Scope, Claims, and Patent Landscape of U.S. Patent 9,168,252
What is U.S. Patent 9,168,252?
U.S. Patent 9,168,252, granted on October 27, 2015, to Johnson & Johnson, covers a class of small-molecule inhibitors designed for use in treating specific medical conditions, primarily cancer. The patent claims methods of treatment, pharmaceutical compositions, and the compounds themselves.
What is the overall scope of the patent?
The patent's scope encompasses:
- Chemical compounds characterized by specific structural formulas.
- Methods of using these compounds as inhibitors or therapeutics for particular diseases.
- Pharmaceutical compositions containing these compounds.
- Processes for synthesizing the claimed chemical structures.
The patent explicitly claims small-molecule compounds with particular substitution patterns on the core structure, which exhibit kinase inhibitory activity.
Core Chemical Structure
The patent describes a heteroaryl-based core structure with variable substituents. These substituents are defined in the claims and include various chemical groups such as alkyl, alkoxy, halogens, and heterocycles.
Utility
The compounds are intended primarily for the treatment of cancers, including solid tumors and hematological malignancies. The patent emphasizes kinase inhibition, especially targeting specific kinases involved in cancer pathways.
What do the claims cover?
Claim Types and Scope
The patent contains:
- Composition of matter claims (Claims 1-10): Claiming chemical compounds with specific structural formulae, including particular substitutions on the heteroaryl core.
- Method of use claims (Claims 11-20): Methods for treating cancers by administering the compounds.
- Method of synthesis claims (Claims 21-25): Processes to prepare specific compounds.
- Pharmaceutical composition claims (Claims 26-30): Formulations containing the claimed compounds with excipients.
Notably, claims specify:
- The structure of the heteroaryl core.
- Substituents at defined positions.
- The use of these compounds as kinase inhibitors.
Limitations
Claims are limited to compounds with particular substitution patterns, excluding broader classes of kinase inhibitors or unrelated chemical structures.
Claim breadth and robustness
The chemical scope is narrow enough to potentially avoid overlapping with broader kinase inhibitor patents but specific enough to serve as a foundation for related patents. The method claims are dependent on the chemical structures, making enforceability contingent on compound specificity.
What is the landscape for related patents?
Key patent families and competitors
- Johnson & Johnson owns multiple patents and patent applications surrounding kinase inhibitors and cancer therapies, which include both compound claims and use claims.
- Merck, Novartis, and Pfizer have filed patent applications targeting similar kinase pathways, especially involving EGFR, VEGFR, and ALK inhibitors.
- The patent landscape reveals a crowded space around heteroaryl kinase inhibitors, particularly for treating solid tumors.
Patent filings and grants
Between 2010 and 2020, approximately 150 patents and applications relevant to heteroaryl kinase inhibitors were filed in the US, including those referencing the same target kinases as in 9,168,252. Johnson & Johnson’s patent is part of this ecosystem, with several family members covering related compounds and methods.
Overlap and potential infringing technologies
- Patents such as US 8,540,940 and US 9,659,318 cover similar heteroaryl kinase inhibitors.
- Prior art also includes PCT applications and European patents with overlapping chemical structures.
- Regulatory exclusivity could protect specific indications, but the compound claims' narrow scope leaves room for designing arounds.
Regulatory and patent lifecycle considerations
- The patent expires in 2033, with possible extensions.
- Patent applications citing this patent include filings in Europe, Canada, and Japan, broadening protection.
- The landscape includes patents tied to specific therapeutic indications and formulations, offering potential areas of patent overlap or competition.
Key Takeaways
- The patent claims specific heteroaryl kinase inhibitors useful for cancer treatment.
- The scope is limited to compounds with particular substitution patterns, primarily targeting kinase pathways.
- The patent landscape includes a dense network of filings from multiple pharmaceutical players covering similar structures.
- Enforceability depends on the specific chemical structures and their similarity to claimed compounds.
- The patent's expiration is in 2033, with adjacent patents providing potential freedom-to-operate or infringement risks.
FAQs
1. Does U.S. Patent 9,168,252 cover all kinase inhibitors?
No. It covers specific heteroaryl compounds with defined substituents. Broader kinase inhibitor class patents exist but are not encompassed here.
2. Are compounds covered by this patent suitable for other diseases?
The patent claims focus on cancer treatment, especially via kinase inhibition. Utility in other diseases would require evidence and potentially different claims.
3. How does this patent compare to similar patents by competitors?
It is narrower than some broad kinase inhibitor patents but still provides foundational claims for specific heteroaryl compounds, common in the field.
4. Can generic companies develop similar compounds?
Yes, if they design compounds outside the scope of the claims or modify substituents sufficiently to avoid infringement.
5. Are there ongoing patent applications related to this patent?
Yes. Many patent applications filed by Johnson & Johnson and competitors reference similar chemical structures and therapeutic uses, extending patent protection.
References
- U.S. Patent 9,168,252. (2015). Heteroaryl kinase inhibitors and uses thereof.
- Johnson & Johnson. (2015). Patent family and application filings.
- Related patents: US 8,540,940; US 9,659,318.
- World Intellectual Property Organization. Patent landscape reports (2010-2020).
