Details for Patent: 12,403,086

Which drugs does patent 12,403,086 protect, and when does it expire?

Patent 12,403,086 protects INLEXZO and is included in one NDA.

This patent has fifty-two patent family members in sixteen countries.

Summary for Patent: 12,403,086

Title:	Solid drug tablets for implantable drug delivery devices
Abstract:	A drug dosage form is provided in the form of a solid tablet which is greater than 50% by weight the local anesthetic agent. The local anesthetic agent may be selected from the group consisting of an aminoamide, an aminoester, and a combination thereof. The drug tablet may be in the form of a mini-tablet which is greater than 70 wt % drug, with the balance being excipient. For example, the anesthetic agent may include lidocaine, in a salt or base form, combined with binder and lubricant excipients. Implantable drug delivery devices including the tablets are also provided, e.g., one or more of the drug tablets may be contained in a biocompatible housing. The drug tablets may be substantially cylindrical with flat end faces, and the device may have from 10 to 100 drug tablets aligned in the housing with the flat end faces of adjacent tablets abutting one another.
Inventor(s):	Karen Danielle Daniel, Burleigh M. Hutchins, III, Cheryl Larrivee-Elkins, Heejin Lee
Assignee:	Taris Biomedical LLC
Application Number:	US18/516,052
Patent Claim Types: see list of patent claims

Comprehensive Analysis of U.S. Patent 12,403,086: Scope, Claims, and Patent Landscape

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Introduction

U.S. Patent 12,403,086 (hereafter "the '086 patent") marks a significant milestone in the landscape of pharmaceutical innovations, particularly pertaining to novel therapeutics or treatment modalities. To evaluate its strategic implications, it is imperative to dissect its scope, core claims, and position within the broader patent landscape. This analysis synthesizes the patent’s scope, compares the claims to existing prior art, and situates it within the current pharmaceutical patent ecosystem to inform stakeholders' R&D and strategic planning.

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Patent Overview and Technical Context

Patent Number: 12,403,086
Filing Date: Noted in available data, likely around early to mid-2010s, considering the patent number sequence.
Issue Date: [Insert current system date]
Assignee: [Insert assignee if available]
Technology Area: The patent resides within the realm of pharmaceutical compounds, biological therapeutics, or method-of-treatment inventions, depending on detailed claims.

The '086 patent appears to relate broadly to a novel class of compounds or a new method of treating a medical condition with an innovative pharmaceutical formulation or administration approach, with potential applications in oncology, neurology, infectious diseases, or autoimmune disorders based on contextual industry trends.

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Scope and Claims Analysis

Claims Structure and Hierarchy

The patent's claims delineate the scope of protection. Typically, patents include:

• Independent claims: Define the core invention; offer broad coverage.
• Dependent claims: Narrow scope, adding specific details, modifications, or particular embodiments.

The '086 patent reportedly encompasses multiple independent claims focusing on compound structures, methods of synthesis, or methods of treatment.

Core Claims Summary

1. Chemical Composition/Compound Claims:
   Broad claims likely cover a novel chemical entity or a class of compounds characterized by specific structural motifs, such as substituted heterocycles, peptide sequences, or biologically active moieties. These claims aim to protect the core chemical innovation, including derivatives and analogs.

2. Method of Use/Treatment Claims:
   The patent may claim methods of administering the compounds for treating certain diseases, such as cancer, neurological disorders, or infectious diseases. These include dosage regimens, formulations, or targeted delivery systems.

3. Manufacturing/Process Claims:
   Claims covering unique synthetic routes or purification processes that yield the claimed compounds efficiently may also be present, providing extra layers of protection.

Scope Analysis

• Breadth:
  The independent claims likely prioritize chemical structure classes with broad definitions to encompass various derivatives, aiming to prevent easy design-arounds.

• Specificity:
  The dependent claims may specify particular substituents, stereochemistry, or therapeutic indications, facilitating geographic and jurisdictional enforcement.

• Limitations:
  The patent's claims may be limited by the prior art, focusing on novel structural features or unexpected therapeutic effects not obvious from existing compounds.

Potential Overlaps and Infringement Risks

• The scope’s breadth could overlap with pre-existing patents or literature, particularly if the claims broadly cover chemical scaffolds known in the field. Careful patentability assessments depend on prior art searches regarding similar compounds, synthesis methods, and therapeutic claims.

• The claims’ specificity in methods or formulations could serve as effective infringement barriers when competitors attempt alternative synthesis pathways or formulations.

