i. History of the proceedings
Claiming excipients generically for preparing dispersible tablet of deferciroxdo not involve any inventive merit. All the essential ingredients present in thecomposition shall be incorporated with proportion in the principal claim of anycomposition application for patent. The applicant in the present applicationfailed to incorporate the essential specific excipients in claim 10. In claim 1,the applicant claimed only the dosage range (5% to 40%) of the Apl and inclaim 2, the said dosage range along with ‘at least one pharmaceuticallyacceptable excipient’. claims 1 and 2 of the present case as follows:
ii.A dispersible tablet comprising compound I of the formuta:
Claim 1 directed to a dispersible tablet with 5% to 40% of the APl. There is noinventiveness involved in claim 1 because dispersible tablet as one of thechoice of medicament and the dosage range is also disclosed in WO’395.The only difference between the prior art (WO’395) and claim 1 of presentinvention is combining the dispersible tablet and dosage range together,which is described in different places of WO’395. A skilled can easily combinemany features disclosed in different places of the prior art according to theneed and requirement. Claim 2 is directed to a dispersible tablet with API in arange 5% to 40o/o and at least one pharmaceutically acceptable excipient.Addition of pharmaceutically acceptable excipient to the subject matter ofclaim 1 is the present independent claim 2. The APl, dose and intendedpharmaceutical preparations are known in the prior art, but selecting the Apl,dose and specific drug delivery system without giving any specific excipientcan not be considered as inventive over the prior art. The term ‘at least’means ‘not less than one’ and open ended, which is not definitive in nature.There are two important requirement for any composition patent application,(1) it is mandatory to disclose the API and all the excipients specifically withproportion in any composition or new drug delivery system for known drug; (2)support pertaining to unforeseen effect of the composition or new drugdelivery system for known drug with closest prior art shall be provided in thespecification. The applicant failed to adhere any of the two requirements
Not an invention
The attorney for the opponent submitted that there is total absence of any”Surprising Effect” in the alleged invention. Therefore Claims 1 to 14 in thealleged patent application are not patentable under Section 3 of the PatentsAct, 1970. Claim 1 to 4 and subsequent dependent claims are for’crystallineform’ of Deferacirox. The Applicants have themselves on page g, para 4 haveadmitted that Deferacirox used for the dispersible tablet in the impugned
