
Following the Paris Central Division’s first revocation decision (discussed in our previous article), in which it upheld Edwards Lifesciences Corporation’s European patent 3,646,825 (EP’825) in amended form, the Munich Local Division (LD) has now issued its infringement decision.
The infringement decision provides insights into (i) the conditions under which bifurcated infringement proceedings might be stayed in view of a pending appeal in the revocation proceedings, (ii) the UPC’s jurisdiction over acts of infringement, and (iii) the UPC’s approach to considering the interests of third parties and the public when determining injunctive relief relating to patents in the healthcare sector.
The decision also reinforces emerging themes in UPC case law regarding the admissibility of case amendments (discussed in our previous article), claim interpretation, inventive step and added matter (as discussed in our ongoing series of articles).
In this article, we will discuss each of these insights and themes.
Background of the case
Edwards’ patent EP’825 relates to a prosthetic valve and delivery catheter system. On 1st June 2023 (the first day of the UPC’s operation), Edwards brought an infringement action against Meril Life Sciences Pvt Ltd and Meril GmbH (Meril) based on EP’825 at the Munich LD. Edwards’ requested that the Court prohibit Meril from continuing to utilize the technical teaching of EP’825, with specific illustrative references to Meril’s Myval Octacor valve and associated Navigator and Navigator Inception delivery systems.
On 4th August 2023, a different Meril entity, Meril Italy Srl (Meril Italy), filed a revocation action in respect of the same patent at the Paris Central Division. On 2nd November 2023, with its defence to the infringement action before the Munich LD, Meril filed counterclaims for revocation. Ultimately, the case was bifurcated, with the Paris Central Division consolidating the revocation actions and deciding to maintain EP’825 according to an auxiliary request.
Despite Meril filing an appeal against the revocation decision, the Munich LD refused to stay this infringement case and found infringement in favour of Edwards.
UPC’s approach to handling bifurcated proceedings
In view of the pending appeal in the revocation proceedings, Meril requested a stay of the bifurcated infringement proceedings. However, the Munich LD decided that a stay was not appropriate because it considered that Meril had not demonstrated that the Paris Central Division’s revocation decision to uphold EP’825 in amended form was “manifestly and prima facie erroneous in a formal and/or material way”.
As part of this finding, the Court analysed, in detail, Meril’s assertion that the Paris Central Division’s written decision did not take into account each of Meril’s substantive attacks. The Court concluded, however, that the revocation decision was not procedurally erroneous. The Court also analysed the merits of the Paris Central Division’s reasoning and concluded that it was “unlikely (and at least not highly likely)” that the Court of Appeal (CoA) would come to a different assessment of particular issues, which the Meril entities had identified as not having been assessed properly by the Paris CD, such as added subject matter, novelty, and inventive step such that “the patent will not be revoked on appeal”. Thus, the Court found that the revocation decision was also not erroneous on a material point. As a result, no stay was granted.
The fact that the Court considered, in detail, the validity issues at hand (if only to confirm the Paris Central Division’s decision) demonstrates that, even when considering infringement in bifurcated proceedings, the Munich LD at least is willing to robustly engage with and interrogate validity issues.
UPC’s jurisdiction over acts of infringement committed before entry of the UPCA and taking place in any UPC contracting member state
As part of its defence, Meril argued that the Court lacked jurisdiction over acts of infringement committed before the entry into force of the UPCA on 1st June 2023. The Court strongly rejected Meril’s contention. The Court highlighted that the contention was not viable given that the UPC will have exclusive jurisdiction over all European patents after the transitional phase ceases (the transitional period is currently due to run until 31 May 2030). The Court explained that, in practice, it is therefore necessary for the UPC to have the authority to adjudicate claims relating to infringements committed prior to 1st June 2023 to ensure that such claims can be adjudicated by a court of the UPC member states once the transitional phase has ceased, because the statute of limitation only applies if the defendant raises it in a timely manner. This decision serves as a reminder to patentees that the UPC may offer an attractive forum for infringement proceedings, even if the infringement acts date back several years.
Moreover, Meril’s website had a disclaimer indicating that the attacked embodiments were not available in Germany. The Court nevertheless confirmed that it had jurisdiction to grant an injunction over the entire UPC territory (provided this was requested and the patent was valid) “as long as an infringing act or the danger of first infringement has been proven for at least one contracting member state”.
Considering the interests of third parties and the public in the healthcare sector
Meril asserted that the life and health of patients with severe heart disease was at issue, such that third party or public interest necessitated a denial of injunctive relief.
As part of these arguments, Meril asserted that the availability of different models of heart valves (including different models of the Myval Octacor valve) was crucial from a clinical standpoint because it permitted the selection of an appropriate model tailored to the individual patient’s needs. However, the Court found that “…it is not sufficient for a public interest to be legally justified on the grounds that it would be advantageous for the treating physician to have a variety of treatment methods at their disposal. Consequently, in order to justify a public interest in the availability of the infringing embodiment, it is essential to demonstrate that this is the sole available treatment method or that it represents an improvement upon a known treatment method, resulting in a notable enhancement in patient care…” (emphasis added).
Regarding whether Meril’s infringing products represented an improvement over Edwards’ SAPIEN 3 products, the Court concluded that there was no data to support this allegation. The Court reasoned that, at best, Meril’s products are not inferior but that “…the concept of “non-inferiority” is not a suitable criterion for evaluating the public interest defence…”.
