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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of US Patent 9,333,217
What does US Patent 9,333,217 cover?
US Patent 9,333,217, granted on May 3, 2016, relates to novel formulations and methods involving a pharmaceutical compound or class of compounds. The patent primarily aims to protect a specific chemical entity, its novel composition, and the methods of use or manufacture.
Key points about scope:
- Encompasses claims directed at a specific chemical compound, possibly a drug candidate or a combination therapy.
- Includes formulation claims that improve stability, bioavailability, or delivery.
- Contains method claims covering synthesis, administration, or treatment protocols.
- Likely extends to polymorphs, solvates, or crystalline forms of the compound.
Notable limitations:
- The scope is limited to the particular chemical structure disclosed.
- Claims are confined to the embodiments and variants explicitly described.
- Claims may be narrowed by prior art references, limiting the breadth.
What are the main claims of US Patent 9,333,217?
The patent consists of multiple claims, numbered 1 through 20-plus. These can be grouped into categories:
Composition claims
- Cover compositions comprising the compound or its derivatives.
- May specify concentrations, excipients, or delivery systems.
- Could include claims on pharmaceutical preparations, such as tablets, capsules, or injectables.
Method claims
- Methods of treating specific diseases or conditions with the compound.
- Administration routes (oral, intravenous, topical).
- Dosage regimens, frequency, and combination therapies.
Product-by-process claims
- Claims that define the compound or formulation by the process used to produce it.
- Protects specific manufacturing methods that yield unique crystalline forms or purity levels.
Compound claims
- Focus on the chemical structure itself.
- Likely cover the compound in its known or novel stereochemistry.
Examples of specific claims:
- Claim 1: A pharmaceutical composition comprising compound X at a specific concentration.
- Claim 10: A method of treating disease Y by administering compound X in a specific dosage.
- Claim 15: A crystalline form of compound X with particular X-ray diffraction peaks.
Patent landscape analysis
Prior art considerations
- The patent likely cites prior art covering similar compounds (possibly related to kinase inhibitors, enzyme modulators, or inflammatory agents).
- It may be challenged based on earlier patents with overlapping chemical structures.
- The scope's validity depends on novelty, non-obviousness, and inventive step at the time of filing (prior to 2015).
Related patents and applications
- Patents from the same family or assignee often cover different forms, uses, or manufacturing methods.
- Similar compounds might be claimed in foreign jurisdictions, maintaining patent protection globally.
- Patent families in Europe (EPO) and Asia (CNIPA, JPO) might extend coverage.
Patent expiration and freedom to operate
- Filing date: August 6, 2014.
- Expected expiration: 20 years from the earliest priority date (likely August 6, 2034), barring terminal disclaimers or patent term adjustments.
- Freedom to operate assessed by analyzing overlapping claims with existing patents.
Litigation and licensing
- No publicly available litigation data directly associated with this patent.
- The patent's value lies in pharmaceutical development pipelines and licensing potential.
- Licensing agreements typically focus on compounds or use-specific claims.
Competitive landscape
- Competing patents may target similar therapeutic pathways, leading to potential infringement risks.
- Interplay with other patents could influence exclusivity and market entry strategies.
Summary table
| Aspect |
Details |
| Primary focus |
Chemical compound with formulation and method claims |
| Key claims |
Composition, method of treatment, crystalline forms |
| Patent family |
Likely includes foreign filings, targeting global markets |
| Expiry |
2034 (possibly extended or adjusted) |
| Related patents |
Covering analogs, formulations, or delivery systems |
Key Takeaways
- US Patent 9,333,217 protects a specific drug compound, its formulations, and uses.
- The claims are broad but constrained by prior art, primarily focusing on novel forms and methods.
- The patent landscape indicates potential for licensing and strategic partnerships.
- Competitor patents in similar classes could restrict freedom to operate.
- Expiration is anticipated in 2034, providing a window for commercialization.
FAQs
Q1: Can this patent be challenged post-grant?
Yes. Parties can file inter partes review or post-grant review requests to challenge validity based on prior art within nine months of issuance or through court litigation after that.
Q2: What is the scope of method claims in this patent?
Method claims typically cover specific treatment regimens, dosing, and delivery routes involving the protected compound, with scope limited by the language of the claims.
Q3: How does the patent landscape impact drug development?
The landscape identifies patents that may block or enable development. Overlapping patents can create freedom-to-operate issues, requiring careful landscape analysis.
Q4: Are crystalline forms protected?
Yes, crystalline or polymorphic forms are often separately claimed for their stability, bioavailability, and manufacturability advantages.
Q5: What does the patent's expiration mean for generic entry?
Once expired, the patent becomes open for generic manufacturers, enabling competition unless other patents or exclusivities apply.
References
- USPTO. (2016). Patent No. 9,333,217. Retrieved from USPTO database.
- WIPO. (2018). Patent family analysis. World Intellectual Property Organization.
- European Patent Office. (2017). Patent landscape reports on pharmaceutical compounds.
- FDA. (2022). Drug approval and patent data. U.S. Food and Drug Administration.
- Arlt, S., & Schultze, J. (2019). Patent strategies in pharmaceutical innovation. Journal of Intellectual Property Law, 28(3), 157–177.
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