UPC CFI, LD Dusseldorf, 13 May 2025; Second medical use claims valid but not infringed
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Second medical use claims: both infringement action and counterclaim for revocation unfounded (Article 25 UPCA, Article 65 UPCA).
Both claimants have standing to sue as respectively patent proprietor and exclusive licensee (Article 47 UPCA).
Objections based on pleading ignorance are in principle disregarded (R. 171.2 RoP). When a party pleads ignorance, the fact is not specifically contested as required by R. 171.2 RoP. Defendants apparently derive this objection from German procedural law, ignoring that the Rules of Procedure contain no corresponding provision.
Priority: “same invention” (Article 87 EPC). A claimed invention is to be considered the “same invention” as the invention in a previous application 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.
Fictional novelty of (first and second) medical use claims (Article 54(4)(5) EPC). Medical use claims constitute an exception to the “normal” rules on novelty and provide a “notional novelty” by virtue of a legal fiction for substances or compositions for a specific (new) use that were already part of the prior art. Absent these provisions, a prior art disclosure of a substance would in principle be novelty destroying for a claim relating to said substance for a new use. The term “for use in”, as such, in a patent claim would normally be interpreted as the claimed product being “suitable for” the claimed use, but the scope of that claim would not be limited to said use. For (second) medical use claims, the novelty is not derived from the claimed substance or composition as such but from the claimed therapeutic use. In the case of a second medical use, a substance or composition within the meaning of Art. 54(4) EPC (for a use in a treating method = first medical use) is used for any specific use which is not comprised in the state of the art. Such a new therapeutic use can be a new indication, e.g. a disease not yet treated by the claimed substance, or an indication for a new group of patients. In order to benefit from the notional novelty afforded by Art. 54(5) EPC, second medical claims must relate to a specific use in a method according to Art. 53(c) EPC.
Inventive step (Article 56 EPC). The ultimate assessment of the relevant facts and circumstances is a question of law which does not lend itself to the taking of evidence. An objective approach must be taken to the assessment of inventive step. The subjective ideas of the applicant or inventor are irrelevant. In principle, it is also irrelevant whether the invention is the result of serendipity or of systematic work involving (potentially costly and laborious) experimentation. It is only relevant what the claimed invention actually contributes to the prior art. In general, a claimed solution is obvious if, starting from the prior art, the skilled person would be motivated (i.e. have an incentive or in German: “Veranlassung” […]) to consider the claimed solution and to implement it as a next step (“nächster Schritt”, […]) in developing the prior art.
Enabling disclosure (Article 83 EPC, Article 138(1)(b) EPC). It is the position of the Court that the subject-matter of a patent claim must be sufficiently disclosed in the patent as a whole, including the examples. It is the patent that has to demonstrate the workability of the claimed subject-matter. However, as the invention has to be disclosed sufficiently clear and complete for it to be carried out by the skilled person, the skilled person´s common general knowledge must also be taken into account when considering the question of sufficiency. In a case of a second medical use claim, the claimed “use”, which is based on a therapeutic effect, is part of the claim. Therefore, the use (including the therapeutic effect) has to be sufficiently (reproducibly) disclosed in the patent (as a whole).
Infringement of a second medical use claim (Article 25(a) UPCA). For a finding of infringement of a second medical use claim, the alleged infringer must offer or place the medical product on the market in such way that it leads or may lead to the claimed therapeutic use of which the alleged infringer knows or reasonably should have known that it does. In other words, as an objective element, there must be either a prescription in order to lower Lp(a) levels, or there must be at least circumstances showing that such a use may be expected to occur. In addition, as a subjective element the infringer must know this or reasonably should have known.
