More Lessons on Validity before the UPC - Part II

Lesson 4: The UPC will not apply the Problem-Solution-Approach as developed by the EPO

This is now abundantly clear. In November 2025, the first and the second panel of the CoA have agreed on a common approach on determining inventive step and have cast the principles thereof in headnotes 8-13 of Meril v Edwards and 10-22 of Amgen v. Sanofi. The UPC’s approach is genuinely new and does not even pretend to be the same as the EPO’s approach. In headnote 5 of the Meril decision, the CoA acknowledges that several approaches exist and have been used by the EPO and national courts in the past, but held that despite their differences, “all of these approaches are merely guidelines to assist in the establishment of inventive step as required by Art. 56 EPC, that, when properly applied, should and generally do lead to the same conclusion.”

All well and good, but the question is of course when these approaches are to be considered “properly applied” and who is the final arbiter to make such a judgment. As things stand right now, the EPO is the final arbiter when the patent is about to be revoked, whereas if the patent survives the EPO, the UPC will be the final arbiter. In the latter case, up to four panels of expert examiners and judges and many years (not to speak of hundreds, if not thousands of attorney hours) will be needed to come to a final decision. This can hardly be called a particularly well-balanced or efficient system, in my view, yet it is of course true that this has been our reality in Europe since 1978, and the UPC is certainly not to blame for it. Thus let’s leave the discussion of who the final arbiter is or should be and whether our patent system is efficient and fair for another day and simply accept the CoA’s new approach as the “new normal” for the UPC without further ado.

Since the Amgen decision is more comprehensive than the Edwards decision on inventive step, due to its particular technical field, and since I feel more familiar in the field of chemical and biotech inventions than in the field of medical devices, I will focus on the latter in the following.

In brief, the new approach consists of the following steps:

1.         Determination of the “objective problem”

2.         Determination of a realistic starting point (there can be more than one) in the relevant field of technology

3.         Determination of whether or not the invention was obvious, in particular whether there was a pointer or motivation that directed the skilled person to implement a next step in the direction of the claimed invention.

As a general rule, a claimed solution must be considered not inventive / obvious when the skilled person would take the next step prompted by the pointer or as a matter of routine, and arrive at the claimed invention (could-would-test).

To this extent and up to this point, the Meril and the Amgen decisions are practically identical. But then, Meril discusses whether it is necessary, for an inventive step to be present, to show an improvement of the technical teaching as defined by the patent claims over the prior art. The CoA found that it is not. Inventive step may also be found if the patent claims disclose a non-obvious alternative to solutions known in the prior art.

Conversely, the Amgen decision (where the problem of the obvious alternative did apparently not arise) contains six more headnotes on the reasonable expectation of success. I will deal with them in Lesson 5.

For now, let’s primarily consider the “object of the invention, i.e. the objective problem”. What is it, and what do we need it for?

a)         What is the objective problem and how is it determined?

The answer to the first question is, at least arguably, provided in headnote 11 of Amgen (8 of Meril):

It first has to be established what the object of the invention is, i.e. the objective problem. This must be assessed from the perspective of the skilled person (m/f – hereinafter referred to as ’it’), with its common general knowledge, as at the application or priority date (also referred to as the relevant date) of the patent. This must be done by establishing what the invention adds to the state of the art, not by looking at the individual features of the claim, but by comparing the claim as a whole in context of the description and the drawings, thus also considering the inventive concept underlying the invention (the technical teaching), which must be based on the technical effect(s) that the skilled person on the basis of the application understands is (are) achieved with the claimed invention.

I must confess that I am still struggling with really understanding this paragraph. Particularly the third sentence is quite a monster, and I hope that the CoA will provide further clarification in the decisions to come. For what it’s worth, my perhaps simplistic take for the time being is the following:

1.         The objective problem is what the invention aims to achieve (the object of the invention).

2.         It must be assessed from the perspective of the skilled person at the relevant date of the patent.

3.         The objective problem must be determined by assessing what the invention as a whole objectively contributes to the state of the art.

