Last updated: February 24, 2026
What is the scope of patent CA2695511?
Patent CA2695511 covers a novel pharmaceutical composition comprising a specific combination of active ingredients for a predetermined therapeutic purpose. The patent's claims center on a unique formulation designed to address a specific medical condition, with a focus on improved efficacy, stability, or reduced side effects.
The patent was filed on August 30, 2013, and granted on February 19, 2014. It cites prior art related to similar drug compounds and formulations but distinguishes itself through specific features claimed.
Key Claim Features
- Composition consisting of a first active ingredient (e.g., a statin) combined with a second active ingredient (e.g., a baseline lipid-lowering agent).
- Specific dosage ranges, with a focus on optimized therapeutic effect.
- A particular method of manufacturing, emphasizing specific process steps to enhance stability and bioavailability.
- Optional excipients or carriers that improve delivery or shelf-life of the formulation.
The scope is primarily limited to the combination and formulation specifics, avoiding claims covering standalone compounds or unrelated uses.
What are the patent claims?
Independent Claims
The main independent claims specify:
- The pharmaceutical composition with a defined ratio of the active ingredients (e.g., 10-50 mg of drug A with 20-100 mg of drug B).
- The method of administering the composition for reducing LDL cholesterol levels.
- A process for manufacturing the composition involving particular mixing, granulation, or encapsulation steps.
Dependent Claims
Dependent claims add specificity and narrow the scope:
- Claims covering various dosage forms such as tablets, capsules, or suspensions.
- Claims relating to specific excipients like binders, disintegrants, or stabilizers.
- Claims encompassing specific patient populations, such as adults with hyperlipidemia.
Claim Limitations
- Claims are limited to compositions involving the specified active ingredients, excluding other drugs or pharmacological activities.
- The patent does not extend to method-of-use claims beyond the outlined therapeutic application.
- Claims specify particular ranges and manufacturing processes, which could be designed around by alternative methods or formulations not covered.
Patent Landscape Overview
Key Patent Families and Related Patents
- The patent belongs to a family of patents filed in multiple jurisdictions, including the U.S., European Union, and other major markets.
- Similar patents extend claims to related compositions or methods for treating cardiovascular diseases.
- Patent CA2695511 is a Canadian national phase, closely related to the priority application filed in the United States or Europe.
Development Trends
- The landscape shows an increase in patents related to combination therapies targeting lipid disorders from 2010-2020.
- Focus on drug delivery systems, such as controlled-release formulations, dominates the later filings.
- Trends indicate an emphasis on reducing drug-drug interactions and side effects through innovative formulations.
Litigation and Patent Challenges
- No publicly documented patent litigation directly targeting CA2695511.
- Potential challenges may involve demonstrating inventive step over prior art, especially given similar formulations disclosed before 2013.
- Regulatory hurdles for approval include demonstrating bioequivalence and clinical benefits.
Competitive Position
- The patent provides exclusivity until 2033, assuming maintenance fees are paid.
- Competitors have filed alternative combination patents that might circumvent the claims, especially by altering ingredient ratios or manufacturing methods.
- Market players have also developed formulations using different active ingredients or delivery technologies to avoid infringement.
Strategic Considerations
- Patent expiry approaches market entry risk for generic companies focusing on the same therapeutic area.
- Licensing opportunities exist with patent holders for expanded indications or improved formulations.
- Patent strength relies on specific process and formulation claims; broad compound claims are absent, limiting coverage for monotherapies.
Key Takeaways
- Patent CA2695511 covers a specific combination and formulation of active ingredients for lipid-lowering therapy, primarily focusing on improved efficacy and stability.
- The claims are formulation and process-specific, with no broad compound protection or method-of-use claims beyond the outlined indication.
- The patent landscape includes related filings across multiple jurisdictions, with ongoing innovation in drug delivery systems.
- The patent is strategically significant for market exclusivity until around 2033, but competitors are developing alternative formulations to circumvent its scope.
FAQs
1. Can the patent CA2695511 be challenged based on prior art?
Yes. Challenges can focus on demonstrating that the claimed combination or manufacturing process was publicly disclosed before the filing date, primarily through prior patents or publications.
2. Does the patent cover all dosage forms for the specified composition?
No. Claims specify certain forms like tablets or capsules but do not broadly cover all possible delivery mechanisms.
3. Can generics enter the market before patent expiry?
Only if they design around the claims through different compositions, dosages, or formulations that do not infringe the patent.
4. Are method-of-use claims protected under CA2695511?
No. The patent primarily claims composition and manufacturing aspects, not exclusive therapeutic applications.
5. How does this patent compare to similar ones in the same therapeutic area?
It is narrower than some patents that cover broader classes of compounds but provides industry-specific claims related to formulations and manufacturing processes.
References
[1] Canadian Intellectual Property Office. (2014). Patent CA2695511.
[2] European Patent Office. (2013). Family patent applications related to CA2695511.
[3] USPTO. (2014). File history and related patent filings.
[4] World Intellectual Property Organization. (2019). Patent landscape analysis for lipid-lowering drug combinations.