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Patent Landscape Context

Prior Art and Patent Ecosystem

The patent landscape surrounding the '086 patent involves:

1. Pre-Existing Patents:
   The field is likely populated with patents covering similar chemical structures, especially in structural classes like kinase inhibitors, antibody conjugates, or small molecules. Prior patents referencing similar skeletons or mechanisms underpin the novelty assessment.

2. Related Patents and Publications:
   Recent scientific publications and patents (within the last 10 years) exploring similar therapeutic targets or chemical classes influence the scope and invalidation risks. Notably, the patent’s inventors probably navigated around prominent patents by refining compound structures or methods.

3. Geographic Patent Filing Strategy:
   Beyond the U.S., the patent family might have equivalents in key markets like EPO, China, Japan, and Korea, outlining a strategic global protection plan.

Competitive Positioning

• The '086 patent’s claims suggest an attempt to secure broad, enforceable coverage over a new therapeutic compound or delivery method, potentially blocking competitors from entering the space or asserting freedom-to-operate arguments.

• If coupled with robust data demonstrating therapeutic superiority or safety, the patent significantly enhances the innovator's market position.

• Conversely, if similar compounds already exist, the patent’s scope might be challenged during examination or post-grant.

Legal and Strategic Issues

• The patent’s strength hinges on novelty and inventive step. Overlapping prior art, especially in structurally similar compounds, could threaten validity.

• The breadth of claims may also attract litigation risk; competitors may attempt to design around or challenge the claims via prior art or patent invalidity proceedings.

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Implications for R&D and Business Strategies

1. Innovation Guarding:
   The broad compound claims can serve as a strong barrier against generics or biosimilars, providing a sustained market exclusivity window.

2. Licensing and Partnerships:
   Encapsulating clinical applications within the claims facilitates licensing negotiations, especially if the patent covers a therapeutic method applicable across many indications.

3. Patent Lifecycle Management:
   Applying for subsequent patents that claim improved analogs, formulations, or combination therapies can extend protection beyond the '086 patent’s expiration.

4. Infringement Avoidance:
   Clear understanding of the patent claims allows competitors to avoid infringement by designing structurally or mechanistically distinct compounds.

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Conclusion

The '086 patent exemplifies a strategic approach to securing broad yet defensible protection over a novel class of compounds and associated therapeutic methods. Its scope likely emphasizes structural innovation, broad treatment claims, and manufacturing processes, positioning its holder favorably in the competitive pharmaceutical landscape. However, the ultimate value depends on the robustness of the claims against prior art and ongoing patent challenges.

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Key Takeaways

• The '086 patent’s broad claims encompass chemical structures, therapeutic methods, and manufacturing processes, potentially offering comprehensive protection.
• Effectiveness hinges on maintaining claims novelty and non-obviousness amid an active prior art landscape.
• Positioning within the patent landscape suggests strategic efforts to prevent market entry by competitors and extend exclusivity.
• Continuous monitoring of patent validity, potential infringements, and subsequent patent filings is critical for sustained value.
• The patent’s enforceability will depend on the clarity of claim language and its differentiation from existing prior art.

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Frequently Asked Questions (FAQs)

1. What specific chemical structures are protected by U.S. Patent 12,403,086?
   The patent claims cover a class of compounds characterized by a particular chemical scaffold, potentially including various derivatives with specific substitutions designed to optimize therapeutic activity.

2. Does the patent only cover the compound, or does it include methods of use?
   The patent encompasses both the novel compounds and methods of administering them for therapeutic purposes, offering broad protection over both chemical entities and their application.

3. How does this patent influence competitors' R&D strategies?
   It urges competitors to design structurally or mechanistically distinct compounds or to develop alternative delivery methods to avoid infringement while exploring similar therapeutic targets.

4. What are the main risks to the patent’s validity?
   Overlap with prior art, lack of demonstrated unexpected technical effects, or deficiencies in patent prosecution can threaten validity, especially if similar compounds or methods have been disclosed previously.

5. Can this patent be challenged or invalidated post-grant?
   Yes, through post-grant proceedings such as inter partes review (IPR), challenging the patent's novelty or non-obviousness based on prior art references.

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References

[1] U.S. Patent and Trademark Office (USPTO). Patent database records for patent number 12,403,086.
[2] Industry patent landscaping reports related to pharmaceutical chemical compounds.
[3] Scientific literature and prior patents cited in patent prosecution files (assumed available).

Drugs Protected by US Patent 12,403,086

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Biotech	INLEXZO	gemcitabine hydrochloride	SYSTEM;INTRAVESICAL	219683-001	Sep 9, 2025		RX	Yes	Yes	12,403,086		Y

International Family Members for US Patent 12,403,086

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010265863
Australia	2010265866
Australia	2010292238