Düsseldorf Local Division renders first UPC's decision on second medical use patents

On 13 May, the Düsseldorf Local Division rendered the first UPC's decision on second medical use patents.

The proceedings, which involved leading international companies in the pharmaceutical sector, is part of a broader context of litigation started since 2014 before national courts.

The dispute, brought before the Unified Court by the holder of the patent and its exclusive licensee, concerns the alleged infringement of a patent concerning the second medical use of a drug already known for the reduction of cholesterol, the second medical use of which is instead aimed at reducing the levels of lipoprotein(a) in the blood. According to the plaintiff, the defendant group of companies commercialized a drug infringing the patent, by marketing it not only for hypercholesterolemia, but precisely for reducing lipoprotein(a), thus infringing the patent.

In addition to requesting the rejection of the opposing claims, the defendant brought a counterclaim for the patent to be declared invalid, raising several grounds for invalidity.

After recalling the general principles on novelty as a parameter for patentability, the Court recognized its existence in the present case. In particular, the judges held that the claimed therapeutic use was novel since neither the therapeutic indication nor the group of patients for which it is intended were included in the state of the art. Based on these findings, the judges also recognized the existence of inventive step, ruling out the possibility that an expert in the field could have achieved the results covered by the patent on the basis of the knowledge available prior to the date of patenting the invention.

As to the sufficiency of disclosure, the Court, reiterating principles already expressed in some previous case law, clarifies how, for the purpose of assessing this requirement, the patent as a whole, including examples, and the common and general knowledge of the expert in the field must be taken into consideration. Furthermore, in cases of second therapeutic use, the use - as part of the claim - must also be sufficiently described. That being said, in the present case, given the technical information provided in the patent at issue, including the clinical data presented, and in light of the common knowledge of the expert in the field, the Local Division held that the requirement of sufficiency of disclosure was also fulfilled.

With regard to the added matter, in the defendants' view, certain key data for identifying the patient population targeted by the second medical use could not be directly and unambiguously inferred from the original patent application. The Court took a different view, however, stating that such information could be directly and unambiguously derived from the patent application by the person skilled in the art, thus setting aside the objection raised.

Having excluded the invalidity of the patent, the Court moves on determining the alleged infringement. Firstly, the Court clarifies that, to date, there are no specific regulatory provisions on infringement of patents for second medical use, and no consolidated orientation of the UPC. That being said, and reiterating the need for a correct balance between the need to ensure adequate protection for the patent holder and that of ensuring reasonable legal certainty for third parties, the Court affirms the existence of infringement when objective and subjective elements are present. In particular, as regards the objective profile, the infringer must have offered, or placed on the market, the drug in such a way as to determine, or be capable of determining, the therapeutic use claimed in the patent. With regard to the subjective element, on the other hand, it is necessary that the infringer knew, or was in a position to know, that the considered therapeutic use would be applied.

In the present case, it is noted that the lipoprotein-lowering effect is mentioned among the drug's properties and not, however, among the official therapeutic indications. This means that it is not a use authorized from a regulatory point of view, nor promoted as such by the pharmaceutical company. In other words, the mention of the therapeutic effect resulting from the second patented use is merely descriptive and not prescriptive: it merely reports an objective fact without inviting the doctor to use the drug for that specific purpose.

In any event, as the Court pointed out, the mere knowledge of the therapeutic effect by doctors or patients is not sufficient to establish liability for infringement. The opposite would have been the case if the company had actively directed the use of the drug towards the patented indication, through instructions, promotions, information materials or other means. However, the plaintiff has not provided any evidence of this.

In light of all these considerations, the Court dismissed the infringement claim.

Düsseldorf Local Division's decision, on the one hand, confirmed the protection granted by European law to second medical use claims, emphasizing therapeutic innovation even in the absence of new molecules. On the other hand, it put a check on it limited extensive interpretations of the notion of infringement, requiring the infringer to have a clear promotional intention, or at least an incentive for patented use, placing a precise burden of proof on the holder of the infringed right.