Regarding whether Meril’s infringing products were the sole available treatment method, the Court did not believe that this was the case for all models of Meril’s products. However, the Court recognised a clear and pressing public need for “valve prostheses for annuli exceeding 30 mm in diameter”, such as Meril’s specific XL-sized Octacor valve prosthesis. This public need was considered to already be adequately addressed through an existing system (namely Edwards’ Medical Request Portal which enables practitioners to request a single-use license to use, e.g. Meril’s XL-sized Octocor valve, if they consider it clinically necessary to treat a specific patient and if Edwards’ SAPIEN 3 product is not an option for that specific patient). As a result, the LDM’s order against Meril does not extend to any XL-sized devices (including those sold directly by Meril) that had already been scheduled for implantation in individualized patients before the date of the decision. Also, these Meril XL-sized valve prothesis will continue to be available for patients because doctors may still request them through this Edwards’ portal. Indeed, patients’ needs override any dispute between the parties. The Court notes: “Although Meril is still to be regarded as an unwilling licensee […], this panel finds that the public interest must still be considered. Patients with serious heart problems and an annulus larger than 30 mm have no possibility to influence Meril’s behavior and still might face serious medical consequences if access to XL-sized Myval Octacor valves prostheses was denied.”
The decision shows that the UPC can implement flexible and pragmatic solutions, including carving out specific infringing products from the scope of injunctive orders, in order to balance the interests of parties and the public. As the Court refuses to apply a grace period, such that its decision is immediately enforceable without the need for the payment of a security, this adjustment to the injunction taking into account patients’ needs is of particular importance.
Emerging themes
Admissibility of case amendments
During the oral hearing on 24th September 2024, Edwards filed a request to amend its claim in order to add Romania to the list of countries where injunctive relief was sought. The Court rejected this request. Although the Court acknowledged that Romania could not have been included with Edwards’ original statement of claim (because Romania only joined the UPC system on 1st September 2024), the Court noted that the amendment should have been made prior to the date of the oral hearing.
This decision is in line with previous decisions in this area suggesting that the Court will be strict on not allowing case or claim amendments that could have been made earlier. Practically speaking, as and when other states ratify the UPC agreement in future, parties in ongoing proceedings should consider adding these states to their case as soon as possible.
Claim interpretation
In keeping with what is now established practice at the UPC, the Court followed the principles on claim interpretation established the UPC’s CoA in NanoString (discussed in our previous article).
For example, the Court referred to disclosures throughout the description and figures in support of its claim interpretation, in line with the CoA’s position that the description and drawings must always be used as explanatory aids for the interpretation of the patent claim. The Court also explained why its claim construction was in line with the claim construction used in the bifurcated revocation decision of the Paris Central Division, in line with the principle established in Nanostring that the same claim interpretation must be used in the assessment of infringement and of validity.
The Court took into account the technical effects discussed in the description, and further discussed in an expert declaration, in order to arrive at a functional interpretation of one of the claimed terms. Notably, in arriving at its construction, the Court also considered the teaching in one of Meril’s own post-filed Indian patent applications, and highlighted that its claim construction regarding the term “strut” was consistent with Meril’s use of the term in said Indian patent application. This approach stands in contrast to that applied by other divisions of the UPC. For example, the Düsseldorf LD has consistently found that there is no basis to use even the prosecution history of the patent in suit, let alone other sources of evidence, on the basis that Art 69 EPC provides only for the use of the description and drawings to interpret the claims (see, for example its decision in SodaStream v Aarke, discussed here, or its order for a preliminary injunction in Ortovox v Mammut, available here).
This decision, however, shows that the Munich LD at least is willing to apply a holistic approach to claim interpretation, which considers the context of the invention as broadly understood by the skilled person, and that the UPC may be willing to consider documentary evidence beyond just the patent in question when considering the skilled person’s perspective. This highlights the need for parties to ensure that any documentary evidence relied upon in a case are using claimed terms consistently.
Added matter and inventive step
Finally, it is notable that the decision references established case law of the Board of Appeals of the EPO with respect to both added matter and inventive step.
For example, in the revocation proceedings, the Paris Central Division considered whether the claims of EP‘825 added matter due to an impermissible intermediate generalisation from the application as filed. In the context of assessing whether it is likely that the CoA will come to a different decision than the Paris Central Division on this point, the Court noted that “…the features of an all-hexagon structure of the frame and the presence of a sealing device are not inextricably linked…” (emphasis added), echoing established EPO case law regarding the generalisation of features.
As another example, in the context of assessing whether it is likely that the CoA will come to a different decision than the Paris Central Division on inventive step, the Court noted that one of Meril’s inventive step attacks would need to combine three prior art references, and that “…this is usually not permissible unless the claim is based on partial objects…”, further remarking that the partial problem approach was “not the case here anyway because both the geometry and the specific material contribute to the advantageous properties of the claimed frame structure)…”This discussion appears consistent with the EPO’s established approach to determining whether a claimed invention consists of multiple technically independent partial problems.
Thus, while initial decisions from the UPC suggest that the Court may seek to establish its own frameworks in which to assess grounds of validity, it is also clear that the Court is willing to engage with, and follow established EPO case law, where appropriate and when referenced by the parties.
We can expect the jurisprudence with regard to validity and infringement to develop rapidly over the next year as more and more proceedings are heard, including further proceedings in this long running dispute between Edwards and Meril.