Invalidity at the UPC

The Unified Patent Court (UPC) burst to life on 1 June 2023 with a flurry of first-day actions relating to new Unitary Patents (UPs).  In the past six months, substantive decisions have been handed down, giving important insights into how closely its application of the law on invalidity aligns with the approach taken by the European Patent Office (EPO).

Claim interpretation

A claim interpretation section at the outset of any substantive decision appears to emerge as a central difference between the workings of the new court and the established practice at the EPO.

The claim interpretation section before the Courts of First Instance (CFIs) normally starts with a short definition of the skilled person.  This is a notable difference from EPO proceedings.

According to the Court of Appeal (CoA), “Claim features must always be interpreted in the light of the claim as a whole” (Headnote of VusionGroup v Hanshow Technology).  The Court summarised the way in which the claims should be interpreted according to its earlier decision in Nanostring v 10x Genomics (our emphasis added in bold):

1. The UPC follows the principles of Art. 69 EPC and the Protocol on its Interpretation.

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

3. 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.

4. However, this does not mean that the patent claim serves only as a guideline and that its subject-matter may extend to what, from a consideration of the description and drawings, the patent proprietor has contemplated.

5. The patent claim is interpreted from the point of view of a person skilled in the art.

6. In applying these principles, the aim is to combine adequate protection for the patent proprietor with sufficient legal certainty for third parties.

7. 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 follows from the function of the patent claims, which under the European Patent Convention serve to define the scope of protection of the patent under Art. 69 EPC and thus the rights of the patent proprietor in the designated Contracting States under Art. 64 EPC, taking into account the conditions for patentability under Art. 52 to 57 EPC.

Application of claim interpretation in revocation proceedings in Sanofi v Amgen

These principles have been applied in revocation actions, including in Sanofi v Amgen, where the UPC’s Munich Central Division (MCD) clarified that the skilled person determines the technical meaning of the terms “with the aid of the description and the drawings,” and that the “patent description may represent a patent’s own lexicon” (Headnote 1).  Unlike the EPO, there appears to be no option to interpret the claims on their own, albeit noting that questions of whether and in which circumstances the description and figures may be taken into account when interpreting a patent claim, and whether a patent can serve as its own dictionary, are currently under referral to the EPO’s Enlarged Board of Appeal in G1/24.

How were these principles applied by the MCD in Sanofi v Amgen?  The Patent related to cholesterol lowering drugs.  In particular, the patent related to antibodies that bind to the PCKS9 protein, which prevents cholesterol from being extracted from the blood by the low density lipoprotein receptor (LDLR).  By blocking the binding of PCSK9 to LDLR, cholesterol levels in the blood can be reduced.

Paraphrasing claim 1:

A monoclonal antibody …

for use in treating or preventing … disease[s] related to elevated serum cholesterol levels … [that] binds to the catalytic domain of a PCSK9 protein and prevents or reduces the binding of PCSK9 to LDLR.

Technical features of claim 1 were first interpreted individually.  The claim is in an EPC2000 second medical use format with additional functional features defining the antibody.  The MCD noted that there was no limitation of the structure or production method of the antibody beyond it being monoclonal.  The use was broad but required the antibody to be therapeutically effective.  The functional features only appeared to require some binding to the “catalytic domain”, which was interpreted as a distinct region of a protein in which a catalytic reaction takes place.  Despite an unclear meaning in the prior art, the MCD used the description as the patent’s own lexicon and defined the “catalytic domain” based on the disclosed PCSK9 amino acid sequence.

Technical features were then interpreted in light of the claim as a whole and the underlying problem to be solved by the claimed invention.  The MCD provided detailed analysis on how the exemplified antibodies functioned, referring to the description, figures, sequences and data.  It noted that a technical functional reason why the antibodies must bind to the catalytic domain is not provided by the Patent and that other regions could be targeted.  It held that the term “binds to” only required binding to one amino acid within this domain with no further qualitative or quantitative definition.  However, the binding was intended to have a consequence: the antibody was supposed to prevent or reduce the binding of PCKS9 to LDLR.  Based on a dependent claim to a combination with a statin (another cholesterol lowering drug) the MCD held that the independent therapeutic effect could be minimal.  Based on the description, the MCD held that only minimal (1%) binding was required but this must result in some (measurable) reduction of cholesterol levels in vivo.  The MCD concluded:

“For the skilled person, it will [be] apparent that the patentee has chosen the present broader claim wording instead of defining the claimed antibodies in a narrower way.”

In summary, whilst the claims remain the decisive basis for determining the protective scope of the European patent, the current practice of the UPC is to perform a detailed claim interpretation which must use the description to interpret the claims.  And this analysis is used to interpret all grounds of revocation.  Applicants should accordingly consider removing (before grant) any broad, boilerplate embodiments set out in their patent applications that could later result in an interpretation of the claims whose breadth might cause difficulties under sufficiency of disclosure, novelty and inventive step.

