PHARMACEUTICAL PATENTING IN INDIA - BREAKING MYTHS
RANBAXY LABORATORIES LTD. VS. PFIZER HEALTH AB.
In 2007, the Indian Patent Office refused the pre-grant opposition filed by Ranbaxy Laboratories Ltd. [hereinafter referred to as Ranbaxy] against the grant of a patent to Pfizer Health AB [hereinafter referred to as Pfizer] for the invention claimed in the patent application titled “A PHARMAXCEUTICAL FORMULATION”.
Dealing with the arguments put forward by Ranbaxy under Section 3(d) of the Act, the Controller held that the therapeutic efficacy was established by the Applicant by way of reduction in the number of urge incontinence episodes per week by 71% in relation to placebo. Further, the Controller addressed the ground raised by the Opponent under Section 3(e) of the Act and held that the invention is patentable on account of the synergistic effect disclosed in the specification. Accordingly, the Controller granted the patent to Pfizer. Relevant excerpts from the order are reproduced hereinbelow:
“The opponent has further argued and stated that the various processes as laid in the examples provided in the instant application for the preparation of formulation as oral and other dosage forms comprises the well known active ingredients and other well known excipients. Under Section 3(d) of the Patents Act, combination of known substances, unless they differ significantly in properties with regard to efficacy, is not patentable; and also no patent can be granted for a composition which does not exhibit any synergistic effect under Section 3(e) of the Patents Act. Since the claims are related to a composition showing neither enhancement in known efficacy nor any synergistic effect, the invention falls under Sections 3(d) &(e) of the Patents Act, the patent should not be granted.
The agent for the applicant in his reply stated that the present invention is Novel, Inventive and Industrially applicable. The composition as claimed therein is not a mere admixture but it is a synergistic composition. In support of their arguments, the applicant was referring to the Exhibit “I” referred to in the affidavit of Paul Abrams, wherein in the paper presented by Kerrebroeck et al., it was shown that Tolterodine controlled release formulation according to the present application has significantly reduced the number of urge incontinence episodes per week by 71% in relation to Placebo. It was further stated that the description with respect to the efficacy is already provided in pages 14 & 15 of the complete specification. Therefore it is prayed to grant the Patent right to the applicants.
Admitting the view of the applicant and also the results provided in the specification, I conclude that the amended claims do not contradict the provisions Section 3(d) and Section 3(e) of the Patents Act and hence are allowable”.