UPC’s Paris CD keeps Edwards Lifesciences patent on prosthetic heart valve alive based on late-filed auxiliary request

Formally, Meril Italy Srl is a revocation claimant, while Meril GmbH and Meril Life Sciences Pvt Ltd (of India) brought revocation counterclaimants that were consolidated in Paris with Meril Italy’s claim. This is the sequence of the initial filings of each kind:

• August 4, 2023: infringement claim (Munich LD)
• September 14, 2023: Meril Italy’s revocation claim (Paris CD)
• November 2, 2023: the other two Meril entities’ revocation counterclaim (Munich LD), raising a superset of the issues in the revocation action

There is an obvious tactical reason for the speed with which Meril Italy made its Paris filing after the Munich infringement complaint: they wanted a decision before the Munich LD would make an infringement decision. Given the limited number of patents in the relevant area, chances are that Meril more or less anticipated the infringement action and had already performed some prior-art search before. Still, in reality that Paris claim was a counterclaim. That’s why the patentee challenged the Paris CD’s jurisdiction, but in vain.

Reasonable people can disagree on whether the UPC should focus more on substance than on form. Meril Italy obviously brought its claim at the direction of the Indian parent company. If Edwards had sued more Meril entities in the first place, they would all have been under an indisputable obligation to bring any revocation claims in the form of counterclaims to the infringement complaint.

The Munich LD had the interesting idea that, in order to avoid divergent rulings, there could be a joint hearing before the judges of the Paris panel and the ones of the Munich panel. The Paris CD did not consider that joint session feasible under the UPC Agreement (UPCA) or the UPC’s Rules of Procedure (RoP). And consolidation in a local division is not possible if one claim belongs in a central division.

The question that is bound to be at the heart of an appeal is the admissibility of the auxiliary request that enabled the patentee to defend the patent in an amended form.

Edwards proposed amendments to the claims on a total of three occasions:

• with its defensive pleading to the revocation claim;
• by means of a second request filed on January 22, 2024; and
• through a third and final request filed on April 12, 2024.

The one in the middle was thrown out by the Paris CD, while the first one was timely (though the patent holder disputed that it contained an operative art) and the third one was late, but admitted and ultimately outcome-determinative.

The Paris CD does consider it a necessary requirement for a second or third auxiliary request to be admitted (as the court may allow) that there be a prior (and admissible) auxiliary request. What the Paris CD does not believe, however, is that the earlier request has to be sufficiently substantiated. Admissibility is sufficient. A complete lack of substantiation may also result in a holding of inadmissibility, but in the Paris CD’s opinion, the earlier request here “contain[ed] an explanation of why the proposed amendments satisfy the requirements of Articles 84 and 123 (2) (3) ‘RoP’ and are valid” and “. Moreover, it “allowed for an understanding of the specific amendments proposed.” In other words, there may have been deficiencies on the substantive side, but not to an extent that would have rendered the auxiliary request inadmissible.

The judgment acknowledges, but ultimately brushes aside, another issue: the high number of proposed amendments. Those numbers are indeed mind-boggling:

• The October 31, 2023 answer to the revocation claim “included a conditional application to amend the patent based on 9 conditional amendments and 84 auxiliary requests.”
• The January 22, 2024 second request (which the court threw out as not sufficiently justified, a determination that the appeals court declined to review) consisted of “41 auxiliary requests based on 9 individual amendments.”
• The April 12, 2024 third request (the second one to actually become relevant as the previous one got nixed) “propos[ed] one unconditional amendment and six auxiliary requests.”

Para. 33 of the judgment explains why the court accepted that unusually high number of proposed amendments:

“Moreover, while this panel considers the number of the amendments originally filed to be extremely high, potentially hindering the efficiency of the ‘UPC’ proceedings and the goal of delivering expeditious decisions, it does not appear that that number is ‘unreasonable’, considering the extreme complexity of the case (in particular, the number of grounds of invalidity raised), the importance of the patent at issue and the interrelationship with other proceedings, both judicial and administrative, concerning related patents of the same family. The lack of a consistent interpretation of the expression ‘reasonable in number’ also suggests a less strict interpretation of this relevant provision.”

The court clearly exercised its discretion in a way that favored the patentee, which Meril could try to challenge on appeal.

The substantive part of the decision will foreseeably also be raised on appeal, with Meril presumably seeking the complete invalidation of the patent and Edwards trying to salvage it in its granted form. There is a linguistic error in the otherwise well-crafted judgment: in para. 40, it says that “the construction of the claim proposed by the claimant […] was not objected to by the defendant for this purpose.” What is actually meant is the claim structure (the numbering of the different claim limitations and their hierarchy), not claim construction. There very much is a claim construction dispute here (for example, concerning the question of whether “cell” and “opening” are identical in this context). Construction means interpretation, not structure.

Another linguistic issue is a repeated spelling error: “dependant” instead of “dependent” (the incorrect spelling here was probably influenced by the local language, French, though the judge-rapporteur is Italian and in his native language the corresponding word (“dipendente”) doesn’t contain the letter A either). Also, the term “optional” is used in connection with a number that the claim only defines as “a plurality,” and presumably the word “arbitrary” would have been more appropriate then.

Like before the Opposition Division of the European Patent Office (EPO) in a matter involving another patent from the same family, the Paris CD identified an intermediate generalization “as a consequence of the isolation of a non-optional feature that was originally disclosed only in combination with the others in the earlier application.”

Auxiliary request I didn’t make a difference in this regard as it was based on the same claim 1.

In connection with auxiliary request II, the question of the correct priority date came up. Here, the Paris CD takes note of, and effectively accepts as correct for the purposes of this decision, the holding of the EPO’s Enlarged Board of Appeal in cases G-1/22 and G-2/22 (October 10, 2023 decisions) that the patentee is entitled to a rebuttable presumption concerning the claimed priority date. Here, however, Meril had a strong argument anyway (in the Paris CD’s opinion), and the priority date for auxiliary request II was pushed back a bit.

Nevertheless, all non-novelty and obviousness contentions were overcome, and the patent was upheld as amended by auxiliary request II.

The value in dispute is (still) 8 million euros, and given that the patent did not survive in its original but only an amended form, the court decided that the patentee has to bear 40% of the costs, with the other 60% being imposed on the Meril entities.

The Paris CD’s panel consisted of the second panel’s Presiding Judge (and judge-rapporteur) Paolo Catallozzi, Judge Tatyana Zhilova (from Bulgaria) and Technically Qualified Judge Stefan Wilhelm (a 3M employee, therefore presumably not conflicted here).

The patentee, Edwards Lifesciences, was represented by Bird & Bird’s Boris Kreye and Elsa Tzschoppe as well as Thum & Partner’s Bernhard Thum (a patent attorney who is an inventor himself) and Jonas Weickert and Powell Gilbert’s Siddarth Kusumakar, Tessa Waldron and Bryce Matthewson.

The two Meril entities sued in Munich that brought their (identical between the two) revocation counterclaims were represented by Dr. Andreas von Falck of Hogan Lovells.

The Meril entity that brought the Paris claim was represented by Gide Loyrette Nouel’s Emmanuel Larere and Raphaëlle Dequiré-Portier as well as Regimbeau’s Jean-Robert Callon de Lamarck and Anne Seibel as well as Marks & Clerk’s (misspelled in the judgment with a superfluous “c”) Jonathan Stafford and Gregory Carty-Hornsby.

This means there were (not exclusively, but also) UK firms involved on both sides (Powell Gilbert and Marks & Clerk).