{"id":1076,"date":"2026-06-16T21:00:07","date_gmt":"2026-06-16T21:00:07","guid":{"rendered":"https:\/\/blog.franke-ip.com\/en\/?p=1076"},"modified":"2026-06-16T21:00:08","modified_gmt":"2026-06-16T21:00:08","slug":"failed-trials-strong-patents-the-federal-court-of-justice-on-fampridine-sr-bgh-x-zr-165-23","status":"publish","type":"post","link":"https:\/\/blog.franke-ip.com\/en\/failed-trials-strong-patents-the-federal-court-of-justice-on-fampridine-sr-bgh-x-zr-165-23\/","title":{"rendered":"Failed Trials, Strong Patents: The Federal Court of Justice on Fampridine-SR (BGH X ZR 165\/23)"},"content":{"rendered":"\n

German Federal Court of Justice (Bundesgerichtshof), judgment of 17 March 2026 \u2013 X ZR 165\/23 \u2013 on appeal from the Federal Patent Court<\/p>\n\n\n\n

In a decision that commentators are already calling a milestone for pharmaceutical patents, the X. Civil Senate (Patent Senate) of Germany’s Federal Court of Justice (Bundesgerichtshof<\/em>, BGH) upheld a patent covering sustained-release fampridine (Fampridine-SR) for improving walking speed in patients with multiple sclerosis (MS). The judgment is notable not only for its outcome\u2014it reversed an invalidation by the Federal Patent Court\u2014but for what it says about two pillars of patent law: the novelty of medical uses and the assessment of inventive step where clinical hurdles stand in the way.<\/p>\n\n\n\n

Background: the patent and the dispute<\/h2>\n\n\n\n

The patent in suit concerned the use of a sustained-release formulation of fampridine (4-aminopyridine) to increase walking speed in MS patients\u2014in essence, a dosing-regimen invention in a disease characterised by demyelination of nerve fibres, which slows or blocks the transmission of impulses along those fibres.<\/p>\n\n\n\n

Generic challengers brought nullity actions. At first instance, the 3rd Senate (Nullity Senate) of the Federal Patent Court (Bundespatentgericht<\/em>) declared the patent null by judgment of 11 July 2023. The patentee appealed (Berufung<\/em>) to the BGH.<\/p>\n\n\n\n

The outcome<\/h2>\n\n\n\n

The BGH reversed. It amended the Federal Patent Court’s judgment, dismissed the nullity actions, and ordered the claimants to bear the costs of the proceedings. The patent therefore stands.<\/p>\n\n\n\n

Key findings of the decision<\/h2>\n\n\n\n

1. A high bar for novelty of a medical use (the “Memantine” line confirmed)<\/h3>\n\n\n\n

The Senate reaffirmed its Memantine<\/em> case law: the suitability of a substance for a particular therapeutic effect is only disclosed in a novelty-destroying way if a prior-art reference makes clear, directly and unambiguously, that the substance actually has that effect. Mere expectations, estimates, or announcements of planned clinical studies\u2014for example in investor materials or conference abstracts\u2014are not sufficient to anticipate the invention. The Court drew a sharp line between disclosed facts and mere hopes.<\/p>\n\n\n\n

2. Inventive step and the “roadblock” principle<\/h3>\n\n\n\n

Even where a prior-art document highlights a particular solution path, inventive step can be denied only if that path could actually have been pursued successfully with the knowledge and means available at the filing or priority date, judged on an ex-ante basis.<\/p>\n\n\n\n

\n

It is not enough that a path was theoretically conceivable. If, after setting out along it, obstacles or other circumstances would have arisen that\u2014from a skilled person’s perspective\u2014made continuing inadvisable, inventive step is not negated.<\/p>\n<\/blockquote>\n\n\n\n

Crucially, the assessment of a reasonable expectation of success must take account of difficulties that were not yet known in the prior art but that would have materialised once the skilled person embarked on the path.<\/p>\n\n\n\n

3. Clinical failures can support inventiveness<\/h3>\n\n\n\n

Where a clinical study (here, the MS-F202 trial) missed its primary endpoint and failed to show statistical significance, that failure can amount to a technical obstacle weighing against obviousness. Far from undermining the patent, a setback in earlier development can serve as evidence that the claimed solution was not<\/strong> obvious\u2014because, without the invention, the skilled person would have faced what looked like a dead end.<\/p>\n\n\n\n

4. Post-hoc analyses are a legitimate means of proof<\/h3>\n\n\n\n

The Court accepted that a post-hoc responder analysis is a valid way to establish a technical property. Although it is a statistical method, it is relevant under patent law because it speaks to a technical matter\u2014the actual effect of the substance\u2014and can support the efficacy of a specific dosing regimen even where the overall study cohort did not reach a significant result.<\/p>\n\n\n\n

Practical takeaways<\/h3>\n\n\n\n