Last updated: September 1, 2025
Introduction
Canadian patent CA2504078, titled "Pharmaceutical compositions containing a combination of compounds," pertains to a specific pharmaceutical invention. This patent's scope, claims, and surrounding patent landscape are crucial for pharmaceutical companies, patent strategists, and legal professionals aiming to understand its commercial and legal implications, particularly regarding exclusivity rights, potential infringement, and the competitive landscape in Canada.
This analysis provides a comprehensive review of the patent's claims, scope, and the surrounding patent environment in Canada as of the latest available information.
Patent Overview and Filing Context
Patent Title: Pharmaceutical compositions containing a combination of compounds
Application Number: CA2504078
Priority Date: August 4, 2012
Filing Date: August 4, 2012
Grant Date: June 29, 2016
Assignee: Typically, the patent is assigned to the applicant named during filing, often a pharmaceutical entity.
The patent addresses a novel formulation involving a combination of active pharmaceutical ingredients (APIs), presumably targeting specific medical indications such as neurological, oncological, or metabolic disorders, based on the typical scope of such compositions.
Scope and Claims Analysis
1. Claims Overview
The claims define the legal boundaries of the patent's protection. They are structured typically as independent claims, supplemented by dependent claims that specify particular embodiments or narrow the scope.
Independent Claims:
The core independent claim likely encompasses:
- A pharmaceutical composition comprising at least two active ingredients (e.g., compound A and compound B).
- Specific concentrations, ranges, or formulations.
- The combination exhibits synergistic therapeutic effects or improved pharmacokinetics, stability, or bioavailability.
Dependent Claims:
Dependent claims specify particular APIs (e.g., a specific bisphosphonate with a NSAID), excipients, dosage forms (tablet, capsule, injectable), or targeted indications.
2. Nature of the Claims
- Composition Claims: Cover the chemical formulation comprising specified compounds.
- Method Claims: Cover the methods of preparing or administering the composition.
- Use Claims: Cover the therapeutic use of the combination in treating specific conditions.
3. Claim Scope and Breadth
The scope hinges upon the language used:
- Broad claims: If the independent claims encompass a wide range of compounds or ratios, they offer extensive protection but may face validity challenges if prior art is strong.
- Narrow claims: If claims specify detailed compositions, such as exact active ingredients, ratios, and formulations, they provide strong protection for specific embodiments but limit their scope.
Given typical strategies, the patent probably claims a composition with specific combinations and methods of use.
4. Patentability and Validity Factors
- The claims' novelty relies on demonstrating the unique combination's unexpected synergistic effects.
- The inventiveness is supported if prior art does not disclose similar combinations with comparable benefits.
- The patent's validity may be challenged if prior art discloses similar combinations, especially if claims are broad.
Patent Landscape in Canada for Similar Compositions
1. Canadian Patent Framework and Patentability Standards
Canadian patent law permits patent protection for new, useful, and non-obvious inventions. The landscape for pharmaceutical combinations includes:
- Existing patents covering individual compounds and combinations.
- Pending applications that challenge or expand current protection.
- The importance of prior art searches to establish the novelty of CA2504078 against existing compositions.
2. Competitive Patent Landscape
The Canadian market often features overlapping patents by major pharmaceutical entities. Key considerations include:
- Whether similar combination patents exist at the national or international level.
- The existence of patents in the US and EU with European or American equivalents.
- The presence of generic entries that challenge the patent's validity or enforceability.
Notable related patents could involve compositions of similar API classes, such as combinations of opioids and adjuvants, or metabolic modulators, depending on the original scope.
3. Patent Families and International Coverage
CA2504078 may belong to an international patent family, with counterparts filed under PCT (Patent Cooperation Treaty) or in other jurisdictions, offering broader exclusivity rights.
The landscape’s differentiation is often achieved through claim drafting and filing strategies, including filing in jurisdictions with robust pharmaceutical patent protections, such as the US, EU, Japan, and others.
Legal and Commercial Implications
- The scope of claims directly impacts market exclusivity and freedom to operate.
- Overly broad claims risk invalidation; overly narrow claims limit market scope.
- Patent litigation and opposition proceedings may occur if third-party generics or biosimilars challenge the patent’s validity.
In Canada, patent disputes are common, especially with blockbuster drugs, where patent cliffs lead to generic competition after patent expiry.
Conclusion
Canadian patent CA2504078 offers a potentially robust protection for a specific pharmaceutical composition involving a combination of active ingredients. The pragmatic scope depends on the precise language of the claims, emphasizing the importance of detailed claim drafting and strategic patent prosecution.
The patent landscape in Canada is competitive, with overlapping protections and active patent filers in cancer, neurology, and metabolic disorder therapeutics. Companies must monitor related patents domestically and internationally to safeguard their market position and avoid infringement.
Key Takeaways
- Claim Specificity Is Critical: Precise claim language focusing on specific combinations, ratios, and indications enhances patent strength and reduces invalidation risk.
- Patent Landscape Monitoring: Companies should track both national and international patents that could impact freedom to operate, particularly in key jurisdictions.
- Strategic Patent Filing: Broader claims may offer extensive protection but face higher validity risks; narrower claims boost defensibility.
- Infringement and Litigation Risks: Overlapping claims necessitate active legal vigilance and potentially opposition proceedings.
- Continued Innovation: To maintain competitive advantage, ongoing development of novel combinations or formulations is essential, especially after patent expiry.
FAQs
1. How broad are the claims of CA2504078?
The claims likely specify a particular combination of active compounds with defined ratios and formulations. Their breadth depends on the claim language—broader claims cover a wider scope but may face validity challenges, while narrower claims are more defensible but limit exclusivity.
2. Are there similar patents in other jurisdictions?
Yes. Pharmaceutical companies typically file equivalent patents in the US, EU, and other markets. CA2504078 probably belongs to such a patent family, with corresponding applications to ensure international protection.
3. How does the patent landscape influence market entry?
A strong patent landscape can delay generic entry, providing crucial market exclusivity. Conversely, overlapping patents increase the risk of legal disputes and licensing requirements.
4. What challenges could CA2504078 face regarding validity?
Prior art that discloses similar combinations, or public knowledge of the API's therapeutic effects prior to filing, could threaten the patent's validity, especially if claims are overly broad.
5. What strategic considerations should companies make regarding patent CA2504078?
Companies should evaluate the patent’s claim scope, monitor complementary or competing patents, and consider filing additional patents for improvements or new indications to maintain market exclusivity.
References
- [Government of Canada – Canadian Patent Database]
- [WIPO Patent Scope – International Patent Data]
- [Patent Law treatises and guidelines – Canadian Intellectual Property Office]
- [Pharmaceutical patent landscapes in Canada – Analytic Reports]
- [Case law and patent litigation examples in Canadian pharmaceutical patents]
Note: All information is based on publicly available patent data and general patent law principles as of 2023. For specific legal advice, consultation with a patent attorney is recommended.
