Written by- Naman Mishra, Himachal Pradesh National Law University
Glochem Industries Ltd. v/s Cadila Healthcare Ltd. & Others
FACTS-Glochem Industries Ltd. [hereinafter alluded to as Glochem] documented a pre-award resistance against the award of the patent application recorded by Cadila Healthcare Ltd. [hereinafter alluded to as Cadila/the Applicant], named “translucent clopidogrel besylate and process for planning thereof”. Said restriction was discarded in January 2009 and all the grounds taken up by Glochem for example expectation by earlier distribution, expectation by earlier guaranteeing, expectation by earlier use, absence of imaginative advance, non-patentable topic, deficiency of revelation were dismissed by the Controller. Especially, the Controller seriously discussed the ground under Section 3(d) of the Act taken up by the Opponent.
JUDGEMENT- The Controller while arbitrating the pre-award restriction observed the substance of the total detail of the application alongside further information put together by the Applicant over the span of the pleadings. The Controller held that:
“The cases 1 to 3 of the supposed creation are coordinated to Crystalline Clopidogrel besylate. The besylate salt of Crystalline Clopidogrel is unadulterated, free streaming, simple to deal with and artificially steady (nor hygroscopic) which can be used on an Industrial scale (pages 2, 3 and 5 of Complete Specification). To help this and furthermore to meet the prerequisites of Section 3(d) of Patents Act, 1970 the candidates with their answer articulation, have presented the Stability study information sheet of bisulphate (Enclosure 5 and 9) and besylate (Enclosure 6); alongside Stability and Comparative Pharmaceutical portrayal Report of solvated (toluene and diozane) and Crystalline Clopidogrel besylate (Enclosures 13 and 14).
The steadiness study information for the Clopidogrel bisulphate salt uncovers that there is increment in the convergence of the latent metabolite which in the long haul lessens the adequacy of bisulphate salt by decrease of remedial portion (Enclosure 5). Further in tablets of bisulphate salt there is an expansion in corrosive polluting influences (Enclosure 9). While the Crystalline Clopidogrel besylate of present innovation shockingly isn’t recognized with inert metabolite for more than a half year in any of the three bunches (Enclosure 6). Subsequently, the Crystelline Clopidogrel Besylate of moment creation is invaluable regarding expanded time span of usability of the Clopidogrel bisulphate salt.
The solidness report given in the Enclosure 13 shows that the Crystalline Clopidogrel besylate of moment innovation is all the more free streaming and stable much following multi month time span in contrast with the solvated (toluene and dioxane) types of Crystalline Clopidogrel besylate (refered to by the adversary).
According to the Petitioners, none of these factors which have weighed with the Respondent No. 4 are germane to answer the core issue as to whether the substance so discovered has a? Better therapeutic effect?. The real question to be answered has not been dealt with by the Respondent No.4 in the impugned order at all. We are in agreement with this submission. Considering the exposition of the Madras High Court, the Respondent No. 4 ought to have examined whether the factors noted in the impugned order had the effect of enhancement of known efficacy of stated substance in the context of ?better therapeutic effect? Which is the legislative intent behind the amendment of Section 3(d) and not recognize the alleged invention merely because of its new form or some other advantages or is better in some respect. These matters though crucial have not been examined by the Respondent No. 4 at all.
The Counsel for the Respondent No.1 had placed reliance on the decision of the Apex Court in the case of J.Mitra & Co. Pvt.Ltd. vs. Asst. Controller of Patent & Designs & Ors. Reported in (2008) 10 SCC 368. In that case, however, the problem considered was about the confusion arising on account of the postponement of in-part commencement of the Patents (Amendment) Act, 2005, in particular with regard to the remedy of appeal against an order rejecting the pre-grant opposition. Indeed, the Court considered the legislative change brought about by introducing pre-grant opposition vide section 25(1) of the Act, which was a radical shift. Nevertheless, the law as it operates after the amendment has come into force is that it provides only one remedy of statutory appeal against the post-grant order. The ratio of this decision does not take the matter any further.
The Petitioners relying on the decision of the Intellectual Property Appellate Board dated 26th June, 2009 in M.P. Nos. 1 to 5/2007 and TA/1to5/2007/PT/CH in the case of Novartis AG v/s. Union of India & ors. would contend that a patent is granted on the basis of its full disclosure of the invention in the specification furnished on the priority date of the application. The law debars an applicant a grant of patent for belated discovery of a new thing which is not disclosed which may or may not be pivotal in determining patentability. According to the Petitioners, the original specification furnished by the Respondent No.1(Applicant) did not disclose matters which have been considered by the Respondent No. 4. The similar Pharmaceutical Properties information gave in Enclosure 14 shows that the solvated (toluene and dioxane) types of Crystalline Clopidogrel besylate are more cardiotoxic contrasted with the Crystalline Clopidogrel besylate of present innovation. The Crystalline cop besylate is non-harmful till 50 uM focus, though the toluene solvated structure demonstrated harmfulness at 5uM and dioxane solvated structure indicated poisonousness at 25uM. Consequently it shows that the Crystalline Clopidogrel besylate is better and worthwhile in issues of harmfulness in contrast with solvated structures.
Taking into account the beneficial impacts of Crystalline Clopidogrel besylate of moment development over the known clopidogrel bisulphate and furthermore over the solvated types of Clopidogrel besylate in various portrayal viewpoints, it tends to be held that the Crystalline Clopidogrel besylate of present innovation compound is patentable and can’t be dismissed under Section 3(d) of the Patents Act, 1970″.
The Controller observed the substance of the total determination, entries made during the pleadings and the additional proof/research information presented by the Applicant, and likewise saw that the trial of patentability set somewhere around Section 3(d) of the Act had been adequately met by the application.
Considering the equivalent, the Controller dismissed the resistance.