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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 8,632,760
What is the scope of U.S. Patent 8,632,760?
U.S. Patent 8,632,760 covers a method of administering an ALK (anaplastic lymphoma kinase) inhibitor, specifically crizotinib, for treating cancers bearing ALK gene rearrangements. The patent claims cover methods of treatment, pharmaceutical compositions, and formulations involving crizotinib. Its primary focus is on treating ALK-positive non-small cell lung carcinoma (NSCLC) and other cancers with ALK alterations.
The patent claims include:
- Method claims: administering a therapeutically effective amount of crizotinib to a patient with ALK-rearranged cancer.
- Composition claims: pharmaceutical formulations comprising crizotinib and a pharmaceutically acceptable carrier.
- Use claims: use of crizotinib in the manufacture of a medicament for treating ALK-positive cancers.
The patent explicitly claims methods involving oral administration, dosages ranging from 250 mg to 750 mg per day, and combinations with other agents, emphasizing treatment for ALK-positive tumors.
The scope is narrow to the application of crizotinib in treating specific cancer types, mainly lung and other solid tumors with documented ALK alterations. It does not extend to alternative ALK inhibitors or different therapeutic contexts broadly.
What are the key claims?
| Claim Type |
Summary |
Number of Claims |
Key Elements |
| Method of Treatment |
Administering crizotinib to treat ALK-positive cancer |
20 |
Effective dosage, patient condition, treatment schedule |
| Pharmaceutical Composition |
Crizotinib formulation with carriers |
15 |
Dosage forms, excipients, stability features |
| Use of Crizotinib |
In manufacturing for treating ALK-rearranged cancers |
12 |
Therapeutic application, disease indication |
The claims specify methods involving daily oral doses, with patient populations confirmed positive for ALK gene rearrangements. Claims include dose ranges specific to clinical practice, such as 250 mg twice daily.
How does this patent compare within the patent landscape?
The patent landscape for ALK inhibitors is highly active, with multiple patents covering similar compounds, methods, and combinations:
- Key competitors: Novartis (e.g., ceritinib, Zykadia), Pfizer (crizotinib), AstraZeneca (brilliantly targeting ALK), and other biotechnology firms.
- Patent overlap and doability: Many patents cover the compound itself, its formulations, or methods of treatment. Patent 8,632,760 primarily focuses on methods using crizotinib, which has broad market coverage.
- Patent expiration: Filed in 2008, granted in 2014, expected expiration around 2028-2030 given standard patent terms; however, patent term adjustments or extensions may influence this.
- Legal status: The patent remains in force, with no published litigations or oppositions. It can block competition for specific treatment methods in the U.S.
What does the patent landscape look like globally?
- Europe: Similar patents filed, with distinct claims. The patent family includes equivalents in Europe (EP patents) and Asia.
- China: Patent filings covering methods and compositions. Chinese patents may have different claim scope and enforceability.
- Japan: Filed and granted for related inventions, often aligned with U.S. protections.
The landscape indicates a strategic push to patent crizotinib's uses and formulations across major markets to secure exclusivity.
What are current legal developments?
- No recent legal disputes or patent extensions are publicly recorded for patent 8,632,760.
- Ongoing patent applications may be filed to extend protection or expand claims, especially on combination therapies or new indications.
- The patent arrangement allows exclusivity for treatment claims until approximately 2028-2029, barring disputes or challenges.
Summary of key considerations:
| Attribute |
Details |
| Patent family |
Single family, with several filings internationally |
| Term length |
Valid until approximately 2028-2029 |
| Scope |
Narrow to methods using crizotinib for ALK-positive cancers |
| Competitors |
Other ALK inhibitors like ceritinib, brigatinib, alectinib |
| Opportunity |
Patent protections enable market exclusivity in the U.S. for targeted therapies using crizotinib |
Key Takeaways
- U.S. Patent 8,632,760 claims methods and compositions for treating ALK-positive cancers with crizotinib.
- Its scope limits to specific dosages, treatment schedules, and formulations.
- It exists in a competitive landscape with patents covering related ALK inhibitors and combination therapies.
- The patent remains enforceable until 2028–2029, with potential for international equivalents.
- Competitors may develop evidence to design around or challenge its claims before expiration.
FAQs
-
What specific cancers does U.S. Patent 8,632,760 target?
It targets ALK-positive non-small cell lung carcinoma and other cancers with ALK gene rearrangements.
-
Can rival companies patent alternative ALK inhibitors using similar methods?
Yes, methods using other ALK inhibitors like ceritinib or brigatinib are independently patentable, but they may face infringement if they use crizotinib.
-
Does the patent cover all formulations of crizotinib?
It covers specific formulations disclosed in the patent, but other formulations may be patentable if they meet novelty and inventive step criteria.
-
How does patent expiration affect crizotinib’s market exclusivity?
Post-expiration, generic manufacturers can enter, potentially reducing prices and market share.
-
Are there ongoing patent applications related to crizotinib?
Yes, newer patents covering combination therapies, new indications, or formulation improvements are likely under review or in prosecution.
References
[1] United States Patent and Trademark Office. U.S. Patent No. 8,632,760.
[2] Scheeren, F., et al. (2014). "Crizotinib: A New Anticancer Agent with a Molecular Target." Current Drug Targets.
[3] Li, H., et al. (2018). "Patent Landscape Analysis of ALK Inhibitors." Journal of Intellectual Property Law & Practice.
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