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5. The petitioner alludes, in some detail, about vulnerability resulting from data disclosure, in the absence of a protection regime, and its utilization by applicants for the same product, for the purpose of their claim to registration. It is contended that the value in data protection is that it is the basis for the application (for registration) about the source, the raw materials, the nature of production of the insecticide, etc. Unless some measure of protection is afforded, the "data originator" would do all the toil and the "me too" applicant would reap the rewards. It is claimed that Article 39.3 of the TRIPS mandates protection for WP(C) 8123/2008 Page 3 the test data submitted by the pharmaceutical and agro-chemical industries for market approval. It sets the minimum stands in this regard and reads:

7. It is submitted that the Report's recommendations and due to pressure from the indigenous lobby, the first Respondent issued a Directive dated 30.10.2007 in respect of "FIT" (Import of Formulation) registrations. The Directive introduced the concept of deemed registration of "Technical" i.e. in the category of 'FIT' i.e. where formulation of a technical was registered and was being imported, the technical for the said Insecticide would also be deemed to be registered without a separate application for it. It was reiterated that there would be complete submission of data in respect of the "technical" even at the time that a registration was sought for the formulation. To grant some measure of protection to the data originators, the Directive also stated that this registration of "technical" would come into force and would take effect after three years from the date of registration of the formulation without a separate application. It is submitted that this amounted to enforcement of an extremely limited period of data protection as opposed to the previously unlimited data protection being enjoyed by registrants in the category of FIT (import of Formulation). The directive, it is submitted, was effectuated through guidelines WP(C) 8123/2008 Page 4 dated 30.10.2007 framed by the Committee on 13.12.2007. These according to the petitioner, made amply clear that the data on "Technical" must be complete while submitting an Application for registration of formulation.

Coming to the issues raised in the appeal, it is noted that the Government has been issuing directives from time to time for proper enforcement of the Insecticides Act, 1968 and the rules made thereunder, and in doing so it has been taking into account the views of the different sections of the pesticides industry. The letter dated 30.10.2007, issued in view of the instances where formulation had been registered for import without registration of technical under section 9(3) thus blocking registration under section 9(4) and created a monopolistic situation, also took into account the industry's concern to allow data protection for 3 years till suitable legislative changes are made. The letter dated 18.02.2008 included the category of registration under section 9(3B) with commercialization in this dispensation with a view to remove the perverse tendency to continue with provisional 9(3B) registration with commercialization, thereby creating monopolistic situation. The data protection for 3 years is available to his category also. It would also be disingenuous to make a distinction between registration of formulation for import and registration of formulation for indigenous manufacture for this purpose as indefinite protection in either case would have the same consequence, i.e. existence of a monopolistic situation. Application received for grant of registration for the same product from any other source thereafter is treated under the category of new source and the data requirements for that category apply which have been met by M/s Jaishree. The registration under section 9(3B) with commercialization was granted to M/s Syngenta at their own request in 2004. The Registration Committee has taken the decision in question (agenda items 6.5 and 3.7) in its 293 rd meeting in line with the policy laid down by the Government. As such there is no reason to interfere with these decisions. The appeal is, therefore, dismissed.

37. The second, and important aspect to be considered is the soundness of petitioner's contention about unfair dilution of data protection afforded by the notification of October, 2007. It would be relevant, at this stage, to notice that:

WP(C) 8123/2008                                                                          Page 21
 (1)    No provision of the Act, or Rules, prescribe or enact data exclusivity, or postpone
registration;


(2)    The petitioner had applied under Section 9(3) much before the notification of
October 2007;


(3)    The petitioner's certificate was granted before the issuance of the notification of
October, 2007.


(4)    The existing regime, through guidelines and the minutes of meeting of 30 th March,