Gleevec has once again captured the front pages. It had been a poignant issue in the debate concerning accessibility of essential drugs vis-à-vis patents especially after India brought in the product-patent regime in January 2005.

Briefly, Novartis had first submitted a patent application in India covering the "Beta Crystalline form of Imatinib Mesylate" pending grant of a product patent in the WTO/Mailbox in 1998 and in 2003 the company was granted exclusive marketing rights (EMR) for the drug for five years. Herein Novartis brought legal actions by way of infringement suits against generic drug makers on the strength of the EMR, before the High Courts of Madras and Bombay. Howsoever the decisions rendered by both the High Courts were conflicting. As against the view of the Bombay High Court, the Madras High Court had validated the EMR.

Novartis had submitted that an EMR application was required to be examined only with respect to compliances of sections 3 and 4 of the Patents Act, 1970 (as per Section 24-A which has been repealed by the Patents (Amendment) Act, 2005) and that the question of anticipation by prior publication or prior claim is not relevant to the examination of an EMR application. The Madras High Court favoured this argument.

At the same time, following serious objections raised by Natco Pharma Ltd, a Hyderabad-based Pharma company, in the pre-grant opposition filed by them, the office of the Controller of Patents & Designs at Chennai ruled against the claim of Novartis AG.

The Submission made to the Controller was that Novartis had filed claim for a polymorphic form of Imatinib Mesylate. As per Section 3(d) of the Patents Act, any salt, polymorph or derivative of known substance is not patentable unless such salt, polymorph or other substance shows enhanced efficacy of the substance. Further, it was also submitted that the patent specification also did not bring out any improvement in the efficacy of the beta-crystal form over the known substances rather it only stated that the base can be used equally in the treatment of diseases or in the preparation of pharmacological agents wherever the beta-crystal is used.

Following this the Assistant Controller on January 25, 2006 concluded that:

Against this Novartis has recently filed two petitions in the Madras High Court challenging the refusal of its patent application and the constitutionality of section 3(d) of India's patent law that protects against trivial patents. It has also termed the aforestated section to be in breach of India’s obligations in the TRIPS Agreement.

The outcome of this move is eagerly awaited since litigations like the present one shall have a great impact on the future availability of life-saving medicines.