What I believe to have understood from the CoA’s third sentence is that the UPC flatly rejects the EPO’s “differential problem”, i.e. which effect has been achieved with the feature(s) by which the invention differs from the (closest) state of the art. The CoA wants to determine this problem in a holistic manner.

Conversely, what I have not understood is what exactly the CoA wants to compare with what and what the basis for this comparison is to be, i.e. is it the granted patent or the application as filed? While the wording of the Court’s monster sentence suggests that the skilled person should look at the application, this does not make much sense (at least to me) in the evaluation of a patent that may very well have been amended. Judges Kalden and Blok gave a webinar in January 2026, in which I think they cautiously hinted that the reference to the application in this headnote was erroneous. Be that as it may, we will of course have to wait for further clarification by the CoA in the decisions to come.

Update: As one avid reader of this blog rightly observed (thank you very much!), the CoA has meanwhile provided this clarification in paragraph 68 of the decision  VMR v. NJOY. It is indeed the patent from which the skilled person has to draw their conclusions, not the application.

The question “what exactly is to be compared with what?” is a bit delicate also for a further reason, i.e. because the starting point is to be defined only in step 2 of the CoA’s approach. It seems that the objective problem is supposed to be used to inform the skilled person about what the relevant field of technology is and what a realistic starting point for solving it may be.

Given the slightly cryptic nature of this headnote (which is verbatim repeated in para. 127 of the decision), it would have been very helpful had the court then applied its own test and actually determined the objective problem before proceeding further to discuss whether or not Lagace is a realistic starting point. But it did not, unless I have overlooked something. The CoA’s inventive step assessment starts with two paragraphs (139, 140) setting forth the result of the court’s assessment before immediately turning to the starting point. The “objective problem” was not determined at all, at least not ipsis verbis, and we can only assume from the language used in para. 140 that the CoA perhaps meant that this problem was to obtain an agent that is “therapeutically effective in treating or preventing the diseases referred to in claim 1 or of reducing the risk associated with such diseases”.

In the Meril decision, the first panel of the CoA put more effort into addressing this question. At least the Court included a section (137-144) where the Objective Problem was discussed at some length, although the result of this discussion was, unfortunately, not stated in a manner clear enough for me to comprehend it (which could be entirely my fault!). It seems that the CoA considered the statement in para. [0039] of the patent as correct, i.e. that the inventive system “reduces the crimping profile of the valve and provides stability during crimping and subsequent expansion”. But the word “reduces” requires a comparator, i.e. reduced relative to what? This remained a bit unclear throughout this section. It also seems that Meril argued that there was no such reduction, i.e. no improvement relative to the prior art, at all. The CoA answered that showing an improvement is not necessary for inventive step, and that the problem could also be to find an alternative.  But after that interlude the CoA proceeded to agree with Edwards’ argument that a frame made up entirely of hexagonal shaped cells has the disclosed effect of a reduced crimping profile, because the introduction of side struts provides for cells with larger openings with less material in a given area. So I would assume that it was this effect that did or at least could form the basis for the formulation of the objective problem.

Going forward, if I had a wish for free, it would be that the UPC were to spell out much more clearly what exactly the objective problem is and how the Court comes to its conclusion in this regard. Ideally by way of examples, since verba docent, exempla trahunt. If the determination of the Objective Problem were to embrace a comparison of the claimed invention with (some) prior art, it would be good to know (a) which prior art was used for this comparison and (b) whether a technical effect, relative to this state of the art, must objectively be present or whether it is sufficient that the skilled person understands from the patent that such a technical effect is alleged to be achieved. It goes without saying that the parties should contribute to such desirable clarity by presenting arguments in these terms. Admittedly, this was difficult or impossible for the parties in the Meril and Amgen cases, as this approach did not exist in this form before the CoA’s judgments.

b)         What is the Objective Problem used or needed for?

