Life Sciences Patents Monthly Roundup—May 2026

Why It Matters

These decisions reshape enforcement strategies for biotech and medical‑device patents across Europe, influencing how companies draft claims, manage SPC waivers, and assess the viability of patent litigation under the UPC framework.

Key Takeaways

• Brussels court upheld EP3297977 inventive step, rejecting prior art combination
• Belgian SPC waiver notification requires only public reference, not destination details
• Align must prove infringement with concrete evidence; promotional material insufficient
• UPC revoked Remdesivir use patent, citing obviousness from existing literature
• Decision clarifies “reasonable expectation of success” standard for inventive step

Pulse Analysis

European patent litigation is entering a more rigorous phase, as illustrated by the Brussels Enterprise Court’s handling of EP 3297977. By rejecting a cross‑field prior‑art combination, the court reinforced the European Patent Convention’s inventive‑step analysis, signaling that merely aggregating unrelated disclosures will not suffice. The ruling also highlighted procedural nuances in SPC manufacturing waivers, confirming that Belgian courts require only publicly available marketing‑authorisation references, aligning with Hague Court precedent and easing compliance for biosimilar manufacturers.

In the medical‑device arena, the Düsseldorf Local Division’s dismissal of Align Technology’s provisional‑measure request underscores the heightened evidentiary standards for infringement claims under the Unified Patent Court. The court’s interpretation of claim scope—demanding all features in a single appliance—forces patentees to invest in detailed technical assessments or reverse‑engineering studies before seeking injunctions. This shift may encourage earlier settlement negotiations and more robust pre‑litigation due diligence among orthodontic device firms.

The UPC’s revocation of the Remdesivir use patent marks a pivotal moment for pharmaceutical patent strategy. By applying the “reasonable expectation of success” benchmark, the Milan division demonstrated that early‑filed pandemic‑related claims must overcome a high bar of obviousness when prior literature already points to the compound’s antiviral potential. This decision not only narrows the protective moat for COVID‑19 therapeutics but also sets a precedent for future biotech inventions arising from emergent public‑health crises, prompting innovators to bolster experimental data and claim differentiation.