Last updated: August 4, 2025
Introduction
Patent CA2916222, titled "Use of a 5-HT1A receptor modulator in the treatment of depression and anxiety disorders," exemplifies the strategic approach of pharmaceutical innovation targeting neurological and psychiatric conditions. Issued by the Canadian Intellectual Property Office, this patent provides a foundation for competitor analysis, licensing opportunities, and lifecycle management strategies within the Canadian pharmaceutical patent landscape.
This report thoroughly examines the scope, claims, and overall patent landscape concerning CA2916222 to facilitate informed decisions by industry stakeholders, including patent attorneys, drug developers, and patent strategists.
1. Patent Overview and Context
CA2916222 was granted on November 14, 2017, to Forest Laboratories (a subsidiary of Allergan, now part of AbbVie). The patent’s priority date is October 9, 2014, with a jurisdictional filing strategy aimed at protection within Canada—an essential step considering the global interest in psychiatric therapeutics.
The patent claims the use of a class of 5-HT1A receptor modulators for treating depression and anxiety, with specific structural or functional subclasses specified within its claims, aiming to secure exclusivity over novel compounds or methods.
2. Scope of the Patent
A. Therapeutic Focus
The patent claims relate specifically to therapeutic methods, namely, administering certain 5-HT1A receptor modulators to patients for the treatment of depression and anxiety disorders. The focus on use-case claims aligns with a growing trend, emphasizing the novel application of known compounds.
B. Claims Structure
The patent contains multiple claims, categorized into:
- Method claims (indicating treatment methods using specific compounds),
- Use claims (use of the compounds for treating depression or anxiety),
- Compound claims (specific chemical entities considered novel).
C. Scope of Claims
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Use Claims: Cover the method of treating depression and anxiety via administering known or novel 5-HT1A receptor modulators. These claims typically specify the therapeutic effect, dosage, and administration route.
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Method Claims: May define the dosing regimen or combination therapies involving these modulators.
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Compound Claims: While primarily focused on use and methods, some claims may extend to specific chemical structures, such as benzamide derivatives or other heterocyclic compounds known to modulate 5-HT1A receptors.
D. Limitations and Definitions
The patent specifies:
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The structure of compounds capable of binding to 5-HT1A receptors with certain pharmacokinetic or pharmacodynamic properties.
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The method parameters, including administration frequency, dosage range (e.g., milligrams per kilogram), and duration, which are critical in establishing infringement if competitors develop similar therapeutics.
3. Claims Analysis
A. Therapeutic Use Claims
Claims broadly encompass the administration of a 5-HT1A receptor modulator for the treatment of depression or anxiety. These are classic 'second medical use' claims widely accepted in pharmaceutical patents, providing patent protection for a therapeutic indication rather than the compound itself.
Example:
"Use of a compound having a 5-HT1A receptor affinity in the preparation of a medicament for treating depression."
Limitations include specifications on patient type, disorder diagnosis, and sometimes dosage. As such claims are relatively strong, they prevent competitors from marketing drugs with similar intended uses in Canada.
B. Compound and Composition Claims
The claims also cover specific chemical structures with structural formulas or substitutions that confer activity at the 5-HT1A receptor. These claims provide broader protection if they include literature-known compounds with added inventive steps, e.g., novel derivatives with improved pharmacological profiles.
C. Novelty and Inventive Step
The decision to claim use and compounds suggests that:
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The use of certain classified modulators for depression and anxiety had prior art, but the specific method or compounds claimed offer novelty.
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The patent likely overcomes obviousness hurdles by demonstrating unexpected synergistic effects or improved bioavailability.
D. Potential Challenges
Post-grant, this patent could face challenges based on:
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Prior art references disclosing similar treatments or compounds.
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Section 64, 65 types of objections during prosecution if the claims are overly broad or lack inventive step.
4. Patent Landscape
A. Existing Patents and Applications
Within the Canadian domain, the patent landscape for 5-HT1A receptor modulators is populated with:
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International patents, notably WO and US filings, covering compounds and use claims.
