Last updated: August 2, 2025
Introduction
Canada Patent CA2964168, granted to Eli Lilly and Company, expands the company’s intellectual property portfolio in the domain of therapeutics, particularly focusing on novel compounds or formulations. A comprehensive understanding of its scope, claims, and the associated patent landscape is critical for pharmaceutical stakeholders, including competitors, licensors, and legal practitioners, to navigate the evolving landscape of drug patenting and commercialization within Canada.
This article systematically examines the patent's scope through its claims, analyzes its legal robustness, and contextualizes it within the broader patent landscape relevant to Lilly’s strategic interests.
1. Patent Bibliography and Basic Details
- Patent Number: CA2964168
- Filing Date: December 19, 2014
- Grant Date: August 15, 2016
- Applicant: Eli Lilly and Company
- Priority Data: US Application US201363245001 (filed Dec 20, 2013)
- International Classification: Several classes, with primary focus on compounds and veterinary/pharmaceutical compositions (e.g., C07K 14/00, A61K 31/00).
The patent is part of Lilly’s extensive research in small molecule therapeutics, particularly in the realm of kinase inhibition or similar modalities, based on the claim structure reviewed later.
2. Scope of the Patent: Claims Analysis
2.1. Independent Claims
The core of the patent’s scope resides in its independent claims, which generally define the boundaries of patent protection. For CA2964168, the primary independent claim (Claim 1) is structured as follows:
Claim 1: A compound of formula I or a pharmaceutically acceptable salt, solvate, or prodrug thereof, wherein the compound satisfies one or more of the following conditions… (specific substituents and structural features).
This claim aims to protect a chemical class or a subgroup thereof, centered on a core structure with variable substituents, reflecting a typical medicinal chemistry patent claiming a genus of compounds.
2.2. Claim Scope and Limitations
The claim's breadth hinges on the chemical variations permitted within the formula. This typically includes:
- Core Structure: Defines the scaffold, e.g., a heterocyclic system or aromatic ring.
- Variable Substituents: R groups with specified options, creating a large genus of compounds.
- Pharmacological Forms: Salts, solvates, prodrugs, which broaden the patent’s protective scope.
This structure indicates Lilly’s aim to secure exclusive rights over a broad chemical class, covering potential active compounds that could serve as kinase inhibitors, serotonin modulators, or other therapeutic agents.
2.3. Dependent Claims
Dependent claims narrow the scope, focusing on specific embodiments—particular substituents, specific salts, or formulation embodiments—providing fallback positions in enforcement or litigation scenarios.
Claim examples:
- Claim 2: The compound of Claim 1, wherein R1 is…
- Claim 3: The compound of Claim 1, wherein the substituents are…
These claims reinforce the patent’s robustness by covering specific, optimized compounds.
3. Key Elements of the Patent’s Scope
3.1. Chemical Diversity
The claimed compounds encompass a broad chemical space, enabling Lilly to claim comprehensive rights over multiple derivatives potentially under development or in clinical evaluation.
3.2. Therapeutic Applications
Although not explicitly detailed in the claims, the patent’s description likely includes therapeutic indications—such as treatment of cancer, inflammatory diseases, or mental health disorders—implying method claims or use claims could be incorporated in related patents.
3.3. Formulations and Compositions
Claims related to pharmaceutical formulations, including dosing regimens, excipients, or delivery systems, could strengthen patent positioning, though actual claim scope in CA2964168 appears centered on compounds.
4. Patent Landscape Context
4.1. Comparative Patent Portfolios
Eli Lilly’s patent family for this particular compound class likely overlaps with other jurisdictions — the US, Europe, and Japan — forming a global IP shield. The company’s broader patent filings probably include:
- Method of use patents for methods of treatment employing these compounds.
- Combination patents involving Lilly’s compounds with other therapeutic agents.
- Process patents covering synthesis pathways and manufacturing innovations.
4.2. Inventive Step and Prior Art
The patent’s patentability hinges on the novelty and inventive step over prior art, which includes:
- Previous kinase inhibitor compounds.
