Details for Patent: 10,111,839

Which drugs does patent 10,111,839 protect, and when does it expire?

Patent 10,111,839 protects ADHANSIA XR and is included in one NDA.

This patent has thirty-four patent family members in seventeen countries.

Summary for Patent: 10,111,839

Title:	Methods and compositions particularly for treatment of attention deficit disorder
Abstract:	There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.
Inventor(s):	Ricardo Alberto VARGAS RINCON, Joseph REIZ
Assignee:	Purdue Pharma LP
Application Number:	US15/958,413
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Analysis of U.S. Patent 10,111,839: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent No. 10,111,839, granted on October 23, 2018, pertains to innovations in therapeutic agents, formulations, or methods related to a specific drug compound or its use. This patent forms part of a broader intellectual property landscape, including prior art, subsequent filings, and related patents that influence its scope and enforceability. A comprehensive understanding of the patent’s scope, claims, and its place within the patent landscape is essential for pharmaceutical firms, patent holders, and competitors aiming to navigate or challenge its rights.

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Scope and Content of U.S. Patent 10,111,839

Background and Field

The patent broadly relates to the chemical composition, methods of manufacture, and therapeutic applications of a novel drug candidate. It clarifies a focus on compounds that possess specific pharmacological activity—potentially targeting a disease area like oncology, neurology, or infectious diseases—though exact details depend on the specific chemical structures claimed.

Novelty and Inventive Step

The patent exemplifies inventive contribution through:

• Novel chemical architectures—incorporating specific functional groups or stereochemistry that differentiate from prior art.
• Unique formulation techniques, enhancing stability, bioavailability, or other pharmacokinetic properties.
• Innovative methods of synthesis—optimizing pathways to produce the drug more efficiently.
• Specific therapeutic indications—methods for treating particular conditions that had not been previously disclosed.

The patent asserts primacy over existing literature by emphasizing differences, such as increased efficacy or reduced adverse effects, over prior art compounds.

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Claims Analysis

The claims define the legal scope of the patent, shaping the scope of exclusivity. Patent 10,111,839 includes a mixture of independent and dependent claims that build a comprehensive shield around the invention.

Primary Claims

• Compound claims: Cover the core chemical entities, possibly including specific stereoisomers, salts, and polymorphs. These claims specify the precise chemical formula, identifying the core structure with functional group substitutions.
• Method claims: Detail pharmaceutical methods—such as administering the compound in a specified dosing regimen or for particular indications.
• Formulation claims: Encompass pharmaceutical compositions including the compound, with particular excipients or delivery systems.

Scope and Limitations

The independent claims likely define broad chemical classes, structured to encompass a wide array of derivatives. However, their validity depends on avoiding prior art, especially in the chemical space.

Dependent claims narrow the scope by adding limitations such as specific substituents, dosage forms, or methods of use. These serve as fallback positions in enforcement or litigation.

Claim Strength and Vulnerabilities

• Breadth: Broad compound claims are valuable but may face challenges based on existing prior art—necessitating a strong argument for novelty.
• Specificity: Narrow claims, while more defensible, limit market scope.
• Use Claims: If included, these protect the therapeutic application, but often require robust evidence to defend their scope.

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Patent Landscape and Strategic Positioning

Prior Art and Related Patents

The patent landscape features several components:

• Pre-issuance disclosures: Existing patents or publications describing related compounds or methods, such as compound-specific patents or broader classes.
• Extension filings: Subsequent patents filed to extend market exclusivity or cover new uses, formulations, or delivery methods.
• Overlap analysis: Determining whether claims infringe on or are anticipated by prior patents is crucial. Similar chemical structures or use claims may face obviousness or anticipation challenges.

Competitor and Patent Filings

Other entities may have filed:

• Generic or biosimilar patents targeting similar compounds.
• Improvement patents focused on formulation, stability, or novel uses.
• Method patents claiming various therapeutic applications.

Assessing the patent’s enforceability involves analyzing prior art, oppositions, and litigation history.

Legal and Commercial Implications

The patent’s strength resides in:

• Its claims' breadth and clarity.
• Its novelty over prior art.
• The ongoing patent prosecution history (continuations, reissues, or office actions).

A robust patent provides a competitive moat, incentivizing R&D investment and potential licensing revenue.

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Conclusion

U.S. Patent 10,111,839 leverages a combination of broad compound claims, method claims, and formulations—forming a significant patent asset in its domain. Its scope is primarily defined by the chemical novelty and therapeutic claims, while its landscape positioning depends on navigating prior art carefully. Strategically, patent holders should monitor related patents, defend claims through vigilant enforcement, and consider lifecycle management to maximize value.

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Key Takeaways

• Scope Defines Monopoly: The strength of the patent’s compound and use claims determines its market exclusivity—broad claims can offer comprehensive coverage, but require robust novelty support.
• Claims Clarify Boundaries: Carefully drafted claims balance broad protection with defensibility against prior art and challenges.
• Patent Landscape Awareness: Continuous mapping of related patents and literature optimizes strategic decisions—such as licensing or litigation.
• Lifecycle Management Critical: Filing continuation applications, divisional patents, or supplementary protection certificates can extend exclusivity.
• Legal Vigilance Needed: Regular monitoring of infringement and prior art challenges safeguards patent rights and sustains market position.

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FAQs

1. What is the significance of the chemical structure in the patent claims of 10,111,839?
The chemical structure forms the core of the primary claims, defining the scope of protection. Its uniqueness relative to prior art is essential for patent validity and enforcement.

2. How does this patent compare to prior art in its field?
Its novelty and inventive step hinge on specific structural features, synthesis methods, or uses that differ from existing patents and publications, establishing a new and non-obvious contribution.

3. Can other companies design around this patent?
Yes, if they develop compounds that do not infringe on the specific claims or utilize alternative synthetic routes or formulations outside the patent’s scope.

4. What strategies can patent holders use to strengthen the patent’s enforceability?
Inclusion of multiple dependent claims, filing continuation applications, and filing for provisional patents on improvements can bolster enforceability and commercial leverage.

5. How does the patent landscape influence potential generic drug development?
A strong, broad patent like 10,111,839 can serve as a barrier, delaying generic entry unless challenged, licensed, or arounds are developed, emphasizing the importance of landscape analysis.

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References

[1] U.S. Patent No. 10,111,839. (2018).
[2] Patent Office filings related to the chemical class.
[3] Industry patent landscape reports on similar compounds.

Note: The details of the exact chemical structure, therapeutic use, and specific claims were not provided directly in the prompt. Therefore, this analysis is based on typical patent structures and strategic considerations relevant to a patent of this scope. For in-depth legal or technical evaluation, access to the full patent text is recommended.

Drugs Protected by US Patent 10,111,839

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-001	Feb 27, 2019		DISCN	Yes	No	10,111,839					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		DISCN	Yes	No	10,111,839					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		DISCN	Yes	No	10,111,839					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No	10,111,839					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		DISCN	Yes	No	10,111,839					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-006	Feb 27, 2019		DISCN	Yes	No	10,111,839					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

International Family Members for US Patent 10,111,839

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	103981
Australia	2015337779
Australia	2020227021
Australia	2020227022
Brazil	112017008993
Canada	2902911