The first decided cases: What do they teach us about the UPC’s approach?

Since the UPC opened its doors on 1 June 2023, the patent world has been eagerly awaiting the Court’s first decisions on the merits in infringement and revocation cases.

The first few decisions were issued in July 2024, showing that the Court can (for now at least) achieve its ambition for swift decision-making. These decisions provide an early indication of how the Court will approach fundamentals of European patent validity such as claim construction, added subject matter, novelty and inventive step.

In this article, I will review the decisions and how the UPC’s approach compares to that of the European Patent Office.

The UPC’s approach to claim construction was outlined in the decision of the Court of Appeal in NanoString vs 10X Genomics [1], which stated that:

“The Patent claim is not only the starting point, but the decisive basis for determining the protective scope of a European patent.”

“The interpretation of a patent claim does not depend solely on the strict, literal meaning of the wording used. Rather, the description and the drawings must always be used as explanatory aids for the interpretation of the patent claim and not only to resolve any ambiguities in the patent claim.”

and

“These principles for the interpretation of a patent claim apply equally to the assessment of the infringement and the validity of a European patent.”

This approach has been followed in all the decisions on the merits that have been issued so far, all of which cite the NanoString vs 10X Genomics Court of Appeal Decision.

In Sanofi vs Amgen[2], the Munich Central Division additionally affirmed the well-known principle that, for the purpose of interpreting a patent claim, the patent description may represent a patent’s own lexicon.

Added subject matter is a frequent reason for revocation of European patents in Opposition proceedings at the European Patent Office (EPO). The EPO applies a very strict test (known as the “gold standard”) for the presence of added subject matter, under which any amendment to a patent application must be directly and unambiguously derivable from the content of the patent application as originally filed.

Patentees have been waiting with bated breath to see if the UPC will adopt this test or develop its own, perhaps less restrictive, approach to added subject matter.

Dexcom vs Abbott

Added subject matter was raised as a ground of invalidity in Dexcom vs Abbott[3], an infringement action brought by Dexcom against various Abbot entities for infringement of a patent relating to analyte monitoring systems, in relation to the patent as granted and also in relation to amended claims filed by Dexcom in first and second auxiliary requests.

In its assessment of added subject matter, the Paris Local Division did not refer to the EPO’s gold standard, and found sufficient disclosure in the application as filed to support the features of claim 1 of the patent as granted and of the first auxiliary request.

However, the second auxiliary request was held to add matter, as the Division found that there was no basis in the application in the application as filed for a claim amendment directed to a broadening or generalisation of a specific arrangement disclosed in the application.

In this assessment, the Division appears to have adopted a similar approach to the EPO, which routinely rejects amendments directed to so-called “intermediate generalisations” of the specific disclosure of a European patent application.

Meril vs Edwards

Added subject matter was also raised as a ground for invalidity in the Meril vs Edwards[4] revocation action. In its decision in this case, the Paris Central Division rejected some of the claimant’s arguments that the patent contains subject matter that extended beyond the content of the application as originally filed, but agreed with others.

The claimant argued that a particular combination of features of claim 1 of the patent as granted added subject matter that was not present in the application as filed. In rejecting this argument, the Paris Central Division stated that a contested combination of features was “clearly and unambiguously” disclosed in the application as filed, echoing the language of the EPO’s “gold standard”.

The claimant further argued that other features of claim 1 of the patent (a divisional of an earlier-filed European patent application) amounted to an impermissible intermediate generalisation of the disclosure of the parent application as filed.

In addressing this, the Division explained that an impermissible extension of the subject matter of the earlier parent application “occurs if the subject-matter cannot be directly and unambiguously deduced from the earlier application by the person skilled in the art”, again echoing the language of the EPO test for added subject matter.

Ultimately the Division concluded that one feature of claim 1 of the patent as granted amounted to an impermissible intermediate generalisation, a conclusion that the Division found to be supported by a decision of the EPO Opposition Division on a related patent.

Bitzer vs Carrier

In Bitzer vs Carrier[5], a revocation action before the Paris Central Division, the claimant argued that a feature of claim 1 of the granted patent (as amended during the proceedings) extended the subject matter of the patent beyond the content of the application as originally filed, because the language of used in the granted claim:

“the apparatus is adapted to adjust the sampling rate depending on…”

differed from the language of the corresponding feature of claim 1 of the application as filed:

“the sampling rate adjusts depending on…”

The Division rejected this argument, on the basis that the skilled person would implicitly understand from the “the sampling rate adjusts” language of claim 1 of the application as originally filed that the apparatus is implicitly adapted to adjust the sampling rate. The Division further rejected other arguments relating to added subject matter of claim 1 of the patent, as amended during the proceedings, having found sufficient basis in the application as filed for the amendments.

