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Unified Patent Court (UPC) Central Division issues its first revocation judgment

Posted: August 5, 2024

On 16 July 2024, just over a year after the UPC opened its doors, the Munich Central Division of the UPC has issued its first revocation judgment.

Unfortunately for Amgen, it resulted in revocation of one of their European patents (EP3666797) for their cholesterol-lowering drug marketed as Repatha^®.  Amgen can still appeal and is likely to do so owing to the commercial significance of the product.

There are also several other litigation proceedings pending elsewhere between the Amgen concerning their Repatha^® product and Sanofi and Regeneron concerning their cholesterol-lowering drug marketed as Praluent^®, so the dispute is far from settled.

Speedy proceedings

Of note is the speed by which the UPC has handled these proceedings.  When the UPC was set up, one of the key promises was of speedy and efficient court proceedings culminating in a single decision enforceable across all EU Member States participating in the UPC.

On the first day of the UPC (1 June 2023), Amgen brought an infringement action concerning this patent in the Munich Local Division against Regeneron and three other parties, Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe and Sanofi Winthrop Industrie S.A. (“the Sanofi parties”).  On the same day, the Sanofi parties brought a revocation action against Amgen’s patent in the Central Division (Munich section).  Regeneron counterclaimed for revocation of the patent on 24 November 2023.  With the agreement of the parties, the Local Division Munich, referred the counterclaim of Regeneron to the Central Division on 2 February 2024.  After referral, the Central Division ordered the revocation action and the counterclaim to be dealt with jointly.  The oral hearings were held jointly on 4 June 2024.  The decisions (in substance identical) in both actions were issued on 16 July 2024.

Therefore, while the decision may not be in Amgen’s favour, the UPC seems to have delivered on speedy court proceedings, with tight deadlines throughout the proceedings.

The Munich Local Division will still hear Amgen’s infringement action later this year to decide whether it will continue with the infringement proceedings or stay them until a final decision on the revocation is issued by the Court of Appeal, if Amgen appeals (which is likely).  There are also ongoing opposition proceedings before the European Patent Office (EPO), which will decide on the validity of the European patent in all its validated countries.

Inventive step guidance

The Central Division concluded that the claims lack an inventive step.

Since the UPC is a new Court system with no existing case law on the assessment of inventive step, this first decision gives key guidance on the principles considered important for the inventive step assessment before the UPC.

The Central Division ultimately decided that the skilled person who was interested in developing a treatment for high cholesterol targeting PCSK9 would, starting from the prior art, without inventive skill develop antibodies against PCSK9 that block the interaction of PCSK9 with the LDL receptor, and would therefore arrive at the claimed antibodies.

Step 1 – claim interpretation

The Central Division first decided that they needed to interpret the claims and compare the claimed subject matter, after interpretation to the prior art.  It is then necessary to answer the question as to whether it would be obvious for the skilled person to, starting from a realistic prior art disclosure, in view of the underlying problem, arrive at the claimed invention.

Step 2 – identify realistic starting point

 The Central Division decided that a starting point is realistic “if its teaching would have been of interest to a skilled person who, at the priority date, was seeking to develop a similar product or method to that disclosed in the prior art which thus has a similar underlying problem as the claimed invention” (cf. Court of Appeal Nanostring/10x Genomics, page 34 under “cc”).  They decided there can be several realistic starting points.

Step 3 – obviousness assessment

The Central Division finally concluded that, in general, “a claimed solution is obvious if, starting from the prior art, the skilled person would be motivated (i.e. have an incentive to consider the claimed solution and to implement it as a next step in developing the prior art”.  (cf. Court of Appeal Nanostring/10x Genomics, page 35, second paragraph).   It may e relevant whether the skilled person would have any particular difficulties in taking any next step(s).  In some circumstances, it may be allowed to combine prior art disclosures.

The Central Division pointed out that a technical effect or advantage achieved by the claimed subject matter compared to the prior art may be an indication for inventive, but if a feature is selected in an arbitrary way out of several properties this cannot generally contribute to inventive step.  The Central Division also emphasised that hindsight needs to be avoided.

This test is somewhat similar to the EPO problem and solution approach, but appears less structured than that approach, which has three main stages, (i) determining the closest prior art, (2) establishing the objective technical problem, and (iii) considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.  In that approach, a single piece of prior art is identified as the closest prior art, which is generally the most promising starting point.  Whereas, in the test of the Central Division, they instead refer to a realistic starting point or several realistic starting points.  Therefore, this could lead to the EPO and the Central Division starting their inventive step assessment from different starting points, which could result in different conclusions on inventive step.  Arguably, the Central Division’s broader view on inventive step creates the opportunity for a broader starting point in the prior art.  It is important to consider these differences in the case law when formulating your inventive step strategy.

At Forresters, we have UPC representatives with significant EPO opposition experience and knowledge of the latest decisions from the UPC, so we can tailor your strategy accordingly.

The decision on inventive step 

1. Claim interpretation – the parties did not agree on the correct approach for claim interpretation, and so the Central Division decided it was necessary to handle this point.

