The United Patent Court (UPC) is surprisingly busy, not only with medical device but also pharma and biotech cases. In fact, following its inception in June 2023, the UPC has been well accepted by the life sciences industry, which will play a significant role in shaping the UPC.
In this article we examine the status of revocation for pharma and biotech patents in the UPC, exploring:
- what we know from revocation decisions so far
- strategy considerations
- what is still unclear.
What we know from revocation decisions so far
One of the first questions potential users of the UPC ask is what the patentee success rates are. Some caution is needed here because win rates do not reflect the complexity of the decision making involved or the different facts and issues raised. However, based on the relatively few cases decided so far on the merits and for preliminary injunctions, the win rate of patentees and defendants is remarkably balanced on both infringement and revocation issues at approximately 50:50, with some divisions finding more in favour of patentees, such as the Munich Local Division and the Paris Central Division, and some more in favour of defendants, such as the Paris Local Division.
Novelty
The technical teaching of a patent claim is new if it differs from what was known in the state of the art in at least one known feature. Only that which is 'directly and unequivocally' apparent to a skilled person in the relevant technical field is anticipated. Prior disclosure must be found integrally ie in one single piece of prior art, and identical with constitutive elements in the claim.
The standard for assessing the disclosure of a publication is what can and may be expected from the knowledge and understanding of the skilled person (Dexcom v Abbott, UPC_CFI_233/2023). Knowledge gained by a skilled person on the basis of further considerations or further publications/uses is not relevant for the assessment of novelty (10x Genomics v Curio Bioscience, UPC_CFI_463/2023). Moreover, if a skilled person has multiple ways of understanding the information this suggests an absence of direct and unambiguous disclosure (Franz Kaldewei v Bette, UPC_CFI_7/2023).
Obviousness
A patent lacks inventive step if the claimed invention would be obvious to the skilled person. An invention therefore needs to go beyond the prior art and routine developments within the skilled person's knowledge (Franz Kaldewei v Bette UPC_CFI_7/2023) and requires additional creative effort (Meril Italy v Edwards, UPC_CFI_255/2023; UPC_CFI_15/2023, Sanofi v Amgen, UPC_1/2023; UPC_14/2023 and Avago v Tesla, UPC_CFI_54/2023.
In 10x Genomics v NanoString (No.1) (UPC_CoA_335/2023) the Court of Appeal made the following observations about assessing obviousness:
- The assessment is of a number of possible prior art documents, rather than a single closest prior art document. In Sanofi v Amgen the judge found that (i) there must be justification for why a skilled person would consider a particular part of the state of the art as a realistic starting point (Syngenta v Sumi, UPC_CFI_201/2024); and (ii) a starting point is realistic if its teaching would be of interest to a skilled person seeking to develop a similar product or method to that disclosed in the prior art, as at the priority date (NanoString v Harvard, UPC_252/2023). Additionally, limiting inventive steps to certain elements of the prior art, such as the closest prior art, bears the risk of introducing subjective elements into the evaluation.
- The structural 'problem-and-solution' approach (PSA), familiar from the EPO, where (i) the closest prior art is identified; (ii) the objective technical problem to be solved is defined; and (iii) obviousness is considered according, is not explicitly provided for in the EPC and therefore does not appear to be mandatory. More recently, however, in Edwards v Meril, it was stated that the PSA, "…shall primarily be applied as a tool to the extent feasible to enhance legal certainty and further align the jurisprudence of the Unified Patent Court with the jurisprudence of the EPO and the Boards of Appeal (BoA)." It is therefore not known whether the PSA is the UPC way of dealing with inventive step, but it might be wise to be prepared to adopt it going forward.
- Where the skilled person could choose from a number of possible routes that does not prevent any one of them being obvious (Sanofi v Amgen).
- Generally, a claimed solution is obvious if, starting from the prior art, the skilled person would be motivated to consider the claimed solution and implement it as a next step.
Additional principles from case law so far, include:
- Assessing inventive step is an objective test. It requires assessment on a case-by-case basis and consideration of all relevant facts and circumstances. Subjective ideas of the applicant or inventor are irrelevant, as is whether the invention was a product of chance or systematic work. Whether the claimed invention contributes to the state of the art is the only relevant factor (Hand Held v Scandit, Ord_46277/2024, UPC_CFI_74/2024).
- Hindsight must be avoided. Inventive step cannot be assessed with retrospection or knowledge of the patent (Sanofi v Amgen).
- The question is not whether the skilled person would inevitably arrive at the same result but whether they would, without inventiveness, arrive at a result covered by the claim (Sanofi v Amgen).
- In the relevant technical field, the skilled person is aware of trade-offs and finding the right balance is simply a matter of design choice which does not involve an inventive step (Bitzer v Carrier, UPC_CFI_263/2023).
- A technical effect or advantage over the prior art may indicate inventive step (Syngenta v Sumi). However, a feature selected in an arbitrary way, from several possibilities, cannot generally contribute to inventive step (Sanofi v Amgen).
Added matter
The Hague Local Division, in a preliminary injunction order for Abbott v Sibio referring to Article 138(1)(c) EPC, affirming that a European patent may be revoked for added matter if the subject-matter of the patent extends beyond that of the application as filed.
The UPC has also applied the EPO Boards of Appeal 'gold standard' disclosure test (DexCom v Abbott, UPC_CFI_395/2023). Accordingly, amendments to a European patent or application can only be made within the limits of what the skilled person would derive directly and unambiguously, using CGK, from the whole of the application(s) as filed. Features cannot be cherry picked from the original disclosure to draft new claims and there must be a pointer to any combination of features. That said, the Court of Appeal in Abbott v Sibio (UPC_CoA_382/2024) has taken a softer stance where the assessment of added matter, and basis for an amended claim, should not be restricted only to the original application. Instead, the context should be considered where the claim does not need to have the exact same wording as the original application, provided the combination of features can be derived from the whole application.
Strategy considerations
As we say in UPC patent infringement – recent updates for the life sciences sector, unlike medical devices, which can be complex and multi-faceted in both structure and function, and result in a large number of patents, pharma and biotech patents (eg for small molecules and biosimilars) are typically covered by one or two main patents. Unlike medical device patents, therefore, the prospect of any one patent being revoked carries a higher risk, potentially impacting any readiness to convert such patents into unitary patents.
That said, whilst the risk may be greater, there remains the attraction to exploit the powerful enforcement possibilities offered by the UPC to obtain an injunction across 18 countries in one action. Moreover, to the extent patent coverage for pharma and biotech patents can be stratified, for example through compound, dosing regimen and formulation patents, it is still possible to enforce patents in different UPC divisions. Although UPC divisions are somewhat consistent, there remains differing features of procedure that may be capitalised upon, such as the speed of decisions and willingness to allow expert examination. A stratified pharma and biotech portfolio may also lend itself to parallel litigation in the UPC and national courts.
What is still unclear
Many questions of substantive law with regard to validity, are yet to be decided, including how to construe the Bolar exemption, how to deal with the interplay between patent law ruled by UPC law on the one hand and EU and national regulatory law on the other hand, and whether a so-called 'plausibility' requirement will be applied, as well as how obviousness will be examined in detail and the application of the problem and solution approach.
