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NL – Biogen v. Generics – DMF / Tecfidera

31 Jan 2025

Biogen MA Inc. v. Sandoz B.V., Neuraxpharm Pharmaceuticals S.L (Lesvi) and Mylan Ireland Limited et al. (joined cases), District Court the Hague, 22 January 2025, Case no. ECLI:NL:RBDHA:2025:496

The Dutch part of Biogen’s patent EP 2 653 873 covering a dosage of 480 mg DMF (dimethylfumarate, Tecfidera®) for the treatment of MS, was revoked last week by the District Court The Hague and Biogen’s infringement claims against three generic companies Mylan (Viatris), Polpharma/Sandoz and Neuraxpharm (Lesvi) were fully rejected.

Inventive step

“With the Generics, the court rules that, starting from Kappos I and Kappos II, the person skilled in the art who, through those presentations and on the basis of general common knowledge, knows that the efficacy (and therefore effectiveness) of DMF is dosage-dependent and that lower doses are also effective for the treatment of psoriasis, would have the reasonable expectation of success that this problem can be solved in an obvious way by testing lower doses of DMF. Contrary to what Biogen argues, the average skilled person would then also perform those tests. In this way, the average skilled person would find, by routinely performing tests – and therefore without inventive effort – that a dosage of 480 mg per day has a therapeutic effect.”

Claim 1 of ‘873 according to the court therefore was obvious.

Sufficiency of disclosure

The court continues that even if EP ‘873 was to be found inventive, it would lack sufficiency of disclosure and would also be invalid on that ground.

“The court acknowledges that it remains to be seen whether […] paragraph 77 of G 2/21 entails that for a second medical use claim to be sufficiently disclosed, there must always be (some) positive evidence in the application that the effect occurs or whether it is sufficient that there must be no doubt about that effect. The court can leave this question aside because it is of the opinion that the average skilled person, based on what they according to Biogen learn from Kappos I and II, would have doubts about whether DMF (or MMF) at a dosage of 480 mg per day would be effective in the treatment of (RR)MS, for which the following is justificatory.

“Although the application/patent specification describes the Nrf2 activation by and the neuroprotective effect of DMF, which the skilled person would associate with the treatment of (RR)MS, this does not yet say anything about the efficacy of the claimed dosage of DMF (or MMF). According to Biogen, the average skilled person is also familiar with the results of Kappos I and Kappos II. In the context of its argument on inventive step, which should therefore be followed in this reasoning, Biogen argues that Kappos I and II teach that a dosage of 720 mg per day is effective, whereas 360 mg per day is not, and even that “there is no indication whatsoever that a dose lower than 720 mg per day is effective” (see para. 151 of the combined Statement of Defence in the Counterclaim). Based on Biogen’s own assertions, the skilled person would therefore have at least doubts as to whether 480 mg per day would be effective, let alone as effective as 720 mg per day. This applies all the more since 480 mg per day is significantly closer to the allegedly ineffective 360 mg per day than to 720 mg per day.

“Furthermore it is of importance that, in order to make it “credible” that (720 mg per day or) 480 mg per day of DMF is effective in the treatment of (RR)MS, Biogen must take (and has taken) the position that Kappos I and II constitute common general knowledge. Without any experimental data in the patent specification/application, such efficacy would otherwise not be established at all. Biogen has insufficiently substantiated this claim. Nor has it otherwise been proven, not least because this does not involve common general knowledge from a textbook, and Biogen itself argues (in the context of inventive step) that these presentations are ephemeral in nature. Moreover, if Kappos I and II were nevertheless to constitute common general knowledge, then (claim 1 of) the patent would all the more lack inventive step.”

The judgment (in Dutch) can be read here.