Background of the Case:
In the case presented before the High Court of Delhi, BDR Pharmaceuticals International Pvt Ltd (BDR) and Kudos Pharmaceuticals Limited ("Kudos") were embroiled in a dispute over the patent rights to the compound Olaparib, a prominent cancer treatment drug marketed under the brand name "LYNPARZA". The subject of the lawsuit was Indian Patent No. IN 2287201 (referred to as IN'720), which covered the Olaparib compound.

When the suit was filed, the patent was nearing its expiration date, which introduced significant urgency and complexity to the proceedings. Kudos, as the patent holder, sought to protect its exclusive rights in the period leading up to the expiration, while BDR, the alleged infringer, had already launched a product containing Olaparib into the Indian market. The dispute over these rights raised questions about the scope of remedies available post-expiration, specifically concerning the injunctive relief sought by Kudos to halt BDR's sale of Olaparib-containing products.

Issue of the Case:
The central issue before the court was whether Kudos was entitled to an interim injunction to prevent BDR from continuing to deal in products containing Olaparib, despite the fact that the suit patent (IN'720) was on the verge of expiration. Kudos also sought an order compelling BDR to deposit all revenues earned from the manufacture and sale of Olaparib in India with the court, covering the period from BDR's first launch until the patent expired.

This case posed an important question for patent law: could an injunction be granted in respect of a patent that was about to expire, and could the court order financial restitution even after the expiration of the patent? Additionally, the broader legal implications involved the interpretation of fundamental patent law principles, such as the differentiation between patent "coverage" and "disclosure"—issues that extend beyond the immediate life of the patent.

Contentions of the Parties:

Kudos Pharmaceuticals' Contentions:

Kudos Pharmaceuticals argued that BDR had acted improperly by launching its Olaparib product before the expiration of the IN'720 patent. Kudos claimed that this action constituted patent infringement and should result in injunctive relief, irrespective of the patent's imminent expiration. Their key arguments included:

• Broader Legal Questions: Kudos stressed that the case involved significant legal questions related to patent law, particularly the difference between "coverage" (the scope of claims) and "disclosure" (the information made available in the patent specification). They urged the court to adjudicate on these matters, arguing that the outcome would have broader implications for future patent jurisprudence.
• Sales Revenue Deposit: In addition to the injunction, Kudos sought a direction from the court that BDR deposit all revenues earned from the sale of Olaparib into the court's registry. This deposit was seen as a precautionary remedy to safeguard Kudos' financial interests pending the final adjudication of the case.
• Continuing the Proceedings: Kudos argued that the court should continue to adjudicate the injunction application even though the patent was nearing expiration, citing the importance of addressing misconduct and protecting their commercial interests during the residual period of the patent.

BDR Pharmaceuticals' Contentions:

BDR Pharmaceuticals took the position that an injunction could not be granted once the patent had expired, as there would be no legal basis to prevent the continued sale of their Olaparib product once the exclusive rights conferred by the patent ceased to exist. Their key arguments included:

• Futility of Injunction Post-Expiration: BDR argued that an injunction would serve no purpose since the patent was on the verge of expiring, and once expired, Kudos would have no right to exclude them or any other competitor from selling the Olaparib product.
• No Misconduct: BDR denied any misconduct, maintaining that they had complied with the legal requirements and had launched their product lawfully in accordance with Indian patent law. They contended that any deposit of sales revenue should only be ordered if they were found liable for infringement after a full trial.
• Pending Appeal: BDR further argued that the matter was already the subject of an appeal before the Division Bench, which would ultimately resolve the issues between the parties. As such, the continuation of the injunction proceedings in the trial court was unnecessary and would only prolong litigation without substantive benefit.

The High Court was faced with several critical issues:

• The Right to Injunction Post-Patent Expiration: Could Kudos still seek an injunction to stop BDR from dealing in the patented product when the patent was only days away from expiring? This question hinged on whether the right to exclude others from using a patented invention remained enforceable through injunctions once the patent expired.
• Coverage vs. Disclosure in Patent Law: The case involved nuanced legal questions about how the claims of a patent (coverage) should be interpreted in light of the technical information disclosed in the patent specification (disclosure). This distinction is critical in patent law and influences how broadly a patent can be enforced.
• The Request for Revenue Deposit: The court had to decide whether BDR should be ordered to deposit its sales revenues from Olaparib into the court's registry as a form of financial security pending the outcome of the trial. The question here was whether this was an appropriate remedy, given that the patent was expiring imminently.
• Urgency of the Matter: Given the imminent expiration of the patent, the court had to determine whether there was sufficient urgency to continue hearing the injunction application or whether the focus should shift to other forms of relief, such as damages or an account of profits.

Reasoning and Final Decision:
The court, after careful consideration of the issues, made the following observations:

1. No Injunction Post-Expiration: The court recognized that once a patent expires, the right of exclusivity granted to the patent holder is extinguished. This means that any ongoing sale or use of the patented invention after expiration does not constitute infringement, as the product enters the public domain. Since the IN'720 patent had expired by the time the case was being heard, the court held that it was legally impossible to grant injunctive relief against BDR to stop the sale of Olaparib-containing products.
    
2. Coverage vs. Disclosure: While the court acknowledged the importance of the issues surrounding patent coverage and disclosure, it concluded that these questions were academic in this case due to the patent's expiration. However, it noted that these issues could still be explored during the full trial, particularly when assessing any claims for damages or profits earned prior to expiration.
    
3. Revenue Deposit: The court rejected Kudos' request for BDR to deposit its revenues from the sale of Olaparib into the court's registry. The court noted that any remedy in the form of monetary compensation, such as damages or an account of profits, would be appropriately decided after the trial concluded, once liability was determined.
    
4. Appeal Proceedings: Given that an appeal was pending before the Division Bench on a related issue, the court refrained from taking any further substantive steps in the matter. It deferred to the Division Bench's ultimate resolution of the issues between the parties.

In light of these findings, the court dismissed the injunction application, holding that no injunction could be granted post-expiration of the patent. The case was set to proceed to trial for the determination of damages or other monetary remedies, if any.

Conclusion:
This case reaffirms the legal principle that injunctive relief is tied to the existence of an enforceable right, which, in patent law, ceases to exist once the patent expires. After expiration, patent holders are no longer entitled to prevent others from using or selling the patented invention. However, the court can still adjudicate on claims for damages or an account of profits for infringing activities that occurred before expiration.

Case Citation: Bdr Pharmaceuticals Vs Kudos Pharmaceuticals: 25.09.2024: Co Comm IPD PAT 1 of 2024:Delhi High Court:Sanjeev Narula, H.J.

Disclaimer:
The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor - Patent and Trademark Attorney
Email: [email protected], Ph no: 9990389539