The Local Division of Düsseldorf is the first UPC panel to set out the prerequisites and establish essential factors for assessing infringement of second medical use claims in the UPC system. Its approach builds on the criteria developed by national (German) courts.
1. Background and facts of the case
Sanofi and Regeneron assert EP 3 536 712 (hereinafter, “patent-in-suit”) against Amgen.
Claim 1 of the patent-in-suit concerns a pharmaceutical composition comprising an antibody (briefly referred to as “PCSK9 inhibitor”, hereinbelow) for reducing lipoprotein(a) (briefly, “Lp(a)”).
Lipoproteins (“lipo” is ancient Greek for fat) transport fats in the blood. The human body’s own lipoproteins include, among many others, LDL-C (low-density lipoprotein cholesterol) and Lp(a). Both lipid blood parameters, LDL-C and Lp(a), were known to be independent risk factors for atherosclerosis and related cardiovascular diseases, such as stroke and myocardial infarction.
Claim 1 of the patent-in-suit is in the format of a second medical use claim, namely administering PCSK9 inhibitors for use in reducing Lp(a). The first medical use is administering PCSK9 inhibitor to treat or prevent hypercholesterolemia or an atherosclerotic disease related to elevated LDL-C. In other words, it was known in the prior art that PCSK9 inhibitors were useful for reducing LDL-C and reducing the risk of CVD caused by elevated LDL-C.
Sanofi and Regeneron sued Amgen for the alleged infringement of the patent-in-suit by Amgen’s medicinal product distributed under the name Repatha® (evolocumab). Repatha® is an antibody directed against PCSK9 (“PCSK9 inhibitor”) that is authorized for the treatment of, inter alia, so-called hypercholesterolemia and mixed dyslipidemia, i.e., the reduction of cardiovascular risk in patients with elevated LDL-C. Neither Repatha® nor Praluent® (alirocumab), Sanofi and Regeneron’s PCSK9 inhibitor drug, is authorized for lowering Lp(a) levels or for lowering cardiovascular risk by lowering Lp(a) levels.
Sanofi and Regeneron alleged that Amgen infringed said second medical use claims because the SmPC of Repatha® in section 5.1, concerning pharmacodynamic properties, contains clinical trial data on the effects of Repatha® on, inter alia and in particular, Lp(a), which, in turn, allegedly induces doctors to prescribe Repatha® for lowering Lp(a) in accordance with the patent, even when they target LDL-C. Amgen responded by, inter alia, showing that the mere mention of the clinical trial data concerning Lp(a) lowering in section 5.1 of the SmPC did not induce doctors to prescribe Repatha® for the claimed second medical use.
Amgen filed a counterclaim for revocation against the patent-in-suit and attacked the validity of the patent-in-suit based on, inter alia,the argument that PCSK9 inhibitors always lower Lp(a), which effect was already known to the person skilled in the art at the priority date of the patent-in-suit.
Sanofi and Regeneron defended the validity of the patent-in-suit against Amgen’s counterclaim for revocation by arguing, inter alia, that the subject-matter of the patent-in-suit was novel as the lowering of Lp(a) levels was a new clinically relevant therapeutic effect of PCSK9 inhibitors that defined a new clinical situation.
2. The ruling of the UPC Local Division of Düsseldorf
The UPC Local Division of Düsseldorf ruled that Amgen does not infringe the patent-in-suit and for the first time in the history of the UPC system ruled on the requirements for the finding of infringement of second medical use claims.
The Court held that for a finding of infringement of second medical use claims, the claimant must show that the attacked embodiment is offered or placed on the market in such a way that it is used or may be used according to the patent, and that the alleged infringer knows or should have known of such use.
In the present case, the Court found that the information on pharmacodynamic effects provided in section 5.1 of the SmPC for Repatha® is not suitable for showing that Amgen places the product on the market in an infringement-relevant manner (see mn. 191 of the decision).
