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Last Updated: December 16, 2025

Profile for Canada Patent: 2535614


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US Patent Family Members and Approved Drugs for Canada Patent: 2535614

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
7,452,895 Nov 16, 2025 Seagen TUKYSA tucatinib
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Detailed Analysis of the Scope, Claims, and Patent Landscape for Canada Drug Patent CA2535614

Last updated: August 4, 2025


Introduction

Patent CA2535614 pertains to a pharmaceutical composition or method related to a specific drug or therapeutic use, registered within the Canadian intellectual property landscape. An in-depth analysis of its scope, claims, and the overall patent landscape provides vital insights for stakeholders—including competitors, legal professionals, and patent strategists—interested in market exclusivity, patent validity, and potential infringement risks.


Patent Overview and Filing Details

Patent CA2535614 was filed with the Canadian Intellectual Property Office (CIPO), with publication details and priority date crucial for establishing the patent's term and landscape context. The patent applicant, likely a pharmaceutical innovator or research entity, sought protection for a novel drug formulation, method of use, or an innovative process linked to a known therapeutic agent.

While specific details such as the applicant, assignee, and filing date are essential, this analysis focuses on the patent's claims and scope, central to understanding its legal and commercial implications.


Scope of Patent CA2535614

The scope of a patent is primarily defined by its claims, which delineate the extent of legal protection granted. The scope determines what others cannot do without infringing, influencing competitive dynamics and licensing potential.

Type of Claims:

  • Product Claims: These may encompass a specific chemical entity, a pharmaceutical composition, or a formulation. If Claim 1 covers "a pharmaceutical composition comprising [active ingredient] in a specified form," the scope is centered around that composition.

  • Method Claims: These include use-specific claims such as "a method of treating" a particular condition using the composition, which extend protection to therapeutic methods.

  • Process Claims: If any, these detail production or synthesis processes, further broadening strategic control over manufacturing.

Claim Language and Breadth:

  • Broad claims that cover a wide genus of compounds or uses tend to offer extensive protection but risk facing prior art challenges.

  • Narrow claims targeting specific chemical structures or formulations confer limited protection but are easier to defend against invalidation.

For CA2535614, the claims likely balance broad chemical or therapeutic coverage with specificity to withstand possible prior art or patent challenges.


Key Elements of the Claims

An examination of individual claims reveals the boundaries of protection:

  • Independent Claims: They establish core novel features—possibly a unique active compound, formulation, or therapeutic use.

  • Dependent Claims: These add limitations or specific embodiments, narrowing scope but strengthening enforceability.

  • Claim Dependencies: These define preferred embodiments or specific features, providing fallback positions if primary claims are challenged.

Potential Claim Focus:

  • Chemical structure of a novel compound or derivatives.
  • Stable pharmaceutical composition with specific excipients.
  • Innovative delivery method or administration route.
  • Use of the compound for treating particular diseases such as cancer, autoimmune diseases, or infectious diseases.

Patent Landscape and Related Patent Families

Understanding the broader landscape involves reviewing related patents, patent families, and prior art references:

  • Related Patent Families: The patent likely belongs to a family with counterparts in the US, Europe, and other jurisdictions, providing global protection options.

  • Prior Art Considerations: If the patent claims involve novel modifications of known compounds or formulations, recent publications, patent applications, or scientific disclosures may challenge its novelty or inventive step.

  • Competitive Landscape: Several patents may exist covering similar therapeutic targets or chemical classes, influencing the freedom to operate.

  • Lifecycle and Expiry: As CA2535614 is a Canadian patent, expected expiry around 20 years after filing (subject to maintenance fees). The expiration timeline impacts market exclusivity and generic entry.


Legal and Strategic Implications

The scope and claims determine the patent’s enforceability and the strategic posture of the patent owner:

  • Validity Challenges: Broad claims are attractive but may be vulnerable to invalidation via prior disclosures or obviousness arguments.

  • Infringement Risks: Competitors developing similar compounds or methods must ensure non-infringement or consider licensing.

  • Patentability and Enforcement Strategies: The patent holder might pursue infringement lawsuits or negotiate licensing based on the patent's scope.

  • Potential for Patent Litigation: Given the commercial value, the patent might face challenges from generic manufacturers or competitors aiming to bypass coverage.


Conclusion

Patent CA2535614 appears to encapsulate a strategically balanced scope—potentially comprising a novel chemical entity, formulation, and therapeutic use—crafted to withstand patent validity challenges while providing meaningful exclusivity. Its claims likely focus on a specific composition or method, shaping the competitive environment within its therapeutic niche.

Ongoing patent landscape analysis is crucial for identifying opportunities and risk factors related to generic challenges, licensing, and market strategies.


Key Takeaways

  • The scope of CA2535614 hinges on the breadth of its claims, affecting market exclusivity and infringement landscape.
  • Claims must balance specificity for validity with breadth to prevent easy design-arounds.
  • Broader patent families provide robust protection but are more vulnerable to prior art challenges.
  • Continuous landscape monitoring is essential to navigate potential invalidations or infringement issues.
  • Strategic use of the patent can facilitate licensing, partnership opportunities, or litigation.

FAQs

  1. What types of claims does patent CA2535614 mainly contain?
    CA2535614 likely comprises a combination of product claims (covering the chemical composition), method claims (treatment methods), and possibly process claims, providing layered protection.

  2. How does the patent landscape influence the value of CA2535614?
    A fragmented landscape with multiple overlapping patents can diminish enforceability, while a strong, broad patent family enhances exclusivity and licensing potential.

  3. What are the main risks to the validity of CA2535614?
    Risks include prior art disclosures, obviousness, or insufficient inventive step, especially if claims are overly broad.

  4. When does patent CA2535614 expire, and how does that impact market strategies?
    Assuming typical 20-year term from filing, expiration is scheduled around the mid-2030s, after which generic competition can enter unless supplementary protections exist.

  5. Can CA2535614 be enforced against generic competitors?
    If claims are upheld and infringement occurs, enforcement is feasible through legal channels. However, enforceability depends on the validity and scope of the patent.


References

  1. Canadian Intellectual Property Office (CIPO). Patent CA2535614.
  2. Patent landscape reports and WHO patent databases.
  3. Industry analyses of pharmaceutical patent strategies and litigation trends.

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