SLP against Del HC Order Granting Permission to Market New Biosimilars for Additional Indications Withdrawn

It is reported that Roche has withdrawn the SLP against Delhi HC judgment that granted permission to market new biosimilars for additional indications. As per Livelaw, the Supreme Court bench of Justices R.K.Agrawal and Abhay Manohar Sapre, noted in its Order, on August 11: “A letter has been circulated by learned counsel for the petitioners seeking permission to withdraw these Special Leave Petitions.  Permission granted. The Special Leave Petitions are dismissed as withdrawn.” The Order is available here.


SpicyIP has extensively covered the ongoing legal battle involving Roche and Biocon-Mylan. In March, 2017, Division Bench of the Delhi High Court passed an interim order allowing Biocon and Mylan to market their biosimilar of Roche’s drug, Herceptin, for two additional indications: early breast cancer and metastatic gastric cancer. Earlier, vide judgment delivered by Justice Manmohan Singh, Biocon and Mylan had permission to market their product for metastatic breast cancer only. [here and here]

The lawsuit was filed by Swiss company Roche against the Drug Controller General of India (DCGI), Biocon and Mylan over the approval process followed during the grant of approvals for the biosimilar of Herceptin.

Recent Development

It may be noted that Roche has not withdrawn the  CS (OS) 355/2014 which was decided by Justice Manmohan of the Delhi High Court in 2016.  Also, FAO(OS) 132/2016, 133/2016 and 226/2016 are pending.

The original suit dealt with the following questions and specifically speaking, did not deal with any issue with respect to any patent (as reported by Livelaw): i) Whether the Plaintiffs’ (Roche and Others’) claim challenging the validity of the approval was maintainable directly in the High Court, considering that they had not exhausted other remedies; ii) The scope of the court’s power to review the legality of the approvals granted to Biocon and Mylan to market the biosimilar version of Trastuzumab; iii) Determination of the legal importance and binding character of the Biosimilar Guidelines, 2012, especially with reference to its application to the approval granted to Biocon and Mylan; iv) The legal tenability of the DCGI’s decision to grant approval even though phase 1 and 2 clinical trials were not conducted; and v) Ascertaining the legal sustainability of the Plaintiffs’ (Roche and others’) common law claims of misrepresentation and false information against the defendants.


The reasons for Roche’s decision are not known. Without making any imputation whatsoever (in the light of absence of verifiable information), I would like to draw your attention to the recent CCI Order wherein CCI ordered investigation against pharma major Roche with respect to the cancer drug, Trastuzumab. The complaint was filed by Biocon and Mylan Pharmaceuticals. In this Order, the CCI observed that the right to bring civil litigation and other claims to assert or defend key interests is a legal right. Further, “such right should not be interfered with, except when warranted by special circumstances. Mere fact that litigation was ultimately unsuccessful does not render it vexatious. However, in exceptional cases, the legal processes can be pursued by a dominant enterprise as a tactic to exhaust smaller rivals’ resources and delay or prevent their  entry  in the relevant market. Where anticompetitive litigation of this kind by a dominant enterprise is identified, it amounts to an abuse within the meaning of the Act. Though there cannot be any straightjacket formula for identifying such exceptional circumstances, there can be certain guiding factors which may help in examining a case. First, it needs to be established that the impugned legal action, on an objective view, is baseless and appears to be an instrument to harass the defendant/respondent; and, Second, the legal action appears to be conceived with an anti-competitive intent/plan to eliminate competition.”  (Paragraph 62).

H/T: We thank Mr. Sandeep K. Rathod for sending us the SC Order.

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