Bombay HC Upholds Rejection Of Cadila (Now Zydus) Trastuzumab Suit, Says Mere Fear Of Roche Interference Was No Cause Of Action Despite Sales Since 2015

Cadila obtained regulatory approvals and a manufacturing licence to launch its biosimilar of Trastuzumab, after Roche’s formulation patent had expired.

Cadila sued Roche, seeking declarations of its right to launch and market the biosimilar and an injunction against Roche interfering with its launch and marketing.

Cadila based its claim on Roche’s proceedings against other manufacturers and Roche’s published position paper stating it would take necessary steps regarding biosimilar claims.

Roche sought rejection of the plaint under Order VII Rule 11 CPC, arguing that it disclosed no cause of action and that the suit was barred by Section 41(b) of the Specific Relief Act.

The Single Judge allowed the application; Cadila appealed.

Under Order VII Rule 11(a) and (d) CPC, a plaint may be rejected if, on a meaningful reading of the plaint as a whole, it discloses no cause of action or the suit appears from the plaint’s statements to be barred by law.

The court must assess the plaint and its pleaded basis for relief, without isolating passages or adding to or subtracting from the pleadings; a cause of action created by clever drafting or an illusory claim may be rejected at the threshold.

The Court relied on T. Arivandandam v. T.V. Satyapal and Dahiben v. Arvindbhai Kalyanji Bhanusali for these principles.

Section 41(b) of the Specific Relief Act prohibits an injunction restraining a person from instituting or prosecuting proceedings in a court not subordinate to the court granting the injunction.

The Court also held that a suit becoming infructuous was not, by itself, a ground for rejection under Order VII Rule 11.

Reading paragraphs 44–51 of the plaint together, the Court found that Cadila’s pleaded cause of action was its apprehension that Roche would initiate proceedings similar to those brought against other manufacturers.

The pleaded defences—that Roche lacked standing or rights to prevent the biosimilar’s launch—addressed a possible future suit rather than an existing actionable interference.

The position paper, read in context, described action concerning products claimed to be biosimilars without supporting scientific evidence; it did not establish that Roche had interfered with Cadila’s product.

The Court also noted that Cadila had launched and marketed the product since 2015 without interference.

In the Court’s view, the substance of the suit also sought to prevent Roche from bringing legal proceedings, attracting Section 41(b); Roche had in fact filed proceedings in the Delhi High Court, which Cadila was defending.

The Court did not treat the launch of the product as making the suit infructuous, but held that this did not affect rejection for want of a cause of action.

It dismissed the appeal and upheld the Single Judge’s order rejecting the plaint under Order VII Rule 11 CPC.