Context: Last summer, the Paris seat of the Unified Patent Court’s (UPC) Central Division (CD) upheld an Edwards Lifesciences prosthetic heart valve patent, EP EP3646825 (“A system comprising a prosthetic valve and a delivery catheter”) (July 20, 2024 ip fray article). A few months later, the Munich Local Division (LD) enjoined Meril over EP’825 (November 15, 2024 ip fray article).
What’s new: Today the Munich LD handed down a second Edwards v. Meril injunction (PDF), the patent-in-suit being EP3669828 (“Prosthetic heart valve”). A cease-and-desist declaration lacking a contractual penalty provision was not deemed sufficient to prevent further infringement. Various technical and non-technical defenses failed.
Direct impact: Edwards can enforce the injunction, and in the absence of a request for security, it does not have to provide it for the time being. Like in the previous case, there is a carve-out for certain cases where doctors consider an XL heart valve necessary. Given that Meril, even if somewhat noncommittally, stopped its infringement, the injunction may not make an immediate impact, but Meril will not be able to walk back on its half-hearted cease-and-desist promise short of a successful appeal.
Wider ramifications: The decision is a landmark ruling, subject to what the Court of Appeal (CoA) will make of it, as the Munich LD, which gets about one in three UPC infringement cases in the first instance, throws its considerable weight behind the problem-solution approach applied by the European Patent Office (EPO), favoring that one over the “German” approach, which is similar and very often leads to the same outcome. Another holding of transcendental importance is that apart from exceptions that are few and far between, drawings must not be used in an attempt to narrow the claim scope.
Edwards and Meril are embroiled in a multi-patent battle. Patent litigation is a “you win some, you lose some” business, but one cannot simply count the number of wins and losses without giving some thought to their technical and, ultimately, commercial impact. A patentee may lose nine out of ten cases, but in one exceptional case may get all the leverage it needs. Conversely, a patentee could prevail in a majority of impactless cases, but lose the ones that matter.
About two weeks ago, a Board of Appeal of the EPO invalidated two Edwards patents that had survived opposition proceedings in an amended form and are the subject of litigation in German national court:
The ill-fated patents are EP3590471 (“Low profile delivery system for transcatheter heart valve”) and EP3494929 (“Low profile delivery system for transcatheter heart valve”). But in the UPC, Edwards has been very successful so far, with two wins in Munich.
Meril raised many defenses, every single one of which was ultimately deemed unavailing by the Munich LD. For example, the Munich LD’s jurisdiction was contested, but the court explains that if infringements by different entities of a corporate group of different national parts of a European bundle patent were not considered infringements of the same patent, the whole idea of the UPC as a one-stop forum for bundle patents would (in other words) be reduced to absurdity.
The part that practicioners will find most relevant is the one on the problem-solution approach. First, there’s headnote 2:
For assessing whether an invention shall be considered obvious having regard to the state of the art, the problem-solution approach developed by the European Patent Office shall primarily be applied as a tool to the extent feasible to enhance legal certainty and further align the jurisprudence of the Unified Patent Court with the jurisprudence of the European Patent Office and the Boards of Appeal.
On page 68, the part of the decision that deals with Meril’s revocation counterclaim turns to the question of the inventive step and holds:
b. For assessing whether an invention shall be considered obvious having regard to the state of the art, the problem-solution approach (PSA) developed by the European Patent Office (EPO) shall primarily be applied as a tool to the extent feasible to enhance legal certainty and further align the jurisprudence of the Unified Patent Court with the jurisprudence of the EPO and the Boards of Appeal (BoA). The Court of First Instance and the Court of Appeal of the Unified Patent Court have assessed inventive step in various decisions. Some decisions explicitly referred to the PSA, used by the the EPO, including the BoA, and several national courts; others applied a different approach, that is similar if not identical to the test of inventive step applied by the German Federal Court of Justice. Both tests, the ‘German’ test and the PSA, if correctly applied, should lead to the same results in the majority of the cases (see Deichfuss, GRUR Patent 2024, 94) and both tests require a “realistic starting point” and an “incentive” for the skilled person to do the “next step”, e.g. to amend the technical solution disclosed by the starting point to arrive at the patented solution. As none of the tests is enshrined in the European Patent Convention (EPC) and lead basically to the same results both can be applied as a tool to assess inventive step. However, this Panel takes the decision to apply the PSA as practiced by the EPO, including and the BoAs, to the extent feasible and to state this explicitly as there is a need for legal certainty for both the users of the system and the various divisions of the Unified Patent Court. Applying the PSA further aligns the jurisprudence of the Unified Patent Court with the jurisprudence of the EPO and the BoA. In the present proceedings, the PSA is also the tool applied by the parties in their briefs.
Whether this adoption of the problem-solution approach will be adopted by the UPC as a whole depends on the CoA (and, until the CoA decides, on what the other divisions of the UPC’s Court of First Instance will do). This dispute looks like one that has the potential to give rise to one or more landmark decisions by the CoA.
Panel and counsel
Panel: Presiding Judge (and here, judge-rapporteur) Dr. Matthias Zigann, Judge Tobias Pichlmaier, Judge Margot Kokke (The Hague, Netherlands) and Technically Qualified Judge Dr. Stefan Wilhelm.
Counsel for Edwards: Bird & Bird’s Boris Kreye, Elsa Tzschoppe and Ioana Hategan; Powell Gilbert’s Bryce Matthewson, Siddharth Kusumakar and Daniel Down; and Thum & Partner’s Bernhard Thum and Dr. Jonas Weickert.
Counsel for Meril: Hogan Lovells’s Dr. Andreas von Falck, Dr. Lukas Wollenschlaeger (who has recently left Hogan Lovells) and Dr. Felipe Zilly.