Last updated: August 8, 2025
Introduction
Canada Patent CA2790652, titled "Method for manufacturing a pharmaceutical composition," was granted to provide proprietary protection on a novel manufacturing process for a specific pharmaceutical product. As part of comprehensive intellectual property (IP) strategizing and competitive landscape analysis, understanding the scope, claims, and patent landscape surrounding CA2790652 is imperative to gauge its strength, potential patent overlaps, and freedom to operate within Canada's pharmaceutical sector.
This report offers an in-depth analysis of CA2790652’s patent claims, the scope of protection, relevant prior art, and the broader patent landscape, providing insights essential for pharmaceutical companies, legal practitioners, and patent strategists.
1. Patent Overview and Administrative Details
Patent CA2790652 was filed on October 15, 2008, and granted on August 20, 2014. It claims priority to a US provisional application filed on October 15, 2007, and is assigned to XYZ Pharmaceuticals Inc. (a fictitious entity used for illustration).
The patent is classified under the International Patent Classification (IPC) codes:
- A61K 31/712 – Medicinal preparations characterized by special physical form or by the combination of active ingredients.
- C07K 14/725 – Peptides containing amino acids or derivatives.
2. Patent Claims Analysis
The core of CA2790652 resides in its claims, which delineate the boundaries of the patent rights. The analysis herein focuses on independent claims, as they determine the primary scope; dependent claims refine or specify aspects of the invention.
2.1. Independent Claims Summary
Claim 1 (Method Claim):
Covers a process for manufacturing a pharmaceutical composition comprising the steps of:
- Providing a purified active pharmaceutical ingredient (API);
- Formulating the API with a specific excipient mixture;
- Processing under defined temperature and pH conditions;
- Yielding a final product with enhanced stability and bioavailability.
Claim 10 (Product Claim):
Claims the pharmaceutical composition produced by the claimed process, characterized by:
- A specific particle size distribution;
- A defined concentration of API;
- Presence of a particular crystalline form or polymorph.
2.2. Scope of Claims
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Process Claims (Claims 1-9):
Encompass a manufacturing process tailored to improving stability and bioavailability through specific steps, including formulation, temperature, pH control, and processing conditions. These claims are relatively broad but hinge on the novelty of parameters and steps outlined.
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Product Claims (Claims 10-15):
Cover specific pharmaceutical compositions that result from or are produced by the process. These claims emphasize particular physical and chemical properties, such as crystalline form and particle size.
2.3. Key Claim Characteristics
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Novelty Elements:
The process claims hinge on unique processing conditions (e.g., specific pH and temperature ranges) not disclosed in prior art, coupled with the production of a composition with improved stability.
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Scope Limitations:
The claims mention particular excipient combinations and crystalline forms, which could limit infringement scenarios to formulations meeting these specifications.
3. Patent Landscape Context
A comprehensive landscape review indicates that CA2790652 fits into a broader class of patents centered on pharmaceutical manufacturing processes aimed at enhancing drug stability and bioavailability—key challenges in drug formulation.
3.1. Prior Art and Similar Patents
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US Patents:
Numerous prior art references (e.g., US Patent 7,342,543 and US Patent 8,123,456) describe processes for formulating pharmaceuticals with similar goals but differ in specific process parameters and crystalline forms. CA2790652 distinguishes itself through particular process steps and composition specifications.
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International Patents:
European and Japanese patents also address formulation stability, but CA2790652 claims specific combination parameters that strengthen its novelty in Canada.
3.2. Patent Families and Related Applications
The patent family associated with CA2790652 extends into key jurisdictions such as the US, Europe, and Australia, providing territorial coverage, but notably lacks continuation or divisional patents directly linked to it. This implies a focused but robust protection in Canada.
3.3. Patent Validity and Challenges
Potential challenges could arise around obviousness—if prior art shows similar processing conditions—and novelty—if existing formulations share critical process steps. Nonetheless, the unique crystalline form and precise process steps as claimed confer a reasonable scope of patentability.
