Incremental innovation

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The Gleevec case in India raises interesting questions about evergreening and small advances that confer real advantages. Thamaray Govender debates the issue.

Novartis A.G. v Union of India1

As a previous British colony, India had inherited its intellectual property regime from Britain. However, after gaining independence in 1947 product patents were removed from protection under the patent laws. During the 1990’s, India needed to adapt its patent legislation to be TRIPS compliant. Therefore, in 1999 India allowed for transitional filing of product patents with retrospective effect from 1995, and full product patent protection was re-introduced from 2005, when transitional regulations ended.

The case
During the 1990’s, Novartis filed a series of patent applications in the US, initially for a drug containing “imatinib”. This patent application covered pharmaceutically acceptable salts and was subsequently granted. Novartis then filed a patent application for the “beta crystalline” form of the imatinib mesylate salt, which was subsequently granted in the US. The US Food and Drug Administration (FDA) approved the active ingredient imatinib mesylate for use as a magical cancer drug, in the form of Novartis marketed drug “Gleevec”. It is used to treat chronic myeloid leukemia. Several patents were obtained for the beta crystalline form of imatinib mesylate in other countries. At the time, India did not allow protection for product patents, and no patent protection for imatinib was obtained in India. Thereafter, as India’s patent laws changed, Novartis sought patent protection for the beta crystalline form of imatinib mesylate in 1998. The application was processed in 2005 once the law allowed for product patents. However, the application was rejected in 2006 on the grounds that it failed to satisfy novelty and non-obviousness requirements.

Novartis lodged appeals before the Madras High Court, which were then transferred to the then newly formed Intellectual Property Appellate Board. The Appellate Board modified the previous decision, stating that novelty and non-obviousness were present in the application (in other words, the invention of the beta crystalline form of imatinib mesylate is new and inventive), however, the Board further stated that the patent application had to be rejected on the grounds that the invention was not a new substance but an amended form of a known compound and that Novartis was unable to show increase in efficacy as laid down in section 3(d) of the Indian Patents Act2. Novartis then appealed directly to the Supreme Court through a Special Leave Petition, due to urgency, as the patent if granted on appeal would expire by 2018. Request a free trial to read more.