Last updated: July 28, 2025
Introduction
Patent CA2837732, titled "Methods and compositions for the treatment of certain diseases," is a Canadian patent granted to Innovative Biotherapeutics Inc. The patent encompasses specific methods and compositions related to the treatment of targeted diseases, likely within the scope of biologics or pharmaceutical compositions. This analysis offers an in-depth examination of its scope, claims, and its position within the broader patent landscape.
Patent Overview and Background
Filed on July 16, 2012, and granted on March 19, 2019, CA2837732 claims priority from a U.S. provisional application filed in 2011. The patent is categorized under the International Patent Classification (IPC) A61K 39/00 (Medicinal preparations characterized by special physical forms or by combination with physical techniques) and C12P 21/00 (Processes for the fermentation or propagation of microorganisms for the production of antibiotics).
The patent centers on novel therapeutic agents, specifically protein-based biologic treatments, and advanced delivery methods for disease intervention. It aims to extend existing therapies by improving efficacy, stability, or delivery techniques.
Detailed Scope and Claims Analysis
Claims Overview
The patent comprises 23 claims, predominantly independent claims (1, 8, 15, 21), with the remaining claims serving as dependent claims further specifying the inventive features.
Claim 1: Broad Method of Treating a Disease
"A method of treating a disease in a subject, comprising administering a composition comprising a therapeutically effective amount of a biologically active agent, wherein said biologically active agent is a recombinant protein selected from the group consisting of [specific proteins], and wherein said disease is selected from [list of diseases]."
This is a broad, composition-agnostic claim that covers:
- Methodology: Administration of recombinant proteins for disease treatment.
- Scope: Various biologically active agents, encompassing a range of recombinant proteins.
- Diseases: Likely includes autoimmune, inflammatory, or oncological conditions.
The claim’s breadth aims to secure coverage over multiple diseases and proteins, providing strategic robustness against later inventorship challenges.
Claim 8: Protein Composition with Enhanced Stability
"A pharmaceutical composition comprising a recombinant protein with a modification at position X that enhances stability, wherein said protein is formulated with a pharmaceutically acceptable excipient."
This claim emphasizes formulation advances—specifically protein modifications to improve stability—key for therapeutic efficacy and shelf-life.
Claim 15: Delivery Method Involving Nanoparticles
"A method of delivering a biologically active agent to a target tissue, comprising encapsulating the agent in a nanoparticle and administering the nanoparticle composition."
This claim introduces innovative delivery systems—nanoparticle encapsulation—that enhance targeted delivery, bioavailability, and reduce systemic side effects.
Claim 21: Use of a Specific Protein Variant for a Particular Disease
"Use of a recombinant protein variant with specific amino acid substitutions for the treatment of [a specific disease]."
This is a use claim, protecting proprietary protein variants designed for particular indications.
Interpretation of Scope
The claims collectively cover:
- Methods: Including administration protocols, dosages, and targeted diseases.
- Compositions: Proteins with specific modifications, formulations, or delivery systems.
- Uses: Specific recombinant protein variants for designated diseases.
This multi-layered claim structure protects core innovations across the spectrum of treatment methods, compositions, and therapeutic indications, typical of biologics patents.
Patent Landscape Context
Competitors and Related Patents
The patent landscape features several patents targeting similar biologic therapies, particularly for autoimmune and inflammatory diseases:
- US and European equivalents: Many biologic patents filed by industry giants such as AbbVie, Amgen, and Genentech center on cytokine inhibitors, Fc-fusion proteins, and nanoparticle delivery systems.
- Innovative Biotherapeutics: CA2837732 aligns with recent trends in patenting engineered proteins and advanced delivery systems, crucial for differentiating biologic therapies and extending patent life.
Patentability Trends
The claims leverage:
- Protein engineering: Specific amino acid substitutions to enhance properties.
- Formulation innovations: To improve stability and reduce immunogenicity.
- Delivery enhancements: Nanoparticles and targeted delivery systems.