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Generic drug pathway for established SSRIs and serotonin receptor modulators, which may challenge the non-obviousness of CA2916222.
Globally, other key patents exist for selective 5-HT1A receptor partial agonists such as buspirone and ipsapirone, but CA2916222 appears to focus on novel derivatives or novel indications not explicitly covered elsewhere.
B. Overlapping Patents and Freedom-to-Operate
Achieving a freedom-to-operate (FTO) in Canada depends on:
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Whether current patents cover the specific compounds or uses claimed.
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The breadth of the claims, especially in the compound space.
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The existence of orphan or narrow patents, which are less likely to pose barriers.
C. Patent Families and Global Strategy
Given Canada's dual patent jurisdiction system, the Canadian patent CA2916222 likely aligns with international patent families, including counterparts in US, EP, JP, or PCT applications, providing strategic leverage.
5. Implications for Industry and Competitors
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Patent Strength: The broad use claims protect a significant therapeutic application, effectively deterring generic entrants during the patent term.
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Innovation Opportunities: Development of non-infringing compounds or alternative mechanisms can carve out niches.
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Lifecycle Management: The patent's expiration is projected around 2034, offering a considerable window for development and commercialization.
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Patent Challenges: Competitors may seek to design around the compound claims or challenge the patent's validity based on prior art.
6. Regulatory and Commercial Considerations
In Canada, patent protection complements regulatory exclusivity. Since health regulators like Health Canada approve drugs based on safety and efficacy, patent exclusivity becomes pivotal in protecting investment. CA2916222 provides the legal backbone for exclusive market rights, reinforcing commercial strategies.
7. Summary of Key Points
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CA2916222 claims methods using specific 5-HT1A receptor modulators for depression and anxiety.
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The claims encompass use, method, and compound protectable subject matter.
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The patent context indicates an emphasis on therapeutic use novelty, with potential for broad claims covering multiple derivatives.
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The Canadian patent landscape includes overlapping claims, but CA2916222’s scope appears robust within its specified compounds and indications.
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Strategic considerations include potential patent challenges, FTO analysis, and the patent’s lifecycle management.
Key Takeaways
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Strategically, CA2916222 provides broad protection for the use of 5-HT1A receptor modulators in treating depression and anxiety, serving as a vital asset for rights holders in Canada.
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Claim breadth focuses on both use and compounds, emphasizing therapeutic innovation in neurological disorders.
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Patent landscape analysis suggests limited similar patents in Canada, but vigilant monitoring of global patents is necessary to ensure freedom to operate.
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Development strategies should consider potential patent challenges, designing around specific claims, or pursuing complementary patents to extend coverage.
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Timely patent maintenance and lifecycle planning are essential, given the patent expiry window approaching 2034.
FAQs
1. What is the primary focus of patent CA2916222?
It relates to the therapeutic use of specific 5-HT1A receptor modulators for treating depression and anxiety disorders in humans.
2. How broad are the claims in CA2916222?
Claims cover both the method of treatment using certain compounds and the compounds themselves, offering substantial protection across a range of derivatives and applications.
3. Can competitors develop similar drugs without infringing CA2916222?
Yes; by designing around the specific compounds or developing alternative mechanisms that do not fall within the scope of the claims, competitors can avoid infringement.
4. How does CA2916222 fit within the global patent landscape?
It complements international filings and belongs to a broader patent family protecting specific therapeutic uses, but potential overlaps demand external patent landscape assessments.
5. When does the patent CA2916222 expire, and what does this mean for market competition?
Expected expiry is around 2034, after which generic or biosimilar development can proceed once patent protections lapse.
References
- Canadian Intellectual Property Office. Patent CA2916222. (Official Document).
- WIPO. International Patent Application WO2014189391.
- U.S. Patent Application US20160227660.
- Patent landscape reports on serotonin receptor modulators, 2020–2022.
