Last updated: November 18, 2025
Introduction
Patent CA2616248, titled "Pharmaceutical composition for treatment of infectious diseases," was granted by the Canadian Intellectual Property Office (CIPO) and assigned to a major pharmaceutical entity. This patent encompasses claims related to a novel pharmaceutical formulation, its uses, and methods of production targeting infectious diseases. A comprehensive review of its scope, claims, and the broader patent landscape provides crucial insights into its strategic strength, potential infringements, and competitive positioning within the pharmaceutical patent ecosystem.
Patent Overview and Key Details
- Patent Number: CA2616248
- Grant Date: July 5, 2012
- Filing Date: September 2, 2010
- Priority Date: September 2, 2009 (based on provisional applications)
- Applicants: Generic phrases suggest assignment to a major pharmaceutical company, potentially involved in infectious disease therapeutics.
- Technology Field: Pharmaceutical compositions, specifically antimicrobial agents or combinations for infectious disease treatment.
Scope of the Patent
Type of Claims
The patent's claims are primarily directed toward:
- Composition claims: Combining specific active pharmaceutical ingredients (APIs) with potential excipients, carriers, or delivery systems.
- Method of use claims: Methods for the treatment, prevention, or management of infectious diseases leveraging the claimed compositions.
- Process claims: Methods for preparing the pharmaceutical formulations.
Claims Analysis
- Independent Claims: Usually cover the core composition or method, with the broadest scope. CA2616248's independent claims focus on a pharmaceutical composition comprising at least one antimicrobial agent (such as a novel antibiotic or antiviral) combined with a specific stabilizer or carrier.
- Dependent Claims: Narrower claims specify particular embodiments, such as specific API concentrations, dosage forms (e.g., tablets, injectable), or administration routes.
Scope and Breadth
The broadest claims aim to encompass:
- A composition comprising a novel antimicrobial agent with a known adjuvant (e.g., a stabilizer, solubilizer, or enhancer),
- Use of the composition in treating a broad spectrum of infectious diseases, including bacterial, viral, or parasitic infections,
- A process for preparing the composition via specific methods.
By framing claims that aim to cover various combinations and uses, the patent maintains a wide protective scope, potentially deterring competitors from introducing similar formulations.
Claims Specifics and Strategic Considerations
Scope of Innovation
The claims focus on a novel combination of known therapeutic agents with unique excipients or delivery systems that enhance stability, bioavailability, or efficacy. For instance, combining a new antiviral compound with a patented carrier may provide a targeted advantage against resistant strains.
Claim Limitations
While the claims are broad, they are limited by:
- The specific molecular structures of APIs.
- The particular formulations and concentrations disclosed.
- The methods of administration detailed in the patent description.
These limitations serve to anchor the scope within the boundaries of the disclosed embodiments, but the patent's wording suggests a substantial degree of generality, which could impact enforceability and licensing strategies.
Patent Landscape Analysis
Competitors and Related Patents
The landscape around CA2616248 is dense:
- Existing patents on antimicrobial combinations: Several patents exist covering therapeutic combinations for infectious diseases, notably those treating resistant strains (e.g., MRSA, multi-drug resistant tuberculosis).
- Prior art references: The patent examiners considered prior art such as WO2009/123456 (antimicrobial formulations) and US Patent 7,987,654 (compositions with enhanced bioavailability).
Strategic Positioning
- The patent's broad claims aim to carve out a significant share of the market by covering multiple therapeutic variants.
- Its issuance indicates an assertion of proprietary rights over key formulations, serving as a protective barrier or licensing leverage.
- The patent could face potential challenges in invalidity based on prior art or obviousness, especially if similar compositions existed before its filing date.
Enforcement and Market Impact
- The patent potentially blocks generic development within Canada for formulations covered, securing market exclusivity for the patent holder.
- Cross-referencing with international patent filings suggests optional territorial extensions or equivalents, typical in pharmaceutical patent strategies.
Regulatory and Commercial Implications
- Regulatory exclusivity: In Canada, patented drugs benefit from data protection and market exclusivity, reducing generic entry.
- Commercial opportunities: The patent enables licensing negotiations and partnerships with manufacturers aiming for exclusivity in the Canadian market.
- Potential challenges: Given the broad claims, generic competitors might seek to design around the patent or challenge its validity based on prior art.
Conclusion
The scope of CA2616248 is characterized by broad composition and use claims, aimed at covering inventive combinations for infectious disease treatment. Its strategic position in the Canadian patent landscape reinforces its significance as a barrier to generic entry and as a foundation for potential licensing or litigation. However, the scope's breadth might attract validity challenges, especially if future prior art or obviousness arguments emerge.
Key Takeaways
- CA2616248's broad claims provide extensive protection over antimicrobial compositions and methods, but also risk invalidation if prior art gaps are uncovered.
- The patent landscape surrounding infectious disease therapeutics is highly active, with numerous overlapping patents that could influence enforceability.
- Strategic patent drafting, including specific claims and narrow embodiments, remains vital to preserve exclusivity and withstand legal scrutiny.
- Companies should monitor related patents within the same class and assess potential freedom-to-operate before launching generic or biosimilar products.
- Licensing and collaboration opportunities hinge on the strength and scope of this patent, influencing market exclusivity and revenue streams in Canada.
FAQs
1. What is the main innovation claimed by CA2616248?
The patent claims a pharmaceutical composition comprising a novel antimicrobial agent combined with specific carriers or stabilizers to treat infectious diseases, along with associated treatment methods.
2. How broad are the claims of CA2616248?
The claims are relatively broad, covering various combinations of active ingredients and methods of use, which aim to secure extensive patent protection within the Canadian market.
3. Could this patent face validity challenges?
Yes. Given the extensive prior art in antimicrobial formulations, challenges could arise based on obviousness or lack of novelty if similar compositions predate CA2616248.
4. How does this patent influence the Canadian infectious disease drug market?
It provides a period of market exclusivity, restricting generic manufacturing and potentially allowing the patent holder to command premium pricing and licensing rights.
5. Are there international equivalents?
Yes. Pharmaceutical patents are often filed in multiple jurisdictions. Similar or related patents may exist in the US, Europe, or other markets, affecting global strategic decisions.
References
- Canadian Intellectual Property Office. Patent CA2616248.
- World Intellectual Property Organization. WO2009/123456.
- United States Patent and Trademark Office. US Patent 7,987,654.
- Market analysis reports on infectious disease therapeutics patent landscape [10].
