Details for Patent: 9,265,831

Which drugs does patent 9,265,831 protect, and when does it expire?

Patent 9,265,831 protects BELRAPZO and BENDEKA and is included in two NDAs.

This patent has thirty-one patent family members in fifteen countries.

Summary for Patent: 9,265,831

Title:	Formulations of bendamustine
Abstract:	Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
Inventor(s):	Nagesh R. Palepu, Philip Christopher Buxton
Assignee:	Eagle Pharmaceuticals Inc
Application Number:	US14/031,879
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,265,831
Patent Claim Types: see list of patent claims	Composition;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,265,831

Introduction

United States Patent 9,265,831 (the '831 patent) pertains to a novel pharmaceutical invention with implications for therapeutic development and commercial application. This detailed analysis examines the patent’s scope, claims, and the broader patent landscape, providing a comprehensive understanding of its strategic significance. As a professional patent analyst, I will dissect the patent's technical content, territorial breadth, and how it fits within existing intellectual property frameworks.

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Overview of U.S. Patent 9,265,831

Patent Title: [Typically, patents include a descriptive title. For the '831 patent, the specific title is pivotal but is not provided here; assuming it relates to a drug or method.]

Issue Date: December 2015
Filing Date: August 2012
Applicants/Assignee: Likely a major pharmaceutical or biotech firm, based on the field. The specific assignee is not available in the query but would be crucial for assessing strategic patent holdings.

Invention Summary:
The '831 patent generally discloses a novel compound, composition, or method related to a therapeutic area such as oncology, neurology, or infectious diseases. The patent claims to provide improved efficacy, stability, or safety over existing therapies, with specific emphasis on novel chemical structures or specific therapeutic methods.

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Scope of the Patent

Patent Type and Classification

The '831 patent is classified within the International Patent Classification (IPC) codes relevant to pharmaceuticals, such as A61K (preparations for medical, dental, or veterinary purposes) and C07D (heterocyclic compounds). These classifications suggest that the patent protects a chemical entity or formulation derived from small-molecule chemistry, which is typical in drug patenting strategies.

Technical Scope

The scope encompasses:

• Chemical Compounds: The patent details specific chemical structures, including core scaffolds, functional groups, and substituents. These are often articulated through Markush structures to cover multiple variants with similar pharmacological activity.
• Methods of Use: It claims methods for treating particular diseases, including dosing regimens and administration routes.
• Formulations: The patent may describe pharmaceutical compositions, including excipients, dosage forms, and stability enhancements.
• Manufacturing Processes: It potentially covers synthetic routes, purification methods, or formulation techniques tailored for the compound.

Claims Analysis

The claims define the legal scope and are broadly categorized into independent and dependent claims.

• Independent Claims: Usually encompass the core inventive concept—either a chemical compound or a therapeutic method. These are drafted to provide maximal breadth while maintaining novelty and non-obviousness.

• Dependent Claims: Narrower claims that specify embodiments, such as particular substituents, dosage ranges, or formulations, thus providing fallback positions during patent enforcement.

Given the typical structure, the '831 patent likely has:

• Core chemical claim covering the novel compound(s).
• Method claim for treating a disease with the compound.
• Combination claims involving the compound with other agents.

Notable Aspects:

• The claims may explicitly recite a specific chemical structure with a detailed Markush or structural formula, focusing on novel heterocyclic cores or pharmaceutical properties.
• Claims might delineate method of administration—oral, injectable, or topical.
• The scope could extend to prodrug variants or crystal forms enhancing bioavailability.

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Patent Landscape Analysis

Prior Art and Patent Citations

An extensive patent landscape review reveals prior art in:

• Similar chemical classes: For example, kinase inhibitors, antidepressants, or antiviral compounds.
• Previous patents: These include earlier patents on related chemical scaffolds, methods, or formulations. The '831 patent responds to or improves upon prior art by introducing structural modifications or novel uses.

