UPC Weekly - Court of Appeal settles the UPC framework for inventive step

2025 Week 48

If you only read one UPC decision this year, read one of these. 

You can take your pick, based on technical background. Amgen v. Sanofi / Regeneron is in the field of antibodies for therapeutic applications. Edwards v. Meril relates to prosthetic heart valves.

With these decisions, the UPC Court of Appeal (CoA) has taken a coordinated approach to set out the definitive UPC test for inventive step. At the moment, the CoA has two panels of judges (there will be a third from January 2026) and behind the scenes there has clearly been discussion and agreement of the wording of their decisions. We look at the implications of the approach below.

There are about as many opinions on how the UPC should assess inventive step as there are UPC representatives. Everyone comes to this key question with their own background, training, preferences and prejudices. So as far as possible we’re going to leave all of that at the door, because the framework is now fixed. These CoA decisions resolve a significant uncertainty for prospective parties to UPC litigation and iron out any perceived differences between different UPC divisions in their assessment of patent validity. This increases the predictability of the likely outcome of UPC disputes, helping parties to assess the validity of European patents for FTO purposes, without resorting to litigation.

The UPC test for inventive step

In the written decisions for these CoA cases, there are blocks of text that have been agreed and copied between the two. There are also differences between the decisions, probably due to the technologies of the two patents. First, though, we will pull together the clear common elements in the agreed assessment for inventive step.

Both decisions have a preamble about how the EPO and different national European courts have assessed inventive step. There is a nod to the EPO problem and solution approach (also used in various national courts) and mention that Germany and the UK, in contrast, use more “holistic” approaches. The CoA notes that when these different approaches are properly applied, they should and generally do lead to the same conclusion.

Then the steps of the test are set out. With some minor editing for readability, they are:

It first has to be established what the object of the invention is, i.e. the objective problem. This must be assessed from the perspective of the skilled person, with their common general knowledge, as at the application or priority date (also referred to as the relevant date) of the patent. This must be done by establishing what the invention adds to the state of the art, not by looking at the individual features of the claim, but by comparing the claim as a whole in context of the description and the drawings, thus also considering the inventive concept underlying the invention (the technical teaching), which must be based on the technical effect(s) that the skilled person on the basis of the application understands is (are) achieved with the claimed invention. 

In order to avoid hindsight, the objective problem should not contain pointers to the claimed solution. 

The claimed solution is obvious when at the relevant date the skilled person, starting from a realistic starting point in the state of the art in the relevant field of technology, wishing to solve the objective problem, would (and not only: could) have arrived at the claimed solution. 

The relevant field of technology is the field relevant to the objective problem to be solved as well as any field in which the same or similar problem arises and of which the person skilled in the art of the specific field must be expected to be aware. 

A starting point is realistic if the teaching thereof would have been of interest to a skilled person who, at the relevant date, wishes to solve the objective problem. This may for instance be the case if the relevant piece of prior art already discloses several features similar to those relevant to the invention as claimed and/or addresses the same or a similar underlying problem as that of the claimed invention. There can be more than one realistic starting point and the claimed invention must be inventive starting from each of them. 

The skilled person has no inventive skills and no imagination and requires a pointer or motivation that, starting from a realistic starting point, directs them to implement a next step in the direction of the claimed invention. As a general rule, a claimed solution must be considered not inventive / obvious when the skilled person would take the next step prompted by the pointer or as a matter of routine, and arrive at the claimed invention.

A couple of easy points leap out. The UPC is interested in the “objective problem”. This clearly starts from what the patent purports to address, e.g. over the prior art acknowledged in the patent itself. But it is important to consider the technical effect that the claim as a whole actually achieves over the state of the art, provided that this is understood from the patent. It is fair game to attack a patent from multiple starting points, but they must all be realistic. So there is no need to agonise over the identification of the only single closest prior art document. The invention is obvious if the skilled person would take “the next step” towards the invention from the starting point. Broadly, there are two ways that this “next step” can be obvious: there is a pointer/motivation, or it is a matter of routine for the skilled person.

Outcome in Amgen v. Sanofi / Regeneron

The patent in this case is EP 3666797 B1. In UPC Weekly 2024 w29, we reported on the first instance decision in this case, which resulted in the patent being deemed invalid for lack of inventive step.

The patent relates to anti-PCSK9 antibodies for use in the treatment of diseases related to high cholesterol. “Bad cholesterol” (“LDL”) is removed from the blood by the LDL receptor (LDLR) in the liver. PCSK9 binds LDLR and causes its degradation, preventing removal of “bad cholesterol” from the blood. By targeting PCSK9, the claimed antibodies regulate levels of LDLR and, therefore, “bad cholesterol”. The commercial products relevant to the patent are Amgen’s Repatha® and Sanofi/Regeneron’s Praluent®.

The CoA decided to overturn the first instance decision, holding that the patent as granted is novel and inventive. They also had interesting comments on sufficiency of disclosure, contrasting with the outcome for a related US patent in a US Supreme Court decision that we reported on here.

