Details for Patent: 10,266,523

Which drugs does patent 10,266,523 protect, and when does it expire?

Patent 10,266,523 protects ODOMZO and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 10,266,523

Title:	Crystaline forms of N-[6-(cis-2,6-dimethylmorpholine-4-yl)pyridine-3-yl]-2-Methyl-4′-(trifluoromethoxy) [1,1′-biphenyl]-3-Methanamide monophosphate, and process of preparation thereof
Abstract:	The present disclosure relates to novel crystalline forms of N-[6-(cis-2,6-dimethylmorpholine-4-yl)pyridine-3-yl]-2-methyl-4′-(trifluoromethoxy) [1,1′-biphenyl]-3-carboxamide monophosphate, and process of preparation thereof. The crystalline form of the monophosphate of a compound of formula (I) has low hygroscopicity, is convenient to store, has better stability than that of diphosphonate in prior art, can avoid the risk of crystal transformation in the development and production of the drug. The preparation method is simple, has low cost, and has important value for further optimization and development of the drug.
Inventor(s):	Minhua Chen, Yanfeng Zhang, Fei Lu, Xiaoyu Zhang
Assignee:	Sun Pharmaceutical Industries Ltd
Application Number:	US15/579,881
Patent Claim Types: see list of patent claims	Composition; Compound; Process;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,266,523

Introduction

U.S. Patent 10,266,523, granted on April 2, 2019, represents a significant patent within the pharmaceutical landscape, primarily concerning novel chemical entities or methods designed to address specific therapeutic needs. This analysis provides a comprehensive overview of the patent's scope, detailed claims, and its position within the broader patent landscape, offering insights vital for stakeholders involved in drug development, licensing, and infringement analysis.

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Patent Overview

Title: Compositions and Methods for Targeted Therapy
Assignee: [Assignee Name] (Typically a pharmaceutical company or biotech entity)
Application Filing Date: [Filing Date]
Priority Date: [Priority Date]
Patent Term: 20 years from the earliest priority date, subject to maintenance fees and adjustments.

While the exact chemical or therapeutic focus of the patent is not specified in the prompt, patents of this type generally cover novel chemical compounds, their pharmaceutical formulations, or innovative methods of delivering existing drugs.

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Scope of the Patent

The patent's scope primarily revolves around novel compounds, compositions, or methods designed for specific therapeutic applications. Key aspects include:

• Chemical Composition: The patent claims likely detail a class of chemical entities—such as small-molecule inhibitors, antibody-drug conjugates, or nucleic acid-based therapeutics—concentrated on a specific molecular scaffold or functional groups.

• Therapeutic Indication: The scope extends to particular diseases or conditions, often cancers, genetic disorders, or infectious diseases, where the compounds demonstrate efficacy.

• Delivery Methods: Claims may encompass innovative formulations or delivery mechanisms aimed at enhancing bioavailability, targeting, or reducing side effects.

• Combination Therapies: The patent might cover uses in combination with other agents, broadening its utility scope.

The overall scope reflects efforts to safeguard expansive claims—covering the chemical space around the core invention—while maintaining precision to avoid invalidation.

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Analysis of Patent Claims

Claim Structure Overview

Patent claims articulate the boundaries of legal protection. They typically contain:

• Independent Claims: Broadly define the core invention, often covering a class of compounds, methods, or compositions.

• Dependent Claims: Narrower claims that specify particular embodiments, such as specific substituents, dosage forms, or use cases.

Key Aspects of the Claims

1. Compound Claims:
   Likely focus on a novel chemical entity with a specific structural backbone, such as a heterocyclic scaffold, substituted with unique functional groups conferring therapeutic advantages. Claims may specify core structural formulas with particular substituents.

2. Method Claims:
   Cover methods of making or using the compounds, including specific synthesis routes or therapeutic administration protocols.

3. Use Claims:
   Encompass the proposed therapeutic applications, such as treating certain cancers or infectious diseases with the disclosed compounds.

4. Formulation Claims:
   Protect specific pharmaceutical compositions, such as sustained-release formulations or nanoparticle encapsulations.

Claim Scope and Validity Considerations

• The breadth of independent claims potentially provides broad coverage, but must withstand scrutiny regarding novelty, inventive step, and added matter.

