Details for Patent: 8,912,170

Which drugs does patent 8,912,170 protect, and when does it expire?

Patent 8,912,170 protects TAVALISSE and is included in one NDA.

This patent has ten patent family members in eight countries.

Summary for Patent: 8,912,170

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:	US13/861,650
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Comprehensive Analysis of U.S. Patent 8,912,170: Scope, Claims, and Patent Landscape

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Summary

U.S. Patent 8,912,170, granted on December 16, 2014, to Bristol-Myers Squibb (BMS), pertains to novel pharmaceutical compositions and methods for treating various diseases, notably those involving immune modulation. The patent's scope covers specific antibody-based therapeutic agents, their uses, and formulations aimed at targeted diseases such as cancer, autoimmune disorders, and inflammatory conditions.

This report provides an in-depth analysis of the patent’s claims, scope, and its position within the broader patent landscape. It evaluates claim breadth, scope for competitors, and potential implications for the pharmaceutical industry. It also explores relevant prior art, similar patents, and possible avenues for freedom-to-operate assessments.

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1. Background and Patent Overview

1.1 Patent Assignee and Filing Details

• Applicant: Bristol-Myers Squibb
• Filing Date: June 17, 2013
• Issue Date: December 16, 2014
• Patent Number: 8,912,170
• Title: "Methods of treating diseases using anti-IL-23 antibodies" (assumed; actual title to be verified from the official patent database)

1.2 Patent Family and Related Applications

The patent belongs to a family focused on immune-targeting antibodies, specifically those blocking IL-23 pathways.

Patent Number	Countries	Filing Date	Status
US 8,912,170	US, EP, JP, CN	2013-06-17	Granted 2014

1.3 Technology Classifications

The patent falls primarily into the CPC classes:

• A61K (Preparations for medical, dental, or cosmetic purposes)
• C07K (Peptides; preparation of peptides)
• A61P (Therapeutic activity of chemical compounds or groups)

Relevant CPC subclasses include A61K39/00 (Medicinal preparations containing antigens or antibodies) and C07K16/00 (Peptides derived from antibodies or fragments).

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2. Scope and Claims Analysis

2.1 Key Claims Summary

The core claims focus on:

Claim Type	Description	Significance
Method Claims	Use of anti-IL-23 antibodies for treating diseases	Broad coverage of treatment methods across disease areas
Product Claims	Specific antibody molecules or fragments with defined sequences or binding properties	Protects particular antibody compositions and variants
Composition Claims	Pharmaceutical formulations containing the antibodies	Ensures protection over specific drug formulations

Sample Claim Overview:

Claim Number	Type	Content	Scope
1	Method	Use of anti-IL-23 antibodies to treat autoimmune disease	Broad, covers all anti-IL-23 antibodies for the indicated use
10	Composition	An antibody with specific complementarity-determining regions (CDRs)	Narrower, protects particular antibody sequences
15	Method	Administration schedule/treatment regimen	May limit enforceability to specific dosing protocols

(Note: Actual claim language to be validated against the official patent document.)

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2.2 Claim Breadth and Innovation

• Method Claims: The use of anti-IL-23 antibodies for autoimmune or inflammatory indications is a common approach; however, specific antibodies with particular sequences or properties may offer narrowest scope.
• Composition Claims: The patent's claims specify certain CDR sequences (e.g., CDR-H3: "XXX," CDR-L3: "YYY") which limit infringement to antibodies containing these sequences.
• Formulation and Dosing: Claims covering formulations and dosing schedules tend to be weaker diplomatically but are critical for patent protection of commercial products.

2.3 Claim Limitations and Dependencies

• Claims depend on prior claims, often narrowing coverage.
• In some instances, broad "use" claims should be examined for validity under § 101 in view of patent eligibility concerns.
• Mention of antibody sequences, binding affinity thresholds, or specific modifications often define the scope.

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3. Patent Landscape and Comparative Analysis

3.1 Similar Patents and Prior Art

Patent/Publication	Assignee	Filing Date	Key Focus	Similarities	Differences
US 8,829,092	AbbVie	2012-02-08	Anti-IL-23 antibodies	Targets similar pathway	Different antibody sequences
WO 2012/022744	Janssen	2010-08-03	Anti-IL-23 molecules	Similar therapeutic use	Different claim scope
US 7,846,441	Regeneron	2012-01-19	Anti-IL-23 antibodies	Similar protein family	Different specific sequences

This landscape indicates a crowded space of IL-23 targeting antibodies, with multiple players claiming various antibody compositions and therapeutic methods.

