Fumarsäureester_2U11622.jpg

Fumaric acid ester (Higher Regional Court Düsseldorf)

Higher Regional Court Düsseldorf, Judgment dated February 23, 2023 - 2 U 116/22

Law applied:

ZPO § 935, § 940

EPC Art. 64(1), (3)

Patent Act Sec. 139 (1)

Summary:

  1. The granting of the patent for invalidity with the participation of a third party does not justify an injunction even in a generic case if it is opposed by the revocation decision of the superior opposition division on the parent patent with the same content.
  2. If a previously known dose-finding study (here: for the treatment of multiple sclerosis) discloses, in addition to two ineffective active substance doses (here: 120 mg/day, 360 mg/day), a therapeutically effective dose (here: 720 mg/day), which is associated with comparatively low side effects, the person skilled in the art has reason to test a lower active ingredient dose (480 mg/day), which has not yet been investigated in the study, even if the study has not revealed any evidence that there is a relationship between the amount of active ingredient and the side effects, which would lead to the expectation that a lower level of side effects is associated with a lower amount of active ingredient.
  3. The reason arises from the fact that the study skipped several possible dosage steps (here: 480 mg/day and 600 mg/day) between the ineffective dosage (here: 360 mg/day) and the proven effective dosage (here: 720 mg/day), and it would represent a real stroke of luck if the first and lowest therapeutically effective dose had been found by chance with the active substance dose tested - omitting several possible lower doses - (here: 720 mg/day).
  4. From an expert point of view, the efficacy limit had not yet been determined with the study. To pursue it and to clarify the efficacy limit for its own sake may have been unreasonable from an economic point of view. However, this does not make the project inventive, because the results of the study not only clearly revealed the remaining knowledge gap, but it was also obvious what had to be done to close it.

Higher Regional Court of Düsseldorf, judgment dated February 23, 2023 – 2 U 116/22

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