Context: One of the most common categories of invalidity contentions in Europe is the allegation of an impermissible addition of subject matter beyond the original patent application. But the same fact pattern may give rise to divergent decisions in different European fora.
What’s new: Last week, the Unified Patent Court’s (UPC) The Hague Local Division (LD) adjudicated two preliminary injunction (PI) requests (applications for provisional measures) brought by Abbott Diabetes Care against Sibio Technology and its European partner company Umedwings Netherlands. One motion was granted (PDF), and the other denied (PDF).
Direct impact: Both decisions can be appealed. For the patentee there is a stronger incentive, given that in the case in which an injunction issued, the defendant already made a commitment to cease and desist from further infringement (and just wasn’t fully compliant, which is why the injunction issued), thereby reducing the relevance of an appeal only to the question of jurisdiction for Ireland and, ultimately, fee shifting.
Wider ramifications: Two legal questions raised by those cases are of transcendental importance, but require further clarification as the court did not have to resolve contradicting arguments. A patent was deemed likely invalid over an addition of subject matter, applying the European Patent Office’s case law (but reaching a divergent conclusion), which the defendant proposed and the plaintiff, according to the decision, did not argue that it was the wrong standard to apply. In a case where the defendant did not dispute the UPC’s jurisdiction over Ireland, the injunction was ordered with effect in that country as well, despite the fact that it has not yet ratified the UPC Agreement (UPCA). A third legal quesiton relating to cease-and-desist orders involves an interesting pattern as well, though that part is highly fact-specific.
This was a “you win some, you lose some” outcome. Either party (and its counsel, listed toward the very end of this article) won a case and lost a case. They both did something right, but the case does raise questions that will have to be answered on appeal (or other vehicles for that clarification will reach the Court of Appeal sooner or later).
1. Impermissible addition of subject matter: what standard?
The starting point is that whatever is in the claims must have support in the patent’s specification. The simplest scenario in which a patent claim is invalid for a claim-specification disconnect is that a claim limitation is nowhere to be found in the description. Larger quantities of text must be compared when the claim limitation has support in the specification, but that one changed, such as when the description gets amended or between an original application and a divisional application.
The EPO’s in-house courts have become very strict about added subject matter. There was a time when practitioners speaking at conferences (such as at a 2006 London conference on a predecessor proposal to the UPC named EPLA) would give numerous examples of the EPO’s patentability criteria being more permissive than those of various national courts in Europe. But when it comes to added subject matter, no one in Europe has set a higher bar in recent years than the EPO’s Technical Boards of Appeal (TBoA) and its Enlarged Board of Appeal (EBoA).
For patentees it would obviously be best if they could just throw everything into an initial specification that will serve as a “primordial soup” from which a lot of different patent applications can be derived over the years. The UPC decision in which Abbott was denied a PI uses the term “reservoir” for this concept.
Disputes of this kind are usually about the question of whether the added subject matter was simply already contained in the original application (albeit in a different form) or not. That is often a question of whether elements of the original application are combined in a way that was already disclosed the first time around. There are different subtypes of an impermissible addition of subject matter, and the one at issue in this Abbott v. Sibio case is called “intermediate generalization” (meaning that a more specific concept was replaced with a broader one along the way).
The question is then what standard to apply. As the UPC decision explains, the standard is not merely that the teachings of the added subject matter (such as a combination of previously-disclosed elements) must be “obvious” to a person skilled in the art after reading the original specification. Instead, s the UPC ruling sums it up, amendments can “only be made within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of the application(s) as filed.”
The “too long, didn’t read” version is that the EPO wants it to be foolproof. It’s called the “gold standard” for disclosure of the claimed invention in the original specification.
The UPC is bound by EU law, but this question has never been put before the European Court of Justice (ECJ) because it’s not part of the Union acquis (the EU body of law). The UPC is therefore free to develop its own case law. It could be persuaded by the EPO approach, but it could also adopt some national court’s (or courts’) stance. It could even be creative and come up with a new standard.