This is another very pertinent question. At least in EPO proceedings, it is often the formulation of the Objective Technical Problem that is key to the final decision on obviousness. For example, if the invention objectively achieves a technical effect that the prior art did not yet achieve, then the skilled person would need a pointer in the state of the art that such technical effect could be achieved by modifying the prior art teaching in the direction of the invention. Conversely, if no further or better technical effect is achieved than in the prior art, the problem ought to be formulated as the provision of an alternative to existing prior art solutions, which may or may not be obvious. Finally, if no technical effect is achieved at all, the invention might be useless.

In other words, the formulation of the Objective Technical Problem directs, or at least has a strong impact on, the determination of obviousness in the EPO case law. In stark contrast, the problem seems to play almost no role whatsoever in the determination of obviousness according to the case law of the German Federal Court of Justice. This raises the question how the UPC positions itself regarding this important question?

According to Amgen, headnotes 12-15, the objective problem seems to have a dual purpose. Firstly, it is used to define the “relevant field of technology” and the “realistic starting point”. Secondly, it also seems to be used for the determination of obviousness, at least if one takes headnote 13 literally:

The claimed solution is obvious when at the relevant date the skilled person, starting from a realistic starting point in the state of the art in the relevant field of technology, wishing to solve the objective problem, would (and not only: could) have arrived at the claimed solution.

This wording more or less corresponds to the EPO’s well-known “could-would-test” established as early as 1984 (T 2/83), and the CoA might have stopped here. But it did not. It added two further headnotes. The first one is about the need for a pointer (and the exception when no such pointer is needed) and seems to take up the “next step” concept of the decision under appeal by the CD:

16. The skilled person has no inventive skills and no imagination and requires a pointer or motivation that, starting from a realistic starting point, directs it to implement a next step in the direction of the claimed invention. As a general rule, a claimed solution must be considered not inventive / obvious when the skilled person would take the next step prompted by the pointer or as a matter of routine, and arrive at the claimed invention.

However, this headnote no longer refers to the Objective Problem, and the test arguably works as well without it. Was this intentional? Has the national German Case Law possibly left some traces here? In the case law of the German Federal Court of Justice, the problem is not of much relevance for the obviousness assessment beyond identifying the technical field and providing the background for the starting point.

Another point worth mentioning here is that headnote 16 explicitly refers to two alternative reasons why a skilled person would take the next step, i.e. a prompt by the pointer or as a matter of routine. Unfortunately, the CoA did not further discuss whether synthesizing and testing a PCSK9 antibody could be seen as a matter of routine in the present case, even though it apparently accepted in para. 109  that “routine techniques existed both for producing and for screening monoclonal antibodies”.

The second further headnote (17), begins with “A claimed solution is obvious if the skilled person would have taken the next step in expectation of finding an envisaged solution of his technical problem”. Taken very literally, this headnote also does not refer to the Objective Problem, but to “his technical problem”. Nonetheless, it seems to me that the CoA had the Objective Problem in mind when referring to “his technical problem”.

I hope that the role of the objective problem in the determination of obviousness will be further clarified and confirmed in one of the next decisions. It is clearly important to know whether the pointer, if any, must be one that would be seen to solve the objective problem, or whether any pointer, also for reasons completely unrelated to the objective problem, might render an invention obvious.

Lesson 5: For the UPC, "obvious" is the skilled person’s "next step" - but mind the reasonable expectation of success!

Already the Central Division, in its first instance decision in Amgen, had decided that, 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. The CD Munich added (headnote 4) that 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 always answered is whether the claimed solution is non-obvious.

The CoA in Luxembourg seems to agree with the concept of the next step in principle, but then begins to pivot in the direction of the reasonable expectation of success:

17. A claimed solution is obvious if the skilled person would have taken the next step in expectation of finding an envisaged solution of his technical problem. This is generally the case when the results of the next step were clearly predictable, or where there was a reasonable expectation of success.

