Irides: Weekly patent litigation update

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.

Our latest edition - 19 July 2024 - is below:

Israel

Israel Patent Office finds that Amgen’s functional antibody claims are not enabled.

In a decision dated 10 July 2024, the Israel Patent Office (ILPTO) granted Sanofi’s opposition against Amgen’s broad claims to PCSK9 antibodies.

Low-density lipoprotein receptors (LDL receptors) are responsible for regulating the amount of low-density lipoprotein (i.e. “bad” cholesterol”) in the bloodstream. PCSK9 is a protein that binds to LDL receptors and facilitates their degradation, thereby reducing the clearance of bad cholesterol from the blood. Amgen and Sanofi market monoclonal antibodies that lower levels of bad cholesterol in the blood by binding to and inhibiting the activity of PCSK9. Amgen’s product is marketed under the brand name Repatha (evolocumab), and Sanofi’s is marketed under the brand name Praluent (alirocumab).

In 2010, Amgen filed a patent application (IL Application No. 204013) claiming monoclonal antibodies that bind to PCSK9, neutralise its effect (in that an excess of the antibody is capable of reducing the amount of bound PCSK9 and LDL receptor), and compete for binding with two reference antibodies. The claims were not limited to structurally defined antibodies. Consequently, the claims covered a large genus of antibodies.

The ILPTO held that a skilled person could not reasonably and consistently expect that, by following the antibody screening methods disclosed in the specification, they would obtain antibodies with the claimed functional properties without the need for additional research and development. As such, the patent does not enable the broad class of antibodies claimed by Amgen.

Amgen argued that its reference antibodies bind a small epitope of PCSK9 and, by claiming competing antibodies, the claims are directed only to antibodies that bind to the same epitope. The ILPTO rejected this argument, finding that the claims also encompass antibodies that bind outside the epitope and compete with the reference antibodies due to steric hinderance. On this basis the ILPTO suggested that the claims in the IL application might be wider than those that were held to be invalid by the United States Supreme Court in 2023. In any event, the ILPTO considered that Amgen was not entitled to claim every antibody binding the epitope.

In light of the forgoing, the ILPTO held that Amgen’s inventive contribution is limited to the development of the 26 specific antibodies exemplified in the specification. Amgen cannot therefore patent the concept of inhibiting PCSK9 activity using antibodies, they can only claim the 26 exemplified antibodies as defined by their amino acid sequences.  The ILPTO emphasised that the scope of protection afforded by the claims must be consistent with the applicant’s technical contribution.

UPC

Munich Central Division revokes Amgen’s PCSK9 inhibitor patent.

On 16 July 2024, the Munich Central Division published its decision in an action for revocation by a Sanofi group of companies (Sanofi) of EP 3 666 797 B1 (EP 797), held by Amgen, Inc. (Amgen) (UPC_1/2023). Amgen had brought an infringement action against Sanofi and Regeneron Pharmaceuticals Inc. (Regeneron) relating to the same patent in the Munich Local Division of the UPC (UPC_14/2023). Regeneron counterclaimed for revocation, which was referred to the Central Division with the agreement of the parties. Following referral, the Central Division ordered that the revocation action and counterclaim be dealt with jointly.

EP 797 was granted on 17 May 2023. Alongside the UPC challenge, the patent has also been opposed at the EPO by Sanofi-Aventis Deutschland (on 10 November 2023) and Regeneron Pharmaceuticals Inc. (on 19 February 2024).  

EP 797 relates to antibodies (or antibody fragments) that bind to proprotein convertase subtilisin kexin type 9 (PCKS9) and methods of using and making them. 

Claim 1 of EP 797 as granted claimed “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.”  

Sanofi and Regeneron argued before the Central Division that EP 797 should be revoked for adding subject-matter beyond the content of the application as filed, lack of sufficiency, lack of novelty and/or lack of inventive step. Amgen put forward various defences, which included an application to amend EP 797.  

Claim interpretation 

The parties differed in their approach to claim construction and so the Central Division considered it necessary to interpret claim 1. Having set out the legal framework on interpretation of claims laid down in 10x Genomics and Harvard v Nanostring (UPC_CoA_335/2023) (10x Genomics v Nanostring), the Central Division accepted the position of Amgen that claim 1 is not limited to antibodies that bind exclusively (or even predominantly) 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. 

Novelty and Priority

The claimants’ challenge to the novelty of EP 797 relied on two documents that could only form part of the state of the art if EP 797 was not entitled to its claimed priority date. The Central Division rejected the claimants’ arguments on priority, applying the test set out in EPO EBA Case no. G 2/98, that a claimed invention will only be considered the “same invention” for the purpose of claiming priority if “the skilled person can derive the subject-matter of the claim directly and unambiguously, using common general knowledge, from the previous application as a whole” (emphasis added). This reflects the EPO’s “gold standard” approach that we have seen applied in other areas of validity, including added matter by the Hague Local Division in Abbott v Sibio (UPC_CFI_131/2024) and novelty in DexCom, Inc. v Abbott Laboratories (UPC_CFI_230/2023).

