The much speculated ongoing litigation with respect to Glivec (Gleevec), a Novartis anti-cancer drug has finally been put to rest by the IPAB, by rejecting the grant of a patent for the same. The patent application in the regard earlier gave way for a writ petition, challenging the constitutionality of S. 3(d) of the Patents Act, 1970 before the Madras High Court and the consequent appointment of a technical member under the direction of the Supreme Court of India, to decide upon the appeal to the five orders rendered by the Controller, declining to pursue further the application for the grant of the patent, consequent to the success of the pre-grant opposition filed under Section 25 (1) of the Act.

Analyzing the contents of the application, the IPAB noted that the background to the invention revealed that “imatinib”, the free form of the drug applied for was known. The beta crystalline form “imatinib mesylate” (Glivec) a methanesulfonate salt form of imatinib was discovered to have advantageous properties over the earlier known free form. However, the application also mentioned that inhibitory and pharmacological effects of imatinib mesylate preferably in the beta crystal form were also found with the free base imatinib. The application was a “mailbox application” and Exclusive Marketing Rights (EMR) were procured to the same in November 2003. The application for Glivec had been opposed by five pre-grant oppositions during May-July 2005, pursuant to which it was ruled that the invention was anticipated by US Patent No. 5521184 of 1993 and was obvious owing to the prior publication of the same. Further, in view of S. 3(d) of the Act, the drug was said to be non-patentable, since Novartis was said to have failed to prove enhanced efficacy of the beta isomer over the known substance.

The Intellectual Property Appellate Board deciding upon the grant of the patent on 26^th June 2009, held against the same for a plethora of reasons. While the Board attributed novelty and inventiveness to the invention in contention, the basic test of patentable subject matter as under Section 3(d) of the Patents Act was said to be unfulfilled for the lack of “significantly enhanced efficacy”. Furthermore, it was ruled that only “therapeutic efficacy” qualified under Section 3(d) and properties claimed to be displayed by Glivec including improved bioavailability, thermodynamic stability, improved flow properties and lower hygroscopicity, did not amount to an increase in "therapeutic efficacy".

While the assertions included that Glivec had already procured patents in 35 different countries, the ground was disregarded by the Board since they opined that Section 3(d) embodied a high level of scrutiny and owing to which, patents granted in other countries may not be granted to India. Further, the Court denied admitting any additional material submitted by Novartis to support the patentability of its invention. Rather, they opined that material supplied as on the date of applying for the patent, could only be taken into consideration while deciding the present challenge to the Controller’s decision. Section 3(e) was also brought into purview in as much as the same was said to be a ground to deny a patent for Glivec being non-patentable under Section 3(d), any composition or formulation of this composition was also not patentable under Section 3(e) since it entailed a mere an addition of individual components, sans a synergistic effect. The IPAB noted that although the product claim for Glivec was not patentable, however the process for manufacturing the same was likely to be patented. Additionally, the Board also noted that Glivec being priced at Rs. 1,20,000 per month per patient, was too high a price and raised Section 3(b) as an additional ground to substantiate the denial of the grant of the patent.