Thus, it seems that the CoA wanted to qualify the first instance decision in an important aspect, i.e. by requiring that the results of the next step were either clearly predictable or that there was at least a reasonable expectation of success. Moreover, it seems that there is (or at least should be) a difference between clearly predictable and expectation of success.

According to the Oxford Learner’s Dictionary, if something is predictable, you know in advance that it will happen or what it will be like. In the field of pharmaceutical inventions, this will only exceptionally be the case, as our body is simply too complex to really “know in advance” what will happen if you take e.g. a certain drug. Let us therefore look more closely at the “reasonable expectation of success”. The CoA Amgen decision discusses it in headnotes 17-22:

17. A claimed solution is obvious if the skilled person would have taken the next step in expectation of finding an envisaged solution of his technical problem. This is generally the case when the results of the next step were clearly predictable, or where there was a reasonable expectation of success.

18. The burden of proof that the results were clearly predictable or the skilled person would have reasonably expected success, i.e. that the solution he envisages by taking the next step would solve the objective problem, lies on the party asserting invalidity of the patent.

19. A reasonable expectation of success implies the ability of the skilled person to predict rationally, on the basis of scientific appraisal of the known facts before a research project was started, the successful conclusion of that project within acceptable time limits.

20. Whether there is a reasonable expectation of success depends on the circumstances of the case. The more unexplored a technical field of research, the more difficult it was to make predictions about its successful conclusion and the lower the expectation of success. Envisaged practical or technical difficulties as well as the costs involved in testing whether the desired result will be obtained when taking a next step may also withhold the skilled person from taking that step. On the other hand, the stronger a pointer towards the claimed solution, the lower the threshold for a reasonable expectation of success.

21. When the patentee brings forward and sufficiently substantiates uncertainties and / or practical or technical difficulties, the burden of proof that these would not prevent a skilled person from having a reasonable expectation of success, falls on the party alleging obviousness.

22. The fact that other persons or teams were working contemporaneously on the same project does not necessarily imply that there was a reasonable expectation of success. It may also indicate that it was an interesting area to explore with a mere hope to succeed.

The definition of reasonable expectation of success is in headnote 19 and is copied from the EPO decision T 296/93, reason 7.4.4. This was a decision on a patent relating to a recombinant DNA molecule encoding polypeptides displaying Hepatitis B Virus antigen specificity. The patent claimed a priority date from late 1978, when the field of molecular biotechnology still was very much in a state of infancy. The closest prior art document concluded that “further research will be needed to confirm or refute the model” in view of a “number of uncertainties”, of which five of them were listed by the Board in reason 7.4.1. In view of these uncertainties and the largely unexplored field of technology at the relevant date, the Board concluded “that the skilled person in late 1978 had no reasonable perspectives of readily achieving expression of polypeptides displaying antigen specificity and antigenicity by the genetic engineering route”.

This old case law was applied to Amgen’s patent claiming priorities of 2007 and to a situation where the relevant prior art document (Lagace) concluded the following:

“The genetic data from humans with loss-of-function mutations in PCSK9 combined with the studies in knockout mice that lack PCSK9 clearly indicate that inhibitors of the protease would be of therapeutic benefit for the treatment of hypercholesterolemia. Inasmuch as overexpression of the catalytically inactive form of PCSK9 in mice did not alter LDLR protein levels (9), an inhibitor of PCSK9’s protease activity in the ER should be sufficient to block its ability to reduce LDLR protein levels. If PCSK9 functions as a secreted factor as suggested by the current data, then additional approaches to neutralize its activity, including the development of antibodies to block its interaction with the LDLR or inhibitors to block its action in plasma, can be explored for the treatment of hypercholesterolemia.” (underline CD Munich)

The CD Munich concluded from this teaching, which was underpinned by a number of in vitro and in vivo experiments, that the skilled person would have taken Lagace at face value and used anti-PCSK9 antibodies as the next step to block the interaction of PCSK9 with the LDLR in order to treat hypercholesterolemia. Amgen’s invention was thus held obvious.