As the priority challenge failed, it followed that the claimants’ novelty challenge also failed. 

Inventive Step 

Reflecting the approach taken in 10x Genomics v Nanostring, the Central Division took a more holistic approach to assessing inventive step than the strict EPO-style problem-solution approach. The Central Division identified the relevant test as follows: 

(i) Identify a realistic starting point; and

(ii) Compare the claimed subject matter and prior art to determine 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 solution.

The Central Division considered that a starting point will be considered realistic if its teaching would have been of interest to a skilled person who, at the priority date of the patent in issue, was seeking to develop a similar product or method to that disclosed in the prior art and therefore had a similar underlying problem as the claimed invention.

Further, a claimed solution is obvious if, starting from the prior art, the skilled person would be motivated to consider the claimed solution and to implement it as a next step in developing the prior art. The Central Division set out the principle that a technical effect or advantage of a feature of the claimed subject matter may be indicative of inventive step, whereas a feature that results from an arbitrary selection from several possibilities will generally not be. The Central Division also emphasised that hindsight must be avoided.

The Central Division ultimately concluded that EP 797 was invalid for lack of inventive step over the prior art identified by the claimants as the starting point for the assessment, namely Lagace et al. 2006 (Lagace). Amgen sought to argue that a later citation, Graham 2007 was a closer and more realistic starting point. However, it was not disputed that Lagace was a realistic starting point, which the Central Division agreed with. Having concluded that Lagace was a realistic starting point, the Central Division did not consider it necessary to assess whether any other starting point would be “more promising”. The Central Division also noted that there “can be several realistic starting points… [it is] not necessary to identify the “most promising” starting point”.

Lagace included a statement suggesting that “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, it 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 indicated that these differences must be considered for the assessment of obviousness.

Applying the tests outlined above, the Central Division concluded that using Lagace as a starting point, the skilled person would pursue the route of developing antibodies as suggested in Lagace, thereby arriving at antibodies as defined in the claims of EP 797 without any inventive skill. In reaching its decision, the Central Division considered it relevant that, at the priority date, there was significant commercial interest in PCSK9 as a target for the treatment of hypercholesterolemia; a significant number of pharmaceutical companies were pursuing options to target PCSK9 at the time. Further, the Central Division disregarded the uncertainties Amgen sought to argue would have stood in the way of the skilled person’s arrival at the antibodies claimed in PCSK9, noting that none of these concerns were clearly expressed in the cited prior art. The same reasoning applied to Amgen’s auxiliary requests.

Decision

The Central Division therefore ordered that EP 797 be revoked for lack of inventive step in all of the UPC Contracting States in which it was in force (as per the claimants’ request). Amgen was ordered to pay €1.375 million for the claimants’ legal costs.

UPC

Mannheim Local Division considers transfer to Central Division.

Following a string of decisions in the last year from UPC local divisions not to bifurcate infringement and validity proceedings, a decision issued on 10 July 2024 by the Mannheim Local division in MED-EL v Advanced Bionics (UPC_CFI_410/2023) breaks this trend. 

The proceedings began when Advanced Bionics AG filed a revocation action at the Paris Central Division on 27 September 2023. In response, the patentee MED-EL filed an infringement action against three defendants (including Advanced Bionics AG) at the Mannheim Local Division on 7 November 2023. The claimant could have filed the infringement action at the Paris Central Division, but this was not obligatory. From the patentee’s perspective, it is easy to envisage the possible advantages of bifurcated proceedings; in particular, potentially different claim interpretations between the validity and infringement proceedings which might reduce the pressure of typical infringement/validity squeezes that patentees face. 

Most likely in an effort to avoid this, the defendants filed an application requesting that the Mannheim Local Division refer the infringement proceedings to the Paris Central Division or, in the alternative, to stay the infringement proceedings pending the outcome of the revocation action. In February 2024, the Local Division issued its decision refusing these requests. This refusal is currently under appeal. 

Following this, in March 2024, the defendants filed a counterclaim for revocation at the Mannheim Local Division. The counterclaim contained the same attacks as the revocation action filed at the Paris Central Division, with the addition of an insufficiency attack. The patentee filed a request to amend the patent in response to the counterclaim. 

In relation to the revocation action at the Paris Central Division, written proceedings were concluded in May 2024 and an oral hearing is scheduled to take place in October 2024. 