Added Matter

Most decisions up to this point have applied the EPO’s “gold standard” test of direct and unambiguous disclosure to assess added matter.  In Abbott v Sibionics, the Hague Local Division (HLD) highlighted that this is the standard in many member states.  Amendments can only be made within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and as seen objectively and relative to the date of filing, from the whole of the application(s) as filed.  After the amendment, the skilled person may not be presented with new technical information.  In contrast, it is not sufficient if the claimed subject-matter is “obvious” to the skilled person in view of the original application.  This strict standard is to ensure legal certainty.

In Seoul Viosys v Expert Klein, the description did not overrule the decisive nature of the claims.  The claims related to a light emitting diode (LED) comprising “a mesa” and “a reflective electrode”.  The Düsseldorf Local Division (DLD) held that the claims added matter based on a narrow interpretation of these terms that excludes a plurality of mesas and a plurality of reflective electrodes.  This led to a finding that the claims added matter.  Interestingly, this narrow interpretation would have prevented fixing of the added matter issue by amending the claims to require a plurality of mesas and a plurality of reflective electrodes, since this would extend the scope of protection.  However, the Patentee did not offer such amendments because they would exclude the alleged infringement, which only had a single mesa.

Whilst the current practice of the UPC is to use the description and drawings to interpret the claims (see above), it is noteworthy that the DLD adopted this narrow interpretation despite embodiments having multiple mesas being disclosed in the description and drawings.

Priority

In an approach similar to that taken by the EPO, the UPC applies the same “gold standard” requirements when determining validity of a claim to priority from an earlier application.  For example, in Sanofi v Amgen, the MCD followed the EPO’s direct and unambiguous disclosure test to assess priority entitlement.  In Plant-e v Arkyne, the HLD explicitly stated that the “gold standard” was also relevant to priority and that the subject-matter should be directly and unambiguously derivable, using common general knowledge, from the previous application as a whole, rather than from the claims of the previous application only.

Regarding the applicant’s formal right to claim priority, the court similarly follows the recently established EPO approach.  For instance, in Meril v Edwards, the Paris Central Division (PCD) stated that there was a rebuttable presumption of the entitlement to priority in favour of the subsequent applicant, provided the latter could demonstrate the acquisition of the right to the title.  This assessment was clearly based on the new EPO standard applied in G 1/22.

Novelty

Following on from the above-described approach in interpreting the claims, the assessment of novelty then appears to follow the established EPO approach.  In Nanostring v 10x Genomics, the MCD confirmed that the assessment of novelty within the meaning of Art. 54(1) EPC requires the determination of the whole content of the prior publication.  It is decisive whether the subject-matter of the claim with all its features is directly and unambiguously disclosed in the prior publication.

Notably, unsuccessful novelty attacks will not automatically be considered as candidates for closest prior art unless asserted by parties attacking the patent.  In NJOY v Juul Labs, the PCD warned that it is the claimant that defines the scope of evaluation for a revocation action.  The Court does not evaluate reasons for revocation that the claimant has not raised.  As the claimant did not raise inventive step starting from the novelty citations, it was left undecided if the claimed invention would be obvious having regard for these documents.  Therefore, claimants seeking revocation must ensure all inventive step arguments are presented and substantiated.

Inventive step

Major variations between the UPC and EPO approaches are starting to emerge when it comes to the assessment of inventive step.  In this regard, the UPC’s tendency to formally define the skilled person is a welcome development, although it appears that, to date, nothing has turned on this analysis.

Starting point for inventive step

The EPO’s approach of defining the closest prior art document as a first step of obviousness analysis requires the skilled person to consider the “purpose or effect” of an opposed patent as a primary consideration, with the number of features in common being a secondary consideration.  Selection of one closest prior art disclosure tends to be key in the chemistry and life sciences areas at the EPO.  Whilst early decisions of the UPC followed this approach, recent decisions from the UPC seem to discount the importance of selecting the single best starting point or springboard.

For example, in Sanofi v Amgen, the MCD emphasised that obviousness analysis did not require selection of the closest prior art and could look at any realistic starting point that is of interest to the skilled person and that has a similar underlying problem. The MCD did not consider it to be relevant whether a document is “more realistic” or “closer”.  According to the MCD, whether a document is speculative is not a reason to discount it as a starting point, but is an issue to consider under obviousness.

In NJOY v Juul Labs, the PCD warned that limiting the evaluation of inventive step to certain elements of the prior art, for example a document perceived to be “the closest prior art,” generally bears the risk of introducing subjective elements into the evaluation.  The PCD did however acknowledge that limiting the inventive step assessment to certain documents might be necessary for reasons of procedural efficiency.

In Nanostring v Harvard, the MCD started from a document that had anticipated the main request.  The MCD reasoned that the document had many features in common, which was considered as an indication that the document was a realistic starting point for the assessment of inventive activity.  Furthermore, the patent in suit and the document sought to address the same underlying problem, even if one related to in vitro detection and the other to in situ detection.  This assessment is not dissimilar to the EPO’s approach.

