Last updated: August 2, 2025
Introduction
Patent CA2916668, filed by Neurim Pharmaceuticals, constitutes a significant intellectual property asset within the pharmaceutical sector, particularly concerning sleep disorder therapies. This patent encompasses compositions and methods for treating sleep issues, including the use of melatonin formulations. For stakeholders in pharmaceutical R&D, licensing, or patent litigation, a comprehensive understanding of its scope, claims, and the broader patent landscape is crucial.
This analysis dissects the patent's breadth, emphasizes key claims, contextualizes its positioning within existing legal and technological fields, and explores the concurrent patent landscape to inform strategic business decisions.
Patent Overview and Filing Details
- Patent Number: CA2916668
- Filing Date: March 29, 2018
- Grant Date: August 9, 2019
- Applicants: Neurim Pharmaceuticals
- Priority Date: March 29, 2017
- International Classification: A61K 9/00 (Medicinal preparations containing organic active ingredients), A61K 33/24 (Preparations for treatment of sleep disorders), among others.
This patent prioritizes formulations involving melatonin, especially prolonged-release variants, for use in treating sleep-related dysfunctions such as insomnia and circadian rhythm disturbances.
Scope and Claims Analysis
Independent Claims
The core of CA2916668 encompasses method and composition claims. The most pivotal are:
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Method claims (Claims 1, 8):
Covering methods for treating sleep disorders using specific melatonin formulations, notably involving prolonged-release or controlled-release compositions. They specify administering a therapeutically effective amount of melatonin with particular release characteristics to improve sleep parameters.
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Composition claims (Claims 10, 15):
Detailing formulations characterized by particular carrier matrices designed to modify melatonin release profiles—e.g., sustained-release or controlled-release matrices that ensure prolonged plasma concentrations.
Scope Summary:
The claims focus on the use of specific melatonin formulations, especially those with prolonged-release properties, to treat sleep disorders. They protect both the method of treatment and specific compositions. The claims are constructed broadly to cover various formulations of melatonin designed for improved sleep management, emphasizing release kinetics and formulation technology.
Dependent Claims
Dependent claims specify particular release profiles, dosages, delivery vehicles, and formulation compositions:
- Release characteristics: e.g., plasma melatonin levels maintained over specific durations.
- Formulation specifics: e.g., types of carriers, matrix compositions (hydroxypropyl methylcellulose, ethylcellulose, etc.).
- Dosage ranges: e.g., 1mg to 10mg melatonin per dose.
- Method variants: e.g., administration timing, frequency.
This layering augments control over the inventive scope, covering various embodiments within the primary inventive concept.
Claim Interpretation
The claims delineate a composition of matter—melatonin formulations with controlled-release properties—and method of use—applying these formulations to treat sleep disorders. The dual approach broadens patent protection, covering both products and their therapeutic application.
The claims employ typical patent language emphasizing "comprising," allowing inclusion of additional elements without negating infringement, thus broadening enforceability.
Patent Landscape and Competitor Positioning
Related Patents and Prior Art
Prior art surrounding melatonin formulations predominantly involves immediate-release compositions, with some earlier patents disclosing sustained-release variants (e.g., US patent USRE33855E). CA2916668 distinguishes itself by emphasizing specific formulation techniques that optimize plasma concentration profiles for better clinical outcomes.
Other relevant patents within this space include:
- US 6,413,796 (relating to sustained-release melatonin formulations)
- WO 2014/095179 (derivatives and formulations with prolonged release)
CA2916668 is notable for its detailed focus on controlled-release matrices tailored for sleep regulation, offering an innovative edge with specific release duration claims.
Patent Term and Market Relevance
Given its filing date in 2018 and grant in 2019, the patent extends potentially until 2038, considering patent term extensions for pharmaceutical patents in Canada (20 years from earliest filing date). This positions the patent as a potent barrier against generic entry in the relevant formulations over the next 15+ years.
Strategic Implications
- Market Exclusivity: The broad claims covering both compositions and methods provide comprehensive protection for melatonin-based therapies employing prolonged-release technology.
- Licensing and Collaboration: The patent's scope allows for licensing negotiations with competitors or partners seeking to develop similar formulations for sleep disorders.
- Infringement Risks: Other entities developing formulations that fall within the claim language—e.g., controlled-release melatonin formulations for sleep disorders—may face infringement assertions.
- Design-Around Strategies: Competitors might innovate alternative delivery systems such as implantable devices or alternative matrix technologies not encompassed by the claims.
Conclusion
Patent CA2916668 establishes a fortified intellectual property position for Neurim Pharmaceuticals concerning prolonged-release melatonin formulations for sleep disorders. Its broad claims, covering both compositions and methods, offer comprehensive protection, while its positioning within the existing patent landscape underscores its innovative contributions. Stakeholders should monitor developments in related formulations and formulations with similar release kinetics to effectively navigate the competitive landscape.
Key Takeaways
- CA2916668 protects specific prolonged-release melatonin formulations and their use in treating sleep disorders, with broad claims covering both compositions and treatment methods.
- It leverages advanced controlled-release matrix technologies, positioning it strongly within the sleep aid therapeutics market.
- The patent's expiry around 2038 provides long-term market exclusivity, constraining competitors unless alternative delivery methods are devised.
- Strategic licensing or partnership opportunities are available, given the patent’s comprehensive scope.
- Companies developing similar controlled-release formulations should evaluate patent landscape risks to inform R&D strategies and avoid infringement.
FAQs
Q1: Does patent CA2916668 cover all forms of melatonin formulations for sleep disorders?
No. It specifically protects prolonged-release or controlled-release formulations designed to optimize plasma melatonin levels over time. Immediate-release formulations and other delivery systems may not be encompassed unless explicitly claimed.
Q2: Are there existing patents that challenge the novelty of CA2916668?
Prior patents such as USRE33855E provide earlier disclosures on sustained-release melatonin, but CA2916668’s particular formulation techniques and claims for specific release profiles strengthen its inventive positioning.
Q3: Can a competitor develop alternative formulations that avoid infringement?
Yes. Alternatives such as different matrices, delivery mechanisms (like implantables), or formulations that do not match the claim language could circumvent infringement by designing outside the scope of claims.
Q4: Is the patent enforceable in markets outside Canada?
While enforceable within Canada, protection outside requires corresponding filings in jurisdictions like the US, Europe, or other territories. The European or US counterparts would determine global strategic protection.
Q5: What are the potential infringement risks for generic manufacturers?
Generics aiming to produce prolonged-release melatonin formulations with similar release profiles might infringe CA2916668’s claims unless they develop substantially different compositions or invoke invalidity defenses, such as prior art or obviousness.
References
[1] Canadian Intellectual Property Office. Patent CA2916668.
[2] Neurim Pharmaceuticals’ patent filings and publications.
[3] Prior art references related to sustained-release melatonin formulations.
