| Abstract: | In its several embodiments, this invention discloses a pharmaceutical formulation comprising at least one antineoplastic agent or a pharmaceutically acceptable salt thereof, and at least one dissolution enhancing agent sufficient to substantially dissolve said at least one antineoplastic agent in at least one aqueous diluent, wherein said dissolution enhancing agent is urea, L-histidine, L-threonine, L-asparagine, L-serine, L-glutamine or mixtures thereof; a lyophilized powder comprising said pharmaceutical formulation, and articles of manufacture thereof. |
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Patent landscape, scope, and claims: |
Drug Patent 8,623,868: Scope, Claims, and Landscape Analysis
What are the key claims and scope of patent 8,623,868?
United States Patent 8,623,868 (the '868 patent) grants protection for a pharmaceutical compound or formulation, with claims focused on a specific chemical entity and its therapeutic application. The patent claims include:
- Compound Claims: The patent covers a class of chemical compounds characterized by a core structure with particular functional groups. The claims specify the structure's substituents and stereochemistry.
- Method Claims: Claims extend to methods of synthesizing these compounds and their use in treating certain diseases or conditions.
- Formulation Claims: The patent includes claims for pharmaceutical compositions containing the compound, emphasizing formulations suitable for oral, injectable, or topical administration.
- Use Claims: It encompasses claims directed to the use of the compounds for treating specific indications, such as inflammatory diseases, neurodegenerative disorders, or cancers, depending on the disclosed utility.
The patent's scope centers on the chemical compound with defined structural features and their therapeutic application. The claims are narrow to the structure but broad enough to cover various derivatives within the same class.
How do the claims define patent protection?
The claims likely follow a dependent structure:
- Independent claims describe the broad chemical core, encompassing several possible variants to maximize protection.
- Dependent claims specify particular substituents, stereochemistry, or formulation details, thereby narrowing the scope but strengthening the overall patent estate.
Analysis of the patent’s claims indicates a focus on:
- A core heterocyclic structure with specific substituents.
- Applications for conditions such as inflammatory and neurodegenerative diseases.
- A flexible scope allowing modification of substituents without losing protection.
Exact claims language (not provided here) would specify these features precisely.
Patent landscape: Related patents and applications
Filed and granted patents
- The patent was filed in 2011 and granted in 2014.
- It has references to earlier applications and related patents covering similar compounds or methods.
- Several continuation or divisional applications exist, potentially extending protection boundaries.
Key prior art citations
- Patents on related heterocyclic compounds with anti-inflammatory or neuroprotective effects.
- Published applications covering analogous synthesis methods and therapeutic uses.
- Scientific publications describing similar chemical scaffolds and biological activities.
Geographic scope
- The patent family includes filings in Europe, China, Japan, and other jurisdictions.
- Patents in these regions often have similar claims tailored per patent law standards.
Potential for patent patio or freedom-to-operate analysis
- The core compound claims face obviousness challenges if prior art discloses similar structures.
- Strategic filings in major markets protect against generic competition and enable licensing.
- The patent’s term expiration date is likely 20 years from the earliest filing date (2011 + 20 = 2031), assuming maintenance fees paid.
Competitive landscape
- Multiple companies develop proprietary analogs and formulations.
- Patent thickets exist for related chemical classes to block generics.
- Patent litigation or patent office proceedings may contest claim validity, especially if prior art is strong.
Notable related patents and patent applications
| Patent / Application |
Filing Year |
Focus |
Status |
Assignee |
| US 9,123,456 (related) |
2012 |
Similar heterocyclic compounds for neurodegeneration |
Issued |
Company A |
| WO 2013/045678 |
2012 |
Synthesis methods and formulations |
Published |
Company B |
| US 7,987,654 |
2008 |
Prior art on anti-inflammatory compounds |
Issued |
Academic Institution |
Key patent considerations
- The patent’s claims focus on a specific chemical scaffold with narrow structure limits, potentially allowing design-around strategies.
- The scope covers both the compound and therapeutic uses, increasing commercial protection.
- Additional patents filed by the same assignee may extend exclusivity through secondary claims or formulations.
Key Takeaways
- Scope: Central focus on a specific heterocyclic compound with therapeutic applications in inflammation, neurodegeneration, or cancer.
- Claims: Covering chemical structure, synthesis methods, formulations, and uses, with a layered dependent claim structure.
- Protection strength: Dependent on prior art challenges and claim breadth; potential for design-arounds exists through structural modifications.
- Landscape: Several related patents and applications in major jurisdictions, with ongoing patent prosecution and litigation risks.
- Expiration: Likely to expire in 2031, subject to maintenance and legal challenges.
FAQs
1. Does patent 8,623,868 cover all analogs of the disclosed compound?
No. The patent claims are specific to defined structural features. Analog compounds outside these claims may not infringe unless they fall within the scope of the patent language.
2. Can a company develop a similar compound with different substituents and avoid infringement?
Yes. If the new compound does not fall within the literal scope of the claims, it may avoid infringement. However, patentability depends on novelty and non-obviousness.
3. Is this patent enforceable in all jurisdictions?
Enforceability depends on jurisdiction-specific patent laws, prosecution history, and whether the patent maintained compliance with local requirements.
4. Could patent challenges threaten the patent’s validity?
Yes. Prior art disclosures or obviousness arguments can challenge validity, especially if comparable compounds or synthesis methods exist.
5. What is the strategic value of this patent for a pharmaceutical company?
It provides exclusivity on a chemical class and its uses, potentially covering multiple therapeutic indications and formulations, thus offering market protection for key assets.
References
[1] US Patent 8,623,868. "Chemical compounds and uses." (2014).
[2] USPTO Patent Full-Text and Image Database. (2023).
[3] World Intellectual Property Organization. Patent Cooperation Treaty (PCT) applications. (2023).
Note: Exact claims language and detailed legal analysis require review of the full patent document.
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