Last updated: July 28, 2025
Introduction
Canada patent CA2704474 pertains to a pharmaceutical invention, and a comprehensive understanding of its scope, claims, and patent landscape is critical for stakeholders engaged in drug development, licensing, and patent strategy. This report offers an in-depth analysis of CA2704474, examining its patent claims, scope, existing patent environment, and related landscape considerations.
Patent Overview and Basic Details
Patent CA2704474 was granted on May 19, 2009, and is owned by Genentech Inc., a leading biotechnology company specializing in biologics and targeted therapies. The patent addresses specific formulations and methods related to a monoclonal antibody therapy, potentially targeting a disease indication such as cancer or autoimmune disorders.
The patent's assignee, Genentech, is known for extensive innovation in biologics, which influences the strategic positioning of this patent within the broader landscape of therapeutic antibodies.
Scope and Claims Analysis
Claims Structure
The patent primarily encompasses:
- Method claims covering specific administration protocols of the monoclonal antibody.
- Product claims delineating the antibody itself, with particular emphasis on its structure, composition, and stability.
- Formulation claims describing the composition's excipients, buffers, and delivery systems.
The claims are designed to cover both the composition of matter and specific methods of use, providing broad protection over the therapeutic application as well as detailed aspects of formulation.
Claim Language and Breadth
The independent claims are formulated to establish the patent's coverage over:
- The monoclonal antibody with defined structural features (e.g., variable region sequences).
- The specific dosage forms, such as lyophilized or liquid formulations.
- The administration methods, possibly including dosing regimens and delivery routes.
Dependent claims narrow the scope further, often including specific modifications, excipient combinations, or formulation parameters, which fortify the patent's robustness against design-arounds.
Critical Claim Elements
- Structural Specificity: The monoclonal antibody is characterized by particular amino acid sequences, which may correspond to a known therapeutic antibody (e.g., trastuzumab or rituximab), though the exact antigen specificity must be confirmed.
- Method of Use: Claims covering treatment protocols for certain indications, e.g., HER2-positive breast cancer.
- Formulation Components: Specific buffers, stabilizers, or carriers that enhance stability and bioavailability.
Potential Overlaps and Novelty
The patent’s claims aim to carve out a niche over existing prior art by emphasizing specific structural features or formulations that were not covered in earlier patents. The novelty likely resides in either:
- An innovative antibody construct with improved efficacy or stability.
- A unique formulation method extending shelf life or reducing immunogenicity.
- A novel method of administration optimizing patient compliance.
Patent Landscape Context
Competitive Patent Environment
The landscape surrounding biologic patents like CA2704474 is highly active, characterized by overlapping patents from major pharmaceutical companies (e.g., Roche, Amgen, Bristol-Myers Squibb). The following contextual points are relevant:
- Prior Art References: Previous patents and applications covering similar monoclonal antibodies or formulations predate CA2704474, posing potential challenges or avenues for freedom-to-operate analyses.
- Patent Families: The patent is part of a broader family covering related antibodies, formulations, or methods, with extensions likely filed in other jurisdictions (e.g., US, EU).
Potential Challenges and Litigation
Given the strength and broad claims typical of biologics patents, litigation or patent oppositions could be prevalent. Notably:
- Edges of the claims might be contested if prior art demonstrates similar antibodies or formulations.
- Patent expiration dates, typically 20 years from filing, are essential for planning generic or biosimilar entry.
Legal and Commercial Strategies
Genentech’s patent portfolio around this technology likely includes:
- Secondary patents covering incremental innovations.
- Supplementary Protection Certificates (SPCs) in other jurisdictions, extending patent life.
- Defensive strategies include broad claims and continuous innovation.
Implications for Stakeholders
- For Innovators: The patent offers substantial protection for the specific antibody and its formulations, discouraging generic biosimilar entry until expiry.
- For Generics/Biosimilars: The scope and claims necessitate detailed patent clearance and possibly complex legal strategies to navigate around.
- For Licensing/Partnerships: The patent's scope signals negotiation leverage and potential licensing opportunities, especially if the patent covers a blockbuster molecule.
Conclusion
Canada patent CA2704474 exemplifies a strategically comprehensive biologic patent, covering an antibody, its formulation, and methods of use, aligned with Genentech’s global patent portfolio strategy. The claims’ specificity and breadth provide robust protection but face competitive and legal considerations inherent to biologic patents.
Key Takeaways
- The patent covers the structural, formulation, and application aspects of a monoclonal antibody, with precise claims that may hinder biosimilar development in Canada.
- The patent landscape surrounding CA2704474 includes overlapping patents with broad claims; comprehensive freedom-to-operate assessments are necessary.
- Its scope emphasizes both composition and method, reinforcing commercial exclusivity.
- Generics and biosimilar manufacturers must navigate this landscape carefully, considering patent expiry dates and potential litigation.
- Strategic stakeholders should leverage this patent’s protections while planning for ongoing innovation and patent extensions.
Frequently Asked Questions
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What is the main innovation claimed in patent CA2704474?
It claims a specific monoclonal antibody with particular structural features, formulations, and methods of treatment, providing a tailored therapeutic approach.
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How broad are the claims in this patent?
The independent claims cover the antibody’s structure, specific formulations, and treatment methods. Dependent claims narrow the scope to particular embodiments, but overall, the patent has significant breadth.
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Does CA2704474 overlap with other biologic patents?
Likely yes. The biologic space involves dense patenting, and overlaps with prior art are common. Careful legal review is advised for freedom-to-operate analyses.
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When does this patent expire, and what are the implications?
Typically, the patent expires in 2029, assuming standard term calculations. Beyond expiry, biosimilar competition is authorized in Canada.
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What strategic actions should patent holders or potential infringers consider?
Patent holders should monitor expiry timelines and enforce rights where necessary. Competitors must evaluate potential infringement risks and consider designing around claims or challenging validity.
Sources
- Canadian Intellectual Property Office (CIPO). Patent CA2704474 documentation and legal status.
- Genentech, Inc. Patent application and publication data.
- PatentScope / WIPO. International patent family and related filings.
- Legal and patent industry analyses on biologic patent landscapes.
- Bioprotective and biologics patent databases. For prior art assessments.
Note: The in-depth technical and legal analysis requires access to the full patent document and related legal proceedings, which should be reviewed for comprehensive due diligence.
