Even as Novartis is waging a war in the Indian courts challenging the rejection of its blockbuster cancer drug Glivec by the Indian patent office, the Swiss drug major's another patent application for the same drug is pending with the Indian patent office.
While the beta crystal form of Novartis' cancer drug Glivec was rejected by the Indian patent office last year and the same was challenged by the Swiss pharma giant in higher courts which is sub judice, the company's alpha crystal form of the same molecule is pending with the Indian patent office for a decision. The patent application for the alpha crystal form of Glivec drug was filed on August 12, 2004 (799/CHE/O4).
The decision of the Indian patent office on the alpha crystal form holds significance in the wake of the recent Madras High Court rejection of the Novartis plea challenging the constitutional validity of the sect 3 (d) of the Indian Patents (amendments) Act 2005. It was under this section 3 (d) that the Indian patent office had earlier rejected Novartis patent application for the beta crystal form of Glivec.
According to experts, there is a only slight difference between the beta and alpha form of the Glivec. "There is only a slight difference in the properties of the two like melting point, flow properties and solubility. But molecule is the same", an expert said.
Meanwhile, an individual has filed an opposition to the alpha crystal form of Glivec. The pre-grant opposition reads, "The alpha crystal form of the monomethane sulfonate salt of 4-(4-methylpiperazin-1-ylmethyl)-n-[4-methyl-3 (4-pyridin-3-yl) pyrimidin-2-ylamino) phenyl]-benzamide, filed by M/s Novartis AG, a Swiss Corporation of Schwarzwaldallee 215, 4058 Basel, Switzerland, the application does not merit the grant of a patent since the patentability criteria is clearly absent there being no novelty or inventiveness as required u/s 2(1)(j) and section 25(1),25(1)(e),25(1)(f)and 25(1)(i)."
"The specification and claims thereof are clearly supporting our submissions that the invention disclosed in the Patent application no. 799/CHE/04 is not eligible for grant of a patent as the disclosures in prior Patent No US 5, 521,184, clearly destroys the novelty and inventiveness, if any claimed by the applicant in the 799 patent application."
"The disclosures made in the specification of the Patent applications and claims 1 to 23 clearly refers to the alpha crystalline form of imatinib mesylate which is the same as "The alpha crystal form of the monomethane sulfonate salt of 4-(4-methylpiperazin-1-ylmethyl)-n-[4-methyl-3(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]-benzamide as disclosed in US 5, 521,184."
"The Patent application no.799/CHE/04 and the specification and the claims therein totally fails u/s 3 (d) which is described as follows 'the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant'. Consequently the 799 application and invention describe therein fails to meet Patent criteria u/s 25(1)(f)," the pre-grant opposition says.