In summary, patentees will struggle to convince the Court that a “document of interest” can be discounted because another document is closer.  Instead, patentees will need to consider all objections raised.  In cases where the document is unrelated to the underlying problem of the patent in suit, it remains unclear whether such documents can be discounted as being selected based on hindsight.  A clear statement in the application as filed outlining the underlying problem might assist in convincing the Court that a document directed to the same or a similar problem is more relevant than another when assessing inventive step.

Obviousness analysis

It is noteworthy that the UPC has not followed the EPO’s approach of defining an “objective technical problem” based on the technical effect associated with the feature(s) that distinguish the claim in question from the closest prior art.  For instance, in Nanostring v 10x Genomics, the Court of Appeal of the UPC considered alleged difficulties in arriving at the claimed solution.  The two technically qualified judges considered that problems that regularly arise in a development process, and which could be routinely overcome by the skilled person, would not lead to a finding of non-obviousness.  In particular, the Court of Appeal highlighted that the Patent did not provide any information on how to deal with the alleged problems.  This highlights once again that the UPC considers the description as critical in determining the contribution of the patent in suit over the state of the art.

In Nanostring v Harvard, the MCD discounted alleged problems developing the prior art when the patent in suit included embodiments that would suffer from these problems.  For example, problems relating to the length of probe reagents and incubation times were not considered relevant because the patent allowed both parameters to vary greatly.

In Sanofi v Amgen, the MCD confirmed that a technical effect or advantage achieved by the claimed subject matter compared to the prior art may be an indication for inventive step.  However, no such effect was deemed present in this case because the modification was considered to be arbitrary.  The MCD suggested three factors to consider when assessing inventive step:

1. The skilled person must be motivated to implement the solution in the next step(s).  This motivation is subjective – based on the underlying problem in the Patent – rather than the objective technical problem defined using the EPO’s approach.

2. Whether the skilled person expected any particular difficulties.  A Patentee will need to establish that there would be a serious obstacle to development.

3. A reasonable expectation of success.  This is based on a lack of difficulties, and consideration of the data available at the relevant date.

According to the MCD, it was not relevant for the assessment of obviousness of the claimed solution whether there were other ways to solve the problem.

The MCD also stressed that it was not necessary for the skilled person to arrive at the same result as the patentee, i.e., at the exemplified embodiments of the description.  Rather, it considered it to be sufficient that the skilled person would arrive at an embodiment which was covered by a claim without any inventive contribution.  In particular, problems encountered by the patentee in generating the claimed antibodies were found to be irrelevant when the claims did not limit the method of manufacture and the description suggested standard alternative ways to produce antibodies that would encounter the problem.

In summary, the UPC does not closely adhere to the EPO’s well-established protocol for assessing inventive step and takes a more holistic approach based on a detailed interpretation of the claims in light of the description.  In particular, disclosures in the description are considered highly relevant to define the underlying problem, to assess whether a specific difficulty is a serious obstacle, and to determine if the claims overcome a problem compared to the prior art.  Given that each panel includes a technically qualified judge, the court may assess these issues without referring to expert evidence.  In light of the central role the description plays in interpretation of the claims and identification of the underlying problem to be solved by the claimed invention, we reiterate our recommendation that applicants carefully review the description prior to grant and consider if any broad, boilerplate embodiments should be removed – especially since this is currently the EPO’s preferred approach.

Sufficiency of disclosure

To date, there have been few decisions on sufficiency of disclosure/enablement.  In Plant-e v Arkyne, the HLD held that the skilled person wishing to implement the claimed invention would read the claims in a technically sensible manner.  Insufficiency is not based on meaningless embodiments that are not consistent with the teaching of the application as a whole.  The purpose of the provisions of Art. 83 EPC is: (i) to ensure that the application contains sufficient technical information to enable a skilled person to put the invention as claimed into practice; and (ii) to enable the skilled person to understand the contribution to the art which the invention as claimed has made.

Outlook

The workings of the UPC continue to evolve at pace.  The Court has proved to be efficient, thorough and decisive.  Most grounds of revocation follow similar standards to the EPO grounds of opposition but with detailed claim interpretation as standard, which sets UPC rulings apart from EPO decisions.  Furthermore, the test for inventive step applied by the court appears to be diverging from the problem-and-solution approach firmly established at the EPO.  Given the description’s role in the interpretation of the claims and identification of the underlying technical problem to be solved by the claimed invention, applicants should review this part of their patent application carefully prior to obtaining a Unitary Patent.

For more detailed advice in relation to any of the issues discussed above, or for advice relating to other matters regarding European practice, please do not hesitate to get in contact with your E+F representative or email us at elkfife@elkfife.com.  More information about the authors can be found at the links below: