Case: M/S GENENTECH INC Vs. DRUGS CONTROLLER GENERAL OF INDIA

with Biocon and Mylan. The Division Bench felt that respondent no.3 is on similar footing as Biocon and Mylan and therefore parity in marketing of their respective biosimilar product can be allowed. 18. In their challenge to the impugned order, the appellants have contended that in passing the impugned order, the Division Bench had failed to simultaneously consider and dispose of the pending appeals and the interim applications filed by the plaintiffs. We had earlier referred to the order passed by this Court on 8.3.2019 in SLP (C) No.6203/2019 which required the High Court to simultaneously take up the appeals and the interim applications filed by both sides. Although some of the contentions raised by the appellants counsel were taken into consideration, those submissions were examined by the Division Bench only in the context of the application filed by respondent no.3. On this aspect, the learned senior counsel for respondent no.3 submitted that non mentioning of the FAO and the IA of the appellants was an inadvertent omission. However such submission, in the face of the specific observation made by the Division Bench in paragraph 51 of the impugned order, cannot be accepted by us. 19. When the impugned order of the Division Bench is read in the context of the express direction of this Court, it is clearly discernible that the Division Bench had only considered the appeal and application filed by Reliance on merit that is FAO(OS) No. 227/2016 and C.M. Appl. No. 22510/2016; without entertaining the appellants application. In fact the Bench itself clarified the position in paragraph 51 of the impugned order by stating the following:- ……. ………….…… 51. We have heard learned counsels and considered their respective submissions. The submissions made on behalf of the parties are being examined in the context of the appellants application for stay of the impugned order. …………. …… …….. …… ……. …… ………………. 20. The fact that the Division Bench was singularly concerned with taking up the Reliances interim application is further established from the separate order passed on 16.7.2019 in FAO (OS) No. 132, 133, 226, 227 and 268 of 2016 which directs the applications (including the appeal and the application of the plaintiffs) to be listed on 11.2.2020. By way of a separate order, of the same date i.e. 16.7.2019, the Division Bench reserved orders on Reliances application. Therefore, it is difficult for us to accept as has been suggested by the learned Senior Counsel for the respondent no.3 that the segregation of the application of one party by the Division Bench, could be an inadvertent error. 21. In the above context, the Division Bench even without considering the appellants interim application through their observations in paragraph 57, had clearly shut out any scope for the appellants application to be heard and in effect, ordered on the application. 22. In the interim order passed by the learned Single Judge on 25.4.2016, the conditions imposed on Reliances product by the DCGI were taken into account. The said interim order was operating without causing much hindrance and respondent No. 3 was successful in participation in government tenders and supplies, with their drug. Therefore, the contrary submission made by the learned Senior Counsel for respondent no.3 is found to be incorrect. 23. As regards the contention made by Mr. Poorvayya that the condition imposed by the learned Single Judge on the packaging/labelling is contrary to the statutory prescriptions, it must be borne in mind that the arrangement ordered by the learned Single Judge has been in operation since 25.04.2016. Therefore without a final decision on the suit on the basis of relevant evidence, the continuing arrangement in our opinion should not have been disturbed, on this count. 24. The appellants suit before the Delhi High Court is not a trade mark action nor it is an attempt to enforce the appellants patent, which admittedly expired in 2013. The suit is an action for extended passing off and to prevent the respondent from using the appellants data and improper reference to its drug Trastuzumab. Therefore, the expiry of the appellants patent right on the drug Trastuzumab may not have any direct bearing on the contention raised in the Reliance suit. 25. As regards the submission on the timing of the suit and the other contentions raised on the approval secured from the Subject Expert Committee, these are matters which should appropriately be dealt with when the suit is finally decided. Those need not be factored in at this stage, in support of the impugned interim order. 26. Reverting back to the impugned order, the Division Bench had not only considered the contention raised by the appellants in paragraphs 41 to 50 but then rejected those, in paragraphs 52 to 60 of the same order. In such circumstances, directing the Division Bench to now consider the appellants appeal FAO No. 227/2016 and CM No. 26902 of 2016 would in our view be nothing but an empty formality, more particularly in the present appeal when this Court taking note of the order passed by the learned Single Judge imposing conditions and the same being in operation from 25.4.2016 has approved the same to be an appropriate interlocutory order considering the nature of the suit where all other issues are to be considered. 27. Because of the foregoing, and more particularly because the Division Bench did not keep in view the order of this Court dated 8.3.2019 to ensure analogous consideration of the interim applications of both sides in terms of this Courts earlier direction and having regard to the fact that the position prevailing since last three and a half years (pursuant to the learned Single Judges order dated 25.4.2016) have been upset without considering the issue of balance of convenience, we are persuaded to hold that the Division Bench was in error. Without analogous consideration of the appellants applications, the Court should not have unsettled the prevailing situation for the last three and half years, without final conclusion of the Reliance suit.

