EP 3 666 797 B1 relates to antigen binding proteins that bind to proprotein convertase subtilisin kexin type 9 (PCSK9) and methods of using and making the antigen binding proteins.
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The case is interesting not only as is a decision taken by a Section of the Central Division, but an opposition is going on in parallel at the EPO for the patent at stake and for the patent resulting from a first divisional application.
EP 3 666 797 is a divisional application of EP 3 202 791. The parent application of the series is EP 08798550 granted as EP 2 215 124
In T 845/19, the parent has been maintained in amended form.
Brief outline of the case at the UPC
The parties at the UPC were as proprietor/defendant Amgen and as requester in nullity/claimant three companies of the Sanofi-Aventis group.
The Munich Section of the Central Division has revoked EP 3 666 797 B1 for lack of IS.
The panel held that the patent as granted is invalid because it does not involve an inventive step over “Lagace“. AR 1-17 lack inventive step for the same reasons.
The skilled person who was interested in developing a treatment for hypercholesterolemia targeting PCSK9 would, starting from and following the teaching of “Lagace”, without inventive skill develop antibodies against PCSK9 that block the interaction of PCSK9 with the LDLR and would thereby arrive at the claimed subject matter in an obvious way.
The UPC panel was composed of the following persons
- the LQJ Ulrike Voß, as chairperson
- the LQJ András Kupecz as judge-rapporteur
- the TQJ Casper Struve
“Lagace” was quoted as X, for original claims 1, 2 and 4, and Y for original claims 3 and 5 in the ESR.
Brief outline of the case at the EPO
On 10.11.2023, a first opposition was filed by one of the three claimants in the UPC litigation.
On 19.02.2024, a second opposition was filed by Regeneron, not a party in the UPC litigation.
On 30.06.2024, the proprietor, Amgen replied to both oppositions. In reply to the opposition, the proprietor filed 10 AR.
A total of 141 citations were filed by the three parties in opposition.
On 02.07.2024 the first opponent requested that one specifically named examiner should not be member of the OD in the present opposition and in the opposition against the divisional application, EP 3 202 791 B1, as well as member of the ED in the examination of the second divisional application, EP 4 248 976 A1. The objection raised is that of suspected partiality in favour of the proprietor/applicant.
On 03.07.2024, the second opponent supported the objection of partiality against the named examiner raised by the first opponent.
The UPC decision
On the interpretation of the claims
The UPC panel referred to Art 69(1) EPC and Art 1(1) of the Protocol on interpretation.
As held by the Court of Appeal, these principles apply also to the assessment of validity and not merely to the scope of protection.
The panel held that, when interpreting a patent claim, the person skilled in the art does not apply a philological understanding, but determines the technical meaning of the terms used with the aid of the description and the drawings.
The patent description may represent a patent´s own lexicon.
In the present case, the skilled person is represented by a multidisciplinary team composed of a biologist having experience in antibody technology and a specialist in cardio vascular clinical research.
On the validity of the priority
A claimed invention is to be considered the “same invention” as meant in Article 87 EPC (priority right) 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.
On the assessment of IS
The assessment of IS starts from a realistic starting point in the prior art. There can be several realistic starting points. It is not necessary to identify the “most promising” starting point.
In general, a claimed solution is obvious if the skilled person would be motivated to consider the claimed solution and would implement it as a next step in developing the prior art.
It may be relevant whether the skilled person would have expected any particular difficulties in taking any next step(s). The absence of a reasonable expectation of success, or more in general: non-obviousness, does not follow from the mere fact that other ways of solving the underlying problem are also suggested in the prior art and/or would have been pursued by others.
The decisive question that has to be answered is whether the claimed solution is non-obvious.
For assessing ISp it is not the question whether the skilled person would inevitably arrive at the same result falling within the scope of the claim or not.
Rather, it is sufficient, but also necessary, for denying IS that the skilled person would without inventive contribution arrive at a result which is covered by a claim.
A technical effect or advantage achieved by the claimed subject matter compared to the prior art may be an indication for IS. The arbitrary selection of a feature, out of several possibilities cannot generally contribute to IS.
Comments on the UPC decision
Being a decision of first instance, it can be expected that the proprietor will appeal. A more precise assessment of the position of the UPC in matters of IS will only be possible after the decision of the Court of Appeal.
Interpretation of the claims
In view of the composition of the panel, that an interpretation of the claims in the German style, “Auslegung”, does not come as a surprise.
It renders the referral G 1/24, the more important.
Validity of the priority
In this aspect, the panel followed the case of the of EBA/TBA by using the gold standard “directly and unambiguously derivable, using common general knowledge”.
Inventive step
Here the panel has shown that it was not prepared to adopt the PSA.
This is manifest in that it considered that it is not necessary to identify the “most promising” starting point.
The notion of reasonable expectation of success stems however from various decisions of the TBA. The same is valid when the panel considers that a technical effect or advantage achieved by the claimed subject matter compared to the prior art may be an indication for IS, but that an arbitrary selection is not considered leading to IS.
Legality of the decision of the LS Munich of the CD-UPC
The legality of the attribution of the duties formerly allotted to the London Section of the UPC-CD to the Paris and Munich local sections of the UPC-CD has been queried many times, also in the present blog. The problem is unresolved to this day.
The corresponding decisions of the Presidium of the UPC and of its Administrative Committee have no legal basis. This is the more so that no attempt has been made to interpret the UPCA under the VCLT. The withdrawal of the UK from an agreement without any exit clause appears also problematic.
Comments on the EPO opposition
The complaint of partiality against a specific examiner will have to be dealt with under G 5/91, OJ 1992, 617. A corresponding procedure has been established within DG1 and it is the director in charge of the OD/ED which is empowered to decide on a request for partiality raised against a member, or the whole, of a first instance deciding body. This question will have to be decided before the OD will issue summons to OP.
It will be interesting to see whether the OD will follow or not the decision of the UPC and later of its boards of appeal in the opposition procedure.
In view of the nullity action before the UPC , as well as the following appeal, the opposition and appeal procedures should be accelerated ex-officio.
It should be kept in mind that the EPO is not bound by decisions of any other courts, be it the UPC.
It can be argued that the patent is at least dead in the contracting states of the UPC in which it has been validated. Some people claim that for sake of legal certainty, it cannot be revived.
Should the patent be maintained in amended form by the EPO, which is unlikely, but cannot be excluded, see the parent, an interesting and unusual situation would be created. The problem of possible conflicting decisions between the UPC and the EPO has carefully been swept under the carpet by the proponents of the UPC.
The UPC might be quicker in its decision, but in case of parallel actions before the UPC and an opposition before the EPO, the last word is in principle with the EPO as the reach of its decisions go far beyond the contracting states of the UPC.
The present case illustrates best all the problems created by the creation of the UPC and the wishes of its proponents that the UPC should become the leading jurisdiction in patent matters in Europe.
I might have been long, but it was worth it. Thanks for reading up to here.
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