M/s Genentech Inc. & Ors. vs Drugs Controller General of India & Ors.

HELD: 1. As permitted by the interim order dated 25.4.2016, the respondent no.3 launched their biosimilar 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 Single Judge of the High Court did not stop the marketing of the drug ‘TrastuRel’, the Division Bench of the High Court even while adverting to the concern raised by the 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 ‘B&M’. The Division Bench of the High Court felt that respondent no.3 is on similar footing as ‘B&M’ and therefore parity in marketing of their respective biosimilar product can be allowed. [Para 17] [329-D-F]

2. In their challenge to the impugned order, the appellants have contended that in passing the impugned order, the Division Bench of the High Court had failed to simultaneously consider and dispose of the pending appeals and the interim applications filed by the plaintiffs. This Court 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 of the High Court only in the context of the application filed by respondent no.3. On this aspect, the 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 of the High Court in the impugned order, cannot be accepted. [Para 18] [329-G-H; 330-A-B]

3. When the impugned order of the Division Bench of the High Court is read in the context of the express direction of this Court, it is clearly discernible that the Division Bench of the High Court had only considered the appeal and application filed by respondent no.3 on merit; without entertaining the appellants’ application. [Para 19] [330-B-C]

4. 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. [Para 24] [331-CD]

5. Reverting back to the impugned order, the Division Bench of the High Court had not only considered the contention raised by the appellants but then rejected those, in the same order. In such circumstances, directing the Division Bench to now consider the appellant’s appeal and application would be nothing but an empty formality, more particularly in the present appeal when this Court taking note of the order passed by the 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. [Para 26] [331-FG]

6. 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 Court’s earlier direction and having regard to the fact that the position prevailing since last three and a half years (pursuant to the Single Judge’s order dated 25.4.2016) have been upset without considering the issue of balance of convenience, this Court is persuaded to hold that the Division Bench was in error. Without analogous consideration of the appellant’s applications, the Court should not have unsettled the prevailing situation for the last three and half years, without final conclusion of the respondent no.3’s suit. [Para 27] [331-H; 332-A-B]