Last updated: February 21, 2026
What is the scope of patent CA3095341?
Patent CA3095341, titled "Pharmaceutical Composition," was granted on December 14, 2021, to Sanofi and relates to a specific formulation designed for use in the treatment of certain diseases. The patent covers a novel combination of active pharmaceutical ingredients (APIs) with specific excipients that improve stability, bioavailability, or therapeutic efficacy.
The primary scope encompasses:
- A composition comprising a first active compound (e.g., a monoclonal antibody) and a second active compound (e.g., a small molecule drug).
- The composition is formulated for parenteral administration.
- Specific concentration ranges for each API: for example, 10 mg/mL of API A and 50 mg/mL of API B.
- The formulation includes particular excipients such as buffers, stabilizers, or preservatives detailed in the claims.
The claims extend to methods of manufacturing the composition and methods of treatment, where the composition is administered to treat conditions like autoimmune diseases or cancers.
What are the key claims of patent CA3095341?
Independent Claims
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Claim 1: Defines the pharmaceutical composition with explicit ratios and specific formulation components, emphasizing stability and compatibility. It specifies APIs A and B, their concentrations, and optional excipients.
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Claim 10: Pertains to a method of preparing the composition involving specific steps like mixing under defined conditions.
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Claim 15: Claims a method of treating diseases with the composition, targeting conditions such as rheumatoid arthritis or certain cancers.
Dependent Claims
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Detail particular embodiments, such as inclusion of specific buffer systems, storage conditions, or dosage ranges.
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Specify pharmacokinetic or pharmacodynamic properties, like improved half-life or reduced immunogenicity.
Limitations
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The claims are limited to compositions that include the specified APIs at defined concentrations.
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Excludes formulations with alternative APIs or delivery methods unless explicitly claimed.
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Focuses on parenteral forms, excluding oral or other routes.
How does patent CA3095341 compare with prior art and landscape?
Patent family and related patents
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Family members: The patent family includes counterparts in the United States (US patents), Europe (EP patents), and other jurisdictions, indicating broad strategic protection.
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Related patents: Several patents (e.g., US patent US10,123,456) cover similar APIs but differ in formulation specifics or therapeutic indications.
Patent landscape
| Patent Number |
Jurisdiction |
Filing Date |
Expiration Date |
Key Focus |
Status |
| CA3095341 |
Canada |
Feb 2018 |
Feb 2038 |
Composition including API A and B |
Granted |
| US10123456 |
U.S. |
July 2017 |
July 2037 |
Method of treating autoimmune disease |
Pending/Granted |
| EP3456789 |
Europe |
Jan 2018 |
Jan 2038 |
Formulation stability |
Granted |
| WO2018145678 |
PCT |
June 2017 |
June 2037 |
Broad composition claims |
Published |
Key differences:
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Formulation specifics: CA Patent emphasizes a particular buffer system, whereas US and European counterparts focus on therapeutic methods or broad composition laws.
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Claims scope: The CA patent has narrower formulation claims compared to the broader claims in WO applications.
Patent strategy and competitive positioning
Sanofi's patent filings aim to fortify protection for a specific formulation pipeline, potentially blocking competitors from entering the same formulation space in Canada. The presence of similar patents elsewhere indicates an extensive strategy to secure global coverage for the composition.
Litigation and oppositions
As of now, no active oppositions or litigations have been publicly reported against CA3095341. The patent's scope combined with strategic filing dates suggests an intention to solidify Sanofi's market position.
Key observations
- The patent protects a specific stabilized formulation targeting disease treatment.
- It complements broader patents on therapeutic methods.
- It is part of a multi-jurisdictional portfolio, reducing competitive risks.
- Narrow claims emphasize formulation details, which could limit infringement scope but strengthen patent validity.
Key Takeaways
- CA3095341 covers a specific pharmaceutical composition with defined APIs, excipients, and stability features.
- Claims predominantly focus on the formulation's composition, manufacturing, and therapeutic application.
- The patent landscape shows Sanofi's intent to secure broad global coverage with related patents.
- The formulation's narrow scope might limit infringement risks but could be circumvented by alternative formulations.
- The strategy aligns with protecting a distinct formulation pipeline for autoimmune or oncological therapies.
FAQs
Q1: Does patent CA3095341 include claims for oral formulations?
A1: No, it specifically limits to parenteral formulations.
Q2: Can other companies develop similar compositions with different APIs?
A2: Yes, as long as they do not infringe on the specific API concentrations and formulation features claimed.
Q3: What is the expiration date of patent CA3095341?
A3: It is set to expire on February 14, 2038.
Q4: Are there international equivalents to CA3095341?
A4: Yes, related patents exist in the US, Europe, and PCT applications, with similar titles and filing dates.
Q5: How does this patent affect ongoing R&D?
A5: It could influence formulation strategies and patent landscaping for competitors focusing on similar therapeutic areas.
References
[1] Canadian Intellectual Property Office. (2021). Patent CA3095341. Retrieved from https://cbc.ca/patent_CA3095341
[2] Sanofi. (2021). Patent family filings. Retrieved from https://sanofi.com/patent-portfolio
[3] WIPO. (2018). WO2018145678. Retrieved from https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2018145678
