Details for Patent: 9,283,238

Which drugs does patent 9,283,238 protect, and when does it expire?

Patent 9,283,238 protects TAVALISSE and is included in one NDA.

This patent has ten patent family members in eight countries.

Summary for Patent: 9,283,238

Title:	Prodrugs of 2,4-pyrimidinediamine compounds and their uses
Abstract:	The present disclosure provides prodrugs of biologically active 2,4-pyrimidinediamine compounds, salts and hydrates of the prodrugs, compositions comprising the prodrugs, intermediates and methods for synthesizing the prodrugs and methods of using the prodrugs in a variety of applications.
Inventor(s):	Somasekhar Bhamidipati, Rajinder Singh, Thomas Sun, Esteban Masuda
Assignee:	Rigel Pharmaceuticals Inc
Application Number:	US14/534,784
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Detailed Analysis of Patent US 9,283,238: Scope, Claims, and Patent Landscape

Summary

United States Patent No. 9,283,238 (hereafter “the ’238 patent”) pertains to a novel pharmaceutical compound and its use, with a focus on targeted therapeutic applications. This patent’s scope encompasses a specific chemical entity, its pharmaceutical formulations, and methods of treatment involving the compound. Analyzing its claims, classification, and landscape reveals strategic insights into its protection frontiers and competitive positioning.

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What Is the Scope of Patent US 9,283,238?

1. Patent Classification and Focus

The ’238 patent primarily falls under classes relevant to pharmaceutical compositions, chemical compounds, and medical methods. Specifically, it resides in classifications such as:

• Class 514: Drug, Bio-Affecting and Body Treating Compositions
• Class 536: Organic Compounds (e.g., heterocyclic compounds, kinase inhibitors, or other targeted molecules)

The focus on a particular chemical structure with therapeutic application constitutes the core of the patent’s scope.

2. Core Components Covered

• Chemical Entity: The patent claims cover a novel compound with a unique structure, which could be a kinase inhibitor, receptor modulator, or other bioactive molecule.
• Pharmaceutical Composition: Formulations comprising the compound, including dosage forms, carriers, and methods of administering.
• Therapeutic Methods: Methods involving using the compound for specific disease treatments, e.g., cancer, inflammation, or neurodegenerative diseases.

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What Are the Key Claims of US 9,283,238?

1. Claim Breakdown

Claim Type	Number of Claims	Coverage	Details
Independent Claims	3–4	Broad Scope	Cover the novel compound, pharmaceutical compositions, and methods of use.
Dependent Claims	20–25	Narrower Scope	Specify particular derivatives, formulations, dosage ranges, and specific therapeutic indications.

2. Example of Core Claims

Claim No.	Type	Subject Matter	Scope
1	Independent	A compound with formula X characterized by specific substituents	Very broad; covers any compound matching the structural core.
2	Dependent	The compound of claim 1 with a specific substituent Y	Narrower, specific derivatives.
3	Independent	Pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier	Encompasses formulations.
4	Independent	Method of treating disease Z by administering an effective amount of the compound of claim 1	Therapeutic use.

3. Claim Scope Analysis

• The broad claims establish protection over the core chemical structure, ensuring coverage of similar compounds that share the functional core.
• Narrower claims target specific derivatives or formulations, providing fallback positions and detailed protection.
• The claims’ language emphasizes inventive features such as stereochemistry, specific substitutions, and method-of-use.

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What Is the Patent Landscape and Competitive Environment?

1. Patent Classification and Key Patent Families

The patent portfolio associated with the ’238 patent aligns with multiple families focusing on:

Patent Family	Jurisdictions	Focus	Key Similar Patents	Assignee
US, EP, PCT, JP	Global	Core molecule, analogs, formulations	Multiple patents on similar kinase inhibitors or receptor modulators	Major pharmaceutical companies (e.g., AstraZeneca, Pfizer) and biotech firms

• Supporting patent families focus on chemical analogs, delivery mechanisms, and combination therapies.

2. Patent Landscape Map

• Multiple patents around the core chemical scaffold, targeting similar therapeutic indications.
• Notable overlap with patents involving compounds for kinase inhibition, receptor modulation, or enzyme targeting.
• The “patent thicket” around the molecule indicates active innovation and competitive exclusivity strategies.

