UPC clarifies infringement standards for second medical use claims in landmark PCSK9 ruling

Nearly two years after the opening of the UPC in June 2023, the Court has addressed for the first time the topic of second medical use claims and in a case-deciding opinion, set out what a patentee needs to demonstrate to prove infringement. The opinion was set out in a decision of the Dusseldorf Local Division at the beginning of May and concerns an infringement action brought by Sanofi Biotechnology and Regeneron Pharmaceuticals against seven defendants belonging to the Amgen family of companies in the long running patent dispute concerning PCSK9 inhibitors.

The claim in question concerns “a pharmaceutical composition comprising a PCSK9 inhibitor for use in reducing lipoprotein(a) (Lp(a)) levels in a patient who exhibits a serum Lp(a) level greater than 30 mg/dL and who is diagnosed with or identified as being at risk of developing a cardiovascular disease […] wherein the patient is not on a therapeutic statin regimen at the time of administration of the composition”.

The Court noted that claim construction is governed by Art. 69 EPC and its protocol and that the same approach to construction applies to both an assessment of infringement and validity.  Furthermore, the Court correctly held that second medical use claims (in the form of EPC 2000 claims such as the claims in the present case) are purpose limited product claims.  Given that, the Court again correctly held that for second medical use claims, novelty is not derived from the claimed substance or composition as such but from the claimed therapeutic use.

Importantly, the scope of protection is however limited to the same extent – thus in order to find infringement of a purpose-limited product claim, a patentee must prove that the allegedly infringing product fulfils the “use” feature(s) of the claim. 

In the face of Amgen’s challenge as to whether reduction of Lp(a) was in fact a “therapeutic use” the Court, holding the claims to be valid, said this:- “The reduction of Lp(a) levels would thus be understood by the skilled person as a therapeutic intervention of its own right (albeit with the ultimate or overarching goal of treating or reducing the risk of cardiovascular disorders)”. This was therefore the “use” that had to be demonstrated for a finding of infringement.

 In the critical part of its decision, the Court held that, 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.

In assessing this, the Court gave a list of factors that could be considered relevant, including the extent of the allegedly infringing use, the relevant market, the market share of the claimed use compared to other uses, and what actions the alleged infringer has taken to influence the respective market.

In the present case, the Court considered the Summary of Product Characteristics (SmPC) of the allegedly infringing product, Amgen’s Repatha. Whilst the “Pharmacodynamics Properties” section of the SmPC noted that the drug reduced unbound Lp(a), the “Therapeutic Indications” section contained no suggestion of using Repatha to lower Lp(a). The Court held that to find infringement, it would be important to include the effect of lowering Lp(a) in the pharmacodynamic properties, due to its relevance for patients with comorbidities,  but that a decision to prescribe would be based on the therapeutic indications for which the drug is approved. In the case of Repatha, that was in fact to reduce the levels of LDL-C and not (necessarily) Lp(a). Further, Amgen had not placed any emphasis on reduction of Lp(a) when placing the product on the market. For this reason, the claim for infringement was rejected – but the Court went further.

The Court also held that the Claimants failed to demonstrate that the placement on the market of Repatha may lead to the claimed use. However, the Court said that this could have been done by providing evidence that such prescriptions have already been made or that there is a substantial likelihood that they will be made. 

In summary, in the absence of any evidence that Amgen was inducing infringement, or that any prescriptions for the infringing use had occurred, the Court dismissed the infringement action. 

The Court aimed to find a balance between fair protection for the proprietor and a reasonable degree of legal certainty for third parties when considering second medical use claims. Both parties now have two months in which to file an appeal and given the long history of the PCSK9 disputes between the parties, it is expected that the finding of validity and noninfringement will be challenged on appeal. It will be interesting to see if further first instance courts follow the approach adopted by the Dusseldorf Local Division. Further, if this does progress to the Court of Appeal in Luxembourg, will reference be made to how national courts interpret the requirements for infringement of second medical use claims?  There have been diverging opinions in European courts and thus the Court of Appeal may wish to draw comparisons in order to settle any uncertainties following the Dusseldorf decision under appeal.