Cadila v. Roche —Mere Apprehension Of Litigation Not A Sufficient Cause Of Action For Suit

Justice Abhay Ahuja, presiding over the matter, held that Cadila's attempt to secure a blanket declaration against any future interference by Roche Products (India) Pvt. Ltd. was “misconceived, speculative, and without a present cause of action.”

The case centres around Cadila's biosimilar drug name “Vivitra”, which is a version of Trastuzumab, an anti-cancer biologic, originally developed by Genentech Inc. and further imported to India by Roche. Although no active patent existed on the molecule at that point in time, Cadila still filed a suit before the Bombay High Court in 2015, seeking declaratory and injunctive relief on the apprehension of legal obstruction by Roche.

Background: Biosimilars, Competition, and Litigation History

Trastuzumab is a biologic drug used in the treatment of HER2-positive breast cancer. Genentech, through Roche, had brought the drug to Indian markets as “Herceptin”. After patent expiry, Cadila sought and obtained regulatory approval to market its biosimilar version. Nevertheless, Roche had previously initiated litigation proceedings against other manufacturers of Trastuzumab biosimilars, including Mylan and Biocon. It is alleged that data exclusivity and regulatory non-compliance as the reasons for the initiation of litigation. Due to the anticipation of facing similar challenges from Roche, Cadila proactively filed a civil suit seeking a declaration from the court that Roche lacked any legal basis to question its drug.

Cadila's Suit sought:

1- A declaration affirming that it had lawfully launched its drug Vivitra;

2- A declaration that Roche had no authority to question its regulatory approvals; and

3- A permanent injunction thereby restraining Roche from interfering with its product in any manner.

Roche opposed the plaintiff's claim by filing an application under Order VII Rule 11 of the Code of Civil Procedure, contending that the plaintiff failed to disclose a valid cause of action and was even barred by law.

Court: No present cause of action, Suit based solely on apprehension

The court observed that, at the time of filing the suit, Cadila had not pointed to any specific or tangible act of interference by Roche. The plaint did not include any pleading showing that Roche had threatened litigation or sent legal notices. The plaintiff's case was based entirely on a "mere apprehension" derived from Roche's conduct with third parties.

“A plaint must disclose a clear, present, and actionable legal right,” the Court emphasised, citing the Supreme Court's judgment in Dahiben v. Arvindbhai Bhanusali.^[3] “A speculative fear of litigation cannot justify invoking the civil jurisdiction of this Court.”

The Court noted that Cadila had already launched Vivitra in December 2015, before filing the suit. The product had remained on the market for nearly a decade, with no direct restraint from Roche.

Reliefs Barred Under Section 41(b) Of The Specific Relief Act

Section 41(b) of the Specific Relief Act bars courts from granting injunctions that restrain persons from instituting legal proceedings. Roche argued that the primary relief Cadila sought was essentially to prevent it from filing any suit against the biosimilar drug.

Agreeing with this submission, the Court held: “Cadila seeks to restrain the defendants from interfering with its product. That includes, in effect, stopping them from challenging its product in court. Such a relief is expressly barred under Section 41(b).”

The judgment reinforces the principle that the civil court cannot be used to shield a party from potential legal actions. The Bombay High Court cited the Apex Court's decision in Cotton Corporation of India v. United Industrial Bank Ltd^[4], and reaffirmed that the authority to curb vexatious litigation lies with the legislature and not at all with the civil courts acting in anticipation of such litigation.

Suit Rendered Infructuous By Launch And Pending Proceedings

The court further held that Cadila's suit had become infructuous, as the drug Vivitra had already been launched and had not encountered any legal obstruction in the market. Also, the pendency of a separate suit, which was filed by Roche in the Delhi High Court in 2016, challenging the regulatory approval of Trastuzumab biosimilars ( including Vivitra) was duly noted.

While defending itself, Cadila argued that Roche's continued assertion of legal rights, even in the Delhi High Court, validated its fear of legal interference and thus kept the cause of action alive. However, the Bombay High Court was not persuaded by this reasoning and reiterated the same fact that mere apprehension without any direct interference was insufficient to sustain the suit.

“Once the product was launched, and in the absence of any interference, the cause of action ceased to exist. The pendency of the Delhi suit is a separate and subsequent proceeding; it cannot validate a speculative suit filed earlier.”

Regulatory Approvals Fall Outside Civil Court Jurisdiction

Among all the relief sought, Cadila requested a declaration affirming that its product had been lawfully approved under the Drugs and Cosmetics Act. However, the court held that civil courts lack the jurisdiction to adjudicate on the validity of regulatory approvals.

The Court noted: “Granting a declaration on the correctness of regulatory approvals lies within the domain of statutory regulators or the writ jurisdiction of constitutional courts, not within the scope of private civil suit.”

The above reasoning resonated with well-settled principles of regularity jurisprudence that draw a clear line between private civil disputes and administrative issues, particularly where specialised statutory bodies are thereby entrusted with technical oversight.

No Immunity From Lawful Litigation

Another important action that the Court took was to reject Cadila's request for blanket immunity against potential legal proceedings by Roche. Justice Ahuja stated that every party has the right to approach the court under the law, and no civil courts can entertain suits that are aimed at prospectively retraining this right. The court observed: “Even if litigation is anticipated or imminent, courts cannot prohibit a party from pursuing lawful remedies. The appropriate safeguard against frivolous or vexatious litigation lies in the imposition of costs or invoking the court's powers to prevent abuse of process, not in preemptive civil suits.”

Legal Significance And Industry Implications

The decision of the Bombay High Court is not only limited to this particular dispute at hand but also extends far beyond, thereby marking an important precedent in how Indian courts treat speculative or anticipated litigation. The judgment delivers a clear message against the practice of filing suits to pre-empt potential legal challenges, which are mostly common in pharmaceutical companies or intellectual property sectors, where companies usually attempt to insulate their products from anticipated disputes. The High Court further reinstated the requirement that all civil suits must be grounded in a concrete and existing cause of action, not merely in speculative apprehensions. This particular principle is affirmed through the strict application of Order VII Rule 11 of the Civil Procedure Code.

Apart from this, the court invoked Section 41 (b) of the Specific Relief Act, 1963, which further prohibits injunctions that restrain someone from initiating legal proceedings.

The Bombay High Court's ruling in Cadila Healthcare Ltd. v. Roche Products (India) Pvt. Ltd^[5]. reaffirms a core principle of Indian Civil Procedure, which states that specific live or anticipatory litigation is not maintainable. In an age where competitive sectors, particularly pharmaceutical and intellectual property, frequently resort to preemptive legal strategies to secure market advantage or protect innovation.

By dismissing the suit as barred, infructuous and devoid of any valid cause of action, the Court has reinforced the importance of procedural integrity in commercial litigation. It reinforces that the right to access the courts cannot be invoked to preclude hypothetical disputes, even in high-stakes sectors, one of them being pharmaceuticals.

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