Granted claim 1 reads:

“a monoclonal antibody or an antigen-binding fragment thereof for use in treating or preventing hypercholesterolemia or an atherosclerotic disease related to elevated serum cholesterol levels; or for use in reducing the risk of a recurrent cardiovascular event related to elevated serum cholesterol levels; wherein the monoclonal antibody or the antigen-binding fragment thereof binds to the catalytic domain of a PCSK9 protein of the amino acid sequence of SEQ ID NO: 1, and prevents or reduces the binding of PCSK9 to LDLR.”

The Central Division decided that when interpreting a patent claim, the technical meaning of the terms should be interpreted with the aid of the description and drawings.  The technical function the features have individually and as a whole is to be considered.

The Central Division accepted Amgen’s view that claim 1 is not limited to antibodies that bind exclusively to an epitope within the catalytic domain. Instead, the claim covers antibodies that bind to the catalytic domain and also to other domains of PCSK9, i.e. the pro or V-domains.

2. Realistic starting point – the Central Division determined that Lagace et al. 2006 was the realistic starting point in this case with its title “Secreted PCSK9 decreases the number of LDL receptors in hepatocytes and in livers of parabiotic mice”.

The Central Division concludes that from the teaching of Lagace as a whole, the skilled person would have realised that Lagace was interested in finding out more about the mechanism by which PCSK9 reduces the number of LDRs.  They found that the reason for this interest is indicated in the article itself, which is the background knowledge that loss of PCSK9 expression resulting in lower plasma cholesterol levels in vivo.  Neutralising the activity of PCKS9 is mentioned as a potential approach for the treatment of hypercholesterolemia.

The Central Division concluded Lagace therefore has a similar underlying problem as the claimed invention which is to provide a treatment for hypercholesterolemia using PCSK9 as a target, and so should be the realistic starting point.

Interestingly, during EPO prosecution, the EPO examiner found the closest prior art to instead be Graham 2007, which was the first scientific publication to provide in vivo data describing a therapeutic modality that targets PCSK9, and found the claims inventive.  It remains to be seen if the opposition division will take the same view in the opposition proceedings later this year.  This highlights our above observation that this step can mean that the EPO and the Central Division start their inventive step assessment from different starting points, which could result in different conclusions on inventive step.

Having concluded that Lagace is a realistic starting point, the Central Division addressed Graham.  Their view was that they do not have to examine in detail whether another starting point, in particular Graham, is “more promising”, because the claimed subject matter has to be inventive over any realistic starting point.

3. Obviousness assessment

Key to the case, was the fact that Lagace included a speculative statement “the development of antibodies to block [PCSK9] interaction with the LDLR or inhibitors to block its action in plasma, can be explored for the treatment of hypercholesterolemia”.

However, Lagace did not disclose any antibodies that bind to the catalytic domain of PCSK9 and block the interaction between PCSK9 and LDLR which are actually used for the treatment of hypercholesterolemia. The Central Division concluded that these differences must be considered for the assessment of obviousness.

Applying their test, the Central Division concluded that using Lagace as a starting point, the skilled person would have pursued the route of developing antibodies that block the interaction between PCSK9 and LDLR as explicitly suggested by Lagace.

They concluded that in pursuing that route, the skilled person would have ended up with antibodies as defined in the claims without inventive skill.

The Central Division also placed weight on the fact that, at the priority date, there was significant commercial interest in PCSK9 as a target for the treating hypercholesterolemia.

Amgen sought to argue that the skilled person would have faced uncertainties in arriving at the claimed antibodies, but the Central Division found that these concerns were not expressed in the cited prior art.

In terms of the EPO approach to the inventive step of antibody claims, it is important to note that these claims are treated differently to other subject matter and have their own specific guidance in the EPO Guidelines.  Generally,

The Central Division therefore ordered the patent to be revoked for lack of inventive step.

Other points of interest

The Central Division only decided on inventive step, but made an additional point concerning priority.

Priority – before the EPO it is well understood that for the priority claim to be valid, the priority document must relate to the “same invention” as the priority-claiming application.  The Central Division decided that this is the case if the skilled person can derive the claimed subject matter directly and unambiguously, using common general knowledge, from the priority application as a whole.

Therefore, the Central Division seems to follow the EPO approach when assessing priority.

Other UPC divisions also seem to be following the EPO approach in respect of added matter and novelty, adopting their “gold standard” approach.

However, as seen above the EPO and UPC seem to differ in their approach to inventive step.

As a result, patentees may find their patent upheld in opposition by the EPO (so the European patent remains valid in non-UPC states, such as the GB), but found invalid before the UPC (so the Unitary patent is invalid in the UPC states).

Ultimately, we do not yet know if the Court of Appeal at the UPC (if Amgen appeals) will uphold the Central Division’s finding of lack of inventive step.

UPC representation by Forresters

As outlined on our website, we have a team of experienced UPC representatives (who also have significant EPO opposition experience) ready to handle your UPC litigation as well as opt out strategies.  We can coordinate your UPC litigation with parallel opposition proceedings before the EPO and any national litigation.  Please contact us if you have any questions about the UPC system.