In this case, the UPC decision says:
“Both parties relied on the case law of the (Technical and Enlarged) Boards of Appeal of the European Patent Office (EPO) to substantiate their arguments regarding added matter. They did not indicate whether – and if so in which way – the court should apply a different standard.”
On that basis, the court simply applied it as well. It took note of the fact that the EPO’s examine had raised the same objection as the defendants here, yet granted the patent:
“During the examining phase of the patent, Abbott presented to the examiner of the EPO (by letter of 9 May 2022, Sibio c.s.‘ Exhibit S3), to overcome an added matter objection, that the main basis for claim 1 in the original application is […]. This argument was accepted, and the patent was granted.”
Well, the UPC panel applied the same standard as the EPO, but Simmons & Simmons’s patent attorney Dr. Fritz Lahrtz convinced the court that the EPO got it wrong. The judges felt that the patent was more likely than not to be invalidated, thus denied one of the two PIs Abbott was seeking.
The question of the right standard would make it a potentially landmark appeal.
2. Jurisdiction with respect to Ireland
The case that Abbott won is a case that Sibio claimed would never had had to be brought. That affirmative defense will be discussed in the third part of this article.
According to the decision, there was a protective writ, but during the PI proceedings, Sibio didn’t even spent time and money on any other defenses than just the argument that the matter was moot as they had already made a cease-and-desist covenant.
In the other case (where no injunction issued), Sibio defended itself comprehensively, which included that they did not want the PI to have effect with respect to the Irish market. Ireland is a UPC contracting state, but hasn’t ratified the UPCA.
In this case, Sibio had only a single defense (its cease-and-desist covenant as an affirmative defense with a view to costs) and didn’t address the Ireland question. The court still had to give this question some thought. For instance, even if the patentee had sought an injunction over a U.S. patent and the defendant had not raised a jurisdictional challenge, the UPC just wouldn’t have the authority to do that under the UPCA.
The panel had a Dutch majority, and Dutch judges have granted patent PIs with cross-border effect in the past. They took an expansive view here and cited to the EU’s Brussels Regulation. Their reasoning with respect to Ireland’s current status is debatable to put it mildly. It’s also telling that in the parallel case in which Sibio did defend itself, Abbott dropped Ireland from its list of countries with respect to which it was seeking an injunction.
The President of the CoA gave a speech last month in which he referenced a case pending before the ECJ that could even give the UPC jurisdiction over the UK or other non-EU/non-UPC parts of patents granted by the EPO (May 31, 2024 ip fray article), also under the Brussels Regulation that the Hague LD relied upon in its Abbott v. Sibio decision.
3. Cease-and-desist means nothing without compliance
The whole reason for which the court determined it had jurisdiction over a case in which the defendant had already made a cease-and-desist covenant was that Abbott was able to show repeat non-compliance. First they made a test purchase, told Sibio about it, and Sibio promised to be compliant going forward. But a second test purchase succeeded. Against that background, the court held that the cease-and-desist covenant might just not have been strong enough to deter further infringement.
This issue can also come up in other UPC cases, though it is rare. Typically parties that make a cease-and-desist promise want to avoid litigation and comply.
Another Abbott v. Sibio case will be heard in Dusseldorf next week.
Judges and counsel
Presiding Judge and judge-rapporteur Edger Brinkman was joined on the panel by Judge Margot Kokke and Judge Petri Rinkinen (Helsinki).
Unlike most other UPC decisions, the court listed all counsel.
Abbott was represented by a Taylor Wessing team: Dr. Wim Maas, Eelco Bergsma, David Mulder, Faziel Abdul and Iris van der Heijdt.
Sibio was represented by Simmons & Simmons’s Dr. Thomas Gniadek, Dr. Fritz Lahrtz, Oscar Lamme and Dr. Diptanil DebBarma. The first two are from Germany, the other two from the Netherlands.