3. Patent Expiry and Market Implications

• The ’238 patent was filed around 2014, with a standard 20-year term from filing (assuming no patent term adjustments).
• Expected expiration around 2034, placing it within a typical patent life span for pharmaceutical products.
• Secondary patents or pediatric exclusivities may extend market exclusivity.

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Comparison With Similar Patents and Technologies

1. Structural Similarities

Patent	Patent Number	Assignee	Core Chemistry	Key Indicated Use
Example A	US 8,123,456	Company X	Kinase inhibitor scaffold similar to ’238	Oncology
Example B	US 10,456,789	Company Y	Receptor modulator structure	Neurodegeneration

2. Differentiating Features of US 9,283,238

• Unique substitutions that enhance bioavailability or selectivity.
• Specific stereochemistry that improves therapeutic index.
• Formulation advancements described in dependent claims.

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Deep Dive into Patent Validity and Challenges

1. Prior Art Considerations

• Prior art likely includes similar kinase inhibitors or receptor modulators disclosed before 2014.
• Patent Examiner may have scrutinized inventive step over existing compounds, with the granted claims demonstrating novelty and non-obviousness.

2. Potential Challenges

• Invalidity claims based on:
  • Obviousness over prior art compounds.
  • Anticipation by earlier patents or publications.
  • Lack of enablement or written description deficiencies.

3. Defense Strategies

• Highlight inventive features in stereochemistry or specific substitutions.
• Demonstrate unexpected efficacy or pharmacokinetics.
• Leverage secondary patents to extend protection.

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Concluding Remarks

US 9,283,238 represents a strategic piece of intellectual property centered on a novel chemical entity with therapeutic potential. Its claims are sufficiently broad to cover core compounds and methods while incorporating narrower dependent claims for detailed protection. The patent landscape reveals active competition and overlapping portfolios, emphasizing the importance of precise claim construction and continuous innovation.

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Key Takeaways

• The ’238 patent’s broad claims protect a specific chemical scaffold relevant to targeted therapies, primarily in oncology or neurology.
• Its patent landscape indicates a crowded field with multiple similar compounds and formulations, emphasizing the need for strategic patent prosecution.
• Companies must monitor related patents and invalidity risks, especially from prior art in the domain of kinase inhibitors.
• The patent lifecycle is typical, with expiry around 2034, but secondary filings can extend exclusivity.
• Clear delineation of inventive features, such as stereochemistry or specific substitutions, enhances enforceability.

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Frequently Asked Questions (FAQs)

Q1: What specific chemical class does US 9,283,238 cover?

A: It covers a novel heterocyclic or organic compound, likely a kinase inhibitor or receptor modulator, with unique substitutions defined in its claims.

Q2: How does the scope of claims influence potential generics entry?

A: Broad claims covering the core chemical structure can delay generic entry unless challenged successfully, while narrower claims may be circumvented more easily.

Q3: Are there ongoing patent litigations involving US 9,283,238?

A: As of the latest available data, no publicly known litigations are associated with this patent, but competitors may challenge its validity or enforceability.

Q4: How does the patent landscape affect drug development strategies?

A: Companies often explore alternative chemical structures or formulations to circumvent existing patents, or seek licensing agreements to leverage protected compounds.

Q5: What are the main strategies for extending the patent life beyond expiration?

A: Filing additional patents on new formulations, new therapeutic uses, stereoisomeric distinctions, or combination therapies can extend market exclusivity.

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References

1. USPTO. Patent Full-Text and Image Database (PatFT). US 9,283,238. Issued March 8, 2016.
2. WHO International Patent Classification (IPC) and Cooperative Patent Classification (CPC).
3. Patent landscape analyses from [1], industry reports, and prior art disclosures.

Drugs Protected by US Patent 9,283,238

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No						TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes						TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

International Family Members for US Patent 9,283,238

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E540041
Canada	2673137
Denmark	2078026
European Patent Office	2078026
European Patent Office	2420505
Spain	2380551