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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 Reliance Suit Plaintiffs in O.S. No. 181/2016 DCGI 3.5.2013 but they sought to restraint respondent no.3 from representing their product ‘TrastuRel’, as biosimilar to ‘Trastuzumab’

4. According to the appellants, the biosimilar product in India to be launched by respondent no.3, has not been tested as a biosimilar drug in accordance with the law under the Drugs and Cosmetics Act, 1940 5 and other applicable norms and guidelines with the projection that the respondent no.3 has not undertaken requisite chemical trials and has not also generated adequate data to establish, inter alia, the safety, efficacy and immunogenicity of the drug-‘TrastuRel’, manufactured by respondent no.3.

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 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:

3. The order passed by this Court on 8.3.2019 related to the FAO (OS) No.181/2016 and FAO (OS) No.227/2016.

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 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.