M/S Genentech Inc. vs Drugs Controller General Of India

under the brand name HERCEPTIN, HERCLON and BICELTIS. The drug ‘Trastuzumab’ is approved globally for treatment of cancer. The suit before the Delhi High Court came to be filed seeking to inter alia restrain respondent No.3-M/s Reliance Life Sciences Pvt. Ltd. from launching, marketing or selling ‘TrastuRel’, the biosimilar version of the appellants drug ‘Trastuzumab’. In the suit, the approval granted by respondent no.1-Drugs Controller General of India 4 to M/s. Reliance Life Sciences Pvt. Ltd. for the manufacture and marketing ‘TrastuRel’, was also challenged. The suit was filed at a stage when respondent no.3 was yet to introduce their drug in the market. The appellants had obtained patent for the drug ‘Trastuzumab’ but the same had lapsed on 2 Reliance Suit 3 Plaintiffs in O.S. No. 181/2016 4 DCGI Page 2 of 21 3.5.2013 but they sought to restraint respondent no.3 from representing their product ‘TrastuRel’, as biosimilar to ‘Trastuzumab’

6. Prior to the Reliance suit filed against respondent no.3, the appellants had filed the suit being CS (OS) No. 355/2014 against F. Hoffmann-La Roche, AG, their associate Mylan Inc, seeking similar 5 The Act Page 3 of 21 restraint against purported biosimilar version of the appellants drug, “Trastuzumab”. Biocon and Mylan were however already in the market by selling their products “Trastuzumab’ - ‘CANMab’ and ‘Trastuzumab’-‘HERTRAZ’ in the market.

7. The High Court of Delhi passed respective orders on 5.12.2014,14.2.2014 and 28.02.2014 in the Biocon’s suit and permitted Biocon and Mylan to market their drugs subject to the conditions that they would not claim bio similarity with the appellants’ product HERCEPTIN, HERCLON and BICELTIS. However, in the Reliance suit, the learned Single Judge was of the prima facie view that the approval by the DCGI for the biosimilar drug of respondent no.3, was far more egregious than in the case of the drug marketed by Biocon. Accordingly, an interim order was passed on 2.11.2015 in the Reliance suit whereby respondent no.3 was restrained from launching and selling their product ‘TrastuRel’ in India, until the next date of hearing. In the Biocon and the Reliance suits, the appellants had claimed that the biosimilar version of the appellants ‘Trastuzumab’, were being launched without the required test and studies under the applicable laws requiring conducting of tests and obtaining of appropriate approval from the regulatory authority including the DCGI. The appellants’ injunction application was ordered Page 4 of 21 by the learned Single Judge on 25.04.2016. The Court recorded the prima facie finding that ‘TrastuRel was approved by the DCGI under applicable law. The learned Single Judge observed that the approvals granted to ‘TrastuRel’ product are not on the basis of the adherence of the Guidelines 2012 and rules framed under the Drug Act. However, it was observed that the final finding in this respect is yet to be arrived after the suit is heard and completion of the trial. Accordingly, while permitting respondent no.3 to launch and market ‘TrastuRel’ on the basis of the approval from the DCGI, certain conditions were imposed by the learned Judge to safeguard public health and safety as also to protect the innovator of the biosimilar drug ‘Trastuzumab’. The relevant stipulations of the learned Single Judge are noted as follows:

12. The Division Bench of the High Court thereafter considered the FAO (OS) No.181/2016 and the C.M. Appln. No.22510/2016 filed by respondent no.3 against the interim order passed by the learned Single Judge on 25.04.2016 whereunder, respondent no.3 was permitted to launch and market their product ‘TrastuRel’ without projecting the same Page 8 of 21 as biosimilar to the appellants’ drugs HERCEPTIN, HERCLON and BICELTIS. Under the impugned order dated 18.9.2019, the Division Bench allowed the application of respondent no. 3 and granted interim stay of the learned Single Judge order dated 25.04.2016 in terms of the orders dated 28.4.2016 and as clarified vide order dated 3.3.2017, in the FAO (OS) Nos.132/2016 and 133/2016, filed by Biocon and Mylan. The Court justified the interim order by observing that the regulatory authorities have granted their approval to the biosimilar drug of respondent no.3 and prima facie the said approval cannot be considered to be illegal. But it was not possible to determine at that stage, whether respondent no.3 has conducted the requisite trials as are prescribed for a bio similar drug. The Division Bench held that in the face of the expiry of the patent in favour of the plaintiff, their locus standi to file the suit was considered to be relevant issue to be determined and the possibility of the suit being filed with the objective of stifling competition was taken into account and accordingly relief was granted to respondent no.3 in marketing their product ‘TrastuRel’ on the same terms, as was granted to Biocon and Mylan.

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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.

28. In view of the aforesaid, the impugned order is set aside and appeal is allowed. The interim direction given by the learned Single Judge on 25.4.2016 is accordingly made operational. At the same time, as the Reliance’s suit is pending since 2016, the High Court is requested Page 20 of 21 to dispose of the CS (OS) No. 3284/2015 expeditiously and preferably within 12 months of receipt of this order. In the meantime, to avoid prejudice to respondent No. 3, whenever government procurement is proposed for the drug by its generic name ‘Trastuzumab’, the Reliance should be allowed to participate with their biosimilar product, without any impediment. It is made clear that the views expressed here is only for the purpose of this appeal and should have no bearing in the proceeding pending in the High Court.

29. With the above order, the appeal stands allowed without any order on cost.