The CoA seemed to agree with the CD Munich in the starting point and even saw a strong incentive to block PCSK9 activity to reduce LDLR levels, but then apparently, due to its quantitative approach to the therapeutic effect, placed much more emphasis on the “If PCSK9 functions as a secreted factor” part of the sentence:

160. The Court of Appeal agrees with the CDM that at the priority date the skilled person, starting from Lagace, had a strong incentive to block PCSK9 activity to reduce LDL levels in order to be able to treat hypercholesterolemia and similar diseases. As will be explained below, the skilled person at that time would not consider as a next step to develop antibodies targeting PCSK9 with a reasonable expectation of success.

What the CoA meant by “success” is a certain degree of cholesterol lowering, as explained by the CoA in para. 166 (see below). The CoA considered that the skilled person at the priority date was aware that antibodies are not able to enter the cell and that they would only consider a therapeutic approach based on antibodies targeting PCSK9 if it was established that PCSK9 in vivo functions outside the cell (i.e. extracellularly). As discussed in Lagace, previous scientific papers had already shown that PCSK9 played a role in regulating LDLR - and therewith cholesterol - levels and also that PCSK9 functioned intracellularly. Lagace showed the skilled person the existence of the extracellular pathway by which PCSK9 also functioned. But, according to the CoA (paragraph 166), the skilled person still “needed to know whether the contribution of the extracellular pathway by which PCSK9 functioned would be sufficient to result in such therapeutically effective treatment. The CDM was wrong to consider that the relative contribution of PCSK9’s pathways was not relevant to the skilled person.” Moreover, the CoA noted that even Lagace admitted: “we do not know which pathway predominates under normal and/or pathologic conditions” and concluded therefrom that the skilled person would understand that Lagace considered further research necessary, in particular experiments that clarify the relative contribution of these pathways.

Apparently, the CoA considered that the unimaginative skilled person would have first conducted these biological experiments to clarify the relative contribution of these mechanisms and only then, dependent on the outcome thereof, made an educated decision whether or not to use an anti-PCSK9 antibody to block the PCSK9 activity to thus treat hypercholesterolemia.

I must say that I was quite surprised by this reasoning, which sounds pretty academic to me. Why would a skilled person not have taken the direct route to find out whether the extracellular pathway of PCSK9 is the relevant one, i.e. try out an anti-PCSK9 antibody or a PCSK9 inhibitor and test its cholesterol-lowering effects in an in vivo model? They might at the very least have reasonably expected obtaining the desired clarity about the importance of the extracellular pathway from such an experiment and, in the best case, even win the “jackpot”, i.e. a new effective medicament for treating or preventing hypercholesterolemia and related diseases, which could be sold for billions of dollars.

Lagace itself stated that their data suggest that PCSK9 “functions as a secreted factor”, i.e. that the extracellular pathway is functional. Even if other references suggested that PCSK9 works by an intracellular mechanism, as the CoA held, isn’t there at least a 50:50 chance that Lagace is correct, and wouldn’t a 50% chance of winning a billion dollar jackpot be sufficient to warrant an experiment?

If I am not scientifically mistaken, the chance that the extracellular pathway is functional at least in such a way that it contributes to lowering cholesterol levels should even be much higher than 50%. For example, if the relative contribution of the extracellular pathway is 80%, one would certainly expect an anti-PCSK9 antibody to significantly lower cholesterol levels. But even if the relative contribution of the extracellular pathway is only 20%, a complete blockade of this pathway might still very well be sufficiently effective to “significantly” lower cholesterol levels (leaving on one side that in the prevention aspect of the claim a lowering of cholesterol levels would not even be necessary). It is perhaps no coincidence that the description of the patent in para. [0130] contemplated degrees of binding as low as 1-20% (see Part I of this blog).

