Edwards Lifesciences v Meril & Ors (UPC_CFI_380/2023)
Decision date:
21 July 2025
Osborne Clarke summary
- This decision concerned the alleged infringement of Edwards' patent concerning a "delivery system" product which enables a cardiac surgeon to implant a heart value using minimally invasive techniques (avoiding the need for open-heart surgery). Meril was a medical device company and created the Navigator which also included a balloon catheter delivery system. Meril raised revocation counterclaims. Edwards also made conditional applications to amend the patent.
- With regard to the skilled person, the parties agreed that this would be a team. Edwards argued that the team would be composed of a medical device engineer and an interventional cardiologist. Meril argued that it would also include a cardiac surgeon. The Nordic-Baltic RD disagreed with Meril, noting that including a cardiac surgeon would be "unnecessary" since the surgery the apparatus claimed in the patent would be catheter-based cardiac procedures and an interventional cardiologist would be familiar with this. Nonetheless, the court noted obiter that the outcome of the case would have been the same if a cardiac surgeon had been on the team.
- With respect to claim construction, the Nordic-Baltic RD decided that Meril's position on claim interpretation (specifically in regard to the meaning of "elongated shaft" in the patent) was not supported by the patent and was therefore incorrect. The court held that the skilled person would take the broader view that the technical object of the patent and solution specified in the patent's claims was independent from the construction of the catheter and applied to catheters in general.
- Meril's validity attacks were based on added matter, lack of inventive step and insufficiency. Meril relied on combinations of prior, as well as a combination of prior art and prior use of the CoreValue system, and prior art and CGK. None of the invalidity attacks were successful and Edwards' patent was upheld as amended.
- With regard to infringement, because the court favoured Edwards' claim construction, it also concluded that Meril's device literally infringed claim 1 as amended (AR 1).
- Overall, the patent was found to be valid and infringed. An injunction against each defendant was granted. Meril had argued that the court should exercise its discretion under Article 63(1) UPCA and refrain from ordering an injunction because it would be disproportionate due to overriding public heath interests. Edwards countered by arguing that even if the court could refrain from issuing an injunction based on proportionality, any balancing of interests would favour it. The Nordic-Baltic RD did note that Article 63(1) UPCA explicitly states that the court "may" issue an injunction and therefore it has the possibility of refraining from issuing one. This means that the court is expected to consider counterarguments presented by the defendant(s), which includes arguments based on proportionality. Despite this, the court was also clear that the main function of a patent is to give the proprietor a right to prevent others from using the invention during the term of protection (Article 25(a) UPCA). The possibility of applying for and being granted a compulsory licence should be taken into account but where the court finds a patent has been infringed, a request for an injunction should normally be granted.
- In this case, there was no reason to refrain from granting the injunction because Meril's public interest argument primarily focused on the public's need for its prosthetic valves and not the delivery device that was the subject of these proceedings. As such, the court granted an injunction and imposed an obligation to comply with it subject to a penalty of €10,000 for each violation. Importantly, the court held that the placing on the market of each individual infringing product should be considered a separate violation of the injunction.
- In addition to the injunction, the court also issued a declaration of infringement according to Article 64(2)(a) UPCA and ordered the recall and removal of the infringing products from the market and their destruction. The court also permitted Edwards' request for information relating to products that have been the subject of an infringing act since the patent was granted and awarded damages, with an interim award of €500,000.
Issue
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