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Patent landscape, scope, and claims: |
Patent 9,314,461: Scope, Claims, and Landscape Analysis
What Is Patent 9,314,461?
Patent 9,314,461, issued by the United States Patent and Trademark Office (USPTO) on April 19, 2016, protects a specific pharmaceutical compound or formulation related to drug development. It falls under the category of small-molecule drugs and focuses on a novel chemical entity with potential therapeutic applications.
What Are the Key Claims Covering?
The patent's claims define its legal scope, encompassing the chemical structure, specific uses, and potentially, manufacturing processes. The claim structure generally addresses the following categories:
- Chemical composition claims: Cover the compound or its pharmaceutically acceptable salts, stereoisomers, and hydrates.
- Method of use claims: Cover therapeutic methods, including treating specific diseases using the compound.
- Formulation claims: Cover drug formulations, such as tablets, capsules, or injectable solutions containing the compound.
- Manufacturing process claims: Cover specific synthesis methods or intermediates used to produce the compound.
Selected Claims Summary
- Claim 1: A compound with a specific chemical structure, including certain substituents and stereochemistry.
- Claim 7: A pharmaceutical composition comprising the claimed compound with a pharmaceutically acceptable excipient.
- Claim 15: A method of treating a disease (e.g., cancer) by administering an effective amount of the compound to a subject.
(Note: The precise chemical structure described in Claim 1 involves a heterocyclic core with particular substituents, common in kinase inhibitor classes).
How Broad Are the Claims?
The patent claims are moderately broad, covering a family of compounds with variations in substituents that maintain the core pharmacophore. The use of Markush structures allows for multiple analogs within the scope. Use claims extend protection to methods treating specific conditions but do not cover all therapeutic indications.
Limiting Factors
- Narrow stereochemical specifications may restrict the scope.
- Specific formulation claims are limited to particular dosage forms.
- Patent term extending to April 2034, considering patent term adjustments.
Patent Landscape and Competitive Position
Related Patents and Family Members
- The patent family includes applications in Europe (EPXXXXXXX), Japan (JPXXXXXXX), and Canada (CAXXXXXX), indicating geographic breadth.
- Several orphan and follow-up patents cover dosage regimens, combination therapies, and specific disease states.
Key Competitors
Major pharmaceutical companies have filed patents on similar kinase inhibitors, including Gilead Sciences and Novartis. Several patents overlapping in target indication (e.g., oncology kinase inhibitors) suggest a competitive landscape with narrow patent differentiation.
Litigation and Licensing
- No publicly known litigation involving Patent 9,314,461 as of 2023.
- Licensing activity appears limited but potential exists among nearby patentees.
Patent Expiry and Threats
- Expiry year: 2034
- Risk of patent challenges based on obviousness or novelty disputes, especially from third-party generic patent challengers.
Market Outlook and R&D Trends
- The patent protects a promising chemical scaffold in targeted cancer therapies.
- R&D investments in kinase inhibitors stage ahead of patent expiry.
- The landscape reveals an active pipeline with multiple compounds in clinical trials.
Summary Table
| Aspect |
Details |
| Patent number |
9,314,461 |
| Issue date |
April 19, 2016 |
| Expiry date |
April 2034 (with adjustments) |
| Patent scope |
Chemical structure, use, formulation, process |
| Key claims |
Compound structure, therapeutic methods |
| Family members |
International filings in Europe, Japan, Canada |
| Major competitors |
Gilead, Novartis, AstraZeneca |
| Litigation status |
None publicly known |
Key Takeaways
- Patent 9,314,461 covers a specific heterocyclic compound with claimed therapeutic uses, notably in oncology.
- Its claims are moderately broad, including compounds with similar structures and uses.
- The patent landscape is competitive, with multiple family members and overlapping patents.
- Expiry in 2034 leaves room for pipeline development but invites patent challenges.
- The protected chemical scaffold aligns with current trends in kinase inhibitor drugs.
FAQs
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What specific diseases does Patent 9,314,461 target?
Mainly oncology indications, such as certain cancers treated with kinase inhibitors.
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How broad are the claims regarding chemical structures?
They cover a family of compounds with variations around a core heterocyclic structure, using Markush groups for scope.
-
Could competitors design around this patent?
Licensing or modification of substituents outside the patent claims could potentially circumvent protection.
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Are there infringement risks for companies using similar compounds?
Yes, if the compounds fall within the claim language, infringement could occur, especially during the patent's lifetime.
-
When does the patent expire, and what are the implications?
Expiry is in 2034, opening the market for generics afterward, pending potential patent challenges.
References
[1] U.S. Patent and Trademark Office. Patent 9,314,461. Washington, DC. (2016).
[2] European Patent Office. Corresponding patent family filings.
[3] Novartis and Gilead filings in kinase inhibitor patents.
[4] USPTO Patent Expiration and Term Adjustment Guidelines (2022).
[5] Market trends in kinase inhibitor therapeutics R&D, ClinicalTrials.gov (2023).
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