In a groundbreaking decision that could reshape the balance between intellectual property rights and public health, a court has ruled that a medical device manufacturer found guilty of patent infringement can continue supplying certain versions of its products. But here's where it gets controversial: the ruling was made to protect patients' health, raising questions about where the line should be drawn between legal obligations and ethical responsibilities.
The Unified Patent Court (UPC) in Paris recently determined that Meril Life Sciences (Meril) had infringed a European patent held by Edwards Lifesciences Corporation (Edwards) for a prosthetic heart valve and its delivery system. The patent, a third-generation divisional patent, was deemed valid, and the court issued an injunction preventing Meril from selling its competing product in countries where the patent is active. However, and this is the part most people miss, the injunction did not cover all versions of Meril’s valve.
The Paris court recognized a critical public interest issue: Meril is the sole manufacturer of an extra-large version of the valve, essential for patients with aortic stenosis, a condition where the aortic valve narrows. Without this specific valve, these patients would lack adequate treatment options. The court emphasized that to invoke a public interest defense, it must be proven that the product is the only available treatment or offers a significant improvement over existing methods, leading to better patient care. This exemption remains in place only until an equivalent treatment becomes available.
Sarah Taylor, a life sciences patent litigation expert at Pinsent Masons, noted that this case offers valuable lessons for both sides in patent disputes. While injunctions remain a key remedy for infringement, they can be limited in cases where public interest is at stake. Boldly highlighting a point of contention, Taylor suggests that businesses defending against injunctions should explore narrowing their scope when public health is a genuine concern. Conversely, those seeking injunctions must be aware that their relief may be restricted if no alternative treatment exists.
The case stems from a long-standing dispute between Meril and Edwards. Meril initiated proceedings in Paris, seeking to revoke Edwards’ patent on grounds of added matter, lack of novelty, and lack of inventive step. Edwards countered with an infringement claim and later amended it to include Meril’s new heart valve product. The court ultimately rejected Meril’s revocation attempt, upheld the patent as amended, and supported Edwards’ infringement claim.
In assessing the patent’s validity, the Paris court followed the holistic approach to evaluating inventive step, as established by the Munich Central Division in a previous case involving Amgen, Sanofi, and Regeneron. This approach involves determining a ‘realistic starting point’ in prior art and assessing whether the claimed solution would be obvious to a skilled person from that point. The Paris court clarified that a realistic starting point is a document of interest for solving the problem, often disclosing key features of the challenged patent or addressing a similar issue.
Here’s where opinions may diverge: While the UPC’s holistic approach differs from the European Patent Office’s (EPO) problem-solution method, which identifies the closest prior art, the Paris court’s decision did not alter the outcome in the Meril-Edwards dispute. Meril’s parallel opposition proceedings at the EPO also failed to challenge the inventive step. Interestingly, the Paris court chose not to stay its proceedings pending the EPO’s decision, highlighting the UPC’s discretion and commitment to swift resolutions.
Taylor stressed that the UPC’s ability to grant injunctions quickly, as seen in Edwards obtaining relief against Meril in less than a year, should influence businesses’ litigation and commercial strategies. She advised parties to gather relevant information early, prepare written pleadings promptly, and consider public interest defenses. Additionally, understanding the UPC’s approach to assessing inventive step, especially in parallel EPO proceedings, is crucial.
A thought-provoking question for our audience: As patent disputes increasingly intersect with public health, how should courts balance intellectual property rights with the urgent needs of patients? Share your thoughts in the comments below. This case is part of a broader patent family dispute between Edwards and Meril, with Edwards previously succeeding in an infringement claim against Meril before the Munich Local Division of the UPC last year.
