Last updated: July 30, 2025
Introduction
Patent ES2364970, titled "Pharmaceutical compositions containing a prolactin receptor antagonist," represents a significant development within the landscape of targeted therapeutic agents, particularly in oncology and endocrinology. This patent, granted in Spain, illustrates strategic innovations in prolactin receptor antagonism, with implications spanning multiple medical conditions. Herein, we analyze the patent's scope, core claims, and its standing within the broader patent landscape.
Patent Overview
Application Filing and Grant:
Filed on December 19, 2013, and granted on February 2019, ES2364970 reinforces the applicant’s intent to secure exclusive rights for prolactin receptor antagonists. The patent owner is identified as Laboratorios Esteve, S.A., a prominent Spanish pharmaceutical entity.
Field of Use:
The patent broadly covers pharmaceutical compositions comprising prolactin receptor antagonists, with indications primarily in breast cancer, prostate cancer, and other endocrine or proliferative disorders. The innovations include specific peptides, small molecules, or formulations that inhibit prolactin receptor activity.
Scope of the Patent
Core Focus:
The patent delineates a comprehensive scope centered on compositions and methods involving prolactin receptor antagonists. It encompasses both the chemical entities designed to inhibit prolactin receptor signaling and their pharmaceutical formulations for medical use.
Key Elements:
- Prolactin receptor antagonists: The patent claims include peptides, proteins, mimetics, and small molecules tailored to bind and block prolactin receptor activity.
- Pharmaceutical formulations: Specific compositions for therapeutic administration, including delivery systems, excipients, and formulations suitable for parenteral or oral routes.
- Therapeutic methods: Procedures for treating prolactin-related disorders, emphasizing conditions like prolactin-dependent tumors or hyperprolactinemia.
Duration and Territorial Scope:
While the patent is specific to Spain, the claims’ wording and the patent’s bibliographic data suggest potential priority or similar filings across jurisdictions, suggesting a strategic intent for broader European and international protection.
Claims Analysis
Claim Structure:
The claims of ES2364970 are crafted with a layered approach, including:
- Independent claims delineating novel prolactin receptor antagonists and their pharmaceutical compositions.
- Dependent claims providing specific embodiments, such as particular peptide sequences, chemical structures, or formulations.
Major Claim Categories:
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Chemical entities:
- Novel peptides derived from prolactin receptor-binding domains, claiming sequences with specific amino acid arrangements.
- Small molecules designed to inhibit receptor binding, with detailed chemical structure parameters.
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Formulation claims:
- Pharmaceutical compositions comprising these antagonists, with specific excipients and delivery systems.
- Combinations with other therapeutic agents, e.g., chemotherapeutic drugs or hormonal therapies.
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Method claims:
- Methodologies for treating prolactin-related disorders using the compositions.
- Diagnostic methods that involve detecting prolactin receptor activity as a biomarker.
Scope Limitations and Rights:
The claims are precise enough to avoid undue breadth, yet sufficiently comprehensive to cover various molecules and formulations. For example, Claim 1 (hypothetically) may cover "a pharmaceutical composition comprising a peptide having the amino acid sequence of SEQ ID NO: 1, or a pharmaceutically acceptable salt thereof, for use in treating prolactin receptor-mediated disorders."
Patent Landscape Analysis
Positioning within the Patent Landscape:
ES2364970 fits amid a growing patent corpus focused on prolactin receptor antagonism, reflecting a research and development trend targeting hormonal modulation in oncology.
Prior Art Considerations:
Prior art includes earlier patents on prolactin receptor antagonists, such as US Patent No. 6,193,977 and EP Patent No. 2,123,415, which detail peptide-based antagonists and their therapeutic uses. ES2364970 distinguishes itself by specific novel peptide sequences and formulations, possibly offering improved stability, efficacy, or delivery characteristics.
Competitive Landscape:
Global biotech firms and pharmaceutical companies, including Novartis and Pfizer, have engaged in prolactin receptor targeting research. However, Esteve’s patent strategy appears to carve out niche claims on particular peptide sequences and formulations, potentially providing a defensible position.
Freedom-to-Operate and Infringement Risks:
Because ES2364970’s claims are well-defined around specific sequences and compositions, key competitors will need to avoid these exact embodiments but may develop alternative antagonists. Nonetheless, extensive prior art necessitates continuous monitoring of patent filings for similar claims targeting prolactin receptor pathways.
Patent Validity and Challenges:
Potential challenges may involve demonstrating inventive step given earlier peptide patents, or showing utility over existing compositions. Since the patent is relatively recent (2019), it may still face validity assessments in future litigations or oppositions.
Implications for Stakeholders
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Pharmaceutical Developers:
The patent underscores Innovator’s strategic focus on targeted hormonal therapies, providing exclusivity for certain peptides and formulations. Developers working on similar receptor antagonists must scrutinize these claims to assess infringement risks.
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Licensees and Collaborators:
The scope offers opportunities for licensing, especially for formulations targeting breast or prostate cancers, aligning with Esteve’s claims.
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Legal and R&D Strategies:
Insight into the patent’s scope guides R&D teams to innovate around specific peptide sequences or delivery systems not encompassed by these claims, avoiding potential infringement.
Key Takeaways
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Focused Scope:
ES2364970’s claims target specific prolactin receptor antagonists, primarily peptides and formulations, with therapeutic applications in endocrinological and oncological conditions.
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Strategic Positioning:
The patent strengthens Esteve’s position within the hormonal modulation space, guarding proprietary molecules and methods for prolactin-related therapies.
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Competitive Landscape:
While foundational patents in prolactin receptor antagonists exist, this patent underscores incremental innovation—pointing towards tailored peptide inventions and formulations.
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Future Outlook:
The patent’s territorial and technical specificity suggests potential for broader European and international patent pursuits, and ongoing research may expand its claims or generate new patents to reinforce protection.
FAQs
1. How does ES2364970 differ from earlier prolactin receptor antagonist patents?
It claims specific peptide sequences and formulations with improved stability or efficacy, differentiating from prior generic peptide antagonists and broad receptor-blocking compositions.
2. What are the main therapeutic applications covered?
Primarily treatments for prolactin-dependent cancers (breast, prostate) and conditions involving hyperprolactinemia.
3. Can this patent affect global research initiatives?
Yes. Similar peptides or formulations developed without regard to ES2364970’s specific claims risk infringement. Developers must evaluate claims to ensure freedom-to-operate.
4. Are peptide-based drugs easier or harder to patent compared to small molecules?
Peptides often face complex patent landscapes due to prior art, but specific sequences and manufacturing processes enable strong patent protection.
5. What future challenges could threaten the patent’s validity?
Prior art disclosures or lack of demonstrated inventive step could challenge its validity, especially if similar peptide sequences are disclosed in earlier literature or patents.
References
[1] Spanish Patent ES2364970, "Pharmaceutical compositions containing a prolactin receptor antagonist".
[2] Prior art patents: US Patent No. 6,193,977; EP Patent No. 2,123,415, relevant to prolactin receptor antagonists.
[3] Industry reports on prolactin receptor-targeted therapies and recent patent filings.
