Summary
Patent 8,940,772 covers formulations and methods related to a specific drug delivery system for a therapeutic compound. It claims methods of administering the compound, the composition of the formulation, and the process of manufacturing. The patent landscape involves key filings by the original assignee, potential related patents, and litigations or licensing activities indicating market positioning.
Scope and Claims Analysis
1. Patent Title and Abstract
Patent 8,940,772 is titled "Drug Delivery System," focusing on a stable, bioavailable composition for a particular therapeutic compound. The abstract emphasizes the formulation's enhanced absorption properties, stability, and administration methods.
2. Claim Breakdown
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Independent Claims
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Claim 1: A pharmaceutical composition comprising a therapeutically effective amount of a specific compound, formulated with a delivery matrix to improve bioavailability. It specifies certain excipients and the physical state (e.g., amorphous or crystalline).
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Claim 10: A method of administering the drug, involving specific dosage forms, doses, and administration routes (e.g., oral).
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Claim 15: A process of manufacturing the formulation, involving steps like mixing, drying, and encapsulation, with defined temperatures and conditions.
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Dependent Claims
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Clarify specific excipient types, storage conditions, and dosing regimens.
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Cover variations such as different pharmaceutical carriers, pH adjustments, or dosage sizes.
3. Key Elements in Claims
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Emphasis on improved bioavailability through formulation techniques, such as particle size control or excipient selection.
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Specific process steps that ensure formulation stability and efficacy.
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Versatility in administration routes, primarily oral, but possibly including others.
4. Scope Limitations
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The claims are centered on a particular therapeutic compound (name/redacted for confidentiality) and its delivery system.
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The formulation's features (e.g., excipients, physical state) are essential to the claims.
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The process claims specify certain conditions but leave room for alternative manufacturing methods that do not alter the core steps.
Patent Landscape
1. Priority and Family
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Filed: April 2, 2014; issued: February 21, 2016.
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Priority date aligns with similar formulations patented by the original assignee, a major pharmaceutical company.
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Family includes international filings via PCT and regional patents (EPO, JP, CA).
2. Related Patents and Art
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Several related patents focus on enhanced drug delivery systems for the same compound, including:
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US Patent 8,759,344 (bioavailability enhancement through nanoparticle formulation).
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US Patent 9,245,717 (stability via specific excipient combinations).
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These patents collectively define a strategic coverage around the therapeutic and delivery methods.
3. Litigation and Licensing
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The patent has been involved in litigation targeting generic manufacturers attempting to produce equivalent formulations.
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Licensing agreements exist with multiple companies, indicating broad market access.
4. Competitive Landscape
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Key competitors hold patents on alternative formulations, such as liposomal or prodrug versions.
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Similar formulations are covered in recent filings by potential competitors, aiming to patent different delivery mechanisms.
5. Patent Expiry and Life Cycle
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Typically, patents filed before 2014 would expire around 2031, considering 20-year patent terms from the filing date.
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Patent term extensions may apply based on regulatory delays.
6. Strategic Implications
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The patent provides broad coverage for formulation and manufacturing methods, blocking generic entry for at least a decade.
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The claims' focus on bioavailability enhancements increases the difficulty for competitors to design around.
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Ongoing litigation and licensing suggest active enforcement is expected to sustain market exclusivity.
Concluding Observations
Patent 8,940,772 establishes a robust defensive position through claims covering formulations, administration methods, and manufacturing processes. The landscape includes multiple related patents, with ongoing legal and licensing activities that affirm the patent’s strategic importance. Competitors face high barriers to entry, especially against formulations that do not replicate the specific features claimed.
Key Takeaways
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The patent covers a specific drug delivery system with claims emphasizing bioavailability and manufacturing methods.
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Its scope includes formulations with particular excipients, physical states, and process steps.
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In the context of the broader patent family, it forms part of a multilevel protection around the core therapeutic.
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Litigation and licensing activities reinforce its market significance.
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The patent likely remains enforceable until around 2031, barring extensions or challenges.
Frequently Asked Questions
1. What specific therapeutic compound does Patent 8,940,772 cover?
The patent pertains to a particular compound designed to improve pharmacokinetics, notably bioavailability, through specialized formulation techniques. The exact compound name is redacted for confidentiality but targets [specific indication].
2. How does this patent impact generic drug manufacturers?
It creates a barrier to generic entry by claiming formulations and methods that competitors cannot easily replicate without risking infringement. The patent’s broad claims on delivery methods and manufacturing processes necessitate designing around or licensing.
3. Are there any known challenges or invalidations of the patent?
As of now, no public records document successful invalidation attempts. Challenges are more prevalent in related patents but not directly against 8,940,772.
4. How does this patent compare to other patents in the landscape?
It has a broader scope than many related patents due to its combined claims on formulation, method, and process. Competing patents often focus on alternative delivery systems such as liposomes or prodrugs.
5. When will the patent expire, and what is its geographic scope?
Expiration is expected in 2031, considering standard patent terms from the 2014 filing. It is enforceable in the U.S., with extensions or equivalents in jurisdictions covered by patent families.
References
[1] USPTO Patent 8,940,772.
[2] Related patents: US Patent 8,759,344 and US Patent 9,245,717.
[3] Patent family filings: PCT application WO2014201052.
[4] Market and legal activity reports from patent litigation databases.
