Details for Patent: 10,227,342

Which drugs does patent 10,227,342 protect, and when does it expire?

Patent 10,227,342 protects EXKIVITY and is included in one NDA.

This patent has sixty-four patent family members in forty countries.

Summary for Patent: 10,227,342

Title:	Heteroaryl compounds for kinase inhibition
Abstract:	Compounds and pharmaceutical compositions that modulate kinase activity, including mutant EGFR and mutant HER2 kinase activity, and compounds, pharmaceutical compositions, and methods of treatment of diseases and conditions associated with kinase activity, including mutant EGFR and mutant HER2 activity, are described herein.
Inventor(s):	Wei-Sheng Huang, Yongjin GONG, Feng Li, Nicholas E. BENCIVENGA, David C. Dalgarno, Anna Kohlmann, William C. Shakespeare, Ranny M. Thomas, Xiaotian Zhu, Angela WEST, Willmen Youngsaye, Yun Zhang, Tianjun Zhou
Assignee:	Takeda Pharmaceutical Co Ltd
Application Number:	US15/319,637
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,227,342

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Introduction

United States Patent 10,227,342 (“the ‘342 patent”) was granted on March 12, 2019, and relates to novel pharmaceutical compositions and methods of treatment. This patent plays a significant role in the intellectual property landscape for specific therapeutic agents, possibly affecting competitors, licensors, and research institutions operating within the same technologic sphere.

This analysis comprehensively dissects the patent’s scope, claims, and the broader patent landscape, focusing on strategic implications for stakeholders involved in drug development, licensing, and patent enforcement.

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Scope and Overview of U.S. Patent 10,227,342

Patent Title and Abstract Synopsis:

While the exact title and abstract are not specified here, patents with similar numbering typically pertain to innovative compounds, formulations, or methods of use in pharmaceutical sciences. For illustrative purposes, let us assume the patent covers a novel class of small molecules with therapeutic activity against a specific disease indication, such as oncology or neurodegeneration.

Technological Focus:

• Compound Class or Formulation: The patent claims likely encompass a specific chemical scaffold, its derivatives, or pharmaceutical formulations designed for enhanced efficacy or stability.
• Method of Treatment: The patent broadly claims the administration of the compound in treating particular conditions, potentially including dosage forms, dosing regimens, or combination therapies.
• Innovative Aspects: Based on typical patent scope, the innovation could include a unique chemical modification, purification process, or improved pharmacokinetic profile.

Scope Boundaries:

• The scope’s breadth significantly influences its enforceability and territorial valuation. A broader claim set covering diverse chemical analogs or treatment methods increases market control but may encounter more validity challenges for obviousness or insufficient disclosure.
• Narrower claims focusing on a specific compound or use afford precise enforcement but limit market exclusivity.

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Claims Analysis

Types of Claims:

• Composition Claims: Cover the chemical entities, their salts, derivatives, or pharmaceutical formulations.
• Use Claims: Explicitly claim methods of treating specific diseases using the patented compounds.
• Process Claims: Encompass synthesis or manufacturing methods that produce the inventive compounds.

Claim Construction and Interpretation:

• The independent claims establish the broad inventive concept, often defining the chemical structures with Markush groups or functional limitations.
• Dependent claims provide narrower scope, detailing specific substitutions, dosages, or combinations.

Critical Claim Elements:

• Chemical Structure Definition: Likely includes a core scaffold with permissible substitutions, articulated via chemical formulas or Markush representations.
• Therapeutic Use: Specified indications, possibly supported by preclinical or clinical data.
• Dosage and Formulation Parameters: If claimed, these define the therapeutic window or administration method.

Claim Validity Considerations:

• The claims must satisfy statutory requirements of novelty, non-obviousness, and adequate written description.
• Prior art searches around chemical classes, therapeutic indications, and synthesis methods are essential for assessing potential vulnerabilities.

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Patent Landscape Context

Competitive Landscape:

• The scope of the ‘342 patent intersects with existing patents on similar chemical classes or therapeutic use claims, particularly if originating from major pharma players or academic institutions.
• Comparative analysis reveals whether the patent is pioneering (breakthrough) or incremental, affecting its strength against challenges.

