The recent High Court decision in Dr Reddy's Laboratories (UK) Ltd v Boehringer Ingelheim International GmbH [2025] EWHC 2834 (Pat) offers important practical insights for life sciences companies navigating patent litigation and generic product launches.

The facts

Dr Reddy's Laboratories (UK) Ltd (Dr Reddy's) sought to revoke Boehringer Ingelheim International GmbH (Boehringer) Supplementary Protection Certificate (SPC) and two patents covering empagliflozin, a treatment used for treatment of type 2 diabetes, heart failure, and chronic kidney disease. Dr Reddy's planned to launch a generic version of empagliflozin in the UK but faced an application for an interim injunction from Boehringer to prevent the launch, pending trial for the revocation proceedings.

The court granted the injunction pending the outcome of the trial which is scheduled for October 2026. It found that damages would be an inadequate remedy for either party if the injunction was wrongly granted or withheld. Crucially, the court emphasized that Dr Reddy's had failed to "clear the path" in that it had not initiated revocation proceedings early enough before its intended launch.

Key takeaways for life sciences companies

Aligning commercial timelines with legal strategy is essential to avoid a target launch date being over-shadowed or put on hold by an unresolved IP dispute. Pharmaceutical companies planning to launch generic or biosimilar products should seek to proactively “clear the path” by challenging any relevant patents and SPCs well in advance of the intended commercialisation date, and build this in to timelines from the outset. 

Without sufficiently “clearing the path” in advance, generic manufacturers risk being subjected to interim injunctions and the significant commercial consequences they entail, including lost revenue, delayed market/patient access, and reputational damage. The court’s finding that damages would be inadequate for either party underscores the high stakes involved in IP litigation in the life sciences sector.

Concluding remarks

The Dr Reddy’s v Boehringer case is a timely reminder that IP strategy must be integrated into commercial planning from the outset. For originators, this case highlights the value of robust patent portfolios and the strategic use of injunctions to protect market exclusivity for as long as possible. For generics, it’s a cautionary tale about the risks of rushing to launch before fully navigating and resolving the complexities of the IP landscape. A well-prepared legal strategy can be the difference between a successful launch and a costly delay.