Sanofi Biotechnologies SAS, Regeneron Pharmaceuticals Inc. v. Amgen Inc., Amgen GmbH, Amgen Europe B.V., Amgen NV, Amgen S.R.L., Amgen B.V., Amgen S.A.S.

This decision was issued by the Düsseldorf Local Division on 13 May 2025 in proceedings concerning European Patent EP 3 536 712 B1, which relates to therapeutic treatments of diseases associated with elevated lipoprotein levels. The patent derives from a divisional application of EP 2 756 004, has an effective filing date of 12 September 2012, and claims priorities from US provisional applications filed in September 2011, November 2011, and May 2012. The patent was granted on 31 May 2023 and is in force in Belgium, France, Germany, Italy, and the Netherlands.

Claim 1 of the patent is a second medical use claim directed to '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 or disorder prior to or at the time of administration of the composition, or who is diagnosed with or identified as being at risk of developing a thrombotic occlusive disease or disorder prior to or at the time of administration of the composition, wherein the PCSK9 inhibitor is an antibody or antigen-binding fragment thereof that specifically binds PCSK9, wherein the patient is not on a therapeutic statin regimen at the time of administration of the composition.'

Regeneron Pharmaceuticals Inc. is the sole proprietor of the patent, and Sanofi Biotechnologies SAS is the exclusive licensee. The Defendants are part of the Amgen group, which markets Repatha® containing the active ingredient evolocumab (a PCSK9 inhibitor) in pre-filled pens and mini-dosers across the relevant member states. Amgen Inc. controls production and European marketing, Amgen Europe B.V. holds the EU marketing authorization, and the other Amgen entities market and distribute the product in specific member states.

The Claimants sought cease-and-desist orders and information regarding the alleged infringing use of Repatha® for reducing Lp(a) levels in the claimed patient population. The Defendants filed a counterclaim for revocation, arguing lack of novelty and inventive step. The Defendants initially raised a preliminary objection regarding the UPC's international jurisdiction in light of pending national infringement proceedings in Düsseldorf but withdrew this objection during the oral hearing on 25 February 2025.

On the infringement action, the Court applied the principle 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 a way that it leads or may lead to the claimed therapeutic use, of which the alleged infringer knows or reasonably should have known. The Court found that the Claimants failed to establish that the Defendants' marketing activities were directed to or would necessarily lead to the claimed therapeutic use of reducing Lp(a) levels in the specific patient population defined in the patent claims. The Court noted that the number of patients identified did not seem sufficient to establish the likelihood of a practice of the claimed use.

On the counterclaim for revocation, the Court examined the Defendants' arguments regarding novelty and inventive step. The Court found that the second medical use claims related to a specific use in a method according to Art. 53(c) EPC and that the notional novelty afforded by Art. 54(5) EPC applied. Regarding inventive step, the Court applied the principle that the subject matter may be obvious if the skilled person would have been motivated to implement it as the next step, but that motivation may be absent or negated if the skilled person faced many uncertainties or expected difficulties. The Court concluded that the Defendants failed to establish that the claimed subject matter was obvious.

The Court also disregarded objections based on pleading ignorance, noting that the Rules of Procedure do not acknowledge this type of pleading.

In its final decision, the Court dismissed both the infringement action and the counterclaim for revocation. The Claimants were ordered to bear the costs of the infringement action in equal shares, while the Defendants were ordered to bear the costs of the counterclaim for revocation in equal shares. The value in dispute was set at EUR 20,000,000 for the infringement action and EUR 25,000,000 for the counterclaim for revocation, with the ceiling of recoverable representation costs set at EUR 1,875,000 in total.