Last updated: April 23, 2025
The European patent EP2968566A1, titled "Compositions utiles pour traiter les règles abondantes et les fibromes" (Useful Compositions for Treating Heavy Menstrual Bleeding and Fibroids), represents a critical innovation in gynecological therapeutics. This analysis examines the patent’s scope, claims, legal standing, and broader landscape within the pharmaceutical sector, contextualized against European Patent Convention (EPC) requirements and competitive developments.
Technical Scope and Claim Architecture
Novel Therapeutic Combination
EP2968566A1 claims a method for treating heavy menstrual bleeding (HMB) and uterine fibroids using 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenyl-ethylamino)-butyric acid (Elagolix), a gonadotropin-releasing hormone (GnRH) antagonist, in combination with estrogens and progestogens[8]. The claims specify:
- Dosage ranges: 300–600 mg/day of Elagolix, administered twice daily.
- Treatment duration: 28 days to one year, with emphasis on sustained regimens (e.g., 168 days)[8].
- Combination therapy: Co-administration with estrogen-progestogen formulations to mitigate hypoestrogenic side effects[1][8].
The patent emphasizes functional synergy, where Elagolix suppresses ovarian hormone production, while add-back hormone therapy prevents bone density loss and vasomotor symptoms[1][8]. Clinical data from Example 1 demonstrate a ≥80% reduction in menstrual blood loss and amenorrhea rates of 40–60% after three months[8].
Structural and Functional Claiming Strategy
Claims are drafted with mixed structural-functional limitations:
- Structural specificity: Elagolix’s chemical structure is meticulously defined, ensuring precision in compound coverage[8].
- Functional elements: Claims 2–10 outline therapeutic outcomes (e.g., blood loss reduction) and dosing protocols, anchoring the invention to clinical utility[8].
Under EPC Article 84, such hybrid claims must remain clear and supported by the description. The patent’s detailed pharmacokinetic data (Figures 1–5) and comparative studies against placebo satisfy the support requirement[6][8]. However, the reliance on functional outcomes (e.g., "reduction in blood loss") risks ambiguity if contested during opposition[6][11].
Legal and Procedural Status
Withdrawn Status and Implications
EP2968566A1 is listed as "Withdrawn" in the EPO register, indicating AbbVie abandoned the application during examination[8]. Potential reasons include:
- Prior art conflicts: The priority date (March 15, 2013) coincides with Elagolix’s Phase III trials (NCT01441635), which may have generated overlapping public disclosures[1][8].
- Objections under Article 84/83 EPC: Examiners may have deemed claims overly broad or inadequately supported, particularly regarding combination therapy’s mechanistic synergy[6][11].
Prosecution Highway Considerations
The patent’s U.S. counterparts (e.g., US2014288031A1) were granted, suggesting AbbVie prioritized the U.S. market[1]. Under the EPO-IPONZ Patent Prosecution Highway (PPH), applicants can expedite examination if claims align with allowable subject matter in another jurisdiction[4]. However, EP2968566’s withdrawal implies divergences in EPO and USPTO interpretations of sufficiency[4][11].
Competitive Landscape and Patent Family
Global Portfolio Strategy
AbbVie’s patent family for Elagolix includes:
- U.S. patents: US9,456,993 and US9,474,722 (expiring October 2033)[2].
- International extensions: WO2018224498 (fibroid treatment), CN110312512 (dosage forms), and IL278082 (sustained-release formulations)[1][8].
This geographic diversification aims to maximize market exclusivity, particularly for Elagolix’s branded formulation (Orilissa®/Oriahnn®). The EPO withdrawal, however, leaves the European market vulnerable to generics post-U.S. expiry[2][8].
Second-Medical-Use Claims
EP2968566A1 includes Swiss-type claims for Elagolix’s use in manufacturing medicaments for HMB[8]. Under EPC Rule 43(2), such claims are permissible if they "sufficiently correspond" to allowed subject matter[4][6]. The patent’s alignment with clinical trial outcomes (NCT01441635) strengthens its validity against insufficiency challenges[1][11].
Validity Risks and Enforcement Challenges
Insufficiency and Undue Breadth
Recent UK Court of Appeal rulings (e.g., Actavis v. ICOS) clarify that broad claims require proportional disclosure[11]. While EP2968566’s dosage ranges (300–600 mg/day) are narrowly defined, the combination therapy’s mechanism ("add-back" hormones) may lack sufficient empirical support across all claimed permutations[8][11].
Priority Entitlement and Inventive Step
The patent’s priority date (2013) predates Elagolix’s FDA approval (2018), raising questions about post-filing data supplementation. Under EPO guidelines, clinical efficacy data generated after filing cannot remedy inadequate disclosure at the priority date[6][7]. Any opposition would likely focus on whether the original application plausibly demonstrated the claimed therapeutic effects[7][11].
Conclusion and Strategic Recommendations
EP2968566A1 exemplifies the complexities of drafting combination-therapy patents in Europe. While its structural specificity and clinical data provide a foundation for validity, the withdrawn status underscores vulnerabilities in claim scope and sufficiency. For stakeholders:
- Competitors: Monitor AbbVie’s continuation applications (e.g., EP2934496B1) for broader claiming strategies.
- Generic manufacturers: Exploit the EPO withdrawal to enter European markets post-2033, contingent on U.S. exclusivity expiry.
- Innovators: Strengthen combination-therapy claims via mechanistic data and cross-jurisdictional alignment during prosecution.
The patent landscape for Elagolix remains contentious, with overlapping claims in fibroid treatment (WO2019203870) and sustained-release formulations (CN112533603) suggesting prolonged litigation risks[1][8]. Navigating this terrain requires meticulous attention to EPC’s sufficiency and clarity standards, particularly in hybrid structural-functional claims[6][11].
References
- https://pubchem.ncbi.nlm.nih.gov/patent/US2014288031
- https://www.drugpatentwatch.com/p/international/index.php?query=EP2934496
- https://curity.io/resources/learn/scopes-vs-claims/
- https://www.iponz.govt.nz/get-ip/patents/apply/expedited-examination-for-patent-applications/european-patent-office-patent-prosecution-highway/
- https://auth0.com/docs/get-started/apis/scopes/sample-use-cases-scopes-and-claims
- https://en.wikipedia.org/wiki/Claims_under_the_European_Patent_Convention
- https://www.boehmert.de/en/bulletin-nov-2024-4/
- https://patents.google.com/patent/EP2968566A1/fr
- https://www.opticsplanet.com/patriot-optics-ghost-1-6x24mm-rifle-scope.html
- https://www.rimonlaw.com/the-importance-of-getting-the-claim-scope-right-in-a-us-patent-application-i/
- https://www.pinsentmasons.com/out-law/news/court-clarifies-law-on-pharma-patent-claims
- https://www.hindles.co.uk/content/reach-through-claims