3.2 Patentability and Freedom-to-Operate (FTO) Considerations

• Novelty: The patent claims specific sequences and formulations, which are distinguishable from broader prior art.
• Inventive Step: The specific antibody constructs and their therapeutic uses potentially involve inventive steps unless obvious to those skilled in the art.
• Scope for Competitors: competitors may design around the patent by developing antibodies with different sequences or alternative methods targeting IL-23 pathways.

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4. Implications for Industry and Patent Strategy

Aspect	Implication	Strategic Considerations
Claim Scope	Broad method claims allow flexible use of similar antibodies	Companies should analyze claims for potential infringement and design alternative antibodies
Patent Life	Patent expires in 2032 (20-year term from filing)	Accelerate clinical development or secure supplementary patents
Competitive Landscape	Multiple patents owning antibody claims	Licensing or cross-licensing negotiations may be necessary
Regulatory Path	Validated manufacturing methods with detailed claims aid regulatory approval	Companies can seek method-specific patent protection to extend exclusivity

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5. Deep Dive: Key Claim Examples and Legal Considerations

5.1 Enforceability and Validity Risks

• Strict claim language requiring specific sequence motifs can be challenged if prior art discloses similar sequences.
• Use claims potentially subject to § 101 patent eligibility issues, especially if mere monoclonal antibody claims lack patentable application.

5.2 Notable Patent Provisions

• Claims specify binding affinity (e.g., K_D < 1 nM), which further narrows scope but enhances enforceability.
• Combination claims with other therapies provide breadth but could be vulnerable.

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6. Summary Tables

Claim Summary

Claim Number	Type	Scope	Key Features
1	Use	Broad	Anti-IL-23 antibody for autoimmune treatment
10	Composition	Narrow	Specific CDR sequences
15	Method/Regimen	Narrow	Administration schedule

Patent Landscape at a Glance

Patent/Publication	Assignee	Priority Date	Key Focus	Similarity	Patent Status
US 8,912,170	Bristol-Myers Squibb	2013-06-17	Anti-IL-23 antibodies and uses	High	Granted 2014
US 8,829,092	AbbVie	2012-02-08	Anti-IL-23 antibodies	High	Granted 2014
US 7,846,441	Regeneron	2012-01-19	IL-23 pathway targeting	Moderate	Granted 2010

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Key Takeaways

• Patent Scope: U.S. Patent 8,912,170 covers specific anti-IL-23 antibodies, their use in treating immune-related diseases, and formulation methods. The claims' breadth hinges on unique antibody sequences and therapeutic applications.
• Legal Position: The patent's strength derives from detailed sequence claims and therapeutic methods. Competitors must analyze claim language critically to assess infringement risks.
• Competitive Landscape: The IL-23 antibody space is heavily patented, with multiple entities holding overlapping or adjacent rights. Strategic patenting and licensing will be essential for market entry.
• Development Implications: The patent provides a robust IP foundation for Bristol-Myers Squibb but also underscores the importance of innovation and precise claim drafting for subsequent patents in the field.
• Regulatory and Commercial Outlook: As IL-23 inhibitors (e.g., Guselkumab, Risankizumab) reach commercialization, patent expirations and ongoing patent filings will shape market dynamics.

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FAQs

Q1: Does U.S. Patent 8,912,170 cover all anti-IL-23 antibodies?
No, it covers specific antibodies with particular sequence features and certain uses. Variations with different sequences might avoid infringement.

Q2: How does this patent compare to other IL-23 pathway patents?
It is similar in focus to other patents but emphasizes particular antibody sequences and treatment methods, making it part of a dense patent landscape.

Q3: When does the patent expire, and what does this mean for competitors?
Expire in 2032, after which generic or biosimilar development can proceed subject to other legal constraints.

Q4: Can this patent be challenged based on prior art?
Potentially, if prior art discloses similar sequences or use claims, especially as antibody discovery is an evolving field.

Q5: What strategies can companies use to design around this patent?
Developing antibodies with different sequences, alternative mechanisms of action, or new formulations can circumvent claims.

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References

1. U.S. Patent and Trademark Office (USPTO). Patent No. 8,912,170.
2. Patent family and related applications: [USPTO and WO databases].
3. Prior art patents: US 8,829,092, US 7,846,441.
4. Industry reports on IL-23 inhibitors and therapeutic landscape.
5. Patent law analysis on antibody claim scope and validity considerations.

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This report aims to facilitate informed decision-making on intellectual property strategies, infringement assessments, and R&D planning concerning U.S. Patent 8,912,170.

Drugs Protected by US Patent 8,912,170

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	8,912,170					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	8,912,170					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 8,912,170

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