The Indian Pharmaceutical Alliance (IPA) in a strongly worded letter to Controller General of Patents & Designs questioned the grant of EMR to Novartis India for its molecule imatinib mesylate. IPA called upon the Controller for immediate cancellation of EMR as he overlooked many facts regarding the inventiveness of the molecule while examining the EMR application.
The IPA letter, a copy of which is with Pharmabiz, said that the EMR was granted for what is not an invention, and it is in gross violation of not only the provisions of S.24(B) of the Indian Patents Act, 1970 but also S.3 of the Act. Pointing out the flaws in the decision, D G Shah, secretary general, IPA said that firstly the molecule does not fit for an EMR as it is clearly a pre-1995 invention and secondly the product on which the EMR has been sought by Novartis on the ground of a patent applied in 1998 is not a new chemical entity.
The IPA letter stated that, originally an application for patent (US Patent # 5521184) on imatinib mesylate was filed in the US on April 28, 1994. In this application, the imatinib base has already been disclosed.
The letter has also mentioned about a Canadian patent application on this molecule, which was even prior to the first US patent application. The Canadian patent application (CA patent # 2093203) was filed on October 4, 1993.
According to the Canadian application, Shah adds that the patent claims a class of compounds that include imatinib and salts of such compounds. Imatinib mesylate is the salt formed by reaction of imatinib base with methane sulfonic acid. "It is thus obvious that Novartis AG application EMR/1/2002 dated 27-03-2002 is for an article or substance identical to the product covered by the Canadian and the US applications noted herein above, which were filed before 1st January, 1995," the letter stated.
However, the IPA points out that the patent application No. 1602/Mas/98 of 17.07.1998 under which the EMR is sought in India is for modification of crystal form and not a new compound. It is thus an invention that is not patentable.
In the Indian context, the IPA asserts, the Drug Controller General of India (DCGI) approval to sell or distribute is only for imatinib mesylate, and not for beta-crystal form of imatinib mesylate. However, the EMR application is for beta-crystal form and as such does not meet the requisite conditions to quality for EMR in India.
It may be mentioned that it is the first time after the media reports about the grant of EMR to Glivec, the Indian Pharmaceutical Alliance, which is the association of leading Indian pharmaceutical research oriented companies, is reacting to the same. IDMA had expressed its concern over the decision of the patent office early this month.