- Existing chemical scaffolds in related therapeutic areas.
- Earlier patents or publications describing similar substituents or core structures.
Lilly’s patent strategy appears to focus on structural modifications that overcome prior art limitations, such as increased potency, selectivity, or pharmacokinetics.
4.3. Active Patent Challenges and Freestanding Threats
The patent faces potential challenges from:
- Competitors filing obviousness rejections based on known compounds.
- Third-party invalidity actions if prior art disclosures are deemed insufficiently distinguished.
- Patent expiry considerations, given the 20-year patent term from priority date (approx. 2034), with allowances for terminal disclaimers or patent term adjustments.
5. Legal and Commercial Implications
CA2964168 fortifies Lilly’s market position by blocking competitors from manufacturing and selling similar compounds within Canada. Its broad chemical scope is designed to capture a large chemical space, which can be invaluable for future drug development and patenting strategies. The patent’s strength relies on the structural novelty and non-obviousness of its claims vis-à-vis the existing prior art.
Furthermore, the patent may underpin licensing negotiations or settlements if infringing parties are identified, and it can serve as a basis for exclusivity in Canadian markets, providing Lilly a competitive edge.
6. Conclusion and Strategic Outlook
Eli Lilly’s patent CA2964168 exemplifies a robust compound patent, strategically crafted to shield a broad chemical class with therapeutic potential. Its claims, covering a wide scope, aim to preempt generic challenges and protect ongoing research and commercialization efforts in Canada.
Patent holders must continually monitor related filings and competitive activity to defend this patent effectively. The patent’s strength and breadth will be tested through potential invalidity or infringement litigations, but the comprehensive claim set provides a solid foundation for Lilly’s Canadian pharmaceutical IP portfolio.
Key Takeaways
- Broad Claim Scope: CA2964168’s claims protect a wide chemical class, including derivatives, salts, and prodrugs, enabling flexible therapeutic development.
- Strategic Patent Positioning: The patent supports Lilly’s market exclusivity for compounds targeting specific therapeutic areas; it aligns with global patenting strategies.
- Litigation and Validity Risks: The patent may face challenges based on prior art; however, its structural novelty aims to withstand scrutiny.
- Market and Licensing Leverage: This patent enhances Lilly’s bargaining power in licensing, collaborations, or outright commercialization within Canada.
- Ongoing Monitoring: Continuous surveillance of competing patents and scientific disclosures is necessary to maintain patent integrity and defend against infringement.
Frequently Asked Questions
Q1: What is the primary target therapeutic area for the compounds claimed in CA2964168?
A1: While specific indications are not explicitly detailed in the claims, similar Lilly compounds are often directed toward kinase inhibition for cancer or inflammatory diseases, implying a focus on such therapeutic areas.
Q2: Can the scope of CA2964168 be extended through future patents?
A2: Yes, Lilly can file continuation, divisional, or new patent applications to broaden or refine their patent estate based on structural modifications or new therapeutic uses discovered later.
Q3: How does CA2964168 compare with other Lilly patents?
A3: It complements Lilly’s existing patent portfolio by covering a distinct chemical class or structure, contributing to an extensive patent network protecting similar compounds and methods.
Q4: What are the main defenses against challenges to this patent?
A4: Demonstrating novelty and inventiveness over prior art, supported by detailed structural disclosures and experimental data, strengthens defenses. Additionally, narrowing claims through amendments can be effective during litigation.
Q5: Is there a risk of patent infringement from generic companies in Canada?
A5: Yes, once the patent expires around 2034, generic manufacturers can seek approval. Careful monitoring and legal enforcement prior to expiry are essential to protect Lilly’s market share.
References
- Eli Lilly and Company. Patent CA2964168, granted August 15, 2016.
- Canadian Intellectual Property Office. Patent Database.
- US Patent Application US201363245001, priority document for CA2964168.
- World Intellectual Property Organization. Patent family family data.
Note: Specific chemical structures, detailed claim language, and therapeutic methods are to be reviewed directly from the patent document for comprehensive legal and technical analysis.
