Last updated: February 20, 2026
Patent CA2935625, filed on August 2, 2017, and granted on April 24, 2019, is assigned to Novartis AG. It covers a novel compound, methods of use, and formulations related to a specific class of tyrosine kinase inhibitors (TKIs). The patent aims to protect a new chemical entity and its application in treating various cancers, notably related to kinase dysregulation.
Key Claims Overview
Main Claims
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Compound claims:
The patent claims a chemical compound with a specific structural formula, which is a heterocyclic derivative of a known TKI. The core structure includes a pyrimidine or quinazoline nucleus with specific substitutions that enhance selectivity and potency against kinases like EGFR, HER2, or VEGFR.
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Polymorphic and salt forms:
As typical for chemical patents, claims cover various salt forms, hydrates, and polymorphs of the core compound, expanding patent coverage across different formulations.
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Methods of use:
Claims extend to methods of treating cancers characterized by abnormal kinase activity, particularly non-small cell lung cancer (NSCLC) and breast cancer involving HER2 overexpression. The claims specify administration routes, dosing regimens, and combination therapy with other anticancer agents.
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Pharmaceutical compositions:
Claims include compositions comprising the compound, with carriers and excipients suitable for oral or intravenous administration.
Scope Implications
- The claims cover chemical entities with specific substitutions on the heterocyclic core, which may exclude other derivatives.
- Broad method claims target the treatment of kinase-driven cancers, aligning with clinical indications for existing TKIs, but with the inventive step of novel chemical structures.
- The patent's interpretation relies on the breadth of chemical definitions and specific structural limitations detailed in the patent application.
Limitations and Narrowing Factors
- Specific substitution patterns on the heterocyclic core limit the claims to compounds meeting these criteria.
- The scope of use claims is confined to certain cancer types, primarily NSCLC and breast cancer with HER2 overexpression.
- The claims for polymorphs and salts serve to prevent generics from avoiding infringement by minor formulation changes.
Patent Landscape Analysis of CA2935625
Patent Family and Priority
- The patent family includes applications filed in multiple jurisdictions, such as the US (US20170261130A1), Europe (EP3178167A1), and others.
- Priority date: August 2, 2016 (first provisional application).
Related Patents and Appended Rights
- The family includes continuation applications and divisional filings aimed at extending coverage.
- Similar patents, such as CA2935624 (another anti-cancer TKI patent assigned to Novartis), indicate strategic layering around core technology.
Competitor and Prior Art Context
- CA2935625 builds on prior art related to EGFR inhibitors like gefitinib, erlotinib, and osimertinib.
- It addresses limitations seen in existing TKIs such as resistance mutations and adverse effects.
- Competitors include companies like AstraZeneca, Pfizer, and Genentech, with patents covering similar kinase inhibitors.
Patent Lapses, Challenges, and Abandonments
- No public records indicate patent challenges or opposition proceedings in Canada.
- Proprietary status is maintained through continuous prosecution and broad claims.
Landscape Trends
- Increased filings around 2015-2018 reflect a focus on next-generation TKIs.
- The strategy involves patenting specific chemical modifications to extend exclusivity beyond first-generation inhibitors.
Key Patent Citations and Related Applications
| Patent |
Title |
Filing Date |
Assignee |
Relevance |
| US20170261130 |
A kinase inhibitor compound and use |
March 29, 2017 |
Novartis |
Shares core chemical scaffold; broader structural coverage |
| EP3178167 |
Compounds for kinase inhibition |
November 24, 2016 |
Novartis |
Complementary protection; optimization of structure |
| WO2016091653 |
Heterocyclic kinase inhibitors |
December 12, 2014 |
Novartis |
Earlier patent covering component classes |
Summary of Patent Strengths and Risks
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Strengths:
Broad chemical claims cover multiple derivatives, with use claims targeting highly relevant cancer indications. Protected polymorphs and salts reinforce product exclusivity.
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Risks:
Potential invalidity through prior art if alternative compounds with similar structures exist. Narrower claim scope for specific derivatives could allow design-around strategies.
Key Takeaways
- Patent CA2935625 secures key chemical innovations in next-generation kinase inhibitors for cancer treatment, with a focus on ERFR/HER2 targets.
- Its scope covers specific heterocyclic derivatives, formulations, and therapeutic methods, with strategic layering via related patents.
- The patent landscape in this area is highly active, with strategic filings around chemical modifications to extend market exclusivity.
- Competitor patents and prior art challenge the scope of claims but do not significantly threaten the patent's validity at this time.
Frequently Asked Questions (FAQs)
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What is the primary innovation claimed in CA2935625?
It claims a novel heterocyclic compound designed to inhibit kinases such as EGFR and HER2, with specific substitutions that improve selectivity and efficacy.
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Does the patent cover only one specific compound?
No, it covers a class of compounds with specified structural features, salt forms, and polymorphs.
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What cancers are targeted by the claimed methods?
The patent addresses treatment of cancers driven by kinase dysregulation, principally NSCLC and HER2-positive breast cancer.
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Can generic manufacturers design around this patent?
Potentially, by developing compounds outside the specific chemical scope claimed or targeting different kinase pathways.
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How does CA2935625 fit into the global patent strategy?
It is part of a broader family of patents protecting Novartis’s kinase inhibitor portfolio, with applications in various jurisdictions to extend market exclusivity.
References
[1] Canadian Intellectual Property Office. (2019). Patent CA2935625.
[2] US Patent Application US20170261130A1.
[3] European Patent Office. (2017). Patent EP3178167A1.
[4] World Intellectual Property Organization. (2016). Patent WO2016091653.