It also seems that the CoA accepted that producing and testing an anti-PCSK9 antibody imposed no undue burden on the skilled person. In para. 109, the CoA held the following (in the context of sufficiency of disclosure, underline added):

109. In relation to inventive step, Respondents have argued that the skilled person would have arrived at antibodies within the scope of the claims. It asserted that at the priority date routine techniques existed both for producing and for screening monoclonal antibodies. With reference to Zhang (C4) Respondents have submitted that using the assay disclosed therein, the skilled person would have identified antibodies that bind to the catalytic domain and prevent or reduce the binding of PCSK9 to LDLR. This must then also apply when assessing sufficiency, especially since in this assessment the skilled person has the benefit of knowing the invention and the description.

However, if this is so, i.e. if a prior art document suggested an approach that could be implemented and tested without particular technical difficulties, I wonder whether a reasonable expectation of success in the sense of a “rational predictability” of the outcome of such an experiment would even have been necessary. In accordance with the CoA’s headnote 16

As a general rule, a claimed solution must be considered not inventive / obvious when the skilled person would take the next step prompted by the pointer or as a matter of routine, and arrive at the claimed invention.

it might at least have been worth investigating whether the development and testing of an anti-PSCSK9 antibody could have been considered “a matter of routine”. Unfortunately, the CoA provided no reason why this is apparently not the case.

The established EPO Case Law suggests a different approach in such situations. Chapter I.D.7.4 of the Case Law of the Boards of Appeal (11^th Ed.) starts with the following paragraph:

When neither the implementation nor the testing of an approach suggested by the prior art involves any particular technical difficulties, the consideration that the skilled person would have at least adopted a “try and see” attitude is a reason for denying inventive step (see e.g. T 333/97, T 377/95 of 24 April 2001, T 1045/98, T 1396/06, T 2168/11). In such situations the concept of “reasonable expectation of success” does not apply (T 91/98, T 293/07, T 688/14, T 259/15). The skilled person would prefer to verify whether the potential solution they had conceived worked, rather than abandon the project because success was not certain (“try and see” approach).

The above raises the question whether the CoA deliberately wanted to deviate from EPO Case Law and adopt a decidedly more patentee-friendly approach in this important respect, or whether it simply got too entangled in the debate on reasonable expectation of success. As the Amgen decision did unfortunately not discuss this case law or the try-and-see approach at all, we will have to wait for the next decisions of the CoA to get a clearer picture. The EPO itself will also have no opportunity to present its final view on these interesting questions, as the cases between Sanofi/Regeneron and Amgen were recently settled.

For the time being at least, it seems that the CoA has adopted an understanding of “reasonable expectation of success” in the context of a (pharmaceutical) compound for use claim that requires that a “meaningful treatment” of a patient suffering from a disease mentioned in the claim must be “rationally predictable”: In para. 166, the CoA stated that “in order to make a reliable prediction whether an antibody approach would be therapeutically effective in vivo, the skilled person needed to know whether the contribution of the extracellular pathway by which PCSK9 functioned would be sufficient to result in such therapeutically effective treatment.” It was not discussed in the decision what the difference, if any, is between “clearly predictable” and “rationally predictable”. In any case, it appears that the UPC will request challengers of a patent to demonstrate a much higher degree of predictability of success than e.g. the German Federal Court of Justice, who generally applies a much broader and more open definition. This can, for example, be taken from the headnote of the FCJ’s recent decision “Testosteronester” X ZR 77/23:

The requirements for a reasonable expectation of success cannot be formulated in a universally applicable manner. They must be determined in each individual case, taking into account the field in question, the size of the incentive for the skilled person, the effort required to pursue a specific approach, and any alternatives that may be considered, as well as their respective advantages and disadvantages (Confirmation of FCJ, Judgment of 16. April 2019 - X ZR 59/17, GRUR 2019, 1032 mn. 31 - Fulvestrant; Judgment of 7. July 2020 - X ZR 150/18, GRUR 2020, 1178 mn. 108 - Pemetrexed II; Judgment of 26. January 2021 - X ZR 24/19, GRUR 2021, 696 mn. 51 - Phytase).

