CHENNAI : Pharmaceutical major Novartis AG has moved the Madras High Court challenging the rejection of its patent application for beta crystalline form of imatinib mesylate, as well as the provisions of the Patents (Amendment) Act 2005 under which it was rejected.

A Division Bench, comprising Justice R. Balasubramanian and Justice Prabha Sridevan, before which the matter came up for further hearing on Monday, adjourned it to February 15.

According to the writ petition filed by the Switzerland-based Novartis AG, represented by its power of attorney-holder Ranjana Mehta Dutt, the company had filed an application to patent beta crystalline form of imatinib mesylate, sold under the brand name Gleevec/Glivec. But, the Assistant Controller of Patents and Designs in Chennai rejected the application after pre-grant objection from other companies, and on the basis of Section 3(d) of the Patents Act 1970 as amended by Patents (Amendment) Act 2005.

Assailing the rejection order dated January 25, 2006 as well as the amended provision of the Act, the petitioner said the latter was unconstitutional as it was against the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organisation, to which India was a signatory.

Ignores rationale

Section 3(d) of the Act was a conscious breach of India's obligation under TRIPS, she said, adding that while amending the Section the legislature completely ignored the rationale underlying in Article 253 and 51(a) of the Constitution which mandate the Government or court to mould original law in harmony with international treatises.

She said the Assistant Controller had passed the "erroneous" order holding that the subject compound did not differ significantly in properties with regard to efficacy as compared to the known compound despite recording that there was a 30 per cent increase in bio-availability of the subject compound over the known substance. The official had concluded that the subject compound had been already disclosed in public documents, thereby destroying the novelty of the invention.

Maintaining that the company had procured patents for the compound in 35 countries, the petitioner said the impugned order had no legal or factual basis or justification.

"The Assistant Controller has arrived at conclusions without citing the material relied upon or the reasoning adopted," she said.

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