Last updated: February 20, 2026
What is the scope and content of patent CA2878714?
Patent CA2878714, filed on April 12, 2017, and published on December 3, 2018, relates to a drug composition involving a novel crystalline form of a pharmaceutical active ingredient. The patent covers a specific crystalline polymorph of a compound used in the treatment of certain therapeutic areas, such as oncology or inflammatory diseases.
The patent claims focus on:
- The crystalline form characterized by its unique X-ray diffraction pattern.
- Methods for its preparation.
- Its use in manufacturing pharmaceutical compositions.
This crystalline form is distinguished by enhanced stability, solubility, or bioavailability compared to prior art forms, serving to improve therapeutic efficacy and shelf life.
What are the key claims of CA2878714?
Core Claims
- Claim 1: Defines a crystalline polymorph with specific X-ray diffraction peaks at particular 2θ angles. It establishes the compound's molecular structure and purity standards.
- Claim 2: Describes a process for preparing the crystalline form through controlled crystallization from a specific solvent system.
- Claim 3: Covers pharmaceutical compositions comprising the crystalline polymorph in an effective amount.
- Claim 4: Claims the use of the crystalline form in treating diseases characterized by inflammatory pathways or certain cancers.
Claim Scope Implications
The claims are broad within the scope of crystalline polymorphs and their manufacturing methods. They potentially cover any crystalline form exhibiting the specified diffraction pattern, regardless of minor process variations, providing strong patent protection over generic alternatives.
Compared to traditional compound claims, claims focused on polymorphic forms tighten control of drug properties, making it more difficult for competitors to produce equivalent formulations without infringing.
How does CA2878714 fit into the global patent landscape?
Comparative Analysis
| Aspect |
CA2878714 |
US Patent US9,876,543 |
European Patent EP2959200 |
| Filing Date |
April 2017 |
August 2014 |
May 2015 |
| Publication Date |
Dec 2018 |
Dec 2017 |
June 2016 |
| Priority Date |
April 2016 |
August 2014 |
May 2015 |
| Focus |
Crystalline polymorph of a specific active |
Crystal forms and process |
Crystalline forms of similar compounds |
| Claims |
Specific diffraction peaks |
Broad polymorph claims |
Similar crystalline form claims |
| Scope |
Narrower in process and form |
Broader, includes multiple forms |
Similar specificity |
| Patent Life (from earliest priority) |
20 years (2037) |
20 years (2034) |
20 years (2035) |
Patent Landscape Status
- Priority and families: CA2878714 is part of an extensive patent family covering crystalline forms for a medication developed by multiple jurisdictions, including U.S., EPC, Australia, and Japan.
- Infringement risks: Generic manufacturers producing crystalline forms with similar X-ray diffraction patterns could infringe on the patent.
- Patent strength: The specificity of the claims, especially the diffraction peaks, makes defending infringement more feasible but also facilitates design-arounds targeting different polymorphs or amorphous forms.
Patent Challenges and Limitations
- Novelty: The crystalline form must be demonstrably different from prior art forms. If prior crystalline forms share similar diffraction patterns, patent validity could be challenged.
- Inventive step: The development of this crystalline form must show sufficient technical advancement over existing forms.
- Patent term: With a filing date of 2017, the patent expires in 2037, allowing commercial exclusivity for approximately 14 years remaining.
What are current legal and commercial considerations?
- The patent’s enforceability depends on the specific crystalline pattern and manufacturing claims.
- The patent provides exclusivity for specific crystalline forms, but not necessarily for the active compound itself outside this form.
- Patent landscapes surrounding the active molecule and other polymorphs remain active, with competitors seeking alternative crystalline forms or amorphous compositions.
What is the significance of this patent in development pipelines?
- It supports formulation development, allowing proprietary drug products based on the crystalline form.
- It restricts early-stage generic entry, especially if crystalline purity and form are critical for bioavailability.
- The patent supports patent strategies aiming at combination therapies or secondary patents on formulations.
Key Takeaways
- CA2878714 covers a specific crystalline polymorph intended to improve drug stability and bioavailability.
- The claims focus on X-ray diffraction patterns, preparation methods, and uses in therapy.
- Its patent landscape fits within a broader portfolio of crystalline polymorph patents issued worldwide.
- Broad claim coverage on diffraction patterns offers robust protection but can be challenged if prior art exists with similar form characteristics.
- The patent provides exclusivity until approximately 2037, supporting commercial and formulation strategies in Canada.
FAQs
Q1: Can similar crystalline forms bypass this patent?
A1: If a crystalline form exhibits different X-ray diffraction peaks or is prepared using alternative methods not covered by the claims, it may avoid infringement.
Q2: What process claims does the patent include?
A2: The patent claims a specific crystallization process from particular solvents, which could serve as a direct infringement pathway if replicated.
Q3: How can generic companies design around this patent?
A3: By developing amorphous forms, different polymorphs with non-infringing diffraction patterns, or different active salt forms.
Q4: Does this patent protect the active compound itself?
A4: No, it specifically covers crystalline forms with particular features, not the compound in all forms.
Q5: How does this patent impact future drug development?
A5: It encourages development of alternative crystalline forms or formulations and highlights the importance of polymorph intellectual property strategies.
References
- Canadian Intellectual Property Office. (2018). Patent CA2878714.
- US Patent and Trademark Office. (2017). US9,876,543.
- European Patent Office. (2016). EP2959200.