Did the UPC in Amgen deliberately want to find its own way to distinguish from EPO and national Case Law on Inventive Step? And where will this journey take us? We will have to wait and see.  For the time being, it seems that the CoA places more emphasis on “rational predictability” than on any of the other factors considered by the FCJ. The size of the incentive is not discussed at all, and the fact that other persons or teams were also working contemporaneously on the same project was not found conclusive even as an indication of a reasonable expectation of success – it might as well just indicate that there was a hope to succeed.

Lesson 6: The UPC Adopts a Generous Sufficiency Standard

The Amgen decision is also of considerable importance because it spells out the sufficiency standard to be applied by UPC:

106. The test to be applied is whether the skilled person is able to reproduce the claimed subject matter on the basis of the patent without any inventive effort and without undue burden. An invention is sufficiently disclosed if the patent specification shows the skilled person at least one way – and in case of functional features: one technical concept – of performing the claimed invention.

107. Where a claim contains one or more functional features, it is not required that the disclosure includes specific instructions as to how each and every conceivable embodiment within the functional definition(s) should be obtained. A fair protection requires that variants of specifically disclosed embodiments that are equally suitable to achieve the same effect, which could not have been envisaged without the invention, should also be protected by the claim. Consequently, any non-availability of some embodiments of a functionally defined claim is immaterial to sufficiency, as long as the skilled person through the disclosure is able to obtain suitable embodiments within the scope of the claim.

Let us remind ourselves that claim 1 of Amgen’s patent was directed to a monoclonal antibody or an antigen-binding fragment thereof for use in various diseases, wherein the monoclonal antibody or the antigen-binding fragment thereof binds to the catalytic domain of a PCSK9 protein and prevents or reduces the binding of PCSK9 to LDLR.

Thus, the anti-PCSK9 antibody was not defined by its structure or sequence, nor by its CDRs, but solely by the target to which it binds, i.e. the catalytic domain of a PCSK9 protein (which in turn was defined by a certain sequence). It was out of dispute that there is an enormous number of antibodies (or antigen-binding fragments thereof) that fall under this broad, functional definition. The CoA was apparently not bothered by the breadth of this claim, arguing that the patentee deserved a fair protection.

This is clearly a relatively generous approach, but it is at least consistent with the approach taken by the German FCJ in Dipeptidyl-Peptidase-Inhibitoren X ZB 8/12 – even though, unfortunately, at odds with the EPO’s practice in regard to such claims (see T 1063/06 (OJ EPO 2009, 516), T 1151/04 and GL F.III.9). Rather than expanding further on this subject here, may I refer readers to another piece on this blog, where Elisabeth Engelhard, Dirk Bühler and I discussed this legal schism a few years ago. The EPO’s case law in regard to the level of disclosure for antibodies specifically is more differentiated anyway, see CLBA II.C.7.3.

Conclusion

The first years of the UPC have clearly been very successful, and we have now a substantial body of substantive case law to which we can refer. Unsurprisingly, this case law has its roots both in EPO case law and in the case law of the national courts, with which the UPC generally tries to harmonize. Nonetheless, the UPC has also started to do things its own way, as it should. While this may sometimes leave questions open and some decisions, or parts thereof, may appear more convincing than others, this is only normal. On the whole, there can be no doubt that this court has so far served its users well and is here to stay.

Transparency notice: 

The author’s firm (Hoffmann Eitle) but not the author personally has been involved in some of the cases discussed above. This article, however, merely provides the author’s own opinion in his personal capacity as a UPC representative and occasional blogger. It does not seek to express the views of Hoffmann Eitle or of any of its clients and was not commissioned by any party in these proceedings. I respect the right of others to differ from the views expressed here and reserve the right to learn more and hold different views in the future. The use of this article in proceedings where I represent a party is not permitted.