Decision (1 = appeal accepted, 0 = rejected): 1

Explanation:
1[ds]17. As permitted by the interim order dated 25.4.2016, the respondent no.3 launched their bio similar product TrastuRel and they have been in the market with their drug for the last about three and a half years. They have also participated in Government tenders and when certain doubts were raised on whether the drug TrastuRel is biosimilar with Trastuzumab, the High Court had intervened in favour of respondent no.3, in separate proceeding. However, while the interim order passed by the learned Single Judge did not stop the marketing of the drug TrastuRel, the Division Bench even while adverting to the concern raised by the learned Single Judge on the issues, which are to be determined when the suit is finally decided, allowed respondent no.3 the parity of operation with Biocon and Mylan. The Division Bench felt that respondent no.3 is on similar footing as Biocon and Mylan and therefore parity in marketing of their respective biosimilar product can be allowed18. In their challenge to the impugned order, the appellants have contended that in passing the impugned order, the Division Bench had failed to simultaneously consider and dispose of the pending appeals and the interim applications filed by the plaintiffs. We had earlier referred to the order passed by this Court on 8.3.2019 in SLP (C) No.6203/2019 which required the High Court to simultaneously take up the appeals and the interim applications filed by both sides. Although some of the contentions raised by the appellants counsel were taken into consideration, those submissions were examined by the Division Bench only in the context of the application filed by respondent no.3. On this aspect, the learned senior counsel for respondent no.3 submitted that non mentioning of the FAO and the IA of the appellants was an inadvertent omission. However such submission, in the face of the specific observation made by the Division Bench in paragraph 51 of the impugned order, cannot be accepted by us20. The fact that the Division Bench was singularly concerned with taking up the Reliances interim application is further established from the separate order passed on 16.7.2019 in FAO (OS) No. 132, 133, 226, 227 and 268 of 2016 which directs the applications (including the appeal and the application of the plaintiffs) to be listed on 11.2.2020. By way of a separate order, of the same date i.e. 16.7.2019, the Division Bench reserved orders on Reliances application. Therefore, it is difficult for us to accept as has been suggested by the learned Senior Counsel for the respondent no.3 that the segregation of the application of one party by the Division Bench, could be an inadvertent error21. In the above context, the Division Bench even without considering the appellants interim application through their observations in paragraph 57, had clearly shut out any scope for the appellants application to be heard and in effect, ordered on the application22. In the interim order passed by the learned Single Judge on 25.4.2016, the conditions imposed on Reliances product by the DCGI were taken into account. The said interim order was operating without causing much hindrance and respondent No. 3 was successful in participation in government tenders and supplies, with their drug. Therefore, the contrary submission made by the learned Senior Counsel for respondent no.3 is found to be incorrect23. As regards the contention made by Mr. Poorvayya that the condition imposed by the learned Single Judge on the packaging/labelling is contrary to the statutory prescriptions, it must be borne in mind that the arrangement ordered by the learned Single Judge has been in operation since 25.04.2016. Therefore without a final decision on the suit on the basis of relevant evidence, the continuing arrangement in our opinion should not have been disturbed, on this count24. The appellants suit before the Delhi High Court is not a trade mark action nor it is an attempt to enforce the appellants patent, which admittedly expired in 2013. The suit is an action for extended passing off and to prevent the respondent from using the appellants data and improper reference to its drug Trastuzumab. Therefore, the expiry of the appellants patent right on the drug Trastuzumab may not have any direct bearing on the contention raised in the Reliance suit25. As regards the submission on the timing of the suit and the other contentions raised on the approval secured from the Subject Expert Committee, these are matters which should appropriately be dealt with when the suit is finally decided. Those need not be factored in at this stage, in support of the impugned interim order26. Reverting back to the impugned order, the Division Bench had not only considered the contention raised by the appellants in paragraphs 41 to 50 but then rejected those, in paragraphs 52 to 60 of the same order. In such circumstances, directing the Division Bench to now consider the appellants appeal FAO No. 227/2016 and CM No. 26902 of 2016 would in our view be nothing but an empty formality, more particularly in the present appeal when this Court taking note of the order passed by the learned Single Judge imposing conditions and the same being in operation from 25.4.2016 has approved the same to be an appropriate interlocutory order considering the nature of the suit where all other issues are to be considered27. Because of the foregoing, and more particularly because the Division Bench did not keep in view the order of this Court dated 8.3.2019 to ensure analogous consideration of the interim applications of both sides in terms of this Courts earlier direction and having regard to the fact that the position prevailing since last three and a half years (pursuant to the learned Single Judges order dated 25.4.2016) have been upset without considering the issue of balance of convenience, we are persuaded to hold that the Division Bench was in error. Without analogous consideration of the appellants applications, the Court should not have unsettled the prevailing situation for the last three and half years, without final conclusion of the Reliance suit.