The principle of “clearing the way” has become a significant, though non-statutory, aspect of Indian patent litigation, particularly in cases involving interim injunctions. This concept, borrowed from UK and European patent law, expects a party intending to enter a market to address any known patent obstacles in advance rather than adopting a “launch first, litigate later” strategy.

At its essence, the clearing-the-way principle scrutinises the actions of an alleged infringer (generally a generic manufacturer) especially if the Defendant was aware of an existing patent and proceeded with commercial preparations or a launch without seeking revocation, a declaration of non-infringement, or otherwise resolving the patent issue.

Origin and Judicial Recognition in India

Indian courts have consistently clarified that clearing the way is not a legal requirement under the Patents Act, 1970. Nevertheless, it is considered an equitable factor while assessing the three-factor test for interim injunctions that is a) prima facie case b) balance of convenience, and c) irreparable harm.

One of the earliest and most cited recognitions of this principle is found in Merck Sharp & Dohme Corp. v. Glenmark Pharmaceuticals Ltd. (2015, Delhi High Court. FAO (OS) 190/2013, C.M. APPL. 5755/2013, 466/2014 & 467/2014). The Court noted that if a defendant knowingly launches a product despite a subsisting patent without first challenging it, such behaviour may count against them when the equities are balanced at the interim stage. The Court observed if a defendant is aware that there may be a possible challenge to its product, but still chooses to release the drug without first invoking revocation proceedings or attempting to negotiate, that is surely a relevant factor. Although the final decision of this case was based on validity and infringement, the rationale on clearing the way has been frequently cited in subsequent cases.

Application by the Delhi High Court

The Delhi High Court has applied this concept with increasing sophistication, particularly in pharmaceutical and biotechnology disputes.

1. In FMC Corporation v. Natco Pharma Ltd (CS(COMM) 607/2024 & I.A. 34151/2024), the Court refused to grant a quia timet injunction, observing that the defendant had cleared the way by filing a revocation petition and disclosing its product before commercial manufacture. The defendant’s proactive challenge to the patent tilted the balance of convenience in its favour, showing how clearing the way can be used defensively to resist interim relief. The court noted:

   A defendant can avoid an interlocutory injunction where litigation is inevitable, provided it “clears the way first”, which can be done by filing revocation proceedings or seeking a declaration of non-infringement before commencing commercial manufacture or sale.

2. More recently, in Novo Nordisk A/S v. Dr. Reddy’s Laboratories Ltd. (CS(COMM) 565/2025 & CRL.M.A. 21608/2025 I.A. 14076/2025, I.A. 17699/2025 I.A. 17802/2025 I.A. 18374/2025 I.A. 19205/2025, I.A. 19361/2025), the Delhi High Court emphasised the defendants’ failure to clear the way before starting the manufacture of semaglutide. Despite raising substantial challenges to validity, the Court held that their decision to proceed without first initiating revocation proceedings reflected poorly on their conduct, justifying the continuation of interim protection in favour of the patentee.

   The court noted that the Defendants have failed to clear the way before they started manufacturing, which shows their procedural mala fide. It is pertinent to note that, after the Genus Patent/IN 275964 (‘964) had expired, the Defendants had applied for a license to the Plaintiff for manufacturing the Semaglutide compound. The Defendants were therefore aware and conscious of the existence of the Suit Patent/ IN 262697 (697), and it failed to ‘clear the way’ before commencing manufacturing in India. The Defendants have a history of litigation vis-à-vis the Semaglutide compound in USA and therefore the Defendants are well aware about the Plaintiff’s proprietary claims. The Defendants however chose to set up its manufacturing facilities in India and commence manufacturing without challenging the Suit Patent/IN’967. The court noted that the prudent defendant has a burden to file a revocation petition or a suit for declaration of non-infringement against the patent that they might infringe through their manufacturing activity and therefore there is no balance of convenience in their favour so as to entitle them to sell the impugned drugs in India until the expiry of Suit Patent/IN’697.

3. Similarly, in biologics and biosimilar litigation, such as E. R. Squibb And Sons, Llc & Ors vs Zydus Lifesciences (CS(COMM) 376/2024 & I.A. 10533/2024), the Court has considered whether the defendant, despite being aware of patent claims and oppositions, took adequate steps to resolve the patent dispute before nearing commercial launch.

Limits of the Doctrine

Indian courts have also cautioned against over-reliance on this principle. Failure to clear the way does not automatically entitle a patentee to an injunction, nor does it shift the burden of proving validity. It remains one factor among many, and strong prima facie evidence of patent invalidity can still outweigh considerations of conduct.

Conclusion

The concept of clearing-the-way in Indian patent law strikes a balance between encouraging responsible market entry and preventing the abuse of patent monopolies. While not a statutory mandate, it significantly influences interim injunction jurisprudence, indicating that courts will closely examine the timing, intent, and fairness of a defendant’s actions when equitable relief is sought. The decided cases mentioned above would show that the Courts would examine whether a defendant, aware of a patent, took proactive steps, such as filing a revocation petition or seeking a declaration of non-infringement, before commencing commercial manufacture or launch. Also, proactively clearing the way can tilt the balance of convenience in the defendant’s favour, while failure to do so reflects procedural mala fides and can justify granting interim relief to the patentee. The principle serves as a safeguard against companies launching products without resolving patent issues, encouraging them to settle disputes beforehand.