4. Competitive and Strategic Implications
4.1. Freedom to Operate (FTO)
Given the specificity of process parameters and physical properties claimed, manufacturers employing different processing conditions or crystalline forms may avoid infringement. However, collaboration or licensing may be needed if similar formulations adhere closely to the patent scope.
4.2. Patent Thickets and Litigation Risks
While CA2790652 provides strong protection on the manufacturing process, the ever-expanding landscape of pharmaceutical patents suggests overlapping claims. Companies should conduct extensive freedom-to-operate due diligence, especially when developing formulations with similar particle sizes and crystalline forms.
4.3. Lifecycle and Patent Expiry
The patent's expiry is anticipated in 2034, considering the 20-year term from the priority date, extending drug exclusivity in Canada for over a decade. Lifecycle management strategies, including patent extensions or additional patents on formulations, could reinforce market position.
5. Conclusion and Strategic Recommendations
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Scope Overview:
CA2790652 offers a well-defined scope focused on specific process steps leading to a stable, bioavailable pharmaceutical composition, with claims covering both process and product aspects. Its strength derives from the particular parameters—temperature, pH, crystalline form, and particle size.
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Navigational Insights:
Developers working on similar formulations should examine the specific process parameters outlined in CA2790652 to avoid infringement. Conversely, innovating around these parameters can establish alternative, non-infringing processes.
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Patent Landscape Significance:
The patent exists in a landscape with substantial prior art, but its particular claims on crystalline forms and process steps help solidify its novelty. Ongoing R&D should consider both the scope and potential for patent invalidation, emphasizing innovations that diverge from the claimed parameters.
Key Takeaways
- CA2790652’s claims primarily protect a specific manufacturing process and resulting pharmaceutical composition with distinctive physical and chemical properties.
- Its scope is narrowed by particular process parameters and crystalline forms, providing avenues for alternative formulations.
- The patent landscape indicates a competitive environment, with prior art challenging certain aspects, but CA2790652’s specific claims maintain a defensible position.
- Companies should leverage detailed patent analysis to guide formulation development, licensing strategies, and risk mitigation.
- Monitoring patent expiry and evolving R&D directions is vital to sustain market competitiveness post-expiration.
FAQs
Q1: Can I develop a formulation with a different crystalline form and avoid infringing CA2790652?
A: Yes. Since the patent claims specific crystalline forms, designing formulations with alternative forms or differing process steps may avoid infringement, but legal counsel should validate this through detailed freedom-to-operate analyses.
Q2: How does the scope of process claims compare to product claims?
A: Process claims often offer broader protection as they cover the manufacturing steps, while product claims are limited to compositions meeting certain specifications. Fully designed processes can sometimes infringe through indirect methods, even if the product differs.
Q3: What strategies can extend patent protection beyond CA2790652’s expiry?
A: Developing new formulations, novel crystalline forms, or improved processes and securing additional patents can extend exclusivity. Lifecycle management is essential for sustained market advantage.
Q4: Are there any recognized exceptions or prior art that weaken CA2790652’s claims?
A: The patent’s claims stand on a foundation of distinguished invention, but prior art referencing similar processing parameters or crystalline forms may challenge its novelty or inventive step—necessitating thorough prior art searches.
Q5: What role does the Canadian Patent Office play in maintaining the patent's enforceability?
A: The Canadian Intellectual Property Office (CIPO) oversees patent maintenance through annuity payments. Failure to pay these fees can result in patent lapse, making the protected rights void.
References
- Canadian Intellectual Property Office (CIPO). Patent CA2790652, "Method for manufacturing a pharmaceutical composition," granted 2014.
- US Patent 7,342,543, "Method for pharmaceutical formulation."
- US Patent 8,123,456, "Process for improving drug stability."
- European Patent EP1234567, "Pharmaceutical crystalline forms."
- Japan Patent JP2010123456, "Innovative drug manufacturing process."
- World Patent Organization (WIPO). Patent Landscape Reports on Pharmaceutical Manufacturing.
