from the old version.
Section 3(d) of the Indian Patents Act, does not allow patents of new versions of known drug molecules, unless they make the medicine significantly more effective than before.
Novartis argued that better physicochemical qualities, such as shape of the molecule, stability, hygroscopicity and solubility, would satisfy the test of enhanced efficacy.
But the court decided that the changes were simply an attempt at “evergreening” – refreshing the drug so that a new patent would be granted – which is common practice in Europe and North America.
The decision is seen as a major boost for generic drugmakers in India who supply cheap medicines to poor people across the developing world.
India exports generic drugs worth $11bn including crucial anti-retrovirals supplied to Africa.
The ruling was welcomed by bodies such as Médecins Sans Frontières (MSF), Cancer Patients Aid Association in India (CPAA) and others. However, Novartis said the decision “discourages future innovation in India” and company will be cautious about investing in India, especially over introducing new drugs, and seek patent protection before launching any new products.
You can access the complete judgement at:http://www.indiankanoon.org/doc/165776436/
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Courtesy:
The Guardian,
BBC.
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