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Patent landscape, scope, and claims: |
Analysis of US Patent 9,393,256: Scope, Claims, and Patent Landscape
What Is the Scope of Patent 9,393,256?
United States Patent 9,393,256 (hereafter "the '256 patent") covers a specific pharmaceutical composition or method directed toward a particular therapeutic agent or combination. Its scope primarily focuses on the use, formulation, or delivery method for treating a defined disease or condition using an active ingredient or combination thereof.
The patent claims are crafted to protect:
- A specific chemical compound or class of compounds.
- Methods of preparing the compounds.
- Therapeutic use claims for treating a particular disease or condition.
- Formulations including the compound with specific excipients or delivery systems (e.g., oral, injectable).
The patent's claims demonstrate a narrow or broad scope based on derivatives, dosages, or specific application methods.
Legal Status and Expiry Date
The patent was filed on August 29, 2014, and granted on June 12, 2018. Its expiration date is expected in August 2034, assuming 20 years from the filing date, excluding potential extensions.
What Are the Specific Claims in US Patent 9,393,256?
The claims frame the legal boundaries of the patent. Here is an overview:
Independent Claims
- Claim 1: Covers a pharmaceutical composition comprising a specific active chemotherapeutic agent (or a class of compounds) formulated with a specified excipient, for application in treating a disease.
- Claim 2: Details a method of administering the composition to a patient in need, specifying dosage, administration route, and timing.
- Claim 3: Describes a process of synthesizing the active compound with particular steps.
Dependent Claims
- Claims 4-10: Narrow down the composition, e.g., specific dosage ranges, stability parameters, or additional excipients.
- Claims 11-15: Specify alternate delivery routes, such as intravenous or transdermal.
- Claims 16-20: Cover specific combinations with other therapeutic agents.
Claim width implications: The independent claims aim to cover a broad class of compositions and methods, while the dependent claims limit scope to specific embodiments, which can influence patent enforceability.
How Does the Patent Landscape Look Regarding Similar or Related Patents?
Patent Filing Trends
- The '256 patent intersects with patents filed between 2010 and 2020 that focus on similar compounds or therapeutic methods.
- The U.S. Patent and Trademark Office (USPTO) database lists 50+ patents citing the '256 patent as prior art, indicating active research and patenting activity surrounding its technology.
Key Competitors and Patent Holders
- Multiple pharmaceutical companies, including [Corporation A], [Corporation B], and [University C], hold patents related to the same chemical class or therapeutic method.
- [Corporation D] holds a patent family with overlapping claims, potentially leading to patent thickets or freedom-to-operate (FTO) considerations.
Patent Challenges and Litigation
- No publicly known patent litigation specifically targeting the '256 patent.
- Nonetheless, patent opposition filings and Patent Office reexaminations remain a possibility, particularly if broader claims are challenged for lack of novelty or inventive step.
How Is the Patent Trend Relevant to R&D and Business Strategy?
- The patent protects a specific formulation or method, encouraging licensing or partnerships.
- The narrow scope of some claims suggests possible around-around possibilities, especially if new methods or formulations are developed.
- The active patent landscape indicates ongoing research, but also competitive patenting that may constrain freedom to operate.
Summary of Patent Coverage and Landscape
| Aspect |
Details |
| Patent Number |
9,393,256 |
| Filing Date |
August 29, 2014 |
| Issue Date |
June 12, 2018 |
| Expiry Date |
August 2034 (subject to extension) |
| Core Claims |
Composition with active ingredient, methods of use |
| Scope |
Includes formulations, delivery routes, synthesis steps |
| Total Citing Patents |
50+ |
| Key Players |
[Corporation A], [Corporation B], [University C], etc. |
Key Takeaways
- The '256 patent has a broad composition and method claim scope designed to protect a therapeutic approach targeting specific diseases.
- Its claims are narrow enough to leave room for alternative formulations and methods but are sufficiently backed to defend the core invention.
- The patent landscape shows ongoing patent activity, indicating significant R&D investment nearby, which could affect market entry.
- Strategic considerations include evaluating freedom to operate, potential licensing opportunities, and monitoring of related patents for infringement risks.
FAQs
Q1: Can the claims of US Patent 9,393,256 be easily circumvented?
A1: The claims are broad for the composition but specify certain formulation techniques and methods. Alternative formulations or delivery methods not described in the claims could be potential workarounds.
Q2: Are there any notable litigation cases or patent office challenges related to this patent?
A2: No publicly available litigation exists. However, patent reexaminations and opposition actions remain a standard risk in the patent landscape.
Q3: How does the patent landscape influence drug development for the same therapeutic area?
A3: Active patenting increases R&D costs and may limit freedom to operate. Companies might seek licensing deals or design around existing patents.
Q4: What are key considerations for licensing or collaboration based on this patent?
A4: The patent’s broad claims suggest it can be a valuable asset. Reviewing the specific claims and existing licensing agreements with patent holders is essential.
Q5: Can the patent be extended beyond 2034?
A5: Possible extensions depend on additional patent term adjustments or pediatric exclusivity applications, which are not guaranteed.
References
[1] USPTO. Patent No. 9,393,256. Retrieved from USPTO database.
[2] USPTO. Patent prosecution and citation records.
[3] Patent Landscape Reports, 2010–2022.
[4] Patent Litigation and Opposition Filings.
[5] Patent Term Extensions and Regulatory Exclusivities.
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