LD Düsseldorf, May 13, 2025, Decision On Second Medical Use Claims, UPC_CFI_505/2024 (Sic!) [UPC_CFI_505/2023]

1. Key takeaways

Requirements for the finding of infringement of second medical use claims

For a finding of infringement of second medical use claims, the claimant must show and prove

(i) as an objective element, that there is either a prescription for use according to the patent, or at least additional circumstances showing that such use may be expected to occur, and

(ii) as a subjective element, that the infringer knows or reasonably should have known of such use.

These requirements cannot be defined in an abstract manner but require an analysis of all relevant facts and circumstances of the individual case.

Relevant aspects that may be considered when assessing (the expectation of) a patented use and the alleged infringer knowing thereof

• The extent or significance of the allegedly infringing use;

• The relevant market, including what is customary on that market;

• The market shares of the claimed use compared to other uses;

• What actions the alleged infringer has taken to influence the respective market, either positively de facto encouraging the patented use or negatively by taking measures to prevent the product from being used for the patented use.

Scope of second medical use claims

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 the 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.

Accordingly, the claimant must show and prove that the claimed effect is indepentely addressed, i.e., that the product is prescribed directly for the specific (second) medical use. A "windfall effect" is not sufficient, i.e., it is irrelevant if during the treatment for the known (first medical) use the claimed (second medical) use occurs and is appreciated.

2. Division

Düsseldorf Local Division

3. UPC number

UPC_CFI_505/2024 (sic!) [UPC_CFI_505/2023]

ACT_597355/2023

CC_24999/2024

4. Type of proceedings

Patent infringement action and counterclaim for revocation

5. Parties

Claimants:

1. Sanofi Biotechnology SAS

2. Regeneron Pharmaceuticals Inc.

Defendants:

1. Amgen Inc.

2. Amgen Europe B.V.

3. Amgen N.V.

4. Amgen GmbH

5. Amgen B.V.

6. Amgen S.A.S.

7. Amgen S.R.L.

6. Patent

EP 3 536 712 B1

7. Body of legislation / Rules

Art. 53 EPC, Art. 54 EPC,

UPC_CFI_505 2023 – LD DUS – May 13 2023