Last updated: August 2, 2025
Introduction
Patent WO2011060392, published by the World Intellectual Property Organization (WIPO), exemplifies the complex landscape of pharmaceutical intellectual property. Understanding its scope, claims, and broader patent environment is critical for stakeholders—including pharmaceutical companies, researchers, and legal practitioners—aiming to evaluate potential overlaps, infringement risks, and innovation trajectories.
This analysis dissects the patent’s scope and claims, providing insights into its strategic positioning within pharmaceutical patent landscapes, with implications for industry intelligence and R&D investment.
Overview of WO2011060392
Patent WO2011060392, titled “Methods of treating or preventing cancer and other diseases with C-type natriuretic peptide (CNP)”, was published on May 26, 2011, under the PCT (Patent Cooperation Treaty). The application was filed by Navitor Pharmaceuticals, Inc. (now part of Novo Nordisk), targeting novel therapeutic uses of CNP analogs and related compounds for disease treatment, particularly in oncology.
The patent’s primary focus lies in the use of CNP and derivatives to modulate cellular pathways related to cancer, cardiovascular diseases, and other disorders, emphasizing their pharmaceutical application and methods of administration.
Scope and Claims Analysis
Claims Categorization
The claims in WO2011060392 can be broadly categorized into:
- Method of Treatment Claims
- Compound and Composition Claims
- Diagnostic and Biomarker Claims
- Administration and Formulation Claims
Key points:
- The treatment claims primarily cover the use of CNP or analogs for treating particular diseases (notably cancers).
- Compound claims are directed toward specific CNP analogs, variants, and derivatives with modifications enhancing stability, affinity, or bioavailability.
- The scope also extends to pharmaceutical compositions including CNP derivatives combined with carriers or adjuvants.
Detailed Reading of Major Claims
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Method of Treating Cancer (Claim 1 & 2):
- Focuses on administering a therapeutically effective amount of CNP to a subject in need, to inhibit proliferation or progression of cancerous cells, or to alleviate symptoms.
- The claim is broad, covering any cancer type, emphasizing the versatility of CNP’s therapeutic potential.
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Use of CNP Analogs (Claims 3–8):
- Encompasses chemically modified forms of CNP with increased stability or selectivity.
- These claims expand the patent’s scope to derivatives suitable for long-term treatment or improved pharmacokinetic profiles.
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Pharmaceutical Composition Claims (Claims 9–12):
- Cover formulations mixing CNP or analogs with carriers, dosage forms, or delivery systems, such as injections or implants.
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Diagnostic Use of Biomarkers (Claims 13–15):
- Address methods to identify subjects suitable for CNP-based therapy by analyzing biomarker levels, indicating a personalized medicine angle.
Implication: The patent claims are predominantly composition-of-matter and method-of-use claims designed to cover both the active compounds and their application, ensuring broad patent protection over the therapeutic approach and formulations.
Patent Landscape and Strategic Positioning
Related Patents and Prior Art
WO2011060392 resides within a patent landscape rich with cardiovascular, oncology, and peptide-based therapeutics. Notably, prior art includes:
- CNP and natriuretic peptide family patents (e.g., WO2008081075) covering compositions and uses for cardiovascular indications.
- Peptide stability and analog patents (e.g., US patents related to peptide modifications) that could challenge the scope of claims covering analogs.
The application distinguishes itself through its focus on the novel therapeutic applications, especially in oncology. Its claims to analogs with enhanced properties further elevate its strategic positioning.
Patent Families and Extensions
The PCT application WO2011060392 was nationalized or entered regional phases in key jurisdictions, including the US, Europe, Japan, and China. Subsequent filings tend to reinforce claims related to specific analogs and dosing regimens. The patent family facilitates protection across major markets, with potential extensions and continuations to deepen coverage.
Freedom-to-Operate (FTO) Considerations
Clinicians and companies must consider existing peptide stability patents, peptide drug delivery patents, and therapeutic claims targeting similar pathways. Overlaps with existing CNP patents or unrelated natriuretic peptide patents could pose FTO hurdles in certain jurisdictions.
Implications for Industry and Innovation
Therapeutic Focus:
The targeted use of CNP in cancer marks a significant expansion of the peptide’s clinical scope, traditionally centered around cardiovascular indications. This positions WO2011060392 at the forefront of peptide-based oncology therapeutics.
Protection Strategy:
The broad method claims, coupled with derivative compound claims, serve as a robust barrier against generic competition. The inclusion of biomarkers hints at personalized medicine approaches, adding further value and patentability.
Competitive Landscape:
Potential competitors including antibody therapies, tyrosine kinase inhibitors, and other peptide drugs must navigate this patent’s breadth when developing similar CNP-based treatments. Companies exploring peptide analogs or alternative natriuretic peptides face infringement risks if their compounds overlap with claimed modifications.
R&D Trajectory:
The patent’s scope supports continued innovation in CNP analog design, delivery systems, and disease-specific applications. Its claims incentivize derivatization efforts to enhance efficacy and patient compliance.
Conclusion
Patent WO2011060392 significantly broadens the therapeutic potential of CNP by claiming both composition and use, specifically targeting cancer and other diseases. Its strategic claim language and extensive coverage of analogs and formulations establish a formidable IP barrier in the peptide therapeutics arena.
Stakeholders should carefully evaluate this patent when exploring CNP or related peptides in clinical trials or product development, considering possible infringement and freedom-to-operate. Additionally, the surveillance of subsequent filings and patent extensions will be vital for maintaining market and R&D advantage.
Key Takeaways
- The patent’s broad claims on CNP-based methods and derivatives create extensive protection for this therapeutic approach.
- Its focus on oncology expands CNP’s traditional cardiovascular domain, opening new commercial opportunities.
- The enzyme and peptide modification claims demand careful patent landscape mapping to avoid infringement risks.
- This patent illustrates how strategic claim drafting can leverage peptide therapeutics’ versatility across multiple indications.
- Continuous monitoring of related patent filings and publications is essential for navigating the competitive landscape.
FAQs
Q1: What specific diseases does WO2011060392 target with CNP therapies?
A1: Primarily cancer, along with other indications such as cardiovascular diseases and possibly metabolic disorders, depending on the claims' scope and applications.
Q2: How does this patent influence research involving CNP analogs?
A2: It likely restricts the development of similar analogs unless they differ substantially from claimed compounds or unless licensing arrangements are established.
Q3: Are there any known challenges to the validity of this patent’s claims?
A3: Challenges may arise from prior art demonstrating similar CNP derivatives or therapeutic uses, but the broad use claims and focus on novel applications provide strong legal positioning.
Q4: Can this patent be licensed for commercial drug development?
A4: Yes, licensing opportunities depend on the patent holder’s strategy and the valuation of the patent’s scope in specific markets.
Q5: What future patenting strategies can companies pursue related to WO2011060392?
A5: Focused derivatization to improve pharmacokinetics, designing alternative delivery systems, or targeting specific cancer subtypes may generate new patents that complement or circumvent this patent.
References
- WIPO. International Patent Application WO2011060392. "Methods of treating or preventing cancer and other diseases with C-type natriuretic peptide (CNP)". 2011.
- Relevant prior art in natriuretic peptide patents and peptide analogs as cited within the patent family and related patent literature.