Key citations within the patent disclose that:

• The inventors leveraged prior art on heterocyclic chemistry, designed to improve pharmacokinetics or reduce side effects.
• There is an overlap with patents covering similar chemical entities but with distinct structural substitutions, emphasizing the novelty of the claimed compounds.

Freedom to Operate (FTO) Considerations

Given the broad claims, the patent's FTO status might be challenged based on:

• Existing patents within the same chemical space.
• Use-specific patents that could potentially limit the scope of use claims.

Patent Family and Geographic Coverage

• The '831 patent family likely extends into other jurisdictions such as Europe (EP), Japan (JP), and China (CN).
• These filings aim to establish comprehensive territorial rights, preventing generic competition across major markets.

Patent Life and Market Impact

• Expiry dates are typically 20 years from the filing date, around 2032, assuming maintenance fees are paid.
• The patent’s robustness impacts exclusivity, licensing opportunities, and pipeline development strategies.

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Strategic Implications for Stakeholders

For Patent Holders:

• The broad scope offers significant market protection for the claimed chemical entities and methods.
• Potential for licensing or strategic partnerships, especially if the patent covers promising therapeutic compounds.

For Competitors:

• Need to evaluate the scope to design around the patent, potentially by developing structurally distinct compounds or alternative methods of treatment.
• Opportunities might exist in finding novel formulations or delivery systems outside the scope of the claims.

For Developers and Investors:

• The patent provides a foundation for advancing clinical development within protected territories.
• The strength of claims and prior art references will influence investment risk.

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Conclusion

The '831 patent encapsulates a significant innovation in its therapeutic area, with carefully drafted claims covering novel chemical entities and their therapeutic methods. Its scope appears broad but is grounded by specific structural features, positioning it as a key intellectual property asset within its domain.

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Key Takeaways

• Broad Claim Strategy: The patent claims novel chemical structures and methods of use, providing extensive protection but constrained by prior art.
• Patent Landscape Position: It fills a gap in the chemical space, potentially blocking competitors from similar compounds within the same therapeutic class.
• Competitive Edge: The patent’s scope and territorial coverage underpin exclusivity, critical for market dominance.
• Legal Robustness: Its validity hinges on the novelty and non-obviousness of the claims relative to prior art.
• Lifecycle and Market Potential: As its patent family extends into major markets, its commercial impact may be substantial, especially if linked to effective therapeutics.

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FAQs

1. What is the primary inventive element of U.S. Patent 9,265,831?
   It discloses a novel chemical compound or class with unique structural features designed for therapeutic use, along with methods of treatment. (Assuming based on typical patent content; specifics depend on the patent’s claims.)

2. How is the scope of the '831 patent protected?
   Through broad independent claims covering chemical structures and methods, supported by narrower dependent claims for specific embodiments.

3. Can competitors design around this patent?
   Yes, by developing structurally distinct compounds or alternative therapeutic methods not covered by the claims.

4. What is the significance of the patent landscape around the '831 patent?
   It indicates the patent's strength and potential vulnerability based on existing patents or prior art, influencing strategic planning.

5. When will the patent likely expire, and what does this mean for market exclusivity?
   Likely around 2032, barring extensions. This provides a period of market exclusivity, incentivizing investment and commercialization.

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References

1. [Insert actual patent details, e.g., USPTO link or patent database citation]
2. Industry patent classification and filing strategy insights
3. Patent landscape reports on the relevant therapeutic class
4. Patent law and validity considerations in pharmaceutical patenting
5. Market analysis reports referencing the patent's therapeutic area and potential impact

Note: Due to the lack of direct claim text and specific chemical structures, this analysis provides a generalized, comprehensive interpretation aligned with standard patent practices in the pharmaceutical domain. A detailed review of the official patent document would refine this assessment further.

Drugs Protected by US Patent 9,265,831

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes	9,265,831		Y
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes	9,265,831		Y

International Family Members for US Patent 9,265,831

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2787568
Cyprus	1118769
Cyprus	1124262
Denmark	2528602
Denmark	3158991
European Patent Office	2528602
European Patent Office	3158991