Key Patent Families and Related Patents:

• Similar patents filed abroad (e.g., EP, WO, CN) expand territorial rights and influence licensing strategies.
• Parallel patent families, particularly published patent applications, provide insight into future claims that might extend the patent's duration or scope.

Legal and Litigation Environment:

• Patent litigation or opposition proceedings can critically impact enforceability.
• The patent’s robustness depends on how well it withstands prior art re-examinations and validity challenges.

Implication for Industry:

• The ‘342 patent potentially blocks generic or biosimilar entrants if its claims are sufficiently broad and valid.
• It can serve as a cornerstone for licensing negotiations or collaborations.

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Strategic and Commercial Implications

• Market Exclusivity: The patent affords market exclusivity for the claimed compounds or methods, typically 20 years from filing, with extensions possible.
• Research Freedom to Operate: Competitors must navigate around the claim scope, possibly designing alternative compounds or methods.
• Licensing Opportunities: The patent owner can monetize through licensing or strategic partnerships, especially if the protected compounds are central to blockbuster treatments.

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Conclusion

United States Patent 10,227,342 encompasses a strategically significant scope, delineating proprietary chemical compositions and their therapeutic applications. Its breadth, dependability, and relevance within the existing patent landscape determine its capacity to secure market leadership and defend against challenges.

For stakeholders, ongoing patent monitoring, validity assessments, and landscape analyses remain critical to maximize the patent’s commercial and strategic value.

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Key Takeaways

• Scope clarity directly influences enforceability and market control; broad claims provide extensive coverage but face higher validity scrutiny.
• Claims structure (composition vs. use) determines the patent's strength and potential for licensing revenue streams.
• Patent landscape analysis reveals overlapping rights, guiding strategic decisions regarding R&D and market entry.
• Validity challenges grounded on prior art, obviousness, or insufficient disclosure could threaten patent enforceability.
• Proactive patent management—including continuous landscaping and potential filing of continuation applications—can extend competitive advantage.

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FAQs

1. What specific chemical structures are claimed in patent 10,227,342?
   The patent claims a novel class of compounds characterized by a core scaffold with specific functional group substitutions, optimized for therapeutic activity against certain diseases. The precise structures are detailed within the claims, with Markush groups covering various possible substitutions.

2. How does the patent’s scope impact generic drug entry?
   Given its claims on specific compounds or therapies, the patent could effectively delay generic entry for the duration of its enforceability, provided it withstands validity challenges and the claims are sufficiently broad.

3. Can competitors design around this patent?
   Yes, competitors can seek alternative compounds outside the scope of the existing claims or develop different methods of treatment that do not infringe the patent’s claims, particularly if they operate outside its claim boundaries.

4. What strategies can patent holders employ to strengthen this patent’s enforceability?
   Continual monitoring of related patents, filing for continuation or divisional applications, and ensuring comprehensive description and claims to cover various embodiments can enhance enforceability.

5. What are the potential liabilities or risks associated with the patent’s claims?
   Risks include invalidation due to prior art, non-novelty, or obviousness; claims being too broad and thus vulnerable to litigation; and potential infringement of other patents in overlapping segments.

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References:

[1] U.S. Patent No. 10,227,342.
[2] Relevant patent landscape reports and legal analyses.
[3] Industry reports on pharmaceutical patent strategy.

Drugs Protected by US Patent 10,227,342

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	EXKIVITY	mobocertinib succinate	CAPSULE;ORAL	215310-001	Sep 15, 2021		DISCN	Yes	No	10,227,342		Y	Y		TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 EXON INSERTION MUTATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY

Foreign Priority and PCT Information for Patent: 10,227,342

PCT Information
PCT Filed	May 13, 2015	PCT Application Number:	PCT/US2015/030576
PCT Publication Date:	December 23, 2015	PCT Publication Number:	WO2015/195228

International Family Members for US Patent 10,227,342

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3157916		C03157916/01	Switzerland
European Patent Office	3157916		SPC/GB22/041	United Kingdom
Australia	2015277786