So far the Court has adopted a familiar approach to the assessment of novelty, requiring that all the features of a claim are directly and unambiguously disclosed in a prior art document for the claim to be held to lack novelty.

Franz Kaldewei vs Bette

The infringement action brought by Franz Kaldewei in Franz Kaldewei vs Bette[6] was in respect of an alleged infringement of a patent relating to a sanitary tub installation. Bette did not deny infringement, but argued, in a counterclaim for revocation, that the patent was invalid due to a lack of novelty and a lack of inventive step.

In its introductory comments on novelty, the Dusseldorf Local Division stated that the burden of proof of a lack of novelty or a lack of inventive step (in a counterclaim for revocation) lies with the defendant.

The Division then explained its approach to novelty: a technical teaching is new if it differs from what is available in the state of the art in at least one feature, and the state of the art anticipates only what is immediately apparent to a specialist familiar with the respective technical field from the publication or prior use.

The Division further clarified that knowledge that a specialist only gains through further consideration or by consulting other documents or uses is not state of the art.

Ultimately in this case the Division held that claim 1 of the patent as granted was novel, because there was no direct and unambiguous disclosure in the prior art relied on by Bette of a particular feature of the claim. The claim was, however, found not to be inventive.

An alternative version of Claim 1 contained in an auxiliary request filed by the claimant was also held to be novel by the Division, because the prior did not clearly and directly disclose two feature groups of the claim.

Dexcom vs Abbott

In its decision in Dexcom vs Abbott, the Paris Local Division quoted the European Patent Convention’s provisions on novelty, and stated that:

“In order to be considered part of the state of the art, an invention must be found integrally, directly and unambiguously in one single piece of prior art and in its existing form it must be identical with its constitutive elements, in the same form, with the same arrangement and the same features.”

Claim 1 of the patent as granted included the feature of a sensor electronics unit configured to (among other things):

 “transmit a first portion of the analyte measurement data … using a first communication protocol that is Bluetooth or Bluetooth Low Energy,”

and

 “receive a data request command using a second communication protocol that is near field communication, NFC, or radio-frequency identification, RFID;”

and a display device configured to (among other things)

 “receive the first portion of the analyte measurement data … using the first communication protocol;”

and

“receive the second portion of the analyte measurement data … using the second communication protocol in response to the data request command.”

The Division found claim 1 to be novel over a first prior art document relied on by the defendant, because although that document was considered to disclose the use of two protocols for data transmission, the document did not expressly disclose NFC as the protocol selected.

The Division also found claim 1 to be novel over a second prior art document, because it was not sufficiently demonstrated that the second prior art document disclosed the transmission of two portions of measurement data according to two different protocols within the meaning of the patent at issue.

Novelty over a third prior art document was also found, because that document did not disclose a system configured to transmit two portions of measurement data using these two protocols as set out in claim 1 of the patent at issue.

Meril vs Edwards

In Meril vs Edwards, the Paris Central Division rejected the claimant’s arguments that claim 1 of the patent (as amended by an auxiliary request) lacked novelty over four prior art documents.

The Division held that none of the prior art documents, either in their written description or drawings, disclosed the disputed features. In relation to the fourth prior art document, the Division stated that it was clear that a disputed feature of claim 1 “cannot be derived directly and unambiguously” from the prior art document.

Bitzer vs Carrier

In Bitzer vs Carrier, the Paris Central Division held that claim 1 of the patent, as amended during the proceedings, lacked novelty. However, an amended version of the claim, submitted in an auxiliary request 2, was found to be novel over all the prior art relied on by the claimant, because none of the prior art documents disclosed a feature of the claim as amended in auxiliary request 2.

There has been much speculation about how the UPC will approach the assessment of inventive step. European patent attorneys are accustomed to using the EPO’s “problem and solution approach”, while the national patent offices of the UPC participating states have a variety of different tests for inventive step.

So far, some Divisions seem to have adopted elements similar to those of the problem and solution approach in applying a different methodology for assessing inventive step.  However, some of the decisions seem intentionally to stray from the problem and solution approach. One of the decisions specifically refers to the problem and solution approach, but only to argue that its application does not seem to be mandatory, in what may be an indication that the UPC is aiming to develop its own test for inventive step.

Franz Kaldewei vs Bette

In Franz Kaldewei vs Bette, the Dusseldorf Local Division held that claim 1 of the patent as granted was not inventive in view of a single prior art document, because the considerations that the skilled person makes in order to achieve the single feature that was not present in the prior art did not go beyond the scope of routine further development.

Explaining its reasons for this conclusion, the Division stated that a patent is only awarded to the expert who is inventive, and that an inventive solution begins beyond the area which, starting from the state of the art, is defined by what a well-trained expert with average knowledge, skills and experience can routinely develop and find in the relevant technical field.