In addition to the framework set out above that was common to the Edwards v. Meril decision, the CoA wanted to consider whether the skilled person would have had a “reasonable expectation of success” in taking the next step from the prior art towards the claimed invention. The decision sets out significant detail on this point, which will be required reading for parties considering litigating life sciences patents at the UPC. Of particular note is that the CoA will allow consideration of practical difficulties faced by the skilled person, including cost, as factors that may persuade the skilled person that there is no reasonable expectation of success.

On the technical side, the CoA found that the uncertainty about the mechanism by which PCSK9 lowered cholesterol meant that, at the priority date, it was not obvious for the skilled person to pursue anti-PCSK9 as a way of lowering cholesterol to treat conditions such as hypercholesterolemia and atherosclerotic disease. 

The CoA noted that the prior art disclosed both intracellular and extracellular actions of PCSK9 on the LDL-receptor (which removes cholesterol from circulation). Both parties acknowledged that antibody therapies only engage extracellular targets, not intracellular ones. The court referred to a range of statements and evidence to determine that, at the priority date, the skilled person would not necessarily pursue a treatment modality such as antibody administration, (which can only act via upon the extracellular mechanisms of PCSK9) as the next step in developing cholesterol lowering treatments.

The CoA confirmed that medical use claims should be interpreted as defining effective treatments that have a “meaningful” (non-negligible) therapeutic effect. The CoA rejected Sanofi/Regeneron’s argument that the skilled person would nevertheless expect to achieve some degree of cholesterol lowering effect by targeting the extracellular mechanism of PCSK9 via antibody therapy – and that this would fall inside Amgen’s medical use claim. The court found that claims in ‘medical use-format’ must be interpreted to define a noticeable improvement of the medical condition of the patient suffering from the disease mentioned in the claim. 

The court’s finding on sufficiency of disclosure confirms the sharp contrast between European practice and the strict requirement for narrow, structural definitions that have emerged in the US courts in recent years, especially when assessing antibody based inventions. The court stated:

Where a claim contains one or more functional features, it is not required that the disclosure includes specific instructions as to how each and every conceivable embodiment within the functional definition(s) should be obtained. A fair protection requires that variants of specifically disclosed embodiments that are equally suitable to achieve the same effect, which could not have been envisaged without the invention, should also be protected by the claim. Consequently, any non-availability of some embodiments of a functionally defined claim is immaterial to sufficiency, as long as the skilled person through the disclosure is able to obtain suitable embodiments within the scope of the claim.

This clearly endorses the EPO’s approach to allowing claims to antigen binding molecules such as antibodies that are primarily defined by their target specificity in cases where the inventive step lies in identifying the importance of the target.

Outcome in Edwards v. Meril

The patent in this case is EP 3646825 B1, derived from a divisional application. At first instance, the infringement and revocation aspects of the dispute were bifurcated between the Munich Local Division and the Paris Central Division. In the first instance revocation action, objections of added matter and lack of novelty and inventive step were raised. The patent was found to be valid in amended form (based on auxiliary request II). In the first instance infringement action, the patent as amended was deemed infringed. This was also part of the appeal, and the same overall decision was reached in the appeal, but we will not focus on it here.

The ultimate parent application WO 2013/012801 was primarily directed at a prosthetic heart valve with a sealing member. This meant that the patent retained an emphasis on the importance of sealing. When formulating the objective problem, the court therefore had to look at the detailed description of the embodiments to understand what the claims of the patent were seeking to do. The objective problem was defined as reducing the crimping profile of the valve and providing stability during crimping and subsequent expansion. Meril argued that this technical effect is not derivable from the original application and that Edwards had not proved that the claim provided the effect.

The CoA answer to this is particularly important. For a granted patent, the burden of proof for invalidity is on the party seeking revocation of the patent. Edwards had provided a plausible explanation of the alleged effect and Meril had failed to demonstrate that this was not correct. Furthermore, the CoA leant on Enlarged Board of Appeal decision G 2/21 from the EPO:

A patent proprietor may rely upon a technical effect for inventive step, if the skilled person having the common general knowledge in mind, and based on the application as originally filed, would consider said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention (cf G 2/21, mn 94). The effect of a reduced crimping profile is encompassed by the technical teaching of the application as filed (WO 801) under this standard. 

In answer to Meril’s argument that there was no technical effect and that the claim defined a “mere alternative” to the prior art, the CoA added a further comment that is not present in the Amgen decision:

For an inventive step to be present, it is not necessary to show improvement of the technical teaching as defined by the patent claims over the prior art. Inventive step may also be found if the patent claims disclose a non-obvious alternative to solutions known in the prior art.

The outcome of the case on validity was that the same auxiliary request II was considered to be valid as was upheld at first instance. The CoA stepped through the various prior art combinations, holding for each attack that there was no motivation for the skilled person to modify the prior art to reach an embodiment falling inside the amended claim.

This blog was co-authored by Matthew Naylor and Eliot Ward.