In another recent decision the Indian Patent Office rejected an application of Sigma-Tau Industrie Farmaceutiche Riunite S.P.A of Italy on the grounds that the application does not meet the requirements of Section 2(1)(j), Section 3(d), Section 3(e) and section 3(n) of the Patents Act, 1970. Sigma-Tau had filed a national stage Indian Application No. 1314/KOLNP/2009 dated April 08, 2009 for their PCT Application No. PCT/EP2007/062929, wherein the claims were directed towards a solid powder comprising a mixture of a) a carboxy vinyl polymer as a gelling agent; b) a buffer; c) a saccharide, d) one or more drugs used for treatment of diseases of the eye. The FER for the said application was issued on July 17, 2014 to which the applicant filed a response on May 13, 2015. However, the Controller was not satisfied with the applicant’s response to the FER and maintained the objections therein and gave the applicant’s an opportunity to be heard.
The Controller maintained the objections that the amendments to claim 1 were not carried out as per Section 59 (1) read with Section 57(2) of the patents Act; amended claims were not novel, obvious and did not comprise an inventive step w.r.t. cited prior art documents; the amended claims were precluded under Section 3(d), Section 3(e) and section 3(n) of the Patents Act, 1970 and lastly that some of the claims were unclear.
After conducting a hearing, the Controller accepted the agent’s submissions that the amended claim 1 lied within the scope of the originally filed PCT claims and hence was in consonance with the provisions of Section 59(1) and 57(2) of the Indian Patents Act. Further, claims objected under Section 3(n) were also deleted.
With respect to Section 2(1)(j), the Controller in his decision found the composition of the ophthalmic preparation (solid powder) of the claimed invention was not novel as all the ingredients were disclosed in the prior art, hence, the product did not qualify as a ‘new’ product. Further, the drug delivery system as claimed in the invention did not involve any inventive step as no therapeutic efficacy was demonstrated. The Controller observed that finding of a drug delivery system of known components and drugs without showing any therapeutic efficacy does not involve any inventive step, as preparing a drug delivery system (powder or gel) of various known components and checking the release rate of the drug (amount of drug released after 30mins to 6hrs.) are routine experimentation carried out by an organic/medicinal chemist, who is a skilled artisan.
It would be obvious to a person skilled in the art to manoeuvre the amount of all ingredients, viscosity and release rate as needed because it is deemed to be merely a matter of judicious selection, which is well within purview of skilled artisan. Therefore, the claims were rejected for lacking an inventive step.
With respect to Section 3(d), the Controller opined that mere increase in retention time and bioavailability of the drug system was not sufficient to bypass the requirements of Section 3(d) and data demonstrating therapeutic efficacy of the product was needed for the same. In absence of such data, the drug delivery system as claimed was precluded under Section 3(d).
Finally, with respect to Section 3(e), the Controller was of the opinion that since the claims attracted section 2(1)(j) and Section 3(d); the question whether the instant claimed composition is a mere admixture or not does not arise at all.