In a landmark decision issued on Tuesday, the UPC Court of Appeal has found Amgen’s PCSK9 antibody patent EP3666797 to be valid. At first-instance, the UPC’s Munich Central Division had found the antibody claims to lack inventive step, leading to a swift revocation of the patent in the UPC-contracting states just over a year from its grant (as we reported here). In the hope of obtaining full revocation across all EPC states, Sanofi and Regeneron had also filed parallel oppositions at the EPO. However, earlier this year, the EPO Opposition Division rejected these oppositions and upheld the patent as granted. As a result, there was some concern that a divergent inventive step assessment was emerging between the UPC and the EPO. The UPC Court of Appeal’s ruling now harmonizes the outcome and appears to bring the UPC into closer alignment with established EPO case law.
Moreover, this is the first decision in which the UPC Court of Appeal has provided detailed guidance on the UPC’s inventive step approach. The decision also comments on the interpretation of medical use claims, added matter and sufficiency of functionally defined antibody claims. The present bulletin focuses on the grounds where the Court of Appeal deviated from the first-instance decision: inventive step and claim interpretation.
Interpretation of medical use claims
Claim 1 of the patent in suit is directed to a PCSK9 antibody for use in treating or preventing specific diseases related to elevated cholesterol levels (hypercholesterolemia, atherosclerotic disease or a recurrent cardiovascular event). In the decision, the UPC Court of Appeal confirmed that the medical use format requires that the antibody is therapeutically effective against the specific diseases mentioned in the claim.
However, the Court of Appeal disagreed with the Munich Central Division that it was sufficient for the antibody to lead to any lowering of cholesterol in vivo. Rather the Court of Appeal held that there must be “a noticeable improvement of the medical condition of the patient” (headnote 2 and §47). This appears to bring the UPC into closer alignment with the EPO’s strict interpretation of medical use claims.
Inventive Step
The UPC’s Court of Appeal has for the first time set out detailed guidance on the inventive step approach of the UPC. As we have seen in the lower UPC courts, there is significant overlap with the EPO’s problem-solution approach, but the inventive step assessment is not identical. Encouragingly, the UPC’s Court of Appeal indicates in the decision that any differences in approach should lead to the same outcome (§124).
The decision contains twelve headnotes detailing the UPC’s inventive step approach, but these can be divided into three core steps:
Essentially, steps 1 and 2 appear to be reversed as compared to the EPO’s problem and solution approach.
Under step 1, the objective problem “must be based on technical effect(s) that the skilled person understands is (are) achieved with the claimed invention” (headnote 11). This is similar to the EPO’s approach, but notably, the UPC does not focus on individual features of the claim when establishing the technical effect(s). Rather, the UPC looks at what the claim as a whole adds to the state of the art, also considering the inventive concept underlying the invention (the technical teaching). This has been described by the lower UPC courts as a more “holistic approach” (as we reported here).
Despite the differences in establishing the objective problem, it is stressed that the problem should not contain pointers to the claimed solution in order to avoid hindsight (headnote 12). In particular, the UPC’s Court of Appeal noted that neither the provision of an antibody nor the use of PCSK9 as the target could be included in the objective problem without introducing hindsight (§38). Rather, the objective problem was held to be simply the provision of a therapeutically effective treatment or prevention of the specific diseases in the claim. Amgen did not seek to rely on any technical effects further to the therapeutic effect already required by the claim. Thus, one limitation of the decision is that it provides no specific guidance on purported technical effects that are not recited in the claim (c.f. the EPO case law under G 2/21).
Under step 2, a document is a “realistic starting point” if it is in the relevant field of technology and if it would have been of interest to a skilled person wishing to solve the objective problem at the effective date (headnotes 14-15). The relevant field of technology encompasses any field in which the same or similar problem arises and of which the person skilled in the art is expected to be aware. This is consistent with the field of the closest prior art at the EPO. However, at the EPO, inventive step can only be attacked from one or more closest prior art documents if they are shown to be equally valid springboards to arrive at the claimed solution. At the UPC, inventive step needs to be demonstrated from all realistic starting points. In this case, a realistic starting point related to the mode of action of PCSK9, and it was irrelevant that there were other prior art documents relating to therapeutic approaches to target PCSK9 with in vivo data (§141-142).
Under step 3, it must be established whether the skilled person, starting from a realistic starting point and wishing to solve the objective problem, would (and not only: could) have arrived at the claimed solution. This requires both:
The Court of Appeal agreed with the Munich Central Division in that the skilled person had a strong incentive to block PCSK9 activity to treat diseases associated with elevated cholesterol, and was also provided with a suggestion towards PCSK9 antibodies (§160 and § 202). However, unlike the Munich Central Division, the Court of Appeal held that the skilled person would not have had a reasonable expectation of success that PCSK9 antibodies would be therapeutically effective (§202-203). This more rigorous assessment of “reasonable expectation of success” aligns with the decision of the EPO’s Opposition Division.
Interestingly, the Court of Appeal comments in the decision that a reasonable expectation of success may be dependent on several factors, including: the extent to which the technical field had been explored, any envisaged practical or technical difficulties and the strength of any pointer (headnote 20). In this case, the Court of Appeal held that the research concerning the mode of action of PCSK9 had not reached the stage where the skilled person could have reasonably predicted that PCSK9 antibodies would be therapeutically effective (§140). In particular, there was uncertainty around the extent to which PCSK9’s extracellular pathway contributed to its therapeutic relevance. Since antibodies only act outside of the cell, this uncertainty was enough to prevent a reasonable expectation of success (§161-204).
Takeaway
Overall, this decision brings the UPC into closer alignment with the EPO’s strict assessment of medical use claims, under both claim interpretation and inventive step. The decision also confirms the UPC’s inventive step approach, which builds on the approach emerging from lower UPC courts. As noted above, one limitation is the lack of specific guidance on purported technical effects that are not recited in the claim. In this regard, it will be interesting to see if the UPC endorses the EPO’s standard under G 2/21 and/or provides further clarity on assessing whether a purported technical effect can be relied upon under inventive step.
