Not necessarily.
In its judgment of 28 April 2026 (3 Ni 7/24 (EP)), the German Federal Patent Court dismissed in its entirety a nullity action against EP 3 068 401 (“ONC906”). The decision provides valuable guidance for pharmaceutical and biotech companies seeking robust protection for innovative compounds.
Here are three key takeaways:
- A novel compound does not require a “double proof” of efficacy.
Where a compound is itself novel and patentable, a corresponding medical use claim (e.g., “for use in the treatment of cancer”) does not require a separate demonstration of therapeutic efficacy. The Court reaffirmed the long-established principles of the German Federal Court of Justice in Imidazolines, rejecting the notion of a “double hurdle” consisting of both providing the compound and independently proving its effectiveness.
- Sufficiency does not require a laboratory protocol for every embodiment.
The fact that the patent specification does not disclose the synthesis of the claimed compound step by step is not, by itself, fatal. What matters is whether the skilled person can arrive at the claimed compound by applying common general knowledge and established synthetic methods without exercising inventive skill.
- Structure–activity relationships cannot be generalized.
The claimant relied on eight prior-art publications concerning fluorinated compounds in an attempt to establish lack of inventive step.
The Court was not persuaded.
Its reasoning is particularly noteworthy: findings relating to one molecular scaffold cannot automatically be transferred to another. Even seemingly minor structural modifications may fundamentally alter a compound’s biological and pharmacological properties. As a result, the required reasonable expectation of success was missing.
Takeaway:
This judgment is a timely reminder that the strength of a compound patent is not determined solely by the volume of experimental data.
Equally important are a well-conceived patent strategy, carefully drafted compound claims, a robust disclosure, and a convincing inventive-step narrative.
When these elements are in place from the outset, a patent is often in a much stronger position when challenged years later.