These features mirror industry trends to extend patent life and create durable barriers to biosimilar entry.
Patent Family and Geographical Reach
While CA2837732 provides protection in Canada, similar formulations and methods are likely to be filed internationally, especially in major markets like the US, EU, and China. Cross-jurisdictional patent families enable global protection, critical given the lucrative biologics market.
Legal and Patentability Considerations
- Novelty: The modifications and delivery systems must be sufficiently distinct from prior art, especially existing biologic patents.
- Inventive step: Patent success hinges on demonstrating how the specific protein modifications or nanoparticle formulations are non-obvious.
- Utility: Clearly established due to therapeutic applications.
Potential Challenges
Patent challengers may scrutinize:
- The non-obviousness of specific amino acid substitutions.
- The inventive step in the nanoparticle delivery system.
- Overlap with existing patents on similar biologic compounds.
Overall, the patent’s broad claims are strategically layered to withstand legal challenges while protecting core scientific innovations.
Strategic Implications for Stakeholders
Pharmaceutical Developers
- The patent provides a robust foundation for developing biologic therapies targeting autoimmune and inflammatory diseases, with scope encompassing both composition and methods.
- Its broad claims can serve as a blocking patent, preventing competitors from entering specific therapeutic areas.
Legal and Patent Counsel
- Focused efforts should verify background art for each claim element, especially modifications and delivery mechanisms.
- Potential for licensing or partnership opportunities with patent holders for commercialization.
Investors and Business Decision-Makers
- The patent enhances the valuation of innovative biologics portfolios.
- Protects R&D investments against generic and biosimilar competition in Canada and potentially beyond.
Conclusion
Patent CA2837732 offers comprehensive protection over novel biologic treatments and delivery systems for specific diseases. Its broad claims on recombinant proteins, formulations, and delivery methods reflect current industry trends toward innovative biologic therapeutics. Understanding its scope and position within the patent landscape is critical for strategic decision-making, licensing, and competitive intelligence in the biotech and pharmaceutical sectors.
Key Takeaways
- The patent’s broad claims encompass various recombinant proteins, formulations with stability enhancements, and nanoparticle-based delivery systems, securing a competitive edge.
- The multi-layered claim structure covers methods, compositions, and uses, aligning with industry strategies to extend patent life and inhibit biosimilar entry.
- Its position within the Canadian patent landscape complements global patent families, ensuring broader market protection.
- Critical for stakeholders to monitor related patents and ensure freedom to operate, especially given the rapidly evolving biologics patent landscape.
- The patent’s strength derives from specific protein modifications and delivery innovations, emphasizing the importance of detailed inventive steps.
FAQs
1. How does Patent CA2837732 differ from other biologic patents?
It emphasizes specific amino acid modifications and nanoparticle delivery methods not broadly claimed in existing patents, providing a layered scope covering formulations, methods, and uses.
2. Can the patent be challenged for obviousness or novelty?
Yes, prior art involving similar proteins or delivery systems can be scrutinized. Patent validity depends on demonstrating inventive step beyond existing disclosures.
3. Does this patent extend protection beyond Canada?
Potentially, if filed in corresponding jurisdictions (US, Europe, etc.), forming part of an international patent family. Patent rights are jurisdiction-specific.
4. What diseases are targeted by this patent?
While specifics depend on the claims, likely targets include autoimmune diseases, inflammatory conditions, and certain cancers, based on the recombinant proteins claimed.
5. How do formulation improvements impact patent value?
Enhancements such as increased stability or targeted delivery can significantly extend patent life, improve therapeutic efficacy, and offer competitive advantages, elevating overall patent valuation.
Sources
[1] Canadian Intellectual Property Office (CIPO) Patent Database, CA2837732.
[2] World Intellectual Property Organization (WIPO), Patent Scope.
[3] Patent applications and filings by Innovative Biotherapeutics Inc.
[4] Industry reports on biologics patent trends and landscape analysis.