In accordance with Art. 33(3) of the UPC Agreement (UPCA), the filing of a revocation counterclaim at the Mannheim Local Division whilst the revocation action was pending at the Paris Central Division left the Mannheim Local Division with the following possibilities (after hearing the parties): 

(a) proceed with both the action for infringement and the counterclaim for revocation;

(b) refer the counterclaim for revocation to the central division and suspend or proceed with the action for infringement; or

(c) with the agreement of the parties, refer the [whole] case for decision to the central division.

The Court heard the parties on the possibility of (b), referring the counterclaim to the Central Division. Upon receiving the parties’ submissions, the patentee did not object to the referral but the defendants did. 

The Local Division acknowledged that, typically, the preference should be not to bifurcate in order to avoid the risk of inconsistent claim interpretation. However, owing to the facts of this case, they concluded that it would be best to refer the counterclaim for revocation and the proposed amendments to the patent to the Central Division. There is no mention of a stay in the Order issued by the Court and we therefore assume that the infringement action must be continuing at the Local Division. The particular facts considered were:

• the invalidity arguments raised in the counterclaim for revocation were almost identical to those in the central revocation action;
• the Central Division revocation action was much closer to completion (with written proceedings closed and an oral hearing scheduled) than the counterclaim for revocation in the Local Division; and  
• the risk of inconsistent interpretation exists regardless of whether or not the revocation counterclaim is referred to the Central Division as the central revocation action will not be stayed. 

The defendants had noted that referring the counterclaim to the Central Division would lead to a change in the language of proceedings, because the Central Division revocation action is in English and the Local Division proceedings are in German. The Local Division considered this and decided it did not go against the referral because, owing to the substantial overlap in issues between the divisions, translations covering the remaining issues would not require any significant effort or cost from the parties. 

The defendants also argued that the central revocation action was “too far advanced“ and would “at least cut off the counterclaimants’ reply”. The Local Division also rejected this, and noted that rather than immediately join the two actions, the Central Division could join the two proceedings at a later date or refrain from joining them altogether to accommodate all rounds of the written procedure; it was noted that, even in this latter scenario there is procedural economy, as both invalidity actions are then (formally) conducted at the Central Division and this does not lead to any significant additional work for the court. 

The key takeaway here is that if UPC proceedings start with a Central Division revocation action, a patentee facing a revocation action may be able to obtain bifurcation of corresponding infringement proceedings if they see benefit in this; for example, by delaying the start of an infringement claim in a Local Division until such time that the revocation action is nearer to completion. Defendants trying to avoid this would have to consider some creative approaches, such as raising new grounds of invalidity in the Local Division.

UPC

Düsseldorf Local Division refuses request for simultaneous translation.

The claimant, based in the Republic of Korea, filed an action for patent infringement of two patents at the Düsseldorf Local Division on 15 October 2023. The action was filed in German, but English had also been available as an authorised official language in the Düsseldorf Local Division since 1 June 2023. 

On 10 July 2024, the claimant filed an application requesting that the court provide simultaneous interpretation, in English, of a hearing scheduled for 5 September 2024. The basis of their request was that representatives of the company who were attending the hearing were from Korea and did not speak German, and German is not a language that is commonly spoken or taught in Korea. They stated that without simultaneous interpretation the persons concerned would not be able to follow the oral submissions of the UPC representatives at the hearing and that it was needed to enable the representatives of the company to participate in the oral proceedings, consult with their UPC representatives without delay and, if necessary, clarify any ambiguities.

Requests of this nature are decided pursuant to Art. 51(2) of the UPCA, which states:

“At the request of one of the parties, and to the extent deemed appropriate, any division of the Court of First Instance and the Court of Appeal shall provide interpretation facilities to assist the parties concerned at oral proceedings.” (emphasis added)

This general principle is further specified in r. 109.2 of the Rules of Procedure (RoP) in that the judge-rapporteur decides, upon a timely request, whether and to what extent simultaneous interpreting is appropriate. If they consider simultaneous interpretation to be appropriate, they instruct the registry to take all necessary steps. In such a case, the associated costs are part of the costs of the proceedings. If the judge-rapporteur refuses to order simultaneous interpreting, a party may instruct an interpreter at their own expense and request that arrangements for simultaneous interpreting be made as far as practically possible, again at their own expense.  If a party makes use of this option, according to r. 109.5 RoP, the costs incurred as a result are not procedural costs; they are to be borne solely by the party instructing the interpreter.

The court denied the request, stating that while simultaneous interpretation is allowed under certain circumstances, it was not warranted in this case. The court reasoned that the claimant had the option to conduct the proceedings in English (an additional authorised language at the Düsseldorf Local Division at the time the action was filed) but chose to proceed in German despite the English language skills of the company representatives and their lack of German language skill. Therefore, the court held that the claimant should bear the cost of hiring their own interpreter.