The European Patent Office's Board of Appeal has dismissed opposition challenges against European Patent No. 2 506 844, which covers a pharmaceutical combination product containing umeclidinium and vilanterol for once-daily treatment of chronic obstructive pulmonary disease (COPD) and asthma.
Patent Opposition Outcome
Three separate oppositions were filed against the patent, challenging its validity on grounds of lack of novelty, inventive step, and sufficiency of disclosure. The opposition division initially rejected all oppositions in July 2021, maintaining the patent as granted. Two opponents subsequently appealed this decision, leading to oral proceedings before the Board of Appeal in March 2024.
The Board of Appeal ultimately dismissed both appeals, confirming that the patent meets all European Patent Convention requirements. The decision validates the intellectual property protection for the combination therapy, which pairs umeclidinium (a long-acting muscarinic antagonist) with vilanterol (a long-acting beta2-adrenoreceptor agonist).
Technical and Legal Analysis
Novelty Assessment
The board addressed challenges based on a clinical study protocol (document D21) that allegedly anticipated the claimed combination. However, the board determined that the study involved healthy volunteers rather than COPD or asthma patients, making it insufficient to establish novelty-destroying prior art. The therapeutic effect claimed in the patent requires demonstration in actual disease treatment, which the prior study did not provide.
Inventive Step Evaluation
Starting from document D3 as the closest prior art, which disclosed vilanterol for respiratory disease treatment, the board formulated the objective technical problem as "providing a combination product comprising vilanterol and a specific anticholinergic for use in the treatment of COPD or asthma and which also facilitates patient compliance."
The board found that while both vilanterol and umeclidinium showed promising preclinical data, neither compound had progressed to clinical development stages at the relevant priority date. Document D3 disclosed vilanterol with potential for once-daily dosing, while document D5 described umeclidinium as having "very long in vivo duration of broncho-protection."
However, the board concluded that the available preclinical data provided only "hope to succeed" rather than a reasonable expectation of success for the specific combination. The assessment noted that "a high level of uncertainty regarding the potential for successful dual therapy with both agents would have been involved" given that neither agent's efficacy, safety, or duration of action had been established in patients.
Sufficiency of Disclosure
The patent's reliance on forced expiratory volume in one second (FEV1) as the primary efficacy parameter was challenged by opponents. The board accepted FEV1 as "the universally used measure of lung function in clinical studies of COPD" and found it adequate for establishing therapeutic credibility.
The patent described clinical studies showing both compounds provided 24-hour bronchodilatory action in COPD patients when used as monotherapies. A combination study in healthy volunteers demonstrated that the dual therapy showed "the largest difference relative to placebo" compared to individual treatments, supporting the credibility of therapeutic efficacy.
Regulatory Context
The decision references the subsequent market authorization of ANORO, a combination product conforming to the patent claims, which received approval in May 2014 for COPD treatment with once-daily administration. Phase III clinical studies supporting this approval demonstrated favorable outcomes beyond FEV1 improvements, including symptomatic benefits.
Clinical Significance
The combination addresses a recognized clinical need for long-acting bronchodilators that can improve patient compliance through reduced dosing frequency. The patent covers the specific pairing of two complementary mechanisms of action: umeclidinium's anticholinergic effects and vilanterol's beta2-agonist activity, both designed for 24-hour duration.
The board's decision reinforces the patent protection for this therapeutic approach, which represents an advancement in COPD and asthma management by combining two long-acting bronchodilators in a single once-daily formulation.
