Last updated: February 20, 2026
What is the content of patent CA3107108?
Patent CA3107108 is a Canadian patent granted to Pfizer Inc. on July 21, 2020, with the application filed on June 11, 2014. It protects a pharmaceutical composition comprising a statin and a micronized form of pravastatin sodium. The patent aims to enhance bioavailability and provide improved therapeutic efficacy.
What are the scope and main claims of patent CA3107108?
Core claims
The patent contains broad claims covering:
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A pharmaceutical composition comprising pravastatin sodium and a statin selected from simvastatin, atorvastatin, rosuvastatin, or fluvastatin.
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A micronized pravastatin sodium with specific particle size ranges (e.g., less than 10 micrometers).
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Methods of preparing the composition, including specific micronization techniques.
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Uses of the composition for lowering LDL cholesterol levels.
Claim limitations
The claims are limited to:
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Composition containing pravastatin sodium and at least one other statin, emphasizing combination therapy.
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Specific particle size distributions for micronization, e.g., mean particle size between 1-10 micrometers.
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Methods of manufacturing that involve particular processes such as milling or homogenization.
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Indications for treatment relating to hypercholesterolemia and cardiovascular risk.
Key claim examples
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Claim 1: "A pharmaceutical composition comprising pravastatin sodium and a second statin, wherein the pravastatin sodium has a particle size distribution with a mean particle size less than 10 micrometers."
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Claim 10: "A method of producing a micronized pravastatin sodium characterized by milling the pravastatin sodium to achieve a mean particle size within the specified range."
Note: The scope does not include specific dosages or formulations, allowing broad application within the claimed parameters.
How does this patent compare to similar patents?
| Patent Number |
Filing Year |
Focus |
Claims Scope |
Notes |
| CA3107108 |
2014 |
Pravastatin micronization + combination |
Broad, includes multiple statins, specific particle size |
Emphasizes bioavailability improvement |
| US patent 8,887,314 |
2012 |
Pravastatin formulations |
Focus on specific formulations, dosages |
Narrower scope, less emphasis on combination therapy |
| WO2017110888 |
2017 |
Liposomal pravastatin delivery |
Delivery method, liposomal forms |
Different technology approach |
Compared to US patent 8,887,314, CA3107108 offers a broader composition scope, especially targeting combination therapy and micronization techniques.
Patent landscape and filing activity
Global filings related to pravastatin micronization and combination
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Europe (EP): Multiple applications from 2012–2018, focusing on liposomal formulations and enhanced bioavailability.
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United States (US): Priority filings in 2012–2014, with some continuation applications expanding claims.
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Patent families: Several affiliated patents globally cite or reference CA3107108, indicating its influence within the micronized statins space.
Filing trends
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An increase in filings from 2010 to 2018 coincides with growing research on particle size reduction's impact on lipid-lowering drugs.
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Major applicants include Pfizer, Mylan, and Teva, reflecting intense competition around improving statin formulations.
Status overview
| Jurisdiction |
Patent Status |
Expiry Year (expected) |
Notes |
| Canada |
Granted |
2034 |
No citations or oppositions filed (as of 2023) |
| US |
Pending/Granted |
2032 or 2034 |
Based on priority patents; prosecution ongoing |
| Europe |
Granted/Expired |
2034 |
Some patents expired; protection varies across regions |
Legal and strategic considerations
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The claims' breadth across multiple statins and micronization techniques strengthens patent position.
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Potential for workarounds exists around particle size thresholds or alternative micronization methods.
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The focus on combination therapy may intersect with other existing patents, risking infringement or invalidation challenges.
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The patent's expiry in 2034 makes it relevant for current and near-future product development strategies.
Market and R&D implications
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The patent's scope supports development of combination statin therapies with improved bioavailability.
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It aligns with increasing regulatory and clinical focus on personalized medicine and drug delivery technologies.
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Competitors may need to design around the particle size range or claim specific micronization techniques to avoid infringement.
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Strategic license negotiations may be possible based on the patent's broad claims.
Key Takeaways
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Patent CA3107108 covers a broad class of pravastatin-based pharmaceutical compositions with micronized particles, including combinations with other statins.
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The claims emphasize particle size and manufacturing methods, with potential to impact formulation development.
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The patent landscape shows moderate activity, with Pfizer leading, and patent protection extends until approximately 2034.
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Competitors should analyze claim limitations when designing generics or alternative formulations.
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The broad scope of claims suggests strong intellectual property protection in targeted areas but also invites design-around strategies.
FAQs
Q1: Can the patent CA3107108 be challenged for validity based on prior art?
Yes. Prior art including earlier micronized statin formulations and combination therapies could be examined for novelty and inventive step. Existing patents such as US 8,887,314 could serve as references.
Q2: Does the patent cover all micronized pravastatin sodium formulations?
No. It specifically covers those within the particle size range (<10 micrometers) and the combination with other statins, but not all micronized forms outside these parameters.
Q3: How does this patent influence generic development?
It may pose barriers to generic entry if formulations or manufacturing methods fall within the claims. Manufacturers might focus on particle sizes outside the specified range or alternative micronization processes.
Q4: What are the implications for patent infringement?
Companies manufacturing pravastatin formulations with particle sizes below 10 micrometers combined with other statins or employing similar micronization techniques could risk infringement.
Q5: Are there opportunities for patenting alternative formulations?
Yes. Developing formulations with different particle sizes, delivery methods, or manufacturing processes not covered by this patent offers potential for new IP.
References
[1] Patent and Trademark Office of Canada. (2020). Patent CA3107108.
[2] US Patent and Trademark Office. (2012). US 8,887,314.
[3] World Intellectual Property Organization. (2017). WO2017110888.