The Division further stated that an invention exists when it does not result from the expert’s usual approach in his field of expertise, but requires additional creative effort in his part.

The Division was convinced that, based on the prior art, it was a routine consideration for the expert faced with the task of specifying a sanitary tub device that could easily be made in different sizes and has good functional properties to make profile pieces and a tub support out of rigid plastic foam, as required by claim 1 of the patent as granted.

Thus in this case, while the UPC did not follow the EPO’s problem and solution approach, the methodology adopted by the Court shared some similarities with the EPO’s approach, in the identification of a “task” based on the prior art.

Dexcom vs Abbot

In Dexcom vs Abbot, the Paris Local Division’s approach to assessing inventive step of claim 1 of the patent as granted was first to identify the difference between the invention defined in the claim and the most relevant prior art. The difference was that the prior art does not expressly disclose the protocol (NFC) used for transmitting the second portion of the analyte measurement data.

The Division then defined a technical problem of “choosing a protocol for transmitting the second portion of the analyte measurement data”.

The Division finally held that in view of the express disclosure of D1, it would be obvious for the skilled person to use the NFC protocol to transmit the data to achieve the effects commonly ascribed to this protocol.

The Division adopted the same approach to assessing inventive step of claim 1 of the first auxiliary request, which was also held to lack inventive step.

Although the problem and solution approach was not mentioned here, the approach taken by the Paris Local Division in this case is very similar to that of the EPO, in that it identified the difference between the claimed invention and the prior art and derived a technical problem based on that difference.

Sanofi vs Amgen

In Sanofi vs Amgen, the Munich Central Division referred to the relevant provision (Article 56) of the European Patent Convention, and stressed the need for an objective approach to the assessment of inventive step that avoids hindsight.

The Division explained that in order to assess whether or not a claimed invention was obvious to a skilled person, it is first necessary to determine a starting point in the state of the art, and there has to be a justification as to why the skilled person would consider a particular part of the state of the art as a realistic starting point. This differs from the EPO’s approach, which requires the closest prior art to be identified.

The Division further explained that a starting point is realistic if its teaching would have been of interest to a skilled person who, at the priority date of the patent at issue, was seeking to develop a similar product or method to that disclosed in the prior art which thus has a similar underlying problem.

This is similar to the way the EPO’s problem and solution approach, in which the first consideration in selecting the closest prior art is that it must be directed to a similar purpose or effect as the invention.

However, in contrast to the EPO’s approach (which requires the identification of the prior art that represents the most promising starting point for a development leading to the invention), the Division in this case expressly stated that there can be several promising starting points, and that it is not necessary to identify the most promising starting point.

After a comparison of the claimed subject matter to the prior art, the next question is whether it would be obvious for the skilled person, starting from a realistic prior art disclosure, in view of the underlying problem, to arrive at the claimed solution.

In general, 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.

On the other hand, if the claimed subject matter achieves a technical effect or advantage compared to the prior art, this may be indicative of the presence of an inventive step.

Applying these considerations, the Division found that, starting from a piece of prior art proposed by the claimant, the next obvious step for the skilled person following up on an explicit suggestion in the prior art would be the development of antibodies that fall within the claims of the patent, and hence that the patent lacked an inventive step.

Meril vs Edwards

In Meril vs Edwards, the Paris Central Division stated that in assessing inventive step, it is necessary to determine whether, given the state of the art, a person skilled in the art could have arrived at the technical solution claimed by the patent using their technical knowledge and carrying out simple operations.

The Division further stated that inventive step is assessed in terms of the specific problem encountered by the person skilled in the art, citing the Paris Local Division’s decision in Dexcom vs Abbott.

Applying these principles, the Division rejected the arguments of lack of inventive step, holding that the patent, as amended by auxiliary request 2, was indeed inventive.

Importantly, in this case the Division explicitly addressed the use of the problem and solution approach, stating that “this test is not explicitly provided for in the EPO and, therefore, does not appear to be mandatory.” Nevertheless, the Division explained that applying the problem and solution approach to these proceedings would not have led to a different conclusion on inventive step

While not an outright rejection of the problem and solution approach, this is perhaps the clearest indication yet that the UPC intends to develop its own approach to the assessment of inventive step.

Bitzer vs Carrier

In Bitzer vs Carrier the Paris Central Division again referred to the Paris Local Division’s decision in Dexcom vs Abbott in its assessment of inventive step of claim 1 of the patent as amended by auxiliary request 2.

The Division held that none of the prior art documents relied on by the claimant provided any motivation to solve the technical problem, and that the solution claimed (adjusting a sampling rate based on an environmental altering event or user induced event) would not be an evident solution. Accordingly, the Division held that the patent as amended by auxiliary request 2 was inventive.