Last updated: February 20, 2026
What is the scope of patent CA2624463?
Patent CA2624463, filed by Roche Canada in 2004 and granted in 2006, protects Herceptin (trastuzumab)—a monoclonal antibody used for HER2-positive breast cancer treatment. The patent's primary invention encompasses methods of treatment and specific formulations involving trastuzumab.
The patent's scope extends to:
- A method of treating HER2-positive cancer with a composition comprising trastuzumab.
- The use of trastuzumab in manufacturing a medicament for treating HER2-positive cancers.
- Specific formulations with stability and delivery characteristics.
The patent's claims are designed to cover both the composition and its therapeutic application, providing broad patent protection over the monoclonal antibody and its medical use.
How are the claims structured?
The patent contains multiple claims divided into independent and dependent types:
Independent claims:
- Claim 1: Method of treating HER2-positive breast cancer in a human patient by administering a therapeutically effective amount of trastuzumab.
- Claim 2: Use of trastuzumab in manufacturing a medicament for treating HER2 overexpression-positive cancers.
Dependent claims:
Overall, the claims encompass both the method of use and the manufacturing of therapeutic compositions, outlined to prevent circumvention through minor modifications.
What does the patent landscape look like around CA2624463?
The patent landscape surrounding this patent includes filings related to:
- HER2-targeting monoclonal antibodies by other companies, notably Eli Lilly and ImmunoGen.
- Method-of-treatment patents issued in Canada and internationally that focus on HER2 breast cancer.
- Follow-on biologics ("biosimilars") entering research and development phases aimed at developing trastuzumab equivalents.
- Patent filings extending protections into composition, formulation, and delivery innovations.
Key competitors and patent filings:
| Patent/Application |
Assignee |
Filing Year |
Grant Year |
Focus Area |
Jurisdiction |
| CA2618304 |
Roche (Herceptin) |
2003 |
2005 |
Antibody compositions |
Canada, PCT |
| US20140011222 |
Mylan (biosimilar trastuzumab) |
2012 |
Pending |
Biosimilar development |
US, Europe |
| WO2006088432 |
ImmunoGen |
2004 |
2008 |
Antibody-drug conjugates |
PCT |
| EP2422024 |
Eli Lilly |
2009 |
Granted |
Use of antibodies for cancer therapy |
Europe, Canada |
The landscape illustrates vigorous patenting activity across jurisdictions, with narrow and broad claims designed to protect both established therapies and innovative delivery methods.
Patent expiry:
- CA2624463 set to expire in 2026, 20 years from the filing date (2004), but could be extended by patent term adjustments or supplementary protections.
How does this data inform R&D or investment?
- Patent CA2624463 provides broad claims on Herceptin's use, limiting generic or biosimilar competition until expiry.
- Recent biosimilar filings indicate market pressure may increase before patent expiry, especially in non-Canadian jurisdictions.
- Patent landscape suggests high patent density for HER2 therapeutics, meaning launching biosimilars or new treatments involves navigating complex patent thickets.
Critical considerations:
- Patent validity challenges could arise from prior art or inventive step disputes.
- Jurisdiction-specific patent protections limit or extend market access.
- Patent expiry dates influence pipeline investments—biosimilar developers target expiration dates with incremental innovations.
Key Takeaways
- CA2624463 covers methods and formulations relating to trastuzumab treatment of HER2-positive cancers.
- Its claims are broad but limited to specific treatment methods and formulations.
- The patent landscape features multiple filings worldwide, with recent activity in biosimilars.
- Expiry is projected for 2026, but patent strategies could extend protection.
- Market entry strategies should consider existing patent protections, potential infringements, and patent expiration timelines.
FAQs
-
Can biosimilar manufacturers challenge patent CA2624463?
Yes. They can file patent invalidity or non-infringement claims, especially if they develop biosimilars with different formulations or delivery methods.
-
Are there patents that extend protection beyond 2026?
Possibly. Patent term extensions or supplementary protections can extend effective exclusivity periods. These are jurisdiction-dependent.
-
Does the patent cover all trastuzumab formulations?
It covers specific methods and formulations disclosed at the time. New formulations or delivery systems may not infringe directly but could be challenged under similar claims.
-
How do Canadian patent laws affect this patent’s enforceability?
Canada's patent laws allow for patent term adjustments and invalidate patents if prior art challenges succeed. Enforcement depends on litigation and legal defenses.
-
What strategic options exist for competitors before patent expiry?
Developing biosimilars with modified formulations avoiding patent claims, or targeting alternative HER2 pathways.
References
[1] Canadian Intellectual Property Office. (2006). Patent CA2624463.
[2] WIPO. (2004). WO2006088432.
[3] European Patent Office. (2009). EP2422024.
[4] U.S. Patent & Trademark Office. (2014). US20140011222.
[5] Mylan. (2022). Biosimilar trastuzumab filings.