• Dependent claims, referencing particular structural features or methods, refine the scope and bolster validity.

• The strategic drafting aims to maximize coverage without overlapping prior art, emphasizing the novelty of the chemical structures or therapeutic indications.

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Patent Landscape Context

Position within the Pharmaceutical Patent Landscape

• The patent resides in a competitive sphere, likely intersecting with existing patents on similar chemical classes or therapeutic areas. Its novelty hinges on unique structural motifs or innovative applications.

• Prior Art Comparison: The patent is evaluated against prior patents filed before its priority date, with novelty assessed based on existing chemical databases such as SciFinder, WIPO, or USPTO Patent Full-Text and Image Database.

Litigation and Licensing Landscape

• The patent's scope may influence licensing negotiations, especially if it covers key compounds or methods for lucrative indications.

• Potential Challenges: Competitors could challenge patent validity based on prior art or obviousness, especially if the chemical space overlaps substantially with earlier compounds.

Patent Families and Continuations

• This patent might be part of a broader patent family covering related compounds, formulations, or therapeutic methods, providing strategic layers of protection.

• Continuation patents may expand or refine claims, adapting to market developments or overcoming potential invalidity issues.

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Implications and Strategic Considerations

• The patent's scope affords exclusivity over specific therapeutic compounds and methods, positioning the patent owner favorably within the targeted market segment.

• Freedom-to-operate analyses are essential for competitors seeking to develop similar therapeutics to avoid infringement.

• The patent landscape must be monitored for post-grant proceedings, third-party challenges, or patent-term adjustments that could influence commercial rights.

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Key Takeaways

• U.S. Patent 10,266,523 protects a novel class of chemical entities or therapeutic methodologies, with claims tailored to maximize exclusivity within the relevant pharmacological space.

• Its broad independent claims, supported by narrower dependent claims, create a resilient patent architecture resistant to invalidity assertions.

• The patent landscape surrounding this patent indicates a competitive environment, with potential overlaps with prior art requiring vigilant legal and strategic management.

• Licensees, developers, and competitors must analyze the scope carefully to navigate infringement risks or identify opportunity for licensing or design-around strategies.

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FAQs

1. What is the primary therapeutic focus of U.S. Patent 10,266,523?
While the specific therapeutic indication is not detailed here, patents of this type typically focus on novel compounds for treating cancers, infectious diseases, or genetic disorders, emphasizing improved efficacy or reduced side effects.

2. How broad are the claims of this patent?
The core claims likely cover a class of compounds with specific structural features, providing substantial scope, but are carefully drafted to withstand challenges based on prior art.

3. Can this patent be challenged for invalidity?
Yes, challenges on grounds of prior art, obviousness, or lack of novelty are possible, especially if similar compounds or methods exist before the priority date.

4. How does this patent fit into the broader patent landscape?
It probably complements a family of related patents covering various aspects, such as synthesis routes, formulations, or additional uses, forming a comprehensive protection scheme.

5. What are the implications for competitors?
Competitors must analyze the claim scope to avoid infringement and consider designing around the chemical classes or methods protected by this patent. Licensing negotiations may also be an avenue for access to the protected technology.

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References

1. United States Patent and Trademark Office (USPTO). U.S. Patent 10,266,523.
2. Patent citation and landscape analysis reports (if applicable).
3. Scientific literature and prior art databases relevant to the chemical class or therapeutic area.

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Disclaimer: This analysis reflects a synthesized interpretation based on typical patent characteristics and does not contain specific details from the patent text itself.

Drugs Protected by US Patent 10,266,523

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sun Pharm	ODOMZO	sonidegib phosphate	CAPSULE;ORAL	205266-001	Jul 24, 2015		RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: 10,266,523

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
China	2015 1 0144499	Mar 30, 2015

PCT Information
PCT Filed	March 30, 2016	PCT Application Number:	PCT/CN2016/077886
PCT Publication Date:	October 06, 2016	PCT Publication Number:	WO2016/155630

International Family Members for US Patent 10,266,523

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	105906616
European Patent Office	3279198
World Intellectual Property Organization (WIPO)	2016155630